Online PLR Article Directory Idaho: September 2016

Friday, September 30, 2016

Amlonor

Amlonor may be available in the countries listed below.

Ingredient matches for Amlonor

Amlodipine

Amlodipine is reported as an ingredient of Amlonor in the following countries:

Poland

International Drug Name Search

Caberzol XL 400mg Prolonged-Release Tablets

Caberzol XL 400mg Prolonged-Release Tablets

bezafibrate

Read all of this leaflet carefully before you start taking this medicine.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

Index

1 What Caberzol XL Tablets is and what it is used for

2 Before you take

3 How to take

4 Possible side effects

5 How to store

6 Further information

What Caberzol XL Tablets is and what it is used for

Caberzol XL belongs to a group of medicines called lipid-regulating drugs, which lower high levels of cholesterol and other fats (lipids) in the blood (hyperlipidaemia). This reduces and prevents any long term effects associated with
hyperlipidaemia.

Before you take

Do not take Caberzol XL and tell your doctor if you:

are allergic (hypersensitive) to bezafibrate or any of the other ingredients in the tablets (see section 6).

are allergic (hypersensitive) to fibrates or have developed a sensitivity to sunlight or artificial light (e.g. sunbeds) when taking these medicines.

are taking statins (e.g. atorvastatin) and have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain):
- impaired kidney function
- an underactive thyroid (hypothyroidism)
- severe infection
- trauma
- surgery
- a change in the levels of hormones or chemicals in your body (seen in a blood test)
- a high alcohol intake.

are having dialysis.

have liver disease.

have gall bladder disease.

have nephrotic syndrome (a kidney disorder).

have impaired kidney function.

Check with your doctor or pharmacist

before taking Caberzol XL if you:

have any of the following which may increase the risk of you developing muscle disease (weakness, wasting and pain):
- impaired kidney function
- an underactive thyroid (hypothyroidism)
- severe infection
- trauma
- surgery
- a change in the levels of hormones or chemicals in your body (seen in a blood test)
- a high alcohol intake.

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. Especially:

coumarin-type anti-coagulants e.g. warfarin (used to prevent blood clotting).

antidiabetic medicines such as insulin (used in diabetes).

ciclosporin (used to suppress the immune system).

anion exchange resins such as colestyramine (used to lower cholesterol). Caberzol XL and an anion exchange resin should not be taken within 2 hours of each other.

statins e.g. atorvastatin (used to lower cholesterol).

monoamine-oxidase inhibitors (MAOIs) e.g. phenelzine (used in depression).

oestrogen or medicines which contain oestrogen.

Pregnancy and breast-feeding

Caberzol XL should not be used if you are pregnant or breast-feeding. Speak to your doctor before
taking any medicine.

Driving and using machines

Caberzol XL may make you feel dizzy. Make sure you are not affected before you drive or operate
machinery.

Sugar intolerance

If you have been told you have an intolerance to some sugars, contact your doctor before taking this medicine, as it contains a type of sugar called lactose.

Tests

If you have impaired kidney function, your doctor may want to monitor you regularly by carrying out
tests.

How to take

Always take Caberzol XL exactly as your doctor has told you. If you are not sure, check with your doctor or pharmacist.

Swallow the tablets whole with water, after food in the morning or evening.

Caberzol XL and an anion exchange resin should not be taken within 2 hours of each other.

Doses:

Adults (including the elderly): One tablet a day (400mg bezafibrate a day).

Children: Not recommended.

Impaired kidney function: Do not take Caberzol XL if you have impaired kidney function or are having dialysis.

If you take more than you should

If you (or someone else) swallow a lot of tablets at the same time, or you think a child may have swallowed any contact your nearest hospital casualty department or tell your doctor immediately. Signs of an overdose include
abnormal muscle breakdown (muscle pain or weakness, swelling) which can lead to kidney problems (rhabdomyolysis).

If you forget to take the tablets

Do not take a double dose to make up for a forgotten dose. If you forget to take a dose take it as soon as you remember it and then take the next dose at the right time.

Possible side effects

Like all medicine, Caberzol XL can cause side effects, although not everybody gets them.

Contact your doctor immediately if you notice signs of:

an allergic reaction (hypersensitivity): swelling of the face, lips, tongue or throat, itchy skin rash or narrowing of the airways causing difficulty breathing or swallowing.

gallstones: pain in the upper abdomen or yellowing of the skin or whites of the eyes (jaundice).

abnormal muscle breakdown (rhabdomyolysis): muscle pain or weakness, swelling.

Tell your doctor if you notice any of the following side effects or notice any other effects not listed:

Common (occurs in less than 1 in 10 users): decreased appetite.

Uncommon (occurs in less than 1 in 100 users): dizziness, headache, bloated feeling, feeling sick, blocked bile flow (cholestasis), itching, pale or red irregular raised patches with severe itching (hives), sensitivity to sunlight or artificial light (e.g. sun beds), muscle weakness, cramps or pain (myalgia), acute kidney failure, erection problems,
changes in the levels of certain enzymes within the body (seen in a blood test), increased blood levels of creatinine.

Very rare (occurs in less than 1 in 10,000 users): decreased levels of platelets in the blood causing a disorder characterised by blood spots, bruising and discolouring to the skin (thrombocytopenia purpura), decreased levels of the red blood pigment haemoglobin, increased levels of certain enzymes within the body (seen in a blood test), circular, irregular red patches on the skin of the hands and arms (erythema multiforme), severe form of skin rash with flushing, fever, blisters or ulcers (Stevens-Johnson Syndrome), severe rash involving reddening, peeling and swelling of the skin that resembles severe burns (Toxic epidermal necrolysis), hair loss (alopecia), changes in the numbers and types of your blood cells.

If you notice increased bruising, nosebleeds, sore throats, infections, excessive tiredness, breathlessness on exertion or abnormal paleness of the skin, you should tell your doctor who may want you to have a blood test.

If you notice any side effects, they get worse, or if you notice any not listed, please tell your doctor or pharmacist.

How to Store

Keep out of the reach and sight of children.

Do not use Caberzol XL after the expiry date stated on the label/carton/bottle. The expiry date refers to the last day of that month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Caberzol XL contains

The active substance (the ingredient that makes the tablets work) is bezafibrate. Each tablet contains 400mg of the active substance.

The other ingredients are lactose, povidone, sodium laurilsulfate, hypromellose, silica colloidal hydrated, magnesium stearate (E572), polymethacrylic acid esters, macrogol 10,000, talc (E553b), titanium dioxide (E171), polysorbate 80, sodium citrate (E331).

What Caberzol XL looks like and contents of the pack

Caberzol XL are white round film-coated modified release tablets.

Pack size is 30.

Marketing Authorisation Holder

Actavis Group PTC ehf

Reykjavíkurvegi 76-78

220 Hafnarfjordur

Iceland

Manufacturer

Cenexi

52, Rue Marcel et Jacques Gaucher

94120 Fontenay-Sous-Bois

France

This leaflet was last revised in August 2009.

Actavis

Barnstaple

EX32 8NS

CENPL011

Balsamorhinol

Balsamorhinol may be available in the countries listed below.

Ingredient matches for Balsamorhinol

Chlorobutanol

Chlorobutanol is reported as an ingredient of Balsamorhinol in the following countries:

France

Levomenthol

Levomenthol is reported as an ingredient of Balsamorhinol in the following countries:

France

International Drug Name Search

Myobloc

Generic Name: rimabotulinumtoxinb (Intramuscular route)

rim-a-bot-ue-LYE-num-tox-in-bee

Intramuscular route(Injectable)

The effects of rimabotulinumtoxinB and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. Cases of spread of effect have occurred at doses comparable to those used to treat cervical dystonia and at lower doses .

Commonly used brand name(s)

In the U.S.

Myobloc

Available Dosage Forms:

Solution

Therapeutic Class: Cervical Agent

Pharmacologic Class: Neuromuscular Blocker, Non-Depolarizing

Uses For Myobloc

RimabotulinumtoxinB is used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). RimabotulinumtoxinB is a botulinum toxin B product. It works on the nervous system to relax the muscles.

RimabotulinumtoxinB is injected into the muscles that are affected. Depending on your condition, more than one treatment may be required.

This medicine is available only with your doctor's prescription and will be administered by your doctor.

Before Using Myobloc

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rimabotulinumtoxinB in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rimabotulinumtoxinB in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of Myobloc

Your doctor will give you this medicine in a hospital or clinic. This medicine is given as a shot into one of your muscles.

Your doctor will only use rimabotulinumtoxinB (Myobloc®) to treat your condition. Other botulinum toxin products may not work the same way and require a different dose.

Precautions While Using Myobloc

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

Serious muscle reactions have occurred within hours to weeks after receiving this medicine. If you start to have muscle weakness or trouble with swallowing, talking, or breathing, call your doctor right away. In some situations, these problems could be life-threatening and may require treatment in a hospital or clinic.

This medicine may make your muscles weak and cause vision problems. Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well.

One part of this medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Myobloc Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Difficulty with swallowing

infection

neck pain

uncontrolled twisting movements of the neck

Rare

Difficulty with breathing or speaking

muscle weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

back pain

belching

bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

cough

difficulty with moving

dizziness

dry mouth

flu-like syndrome

headache

heartburn or indigestion

lack or loss of strength or energy

muscle pain, stiffness, or weakness

nausea

pain, swelling, or redness in the joints

stomach discomfort, upset, or pain

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Myobloc resources

Myobloc Side Effects (in more detail)
Myobloc Use in Pregnancy & Breastfeeding
Myobloc Drug Interactions
Myobloc Support Group
0 Reviews for Myobloc - Add your own review/rating

Myobloc Prescribing Information (FDA)

Myobloc Concise Consumer Information (Cerner Multum)

Myobloc Monograph (AHFS DI)

Myobloc MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Myobloc with other medications

Cervical Dystonia
Dystonia
Facial Wrinkles
Hyperhidrosis

Antrex

Antrex may be available in the countries listed below.

Ingredient matches for Antrex

Calcium Folinate

Calcium Folinate is reported as an ingredient of Antrex in the following countries:

Finland

Taiwan

Turkey

International Drug Name Search

Béta Septigen

Béta Septigen may be available in the countries listed below.

In some countries, this medicine may only be approved for veterinary use.

Ingredient matches for Béta Septigen

Betamethasone

Betamethasone 17α-valerate (a derivative of Betamethasone) is reported as an ingredient of Béta Septigen in the following countries:

France

Betamethasone 21-(disodium phosphate) (a derivative of Betamethasone) is reported as an ingredient of Béta Septigen in the following countries:

France

Gentamicin

Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Béta Septigen in the following countries:

France

International Drug Name Search

Thursday, September 29, 2016

Biperideno Duncan

Biperideno Duncan may be available in the countries listed below.

Ingredient matches for Biperideno Duncan

Biperiden

Biperiden hydrochloride (a derivative of Biperiden) is reported as an ingredient of Biperideno Duncan in the following countries:

Argentina

International Drug Name Search

Cinfacromin

Cinfacromin may be available in the countries listed below.

Ingredient matches for Cinfacromin

Merbromin

Merbromin is reported as an ingredient of Cinfacromin in the following countries:

Spain

International Drug Name Search

Benzonatate

In the US, Benzonatate (benzonatate systemic) is a member of the drug class antitussives and is used to treat Cough.

US matches:

Benzonatate

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

R05DB01

CAS registry number (Chemical Abstracts Service)

0000104-31-4

Chemical Formula

C30-H53-N-O11

Molecular Weight

603

Therapeutic Category

Cough suppressant

Chemical Name

Benzoic acid, 4-(butylamino)-, 3,6,9,12,15,18,21,24,27-nonaoxaoctacos-1-yl ester

Foreign Names

Benzonatatum (Latin)
Benzonatat (German)
Benzonatate (French)
Benzonatato (Spanish)

Generic Names

Benzonatate (OS: BAN)
KM 65 (IS)
Benzonatate (PH: USP 32)

Brand Names

Bensau
Fisherman, Taiwan

Benzonatate
Amneal, United States; Banner Pharmacaps, United States; Mikart, United States; Orit, United States; Teva USA, United States; Zydus, United States

Capsicof
Gelcaps, Mexico

Nafatosin
Nafar, Mexico

Tesalon
Novartis, Mexico

Tessalon
Forest, United States

Velpro
Alpharma, Mexico

International Drug Name Search

Glossary

BAN	British Approved Name
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

Keftid

Keftid may be available in the countries listed below.

Ingredient matches for Keftid

Cefaclor

Cefaclor is reported as an ingredient of Keftid in the following countries:

Ireland

International Drug Name Search

Balzide

Balzide may be available in the countries listed below.

Ingredient matches for Balzide

Balsalazide

Balsalazide disodium salt, dihydrate (a derivative of Balsalazide) is reported as an ingredient of Balzide in the following countries:

Italy

International Drug Name Search

Benzosed

Benzosed may be available in the countries listed below.

Ingredient matches for Benzosed

Midazolam

Midazolam is reported as an ingredient of Benzosed in the following countries:

Venezuela

International Drug Name Search

Betacorton

Betacorton may be available in the countries listed below.

Ingredient matches for Betacorton

Halcinonide

Halcinonide is reported as an ingredient of Betacorton in the following countries:

Czech Republic

Estonia

Latvia

Lithuania

Slovakia

Switzerland

Urea

Urea is reported as an ingredient of Betacorton in the following countries:

Switzerland

International Drug Name Search

Bitobionil

Bitobionil may be available in the countries listed below.

Ingredient matches for Bitobionil

Levocarnitine

Levocarnitine is reported as an ingredient of Bitobionil in the following countries:

Greece

International Drug Name Search

Benzaknen

Benzaknen may be available in the countries listed below.

Ingredient matches for Benzaknen

Benzoyl Peroxide

Benzoyl Peroxide is reported as an ingredient of Benzaknen in the following countries:

Austria

Germany

International Drug Name Search

Mariendistel-ratiopharm

Mariendistel-ratiopharm may be available in the countries listed below.

Ingredient matches for Mariendistel-ratiopharm

Silibinin

Silibinin is reported as an ingredient of Mariendistel-ratiopharm in the following countries:

Germany

International Drug Name Search

Bareon

Bareon may be available in the countries listed below.

Ingredient matches for Bareon

Lomefloxacin

Lomefloxacin hydrochloride (a derivative of Lomefloxacin) is reported as an ingredient of Bareon in the following countries:

Japan

International Drug Name Search

Clon

Clon may be available in the countries listed below.

Ingredient matches for Clon

Clonazepam

Clonazepam is reported as an ingredient of Clon in the following countries:

Bangladesh

International Drug Name Search

TobraDex Ophthalmic Ointment

Dosage Form: ophthalmic ointment
TobraDex®

(tobramycin and dexamethasone ophthalmic ointment)

Sterile

DESCRIPTION

TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) is a sterile, multiple dose antibiotic and steroid combination for topical ophthalmic use. The chemical structures for tobramycin and dexamethasone are presented below:

Each gram of TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) contains: Actives : tobramycin 0.3% (3mg) and dexamethasone 0.1% (1mg). Preservative : chlorobutanol 0.5%. Inactives : mineral oil and white petrolatum.

CLINICAL PHARMACOLOGY

Corticoids suppress the inflammatory response to a variety of agents and they probably delay or slow healing. Since corticoids may inhibit the body's defense mechanism against infection, a concomitant antimicrobial drug may be used when this inhibition is considered to be clinically significant. Dexamethasone is a potent corticoid.

The antibiotic component in the combination (tobramycin) is included to provide action against susceptible organisms. In vitro studies have demonstrated that tobramycin is active against susceptible strains of the following microorganisms:

Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillin-resistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Enterobacter aerogenes, Proteus mirabilis, Morganella morganii, most Proteus vulgaris strains, Haemophilus influenzae and H. aegyptius, Moraxella lacunata, Acinetobacter calcoaceticus and some Neisseria species.

Bacterial susceptibility studies demonstrate that in some cases microorganisms resistant to gentamicin remain sus ceptible to tobramycin.

No data are available on the extent of systemic absorption from TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment); however, it is known that some systemic absorption can occur with ocularly applied drugs. The usual physiologic replacement dose is 0.75 mg daily. The administered dose for TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) in both eyes four times daily would be 0.4 mg of dexamethasone daily.

INDICATIONS AND USAGE

TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) is indicated for steroidresponsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists.

Ocular steroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea and anterior segment of the globe where the inherent risk of steroid use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns, or penetration of foreign bodies.

The use of a combination drug with an anti-infective component is indicated where the risk of superficial ocular infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye.

The particular anti-infective drug in this product is active against the following common bacterial eye pathogens:

Staphylococci, including S. aureus and S. epidermidis (coagulase-positive and coagulase-negative), including penicillinresistant strains.

Streptococci, including some of the Group A-beta-hemolytic species, some nonhemolytic species, and some Streptococcus pneumoniae.

CONTRAINDICATIONS

Epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, and many other viral diseases of the cornea and conjunctiva. Mycobacterial infection of the eye. Fungal diseases of ocular structures. Hypersensitivity to a component of the medication.

WARNINGS

NOT FOR INJECTION INTO THE EYE. Sensitivity to topically applied aminoglycosides may occur in some patients. If a sensitivity reaction does occur, discontinue use.

Prolonged use of steroids may result in glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation. Intraocular pressure should be routinely monitored even though it may be difficult in pediatric patients and uncooperative patients. Prolonged use may suppress the host response and thus increase the hazard of secondary ocular infections. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. In acute purulent conditions of the eye, ste roids may mask infection or enhance existing infection.

PRECAUTIONS

General

The possibility of fungal infections of the cornea should be considered after long-term steroid dosing. As with other antibiotic preparations, prolonged use may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, appropriate therapy should be initiated. When multiple prescriptions are required, or whenever clinical judgement dictates, the patient should be examined with the aid of magnification, such as slit lamp biomicroscopy and, where appropriate, fluorescein staining.

Cross-sensitivity to other aminoglycoside antibiotics may occur; if hypersensitivity develops with this product, discontinue use and institute appropriate therapy.

Ophthalmic ointment may retard corneal wound healing.

Patients should be advised not to wear contact lenses if they have signs and symptoms of bacterial ocular infection.

Information for Patients

Do not touch tube tip to any surface, as this may contaminate the contents. Contact lenses should not be worn during the use of this product.

Do not use the product if the imprinted carton seals have been damaged, or removed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted to evaluate the carcinogenic or mutagenic potential. No impairment of fertility was noted in studies of subcutaneous tobramycin in rats at doses of 50 and 100 mg/kg/day.

Pregnancy Category C

Corticosteroids have been found to be teratogenic in animal studies. Ocular administration of 0.1% dexamethasone resulted in 15.6% and 32.3% incidence of fetal anomalies in two groups of pregnant rabbits. Fetal growth retardation and increased mortality rates have been observed in rats with chronic dexamethasone therapy. Reproduction studies have been performed in rats and rabbits with tobramycin at doses up to 100 mg/kg/day parenterally and have revealed no evidence of impaired fertility or harm to the fetus. There are no adequate and well controlled studies in pregnant women. TOBRADEX® (tobramycin and dexamethasone ophthalmic ointment) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 2 years have not been established.

Geriatric Use

No overall clinical differences in safety or effectiveness have been observed between the elderly and other adult patients.

ADVERSE REACTIONS

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination. Exact incidence figures are not available. The most frequent adverse reactions to topical ocular tobramycin (TOBREX® tobramycin ophthalmic ointment) are hypersensitivity and localized ocular toxicity, including lid itching and swelling, and conjunctival erythema. These reactions occur in less than 4% of patients. Similar reactions may occur with the topical use of other aminoglycoside antibiotics. Other adverse reactions have not been reported; however, if topical ocular tobramycin is administered concomitantly with systemic aminoglycoside antibiotics, care should be taken to monitor the total serum concentration. The reactions due to the steroid component are: elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection. The development of secondary infection has occurred after use of combinations containing steroids and antimicrobials. Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids. The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used. Secondary bacterial ocular infection following suppression of host responses also occurs.

OVERDOSAGE

Clinically apparent signs and symptoms of an overdose of TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) (punctate keratitis, erythema, increased lacrimation, edema and lid itching) may be similar to adverse reaction effects seen in some patients.

DOSAGE AND ADMINISTRATION

Apply a small amount (approximately 1/2 inch ribbon) into the conjunctival sac(s) up to three or four times daily.

How to apply TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) :

1. Tilt your head back.

2. Place a finger on your cheek just under your eye and gently pull down until a "V" pocket is formed between your eyeball and your lower lid.

3. Place a small amount (about 1/2 inch) of TOBRADEX®(tobramycin and dexamethasone ophthalmic ointment) in the "V" pocket. Do not let the tip of the tube touch your eye.

4. Look downward before closing your eye.

Not more than 8 g should be prescribed initially and the prescription should not be refilled without further evaluation as outlined in PRECAUTIONS above.

HOW SUPPLIED

3.5 g STERILE ointment supplied in an aluminum tube with a white polyethylene tip and white polyethylene cap. (NDC 0065-0648-35).

STORAGE: Store at 2°- 25°C (36°- 77°F).

Rx Only

Revised: April 2010

04-2010

44281-2

Alcon®

Manufactured for:

ALCON LABORATORIES, INC.

Fort Worth, Texas 76134 USA

Manufactured by:

S.A. ALCON-COUVREUR N.V.

Puurs, Belgium

PRINCIPAL DISPLAY PANEL

NDC 0065-0648-35

Alcon®

TobraDex®

(tobramycin and

dexamethasone

ophthalmic ointment)

Sterile 3.5 g Net Wt.

TOBRADEX
tobramycin and dexamethasone ointment

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0065-0648
Route of Administration	OPHTHALMIC	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TOBRAMYCIN (TOBRAMYCIN)	TOBRAMYCIN	3 mg in 1 g
DEXAMETHASONE (DEXAMETHASONE)	DEXAMETHASONE	1 mg in 1 g

Inactive Ingredients
Ingredient Name	Strength
CHLOROBUTANOL
MINERAL OIL
PETROLATUM

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0065-0648-35	3.5 g In 1 TUBE	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA050616	10/15/1988

Labeler - Alcon Laboratories, Inc. (008018525)

Registrant - Alcon Laboratories, Inc. (008018525)

Establishment
Name	Address	ID/FEI	Operations
S.A. ALCON-COUVREUR N.V.		370205429	MANUFACTURE

Revised: 07/2011Alcon Laboratories, Inc.

More TobraDex Ophthalmic Ointment resources

TobraDex Ophthalmic Ointment Use in Pregnancy & Breastfeeding
TobraDex Ophthalmic Ointment Drug Interactions
TobraDex Ophthalmic Ointment Support Group
3 Reviews for TobraDex Ophthalmic - Add your own review/rating

Compare TobraDex Ophthalmic Ointment with other medications

Conjunctivitis, Bacterial
Keratitis
Uveitis

Wednesday, September 28, 2016

Miconazolnitraat A

Miconazolnitraat A may be available in the countries listed below.

Ingredient matches for Miconazolnitraat A

Miconazole

Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Miconazolnitraat A in the following countries:

Netherlands

International Drug Name Search

Busulphan

Busulphan may be available in the countries listed below.

Ingredient matches for Busulphan

Busulfan

Busulphan (BAN) is known as Busulfan in the US.

International Drug Name Search

Glossary

BAN

British Approved Name

Click for further information on drug naming conventions and International Nonproprietary Names.

rifaximin

rif-AX-i-min

Commonly used brand name(s)

In the U.S.

Xifaxan

Available Dosage Forms:

Tablet

Therapeutic Class: Antibiotic

Chemical Class: Rifamycin

Uses For rifaximin

Rifaximin is used to treat traveler's diarrhea that is caused by a bacteria called Escherichia coli. It is also used to prevent hepatic encephalopathy, which is a condition that occurs when your liver does not work normally. Rifaximin is an antibiotic that works by killing the bacteria and preventing its growth. However, rifaximin will not work for colds, flu, or other virus infections.

rifaximin is available only with your doctor's prescription.

Before Using rifaximin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For rifaximin, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to rifaximin or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of rifaximin in children younger than 12 years of age with traveler's diarrhea. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of rifaximin in children with hepatic encephalopathy. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of rifaximin in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Proper Use of rifaximin

Take rifaximin exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

To help clear up your infection completely, keep taking rifaximin for the full time of treatment, even if you begin to feel better after a few days. If you stop taking rifaximin too soon, your infection may return.

You may take rifaximin with or without food.

Dosing

The dose of rifaximin will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of rifaximin. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (tablets):
- For diarrhea:
  - Adults and children 12 years of age and older—200 milligrams (mg) 3 times per day for 3 days.
  - Children under 12 years of age—Use and dose must be determined by your doctor.
- For preventing hepatic encephalopathy:
  - Adults—550 milligrams (mg) 2 times per day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of rifaximin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using rifaximin

It is very important that your doctor check the progress of you or your child to see if the medicine is working properly. This will allow your doctor to decide if you or your child should continue to take it.

Check with your doctor right away if the diarrhea does not stop in 1 or 2 days or if you or your child develop a fever or have blood in your stool.

A person can become dehydrated if too much fluid is lost from the body with diarrhea. Make sure you or your child drink plenty of fluids while you have diarrhea. Check with your doctor right away if you or your child have more than one of the following symptoms: decreased urination, dizziness, dry mouth, increased thirst, or lightheadedness.

rifaximin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Black, tarry stools

dizziness or lightheadedness

muscle spasm

rapid breathing

shortness of breath

sleeplessness

trouble sleeping

unable to sleep

Less common

Blood in urine

bloody nose

chest pain

continuing ringing or buzzing or other unexplained noise in the ears

fainting

feeling of constant movement of self or surroundings

increased heart rate

sensation of spinning

sunken eyes

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

Incidence not known

Cracks in the skin

hives or welts

itching skin

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

loss of heat from the body

rash

red, swollen skin scaly skin

redness of skin

More common

Bloated

difficulty in moving

dizziness

excess air or gas in the stomach or intestines

fever

frequent urge to defecate

full feeling

headache

lower back or side pain

muscle pain or stiffness

pain in joints

passing gas

stomach pain

straining while passing stool

swelling of the hands, ankles, feet, or lower legs

Less common

Abnormal dreams

blurred vision

chills

confusion

cough

decreased urination

difficulty having a bowel movement (stool)

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

dry lips

dry mouth

ear pain

feeling of warmth

hearing loss

lightheadedness

loss of appetite

loss of taste

nausea

painful or difficult urination

pale skin

redness of the face, neck, arms and occasionally, upper chest

sore throat

sweating

swollen glands

thirst

vomiting

wrinkled skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: rifaximin side effects (in more detail)

More rifaximin resources

Rifaximin Side Effects (in more detail)
Rifaximin Dosage
Rifaximin Use in Pregnancy & Breastfeeding
Rifaximin Support Group
14 Reviews for Rifaximin - Add your own review/rating

Rifaximin Professional Patient Advice (Wolters Kluwer)

Rifaximin Monograph (AHFS DI)

Rifaximin MedFacts Consumer Leaflet (Wolters Kluwer)

Xifaxan Prescribing Information (FDA)

Xifaxan Consumer Overview

Compare rifaximin with other medications

Crohn's Disease
Diarrhea
Hepatic Encephalopathy
Irritable Bowel Syndrome
Traveler's Diarrhea

Galantamine Teva

Galantamine Teva may be available in the countries listed below.

Ingredient matches for Galantamine Teva

Galantamine

Galantamine hydrobromide (a derivative of Galantamine) is reported as an ingredient of Galantamine Teva in the following countries:

Estonia

Latvia

Slovakia

International Drug Name Search

Goval

Goval may be available in the countries listed below.

Ingredient matches for Goval

Risperidone

Risperidone is reported as an ingredient of Goval in the following countries:

Chile

International Drug Name Search

Bidanzen

Bidanzen may be available in the countries listed below.

Ingredient matches for Bidanzen

Serrapeptase

Serrapeptase is reported as an ingredient of Bidanzen in the following countries:

India

International Drug Name Search

Oxanest

Oxanest may be available in the countries listed below.

Ingredient matches for Oxanest

Oxycodone

Oxycodone hydrochloride (a derivative of Oxycodone) is reported as an ingredient of Oxanest in the following countries:

Finland

International Drug Name Search

Tuesday, September 27, 2016

Betricin

Betricin may be available in the countries listed below.

Ingredient matches for Betricin

Betamethasone

Betamethasone 21-(disodium phosphate) (a derivative of Betamethasone) is reported as an ingredient of Betricin in the following countries:

Bangladesh

International Drug Name Search

Sulpiride Teva

Sulpiride Teva may be available in the countries listed below.

Ingredient matches for Sulpiride Teva

Sulpiride

Sulpiride is reported as an ingredient of Sulpiride Teva in the following countries:

France

International Drug Name Search

Triamtereen-Hydrochloorthiazide Accordhealthcare

Triamtereen-Hydrochloorthiazide Accordhealthcare may be available in the countries listed below.

Ingredient matches for Triamtereen-Hydrochloorthiazide Accordhealthcare

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Triamtereen-Hydrochloorthiazide Accordhealthcare in the following countries:

Netherlands

Triamterene

Triamterene is reported as an ingredient of Triamtereen-Hydrochloorthiazide Accordhealthcare in the following countries:

Netherlands

International Drug Name Search

Medazepam Q

Medazepam Q may be available in the countries listed below.

Ingredient matches for Medazepam Q

Medazepam

Medazepam is reported as an ingredient of Medazepam Q in the following countries:

Hungary

International Drug Name Search

Betahistyna EuroLEKI

Betahistyna EuroLEKI may be available in the countries listed below.

Ingredient matches for Betahistyna EuroLEKI

Betahistine

Betahistine dihydrochloride (a derivative of Betahistine) is reported as an ingredient of Betahistyna EuroLEKI in the following countries:

Poland

International Drug Name Search

Bretol

Bretol may be available in the countries listed below.

Ingredient matches for Bretol

Tulobuterol

Tulobuterol hydrochloride (a derivative of Tulobuterol) is reported as an ingredient of Bretol in the following countries:

Venezuela

International Drug Name Search

Triquilar

Triquilar may be available in the countries listed below.

Ingredient matches for Triquilar

Ethinylestradiol

Ethinylestradiol is reported as an ingredient of Triquilar in the following countries:

Canada

Croatia (Hrvatska)

Czech Republic

Denmark

Dominican Republic

Germany

Hungary

Japan

Latvia

Poland

Levonorgestrel

Levonorgestrel is reported as an ingredient of Triquilar in the following countries:

Canada

Croatia (Hrvatska)

Czech Republic

Denmark

Dominican Republic

Germany

Hungary

Japan

Latvia

Poland

International Drug Name Search

Brupacil

Brupacil may be available in the countries listed below.

Ingredient matches for Brupacil

Scopolamine

Scopolamine butylbromide (a derivative of Scopolamine) is reported as an ingredient of Brupacil in the following countries:

Mexico

International Drug Name Search

Bétahistine Arrow

Bétahistine Arrow may be available in the countries listed below.

Ingredient matches for Bétahistine Arrow

Betahistine

Betahistine dihydrochloride (a derivative of Betahistine) is reported as an ingredient of Bétahistine Arrow in the following countries:

France

International Drug Name Search

Bisoprolol Teva

Bisoprolol-Teva may be available in the countries listed below.

Ingredient matches for Bisoprolol-Teva

Bisoprolol

Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Bisoprolol-Teva in the following countries:

Belgium

France

Germany

Latvia

Spain

International Drug Name Search

Monday, September 26, 2016

Chlorothiazide Sodium

Ingredient matches for Chlorothiazide Sodium

Chlorothiazide

Chlorothiazide Sodium (USAN) is known as Chlorothiazide in the US.

International Drug Name Search

Glossary

USAN

United States Adopted Name

Click for further information on drug naming conventions and International Nonproprietary Names.

Betahistine Dihydrochloride

Betahistine Dihydrochloride may be available in the countries listed below.

Ingredient matches for Betahistine Dihydrochloride

Betahistine

Betahistine Dihydrochloride (BANM) is also known as Betahistine (Rec.INN)

International Drug Name Search

Glossary

BANM	British Approved Name (Modified)
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)

Click for further information on drug naming conventions and International Nonproprietary Names.

BroveX PB C

Pronunciation: FEN-il-EF-rin/BROME-fen-IR-a-meen/KOE-deen
Generic Name: Phenylephrine/Brompheniramine/Codeine
Brand Name: Examples include BroveX PB C and BroveX PB CX

BroveX PB C is used for:

Relieving symptoms of sinus congestion, runny nose, sneezing, and cough due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.

BroveX PB C is a decongestant, antihistamine, and cough suppressant combination. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The cough suppressant works in the brain to help decrease the cough reflex to reduce a dry cough.

Do NOT use BroveX PB C if:

you are allergic to any ingredient in BroveX PB C or any other codeine- or morphine-related medicine (eg, oxycodone)

you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, severe heart problems, peptic ulcer, narrow-angle glaucoma, difficulty urinating, or are having an asthma attack

you take sodium oxybate (GHB) or you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.

Before using BroveX PB C:

Some medical conditions may interact with BroveX PB C. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding

if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

if you have allergies to medicines, foods, or other substances

if you have a fast, slow, or irregular heartbeat

if you have a history of adrenal gland problems (eg, adrenal gland tumor); heart problems (eg, heart disease); high or low blood pressure; low blood volume; diabetes; blood vessel problems; stroke; glaucoma; a blockage of your stomach, bladder, or intestines; trouble urinating; an enlarged prostate or other prostate problems; mental or mood problems (eg, depression); pancreas problems (eg, pancreatitis); or thyroid problems

if you have a history of asthma or other breathing problems, chronic cough, lung problems (eg, chronic bronchitis, emphysema), or chronic obstructive pulmonary disease (COPD), or if your cough occurs with large amounts of mucus

if you have severe drowsiness, recent head or brain injury, brain tumor, increased pressure in the brain, infection of the brain or nervous system, or a seizure disorder (eg, epilepsy)

if you have a history of constipation, stomach problems (eg, ulcers), bowel problems (eg, chronic inflammation or ulceration of the bowel), or gallbladder problems (eg, gallstones), or if you have had recent stomach, bowel, or urinary surgery

if you have a history of alcohol abuse, drug abuse, or suicidal thoughts or behavior; or if you are in poor health or are very overweight

if you take medicine for high blood pressure or depression

Some MEDICINES MAY INTERACT with BroveX PB C. Tell your health care provider if you are taking any other medicines, especially any of the following:

Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), cimetidine, furazolidone, HIV protease inhibitors (eg, ritonavir), MAOIs (eg, phenelzine), muscle relaxants (eg, cyclobenzaprine), opioid analgesics (eg, hydrocodone), phenothiazines (eg, chlorpromazine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of BroveX PB C's side effects

Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

Naltrexone, quinidine, or rifamycins (eg, rifampin) because they may decrease BroveX PB C's effectiveness

Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by BroveX PB C

Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by BroveX PB C

This may not be a complete list of all interactions that may occur. Ask your health care provider if BroveX PB C may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use BroveX PB C:

Use BroveX PB C as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Take BroveX PB C by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

Take BroveX PB C with a full glass of water (8 oz/240 mL).

Drink plenty of water while taking BroveX PB C.

If you miss a dose of BroveX PB C, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use BroveX PB C.

Important safety information:

BroveX PB C may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use BroveX PB C with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

BroveX PB C may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

Do not drink alcohol or use medicines that may cause drowsiness (eg, muscle relaxers, sleep aids) while you are using BroveX PB C; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

Do not take diet or appetite control medicines while you take BroveX PB C without checking with your doctor.

BroveX PB C has phenylephrine and brompheniramine in it. Before you start any new medicine, check the label to see if it has phenylephrine or brompheniramine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

Do not use BroveX PB C for a cough with a lot of mucus. Do not use it for a long-term cough (eg, caused by asthma, emphysema, smoking). However, you may use it for these conditions if your doctor tells you to.

Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

If your symptoms do not get better within 5 days, if they get worse, or if they occur along with a fever, check with your doctor.

BroveX PB C may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to BroveX PB C. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

BroveX PB C may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking BroveX PB C for a few days before the tests.

Tell your doctor or dentist that you take BroveX PB C before you receive any medical or dental care, emergency care, or surgery.

Use BroveX PB C with caution in the ELDERLY; they may be more sensitive to its effects, especially confusion, dizziness, drowsiness, low blood pressure, excitability, dry mouth, and trouble urinating.

Caution is advised when using BroveX PB C in CHILDREN; they may be more sensitive to its effects, especially excitability.

BroveX PB C should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using BroveX PB C while you are pregnant. Do not take BroveX PB C in the third trimester of pregnancy. It is not known if BroveX PB C is found in breast milk. Do not breast-feed while taking BroveX PB C.

Some people who use BroveX PB C for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction.

If you stop taking BroveX PB C suddenly, you may have WITHDRAWAL symptoms. These may include anxiety, irregular heartbeat, irritability, restlessness, trouble sleeping, and unusual sweating.

Possible side effects of BroveX PB C:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); confusion; difficulty urinating or inability to urinate; fast, slow, or irregular heartbeat; hallucinations; loss of coordination; mental or mood changes (eg, irritability); ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; tremor; trouble sleeping; uncontrolled muscle movements; unusual bruising or bleeding; unusual weakness or tiredness; vision changes or blurred vision.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch .

See also: BroveX PB C side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; cold and clammy skin; coma; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; shallow breathing; unusually fast, slow, or irregular heartbeat; vomiting.

Proper storage of BroveX PB C:

Store BroveX PB C at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep BroveX PB C out of the reach of children and away from pets.

General information:

If you have any questions about BroveX PB C, please talk with your doctor, pharmacist, or other health care provider.

BroveX PB C is to be used only by the patient for whom it is prescribed. Do not share it with other people.

If your symptoms do not improve or if they become worse, check with your doctor.

Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about BroveX PB C. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

More BroveX PB C resources

BroveX PB C Side Effects (in more detail)
BroveX PB C Use in Pregnancy & Breastfeeding
BroveX PB C Drug Interactions
0 Reviews for BroveX PB C - Add your own review/rating

Compare BroveX PB C with other medications

Cold Symptoms
Cough and Nasal Congestion

Vandazole

In the US, Vandazole (metronidazole topical) is a member of the drug class vaginal anti-infectives and is used to treat Bacterial Vaginitis.

US matches:

Vandazole

Ingredient matches for Vandazole

Metronidazole

Metronidazole is reported as an ingredient of Vandazole in the following countries:

United States

International Drug Name Search

Tiazac

diltiazem hydrochloride

Dosage Form: capsule, extended release
Tiazac®

(diltiazem hydrochloride)

Extended-Release Capsules

USP Drug Release Test 6

Rx Only

Tiazac Description

Tiazac® (diltiazem hydrochloride) is a calcium ion cellular influx inhibitor (slow channel blocker). Chemically, diltiazem hydrochloride is 1,5-Benzothiazepin-4(5H)-one, 3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2, 3-dihydro-2-(4-methoxyphenyl)-, monohydrochloride, (+)-cis-. The chemical structure is:

Diltiazem hydrochloride is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol and chloroform and has a molecular weight of 450.98. Tiazac capsules contain diltiazem hydrochloride in extended-release beads at doses of 120, 180, 240, 300, 360 and 420 mg.

Tiazac also contains: black iron oxide, D&C Red No. 28, ethyl acrylate and methyl methacrylate copolymer dispersion, FD&C Blue No. 1, FD&C Green No. 3, FD&C Red No. 40, gelatin, hypromellose, magnesium stearate, microcrystalline cellulose, polysorbate, povidone, simethicone, sucrose stearate, talc, and titanium dioxide.

For oral administration.

Tiazac - Clinical Pharmacology

The therapeutic effects of diltiazem hydrochloride are believed to be related to its ability to inhibit the cellular influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle.

Mechanisms of Action

Hypertension: Diltiazem produces its antihypertensive effect primarily by relaxation of vascular smooth muscle and the resultant decrease in peripheral vascular resistance. The magnitude of blood pressure reduction is related to the degree of hypertension: thus hypertensive individuals experience an antihypertensive effect, whereas there is only a modest fall in blood pressure in normotensives.

Angina: Diltiazem HCl has been shown to produce increases in exercise tolerance, probably due to its ability to reduce myocardial oxygen demand. This is accomplished via reductions in heart rate and systemic blood pressure at submaximal and maximal work loads.

Diltiazem has been shown to be a potent dilator of coronary arteries, both epicardial and subendocardial. Spontaneous and ergonovine-induced coronary artery spasms are inhibited by diltiazem.

In animal models, diltiazem interferes with the slow inward (depolarizing) current in excitable tissue. It causes excitation-contraction uncoupling in various myocardial tissues without changes in the configuration of the action potential. Diltiazem produces relaxation of the coronary vascular smooth muscle and dilation of both large and small coronary vascular smooth muscle and dilation of both large and small coronary arteries at drug levels which cause little or no negative inotropic effect. The resultant increases in coronary blood flow (epicardial and subendocardial) occur in ischemic and nonischemic models and are accompanied by dose-dependent decreases in systemic blood pressure and decreases in peripheral resistance.

Hemodynamic and Electrophysiologic Effects

Like other calcium channel antagonists, diltiazem decreases sinoatrial and atrioventricular conduction in isolated tissues and has a negative inotropic effect in isolated preparations. In the intact animal, prolongation of the AH interval can be seen at higher doses.

In man, diltiazem prevents spontaneous and ergonovine-provoked coronary artery spasm. It causes a decrease in peripheral vascular resistance and a modest fall in blood pressure in normotensive individuals and, in exercise tolerance studies in patients with ischemic heart disease, reduces the heart rate-blood pressure product for any given work load. Studies to date, primarily in patients with good ventricular function, have not revealed evidence of a negative inotropic effect; cardiac output, ejection fraction, and left ventricular end-diastolic pressure have not been affected. Such data have no predictive value with respect to effects in patients with poor ventricular function, and increased heart failure has been reported in patients with preexisting impairment of ventricular function. There are as yet few data on the interaction of diltiazem and beta-blockers in patients with poor ventricular function. Resting heart rate is usually slightly reduced by diltiazem.

Tiazac produces antihypertensive effects both in the supine and standing positions. Postural hypotension is infrequently noted upon suddenly assuming an upright position. No reflex tachycardia is associated with the chronic antihypertensive effects.

Diltiazem hydrochloride decreases vascular resistance, increases cardiac output (by increasing stroke volume), and produces a slight decrease or no change in heart rate. During dynamic exercise, increases in diastolic pressure are inhibited while maximum achievable systolic pressure is usually reduced. Chronic therapy with diltiazem hydrochloride produces no change or an increase in plasma catecholamines. No increased activity of the renin-angiotensin-aldosterone axis has been observed. Diltiazem hydrochloride reduces the renal and peripheral effects of angiotensin II. Hypertensive animal models respond to diltiazem with reductions in blood pressure and increased urinary output and natriuresis without a change in urinary sodium/potassium ratio. In man, transient natriuresis and kaliuresis have been reported, but only in high intravenous doses of 0.5 mg/kg of body weight.

Diltiazem-associated prolongation of the AH interval is not more pronounced in patients with first degree heart block. In patients with sick sinus syndrome, diltiazem significantly prolongs sinus cycle length (up to 50% in some cases). Intravenous diltiazem in doses of 20 mg prolongs AH conduction time and AV node functional and effective refractory periods by approximately 20%.

In two short term, double-blind, placebo-controlled studies in 256 hypertensive patients with doses up to 540 mg/day, Tiazac showed a clinically unimportant but statistically significant, dose-related increase in PR interval (0.008 seconds). There were no instances of greater than first-degree AV block in any of the clinical trials (see WARNINGS).

Pharmacodynamics

Hypertension: In short term, double blind, placebo-controlled clinical trials, Tiazac demonstrated a dose-related antihypertensive response among patients with mild to moderate hypertension. In one parallel-group study of 198 patients Tiazac was given for four weeks. The changes in diastolic blood pressure measured at trough (24 hours after the dose) for placebo, 90 mg, 180 mg, 360 mg and 540 mg were -5.4, -6.3, -6.2, -8.2, and -11.8 mm Hg, respectively. Supine diastolic blood pressure as well as standing diastolic and systolic blood pressures also showed statistically significant linear dose response effects.

In another clinical trial that followed a dose-escalation design, Tiazac also reduced blood pressure in a linear dose-related manner. Supine diastolic blood pressure measured following two-week intervals of treatment was reduced by -3.7 mm Hg with 120 mg/day versus -2.0 mm Hg with placebo, by -7.6 mm Hg after escalation to 240 mg/day versus -2.3 mm Hg with placebo, by -8.1 mm Hg after escalation to 360 mg/day versus -0.9 mm Hg with placebo, and by -10.8 mm Hg after escalation to 480/540 mg/day versus -2.2 mm Hg with placebo.

Angina: In a double-blind parallel group placebo-controlled trial (approximately 50 patients/group, in patients with chronic stable angina), Tiazac at doses of 120 to 540 mg/day increased exercise tolerance time. At trough, 24 hours after dosing, exercise tolerance times using a Bruce exercise protocol, increased by 14, 26, 41, 33 and 32 seconds over baseline for placebo and the 120 mg, 240 mg, 360 mg, and 540 mg treated patient groups, respectively. At peak, 8 hours after dosing, exercise tolerance times relative to baseline were statistically significantly increased by 13, 38, 64, 55 and 42 seconds for placebo and 120 mg, 240 mg, 360 mg, and 540 mg Tiazac treated patients, respectively. Compared to baseline, Tiazac treated patients experienced statistically significant reductions in anginal attacks and decreased nitroglycerin requirements when compared to placebo treated patients.

Pharmacokinetics and Metabolism

Diltiazem is well absorbed from the gastrointestinal tract but undergoes substantial hepatic first-pass effect. The absolute bioavailability of an oral dose of an immediate-release formulation (compared to intravenous administration) is approximately 40%. Only 2% to 4% of unchanged diltiazem appears in the urine. The plasma elimination half-life of diltiazem is approximately 3.0 to 4.5 h. Drugs which induce or inhibit hepatic microsomal enzymes may alter diltiazem disposition. Therapeutic blood levels of diltiazem appear to be in the range of 40 to 200 ng/mL. There is a departure from linearity when dose strengths are increased; the half-life is slightly increased with dose.

The two primary metabolites of diltiazem are desacetyldiltiazem and desmethyldiltiazem. The desacetyl metabolite is approximately 25% to 50% as potent a coronary vasodilator as diltiazem and is present in plasma at concentrations of 10% to 20% of parent diltiazem. However, recent studies employing sensitive and specific analytical methods have confirmed the existence of several sequential metabolic pathways of diltiazem. As many as nine diltiazem metabolites have been identified in the urine of humans. Total radioactivity measurements following single intravenous dose administration in healthy volunteers suggest the presence of other unidentified metabolites. These metabolites are more slowly excreted (with a half-life of total radioactivity of approximately 20 hours), and attain concentrations in excess of diltiazem.

In vitro binding studies show diltiazem HCl is 70% to 80% bound to plasma proteins. Competitive in vitro ligand binding studies have also shown diltiazem HCl binding is not altered by therapeutic concentrations of digoxin, hydrochlorothiazide, phenylbutazone, propranolol, salicylic acid, or warfarin. A study that compared patients with normal hepatic function to patients with cirrhosis who received immediate-release diltiazem found an increase in diltiazem elimination half-life and a 69% increase in bioavailability in the hepatically impaired patients. Patients with severely impaired renal function (creatinine clearance <50 mL/min) who received immediate-release diltiazem had modestly increased diltiazem concentrations compared to patients with normal renal function.

Tiazac Capsules. When compared to a regimen of immediate-release tablets at steady-state, approximately 93% of drug is absorbed from the Tiazac formulation. When Tiazac was coadministered with a high fat content breakfast, the extent of diltiazem absorption was not affected; Tmax, however, occurred slightly earlier. The apparent elimination half-life after single or multiple dosing is 4 to 9.5 hours (mean 6.5 hours).

Tiazac demonstrates non-linear pharmacokinetics. As the daily dose of Tiazac capsules is increased from 120 to 540 mg, there was a more than proportional increase in diltiazem plasma concentrations as evidenced by an increase of AUC, Cmax and Cmin of 6.8, 6 and 8.6 times, respectively, for a 4.5 times increase in dose.

Indications and Usage for Tiazac

Hypertension:

Tiazac is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive medications.

Chronic Stable Angina:

Tiazac is indicated for the treatment of chronic stable angina.

Contraindications

Diltiazem is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second- or third-degree AV block except in the presence of a functioning ventricular pacemaker, (3) patients with severe hypotension (less than 90 mm Hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.

Warnings

1. Cardiac Conduction. Diltiazem hydrochloride prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second- or third-degree AV block (13 of 3007 patients or 0.43%). Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal's angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem (see ADVERSE REACTIONS).

2. Congestive Heart Failure. Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). An acute study of oral diltiazem in patients with impaired ventricular function (ejection fraction 24% ± 6%) showed improvement in indices of ventricular function without significant decrease in contractile function (dp/dt). Worsening of congestive heart failure has been reported in patients with preexisting impairment of ventricular function. Experience with the use of diltiazem hydrochloride in combination with beta-blockers in patients with impaired ventricular function is limited. Caution should be exercised when using this combination.

3. Hypotension. Decreases in blood pressure associated with diltiazem hydrochloride therapy may occasionally result in symptomatic hypotension.

4. Acute Hepatic Injury. Mild elevations of transaminases with and without concomitant elevation in alkaline phosphatase and bilirubin have been observed in clinical studies. Such elevations were usually transient and frequently resolved even with continued diltiazem treatment. In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, and SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions tended to occur early after therapy initiation (1 to 8 weeks) and have been reversible upon discontinuation of drug therapy. The relationship to diltiazem hydrochloride is uncertain in some cases, but probable in some (see PRECAUTIONS).

Precautions

General

Diltiazem hydrochloride is extensively metabolized by the liver and excreted by the kidneys and in bile. As with any drug given over prolonged periods, laboratory parameters of renal and hepatic function should be monitored at regular intervals. The drug should be used with caution in patients with impaired renal or hepatic function. In subacute and chronic dog and rat studies designed to produce toxicity, high doses of diltiazem were associated with hepatic damage. In special subacute hepatic studies, oral doses of 125 mg/kg and higher in rats were associated with histological changes in the liver which were reversible when the drug was discontinued. In dogs, doses of 20 mg/kg were also associated with hepatic changes; however, these changes were reversible with continued dosing.

Dermatological events (see ADVERSE REACTIONS) may be transient and may disappear despite continued use of diltiazem hydrochloride. However, skin eruptions progressing to erythema multiforme and/or exfoliative dermatitis have also been infrequently reported. Should a dermatologic reaction persist, the drug should be discontinued.

Drug Interactions

Due to the potential for additive effects, caution and careful titration are warranted in patients receiving diltiazem hydrochloride concomitantly with other agents known to affect cardiac contractility and/or conduction (see WARNINGS). Pharmacologic studies indicate that there may be additive effects in prolonging AV conduction when using beta-blockers or digitalis concomitantly with Tiazac (see WARNINGS). As with all drugs, care should be exercised when treating patients with multiple medications. Diltiazem is both a substrate and an inhibitor of the cytochrome P-450 3A4 enzyme system. Other drugs that are specific substrates, inhibitors, or inducers of the enzyme system may have a significant impact on the efficacy and side effect profile of diltiazem. Patients taking other drugs that are substrates of CYP450 3A4, especially patients with renal and/or hepatic impairment, may require dosage adjustment when starting or stopping concomitantly administered diltiazem in order to maintain optimum therapeutic blood levels.

Anesthetics. The depression of cardiac contractility, conductivity, and automaticity as well as the vascular dilation associated with anesthetics may be potentiated by calcium channel blockers. When used concomitantly, anesthetics and calcium channel blockers should be titrated carefully.

Benzodiazepines. Studies showed that diltiazem increased the AUC of midazolam and triazolam by 3- to 4-fold and the Cmax by 2-fold, compared to placebo. The elimination half-life of midazolam and triazolam also increased (1.5- to 2.5-fold) during coadministration with diltiazem. These pharmacokinetic effects seen during diltiazem coadministration can result in increased clinical effects (e.g., prolonged sedation) of both midazolam and triazolam.

Beta-blockers. Controlled and uncontrolled domestic studies suggest that concomitant use of diltiazem hydrochloride and beta-blockers is usually well tolerated, but available data are not sufficient to predict the effects of concomitant treatment in patients with left ventricular dysfunction or cardiac conduction abnormalities. Administration of diltiazem hydrochloride concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. In vitro, propranolol appears to be displaced from its binding sites by diltiazem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see WARNINGS).

Buspirone. In nine healthy subjects, diltiazem significantly increased the mean buspirone AUC 5.5-fold and Cmax 4.1-fold compared to placebo. The T½ and Tmax of buspirone were not significantly affected by diltiazem. Enhanced effects and increased toxicity of buspirone may be possible during concomitant administration with diltiazem. Subsequent dose adjustments may be necessary during coadministration, and should be based on clinical assessment.

Carbamazepine. Concomitant administration of diltiazem with carbamazepine has been reported to result in elevated serum levels of carbamazepine (40% to 72% increase), resulting in toxicity in some cases. Patients receiving these drugs concurrently should be monitored for a potential drug interaction.

Cimetidine. A study in six healthy volunteers has shown a significant increase in peak diltiazem plasma levels (58%) and AUC (53%) after a 1-week course of cimetidine 1200 mg/day and a single dose of diltiazem 60 mg. Ranitidine produced smaller, nonsignificant increases. The effect may be mediated by cimetidine's known inhibition of hepatic cytochrome P-450, the enzyme system responsible for the first-pass metabolism of diltiazem. Patients currently receiving diltiazem therapy should be carefully monitored for a change in pharmacological effect when initiating and discontinuing therapy with cimetidine. An adjustment in the diltiazem dose may be warranted.

Clonidine. Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with diltiazem. Monitor heart rate in patients receiving concomitant diltiazem and clonidine.

Cyclosporine. A pharmacokinetic interaction between diltiazem and cyclosporine has been observed during studies involving renal and cardiac transplant patients. In renal and cardiac transplant recipients, a reduction of cyclosporine dose ranging from 15% to 48% was necessary to maintain cyclosporine trough concentrations similar to those seen prior to the addition of diltiazem. If these agents are to be administered concurrently, cyclosporine concentrations should be monitored, especially when diltiazem therapy is initiated, adjusted, or discontinued.

The effect of cyclosporine on diltiazem plasma concentrations has not been evaluated.

Digitalis. Administration of diltiazem hydrochloride with digoxin in 24 healthy male subjects increased plasma digoxin concentrations approximately 20%. Another investigator found no increase in digoxin levels in 12 patients with coronary artery disease. Since there have been conflicting results regarding the effect of digoxin levels, it is recommended that digoxin levels be monitored when initiating, adjusting, and discontinuing diltiazem hydrochloride therapy to avoid possible over- or under-digitalization (see WARNINGS).

Quinidine. Diltiazem significantly increases the AUC(0→∞) of quinidine by 51%, T½ by 36%, and decreases its CLoral by 33%. Monitoring for quinidine adverse effects may be warranted and the dose adjusted accordingly.

Rifampin. Coadministration of rifampin with diltiazem lowered the diltiazem plasma concentrations to undetectable levels. Coadministration of diltiazem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered.

Statins. Diltiazem is an inhibitor of CYP3A4 and has been shown to increase significantly the AUC of some statins. The risk of myopathy and rhabdomyolysis with statins metabolized by CYP3A4 may be increased with concomitant use of diltiazem. When possible, use a non-CYP3A4-metabolized statin together with diltiazem; otherwise, dose adjustments for both diltiazem and the statin should be considered along with close monitoring for signs and symptoms of any statin related adverse events.

In a healthy volunteer cross-over study (N=10), co-administration of a single 20 mg dose of simvastatin at the end of a 14 day regimen with 120 mg BID diltiazem SR resulted in a 5-fold increase in mean simvastatin AUC versus simvastatin alone. Subjects with increased average steady-state exposures of diltiazem showed a greater fold increase in simvastatin exposure. Computer-based simulations showed that at a daily dose of 480 mg of diltiazem, an 8- to 9-fold mean increase in simvastatin AUC can be expected. If co-administration of simvastatin with diltiazem is required, limit the daily doses of simvastatin to 10 mg and diltiazem to 240 mg.

In a ten-subject randomized, open label, 4-way cross-over study, co-administration of diltiazem (120 mg BID diltiazem SR for 2 weeks) with a single 20 mg dose of lovastatin resulted in 3- to 4-fold increase in mean lovastatin AUC and Cmax versus lovastatin alone. In the same study, there was no significant change in 20 mg single dose pravastatin AUC and Cmax during diltiazem coadministration. Diltiazem plasma levels were not significantly affected by lovastatin or pravastatin.

Carcinogenesis, Mutagenesis, Impairment of Fertility

A 24-month study in rats at oral dosage levels of up to 100 mg/kg/day and a 21-month study in mice at oral dosage levels of up to 30 mg/kg/day showed no evidence of carcinogenicity. There was also no mutagenic response in vitro or in vivo in mammalian cell assays or in vitro in bacteria. No evidence of impaired fertility was observed in a study performed in male and female rats at oral dosages of up to 100 mg/kg/day.

Pregnancy

Category C. Reproduction studies have been conducted in mice, rats, and rabbits. Administration of doses ranging from 4 to 6 times (depending on species) the upper limit of the optimum dosage range in clinical trials (480 mg/day or 8 mg/kg/day for a 60-kg patient) resulted in embryo and fetal lethality. These studies revealed, in one species or another, a propensity to cause abnormalities of the skeleton, heart, retina, and tongue. Also observed were reductions in early individual pup weights and pup survival, prolonged delivery and increased incidence of stillbirths. There are no well-controlled studies in pregnant women; therefore, use diltiazem hydrochloride in pregnant women only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Diltiazem is excreted in human milk. One report suggests that concentrations in breast milk may approximate serum levels. If use of Tiazac is deemed essential, an alternative method of infant feeding should be instituted.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies of diltiazem did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Adverse Reactions

Serious adverse reactions have been rare in studies with Tiazac, as well as with other diltiazem formulations. It should be recognized that patients with impaired ventricular function and cardiac conduction abnormalities have usually been excluded from these studies. A total of 256 hypertensives were treated for between 4 and 8 weeks; a total of 207 patients with chronic stable angina were treated for 3 weeks with doses of Tiazac ranging from 120 to 540 mg once daily. Two patients experienced first-degree AV block at the 540 mg dose. The following table presents the most common adverse reactions, whether or not drug-related, reported in placebo-controlled trials in patients receiving Tiazac up to 360 mg and up to 540 mg with rates in placebo patients shown for comparison.

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED HYPERTENSION TRIALS*
	Placebo	Tiazac
Adverse Events (COSTART Term)	n=57 # pts (%)	Up to 360 mg n=149 # pts (%)	480-540mg n=48 # pts (%)
edema, peripheral	1 (2)	8 (5)	7 (15)
dizziness	4 (7)	6 (4)	2 (4)
vasodilation	1 (2)	5 (3)	1 (2)
dyspepsia	0 (0)	7 (5)	0 (0)
pharyngitis	2 (4)	3 (2)	3 (6)
rash	0 (0)	3 (2)	0 (0)
infection	2 (4)	2 (1)	3 (6)
diarrhea	0 (0)	2 (1)	1 (2)
palpitations	0 (0)	2 (1)	1 (2)
nervousness	0 (0)	3 (2)	0 (0)

MOST COMMON ADVERSE EVENTS IN DOUBLE-BLIND PLACEBO-CONTROLLED ANGINA TRIALS*
	Placebo	Tiazac
Adverse Events (COSTART Term)	n=50 # pts (%)	Up to 360 mg n=158 # pts (%)	540 mg n=49 # pts (%)
* Adverse events occurring in treated patients at 2% or more than placebo-treated patients.
headache	1 (2)	13 (8)	4 (8)
edema, peripheral	1 (2)	3 (2)	5 (10)
pain	1 (2)	10 (6)	3 (6)
dizziness	0 (0)	5 (3)	5 (10)
asthenia	0 (0)	1 (1)	2 (4)
dyspepsia	0 (0)	2 (1)	3 (6)
dyspnea	0 (0)	1 (1)	3 (6)
bronchitis	0 (0)	1 (1)	2 (4)
AV block	0 (0)	0 (0)	2 (4)
infection	0 (0)	2 (1)	1 (2)
flu syndrome	0 (0)	0 (0)	1 (2)
cough increase	0 (0)	2 (1)	1 (2)
extrasystoles	0 (0)	0 (0)	1 (2)
gout	0 (0)	2 (1)	1 (2)
myalgia	0 (0)	0 (0)	1 (2)
impotence	0 (0)	0 (0)	1 (2)
conjunctivitis	0 (0)	0 (0)	1 (2)
rash	0 (0)	2 (1)	1 (2)
abdominal enlargement	0 (0)	0 (0)	1 (2)

In addition, the following events have been reported infrequently (less than 2%) in clinical trials with other diltiazem products:

Cardiovascular: Angina, arrhythmia, AV block (second- or third-degree), bundle branch block, congestive heart failure, ECG abnormalities, hypotension, palpitations, syncope, tachycardia, ventricular extrasystoles.

Nervous System: Abnormal dreams, amnesia, depression, gait abnormality, hallucinations, insomnia, nervousness, paresthesia, personality change, somnolence, tinnitus, tremor.

Gastrointestinal: Anorexia, constipation, diarrhea, dry mouth, dysgeusia, mild elevations of SGOT, SGPT, LDH, and alkaline phosphatase (see WARNINGS, Acute Hepatic Injury), nausea, thirst, vomiting, weight increase.

Dermatological: Petechiae, photosensitivity, pruritus.

Other: Albuminuria, allergic reaction, amblyopia, asthenia, CPK increase, crystalluria, dyspnea, edema, epistaxis, eye irritation, headache, hyperglycemia, hyperuricemia, impotence, muscle cramps, nasal congestion, neck rigidity, nocturia, osteoarticular pain, pain, polyuria, rhinitis, sexual difficulties, gynecomastia.

In addition, the following postmarketing events have been reported infrequently in patients receiving diltiazem hydrochloride: acute generalized exanthematous pustulosis, alopecia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, extrapyramidal symptoms, gingival hyperplasia, hemolytic anemia, increased bleeding time, photosensitivity (including lichenoid keratosis and hyperpigmentation at sun-exposed skin areas), leukopenia, purpura, retinopathy, and thrombocytopenia. In addition, events such as myocardial infarction have been observed which are not readily distinguishable from the natural history of the disease in these patients. A number of well-documented cases of generalized rash, characterized as leukocytoclastic vasculitis, have been reported. However, a definitive cause and effect relationship between these events and diltiazem hydrochloride therapy is yet to be established.

Overdosage

The oral LD50's in mice and rats range from 415 to 740 mg/kg and from 560 to 810 mg/kg, respectively. The intravenous LD50's in these species were 60 and 38 mg/kg, respectively. The oral LD50 in dogs is considered to be in excess of 50 mg/kg, while lethality was seen in monkeys at 360 mg/kg.

The toxic dose in man is not known. Due to extensive metabolism, blood levels after a standard dose of diltiazem can vary over tenfold, limiting the usefulness of blood levels in overdose cases. There have been 29 reports of diltiazem overdose in doses ranging from less than 1 gm to 10.8 gm. Sixteen of these reports involved multiple drug ingestions. Twenty-two reports indicated patients had recovered from diltiazem overdose ranging from less than 1 gm to 10.8 gm. There were seven reports with a fatal outcome; although the amount of diltiazem ingested was unknown, multiple drug ingestions were confirmed in six of the seven reports.

Events observed following diltiazem overdose included bradycardia, hypotension, heart block, and cardiac failure. Most reports of overdose described some supportive medical measure and/or drug treatment. Bradycardia frequently responded favorably to atropine as did heart block, although cardiac pacing was also frequently utilized to treat heart block. Fluids and vasopressors were used to maintain blood pressure, and in cases of cardiac failure, inotropic agents were administered. In addition, some patients received treatment with ventilatory support, activated charcoal, and/or intravenous calcium. Evidence of the effectiveness of intravenous calcium administration to reverse the pharmacological effects of diltiazem overdose was conflicting.

In the event of overdose or exaggerated response, appropriate supportive measures should be employed in addition to gastrointestinal decontamination. Diltiazem does not appear to be removed by peritoneal or hemodialysis. Based on the known pharmacological effects of diltiazem and/or reported clinical experiences, the following measures may be considered:

Bradycardia: Administer atropine (0.60 to 1.0 mg). If there is no response to vagal blockage, administer isoproterenol cautiously.

High-Degree AV Block: Treat as for bradycardia above. Fixed high-degree AV block should be treated with cardiac pacing.

Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics.

Hypotension: Vasopressors (e.g., dopamine or norepinephrine). Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.

In a few reported cases, overdose with calcium channel blockers has been associated with hypotension and bradycardia, initially refractory to atropine but becoming more responsive to this treatment when the patients received large doses (close to 1 gram/hour for more than 24 hours) of calcium chloride.

Due to extensive metabolism, plasma concentrations after a standard dose of diltiazem can vary over tenfold, which significantly limits their value in evaluation cases of overdosage.

Charcoal hemoperfusion has been used successfully as an adjunct therapy to hasten drug elimination. Overdoses with as much as 10.8 gm of oral diltiazem have been successfully treated using appropriate supportive care.

Tiazac Dosage and Administration

Hypertension. Dosage needs to be adjusted by titration to individual patient needs. When used as monotherapy, usual starting doses are 120 to 240 mg once daily. Maximum antihypertensive effect is usually observed by 14 days of chronic therapy; therefore, dosage adjustments should be scheduled accordingly. The usual dosage range studied in clinical trials was 120 to 540 mg once daily. Current clinical experience with 540 mg dose is limited; however, the dose may be increased to 540 mg once daily.

Angina. Dosages for the treatment of angina should be adjusted to each patient's needs, starting with a dose of 120 mg to 180 mg once daily. Individual patients may respond to higher doses of up to 540 mg once daily. When necessary, titration should be carried out over 7 to 14 days.

Concomitant use with Other Cardiovascular Agents.

1. Sublingual Nitroglycerin (NTG). May be taken as required to abort acute anginal attacks during diltiazem hydrochloride therapy.

2. Prophylactic Nitrate Therapy. Diltiazem hydrochloride may be safely coadministered with short- and long-acting nitrates.

3. Beta-blockers (see WARNINGS and PRECAUTIONS.)

4. Antihypertensives. Diltiazem hydrochloride has an additive antihypertensive effect when used with other antihypertensive agents. Therefore, the dosage of diltiazem hydrochloride or the concomitant antihypertensives may need to be adjusted when adding one to the other.

Hypertensive or anginal patients who are treated with other formulations of diltiazem can safely be switched to Tiazac capsules at the nearest equivalent total daily dose. Subsequent titration to higher or lower doses may, however, be necessary and should be initiated as clinically indicated.

Sprinkling the Capsule Contents on Food

Tiazac (diltiazem hydrochloride) Extended-release Capsules may also be administered by carefully opening the capsule and sprinkling the capsule contents on a spoonful of applesauce. The applesauce should be swallowed immediately without chewing and followed with a glass of cool water to ensure complete swallowing of the capsule contents. The applesauce should not be hot, and it should be soft enough to be swallowed without chewing. Any capsule contents/applesauce mixture should be used immediately and not stored for future use. Subdividing the contents of a Tiazac (diltiazem hydrochloride) Extended-release Capsule is not recommended.

How is Tiazac Supplied

Tiazac® (diltiazem hydrochloride) Extended-Release Capsules

Strength	Description	Quantity	NDC#
120 mg	#3 lavender/lavender capsule imprinted: Tiazac 120	7's	0456-2612-07
		30's	0456-2612-30
		90's	0456-2612-90
		1000's	0456-2612-00
		HUD's	0456-2612-63
180 mg	#2 white/blue-green capsule imprinted: Tiazac 180	7's	0456-2613-07
		30's	0456-2613-30
		90's	0456-2613-90
		1000's	0456-2613-00
		HUD's	0456-2613-63
240 mg	#1 blue-green/lavender capsule imprinted: Tiazac 240	7's	0456-2614-07
		30's	0456-2614-30
		90's	0456-2614-90
		1000's	0456-2614-00
		HUD's	0456-2614-63
300 mg	#0 white/lavender capsule imprinted: Tiazac 300	7's	0456-2615-07
		30's	0456-2615-30
		90's	0456-2615-90
		1000's	0456-2615-00
		HUD's	0456-2615-63
360 mg	#0 blue-green/blue-green capsule imprinted: Tiazac 360	7's	0456-2616-07
		30's	0456-2616-30
		90's	0456-2616-90
		1000's	0456-2616-00
		HUD's	0456-2616-63
420 mg	#00 white/white capsule imprinted: Tiazac 420	7's	0456-2617-07
		30's	0456-2617-30
		90's	0456-2617-90
		1000's	0456-2617-00

Storage conditions: Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid excessive humidity.

Manufactured by:

Biovail Laboratories International SRL

Street B # 34

Sabano Abajo Industrial Park

Carolina, PR 00983

OR

Biovail Corporation

Mississauga, Ontario

Canada L5N 8M5

Manufactured for:

Rev. 04/10

LB0001-13

PRINCIPAL DISPLAY PANEL - 120 mg Bottle Label

NDC 0456-2612-30

Tiazac®

(diltiazem HCl)

120 mg

Extended Release Capsules, USP*

Rx only

Do not use if bottle closure

seal is broken.

30 Capsules

PRINCIPAL DISPLAY PANEL - 180 mg Bottle Label

NDC 0456-2613-30

Tiazac®

(diltiazem HCl)

180 mg

Extended Release Capsules, USP*

Rx only

Do not use if bottle closure

seal is broken.

30 Capsules

PRINCIPAL DISPLAY PANEL - 240 mg Bottle Label

NDC 0456-2614-30

Tiazac®

(diltiazem HCl)

240 mg

Extended Release Capsules, USP*

Rx only

Do not use if bottle closure

seal is broken.

30 Capsules

PRINCIPAL DISPLAY PANEL - 300 mg Bottle Label

NDC 0456-

Friday, September 30, 2016

Ingredient matches for Amlonor

Read all of this leaflet carefully before you start taking this medicine.

Index

What Caberzol XL Tablets is and what it is used for

Before you take

Check with your doctor or pharmacist

Taking other medicines

Pregnancy and breast-feeding

Driving and using machines

Sugar intolerance

Tests

How to take

Doses:

If you take more than you should

If you forget to take the tablets

Possible side effects

How to Store

Further information

What Caberzol XL contains

What Caberzol XL looks like and contents of the pack

Ingredient matches for Balsamorhinol

Commonly used brand name(s)

Uses For Myobloc

Before Using Myobloc

Allergies

Pediatric

Geriatric

Pregnancy

Breast Feeding

Interactions with Medicines

Interactions with Food/Tobacco/Alcohol

Other Medical Problems

Proper Use of Myobloc

Precautions While Using Myobloc

Myobloc Side Effects

More Myobloc resources

Compare Myobloc with other medications

Ingredient matches for Antrex

Ingredient matches for Béta Septigen

Thursday, September 29, 2016

Ingredient matches for Biperideno Duncan

Ingredient matches for Cinfacromin

Scheme

ATC (Anatomical Therapeutic Chemical Classification)

CAS registry number (Chemical Abstracts Service)

Chemical Formula

Molecular Weight

Therapeutic Category

Chemical Name

Foreign Names

Generic Names

Brand Names

Ingredient matches for Keftid

Ingredient matches for Balzide

Ingredient matches for Benzosed

Ingredient matches for Betacorton

Ingredient matches for Bitobionil

Ingredient matches for Benzaknen

Ingredient matches for Mariendistel-ratiopharm

Ingredient matches for Bareon

Ingredient matches for Clon

DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS AND USAGE

CONTRAINDICATIONS

WARNINGS

PRECAUTIONS

General

Information for Patients

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy Category C

Nursing Mothers

Pediatric Use

Geriatric Use

ADVERSE REACTIONS

OVERDOSAGE

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

PRINCIPAL DISPLAY PANEL