Lovispes

Lovispes may be available in the countries listed below.

Ingredient matches for Lovispes

Nebivolol

Nebivolol is reported as an ingredient of Lovispes in the following countries:

• Latvia


• Lithuania

International Drug Name Search

Doc Carvedilol

Doc Carvedilol may be available in the countries listed below.

Ingredient matches for Doc Carvedilol

Carvedilol

Carvedilol is reported as an ingredient of Doc Carvedilol in the following countries:

• Belgium


• Luxembourg

International Drug Name Search

Orabet

Orabet may be available in the countries listed below.

Ingredient matches for Orabet

Metformin

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

• Denmark

International Drug Name Search

Nolpaza

Nolpaza may be available in the countries listed below.

Ingredient matches for Nolpaza

Pantoprazole

Pantoprazole is reported as an ingredient of Nolpaza in the following countries:

• Croatia (Hrvatska)


• Estonia


• Latvia


• Lithuania


• Slovakia


• Slovenia

Pantoprazole sodium (a derivative of Pantoprazole) is reported as an ingredient of Nolpaza in the following countries:

• Hungary

International Drug Name Search

Inverter

Inverter may be available in the countries listed below.

Ingredient matches for Inverter

Molsidomine

Molsidomine is reported as an ingredient of Inverter in the following countries:

• Algeria

International Drug Name Search

Omatan

Omatan may be available in the countries listed below.

Ingredient matches for Omatan

Mefenamic Acid

Mefenamic Acid is reported as an ingredient of Omatan in the following countries:

• Oman

International Drug Name Search

Baza

Generic Name: miconazole topical (my CON a zole)

Brand Names: Aloe Vesta, Aloe Vesta 2 in 1 Antifungal, Baza, Cruex Prescription Strength, Desenex Prescription Strength, Fungoid, Fungoid Kit, Micatin, Micatin Cooling Action, Micatin Foot Powder, Micatin Foot Powder Deodorant, Micatin Jock Itch, Micatin Liquid Foot, Mitrazol, Monistat Derm, Ony-Clear, Zeasorb-AF

What is Baza (miconazole topical)?

Miconazole topical is an antifungal medication. Miconazole topical prevents fungus from growing on your skin.

Miconazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections.

Miconazole topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Baza (miconazole topical)?

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

Who should not use Baza (miconazole topical)?

Do not use miconazole topical if you have had an allergic reaction to it in the past.

It is not known whether miconazole topical will harm an unborn baby. Do not use miconazole topical without first talking to your doctor if you are pregnant. It is not known whether miconazole passes into breast milk. Do not use miconazole topical without first talking to your doctor if you are breast-feeding a baby.

How should I use Baza (miconazole topical)?

Use miconazole topical exactly as directed by your doctor or follow the directions that accompany the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.

Wash your hands before and after using this medication.

Clean and dry the affected area. Apply the cream, lotion, spray, or powder once or twice daily as directed for 2 to 4 weeks.

Use this medication for the full amount of time prescribed by your doctor or as recommended in the package even if you begin to feel better. Your symptoms may improve before the infection is completely healed.

If the infection does not clear up in 2 weeks (or 4 weeks for athlete's foot), or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Avoid getting this medication in your eyes, nose, or mouth. Store miconazole topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of miconazole topical. Do not use a double dose unless otherwise directed by your doctor.

What happens if I overdose?

An overdose of miconazole topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that miconazole topical has been ingested, contact an emergency room or a poison control center.

What should I avoid while using Baza (miconazole topical)?

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear loose-fitting clothing made of cotton and other natural fibers until the infection is healed.

Baza (miconazole topical) side effects

Serious side effects of miconazole topical use are not expected. Stop using miconazole topical and see your doctor if you experience unusual or severe blistering, itching, redness, peeling, dryness, or irritation of the skin.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Baza (miconazole topical)?

Avoid using other topicals at the same time unless your doctor approves. Other skin medications may affect the absorption or effectiveness of miconazole topical.

More Baza resources

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

• Baza Antifungal Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Cruex Prescription Strength Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Lotrimin AF Lotion MedFacts Consumer Leaflet (Wolters Kluwer)


• Micatin Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Monistat 3 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Monistat 3 Prescribing Information (FDA)


• Monistat 7 Cream MedFacts Consumer Leaflet (Wolters Kluwer)


• Zeasorb-AF Gel MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Baza with other medications

• Cutaneous Candidiasis
• Tinea Corporis
• Tinea Cruris
• Tinea Pedis
• Tinea Versicolor

Where can I get more information?

• Your pharmacist has additional information about miconazole topical written for health professionals that you may read.

See also: Baza side effects (in more detail)

Betimol

timolol

Dosage Form: ophthalmic solution
Betimol® (timolol ophthalmic solution)

0.25%, 0.5%

Betimol Description

Betimol® (timolol ophthalmic solution), 0.25% and 0.5%, is a non-selective beta-adrenergic antagonist for ophthalmic use. The chemical name of the active ingredient is (S)-1-[(1,1-dimethylethyl)amino]-3-[(4-(4-morpholinyl)-1,2,5-thiadiazol-3-yl]oxy]-2-propanol. Timolol hemihydrate is the levo isomer. Specific rotation is [α]25 405nm=-16° (C=10% as the hemihydrate form in 1N HCl).

The molecular formula of timolol is Formula C13H24N4O3S and its structural formula is:

Timolol (as the hemihydrate) is a white, odorless, crystalline powder which is slightly soluble in water and freely soluble in ethanol. Timolol hemihydrate is stable at room temperature.

Betimol® is a clear, colorless, isotonic, sterile, microbiologically preserved phosphate buffered aqueous solution.

It is supplied in two dosage strengths, 0.25% and 0.5%.

Each mL of Betimol® 0.25% contains 2.56 mg of timolol hemihydrate equivalent to 2.5 mg Timolol.

Each mL of Betimol® 0.5% contains 5.12 mg of timolol hemihydrate equivalent to 5.0 mg timolol.

Inactive ingredients: monosodium and disodium phosphate dihydrate to adjust pH (6.5 - 7.5) and water for injection, benzalkonium chloride 0.01% added as preservative.

The osmolality of Betimol® is 260 to 320 mOsmol/kg.

Betimol - Clinical Pharmacology

Timolol is a non-selective beta-adrenergic antagonist.

It blocks both beta1-and beta2-adrenergic receptors. Timolol does not have significant intrinsic sympathomimetic activity, local anesthetic (membrane-stabilizing) or direct myocardial depressant activity.

Timolol, when applied topically in the eye, reduces normal and elevated intraocular pressure (IOP) whether or not accompanied by glaucoma. Elevated intraocular pressure is a major risk factor in the pathogenesis of glaucomatous visual field loss. The higher the level of IOP, the greater the likelihood of glaucomatous visual field loss and optic nerve damage. The predominant mechanism of ocular hypotensive action of topical beta-adrenergic blocking agents is likely due to a reduction in aqueous humor production.

In general, beta-adrenergic blocking agents reduce cardiac output both in healthy subjects and patients with heart diseases. In patients with severe impairment of myocardial function, beta-adrenergic receptor blocking agents may inhibit sympathetic stimulatory effect necessary to maintain adequate cardiac function. In the bronchi and bronchioles, beta-adrenergic receptor blockade may also increase airway resistance because of unopposed parasympathetic activity.

Pharmacokinetics

When given orally, timolol is well absorbed and undergoes considerable first pass metabolism. Timolol and its metabolites are primarily excreted in the urine. The half-life of timolol in plasma is approximately 4 hours.

Clinical Studies

In two controlled multicenter studies in the U.S., Betimol® 0.25% and 0.5% were compared with respective timolol maleate eyedrops. In these studies, the efficacy and safety profile of Betimol® was similar to that of timolol maleate.

Indications and Usage for Betimol

Betimol® is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Contraindications

Betimol® is contraindicated in patients with overt heart failure, cardiogenic shock, sinus bradycardia, second- or third-degree atrioventricular block, bronchial asthma or history of bronchial asthma, or severe chronic obstructive pulmonary disease, or hypersensitivity to any component of this product.

Warnings

As with other topically applied ophthalmic drugs, Betimol® is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory and cardiac reactions, including death due to bronchospasm in patients with asthma, and rarely, death in association with cardiac failure have been reported following systemic or topical administration of beta-adrenergic blocking agents.

Cardiac Failure

Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe cardiac failure.

In patients without a history of cardiac failure, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. Betimol® should be discontinued at the first sign or symptom of cardiac failure.

Obstructive Pulmonary Disease

Patients with chronic obstructive pulmonary disease (e.g. chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma or a history of bronchial asthma which are contraindications) should in general not receive beta-blocking agents.

Major Surgery

The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to a major surgery is controversial. Beta-adrenergic receptor blockade impairs the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have been subject to protracted severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported. For these reasons, in patients undergoing elective surgery, gradual withdrawal of beta-adrenergic receptor blocking agents is recommended. If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient doses of beta-adrenergic agonists.

Diabetes Mellitus

Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.

Thyrotoxicosis

Beta-adrenergic blocking agents may mask certain clinical signs (e.g. tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents which might precipitate a thyroid storm.

Precautions

General

Because of the potential effects of beta-adrenergic blocking agents relative to blood pressure and pulse, these agents should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with Betimol®, alternative therapy should be considered.

There have been reports of bacterial keratitis associated with the use of multiple dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. (See PRECAUTIONS, Information for Patients.)

Muscle Weakness

Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g. dipIopia, ptosis, and generalized weakness). Beta-adrenergic blocking agents have been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.

In angle-closure glaucoma, the goal of the treatment is to reopen the angle. This requires constricting the pupil. Betimol® has no effect on the pupil. Therefore, if timolol is used in angle-closure glaucoma, it should always be combined with a miotic and not used alone.

Anaphylaxis

While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

The preservative benzalkonium chloride may be absorbed by soft contact lenses. Patients who wear soft contact lenses should wait 5 minutes after instilling Betimol® before they insert their lenses.

Information for Patients

Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures.

Patients should also be instructed that ocular solutions can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions. (See PRECAUTIONS, General.)

Patients requiring concomitant topical ophthalmic medications should be instructed to administer these at least 5 minutes apart.

Patients with bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, second- or third-degree atrioventricular block, or cardiac failure should be advised not to take this product (See CONTRAINDICATIONS.)

Drug Interactions

Beta-adrenergic blocking agents

Patients who are receiving a beta-adrenergic blocking agent orally and Betimol® should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta-blockade.

Patients should not usually receive two topical ophthalmic beta-adrenergic blocking agents concurrently.

Catecholamine-depleting drugs

Close observation of the patient is recommended when a beta-blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may produce vertigo, syncope, or postural hypotension.

Calcium antagonists

Caution should be used in the co-administration of beta-adrenergic blocking agents and oral or intravenous calcium antagonists, because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, co-administration should be avoided.

Digitalis and calcium antagonists

The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.

Injectable Epinephrine

(See PRECAUTIONS, General, Anaphylaxis.)

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity of timolol (as the maleate) has been studied in mice and rats. In a two-year study orally administrated timolol maleate (300mg/kg/day) (approximately 42,000 times the systemic exposure following the maximum recommended human ophthalmic dose) in male rats caused a significant increase in the incidence of adrenal pheochromocytomas; the lower doses, 25 mg or 100 mg/kg daily did not cause any changes.

In a life span study in mice the overall incidence of neoplasms was significantly increased in female mice at 500 mg/kg/day (approximately 71,000 times the systemic exposure following the maximum recommended human ophthalmic dose). Furthermore, significant increases were observed in the incidences of benign and malignant pulmonary tumors, benign uterine polyps, as well as mammary adenocarcinomas. These changes were not seen at the daily dose level of 5 or 50 mg/kg (approximately 700 or 7,000, respectively, times the systemic exposure following the maximum recommended human ophthalmic dose). For comparison, the maximum recommended human oral dose of timolol maleate is 1 mg/kg/day.

Mutagenic potential of timolol was evaluated in vivo in the micronucleus test and cytogenetic assay and in vitro in the neoplastic cell transformation assay and Ames test. In the bacterial mutagenicity test (Ames test) high concentrations of timolol maleate (5000 and 10,000 g/plate) statistically significantly increased the number of revertants in Salmonella typhimurium TA100, but not in the other three strains tested. However, no consistent dose-response was observed nor did the number of revertants reach the double of the control value, which is regarded as one of the criteria for a positive result in the Ames test. In vivo genotoxicity tests (the mouse micronucleus test and cytogenetic assay) and in vitro the neoplastic cell transformation assay were negative up to dose levels of 800 mg/kg and 100 g/mL, respectively.

No adverse effects on male and female fertility were reported in rats at Timolol oral doses of up to 150 mg/kg/day (21,000 times the systemic exposure following the maximum recommended human ophthalmic dose).

Pregnancy Teratogenic effects

Category C

Teratogenicity of timolol (as the maleate) after oral administration was studied in mice and rabbits. No fetal malformations were reported in mice or rabbits at a daily oral dose of 50 mg/kg (7,000 times the systemic exposure following the maximum recommended human ophthalmic dose). Although delayed fetal ossification was observed at this dose in rats, there were no adverse effects on postnatal development of offspring. Doses of 1000 mg/kg/day (142,000 times the systemic exposure following the maximum recommended human ophthalmic dose) were maternotoxic in mice and resulted in an increased number of fetal resorptions. Increased fetal resorptions were also seen in rabbits at doses of 14,000 times the systemic exposure following the maximum recommended human ophthalmic dose in this case without apparent maternotoxicity.

There are no adequate and well-controlled studies in pregnant women. Betimol® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing mothers

Because of the potential for serious adverse reactions in nursing infants from timolol, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use

Safety and efficacy in pediatric patients have not been established.

Adverse Reactions

The most frequently reported ocular event in clinical trials was burning/stinging on instillation and was comparable between Betimol® and timolol maleate (approximately one in eight patients).

The following adverse events were associated with use of Betimol® in frequencies of more than 5% in two controlled, double-masked clinical studies in which 184 patients received 0.25% or 0.5% Betimol®:

OCULAR:

Dry eyes, itching, foreign body sensation, discomfort in the eye, eyelid erythema, conjunctival injection, and headache.

BODY AS A WHOLE:

Headache.

The following side effects were reported in frequencies of 1 to 5%:

OCULAR:

Eye pain, epiphora, photophobia, blurred or abnormal vision, corneal fluorescein staining, keratitis, blepharitis and cataract.

BODY AS A WHOLE:

Allergic reaction, asthenia, common cold and pain in extremities.

CARDIOVASCULAR:

Hypertension.

DIGESTIVE:

Nausea.

METABOLlC/NUTRITIONAL:

Peripheral edema.

NERVOUS SYSTEM/PSYCHIATRY:

Dizziness and dry mouth.

RESPIRATORY:

Respiratory infection and sinusitis.

In addition, the following adverse reactions have been reported with ophthalmic use of beta blockers:

OCULAR:

Conjunctivitis, blepharoptosis, decreased corneal sensitivity, visual disturbances including refractive changes, diplopia and retinal vascular disorder.

BODY AS A WHOLE:

Chest pain.

CARDIOVASCULAR:

Arrhythmia, palpitation, bradycardia, hypotension, syncope, heart block, cerebral vascular accident, cerebral ischemia, cardiac failure and cardiac arrest.

DIGESTIVE:

Diarrhea.

ENDOCRINE:

Masked symptoms of hypoglycemia in insulin dependent diabetics (See WARNINGS).

NERVOUS SYSTEM/PSYCHIATRY:

Depression, impotence, increase in signs and symptoms of myasthenia gravis and paresthesia.

RESPIRATORY:

Dyspnea, bronchospasm, respiratory failure and nasal congestion.

SKIN:

AIOPecia, hypersensitivity including localized and generalized rash, urticaria.

Overdosage

No information is available on overdosage with Betimol®. Symptoms that might be expected with an overdose of a beta-adrenergic receptor blocking agent are bronchospasm, hypotension, bradycardia, and acute cardiac failure.

Betimol Dosage and Administration

Betimol® Ophthalmic Solution is available in concentrations of 0.25 and 0.5 percent. The usual starting dose is one drop of 0.25 percent Betimol® in the affected eye(s) twice a day. If the clinical response is not adequate, the dosage may be changed to one drop of 0.5 percent solution in the affected eye(s) twice a day.

If the intraocular pressure is maintained at satisfactory levels, the dosage schedule may be changed to one drop once a day in the affected eye(s). Because of diurnal variations in intraocular pressure, satisfactory response to the once-a-day dose is best determined by measuring the intraocular pressure at different times during the day.

Since in some patients the pressure-lowering response to Betimol® may require a few weeks to stabilize, evaluation should include a determination of intraocular pressure after approximately 4 weeks of treatment with Betimol® .

Dosages above one drop of 0.5 percent Betimol® twice a day generally have not been shown to produce further reduction in intraocular pressure. If the patient's intraocular pressure is still not at a satisfactory level on this regimen, concomitant therapy with pilocarpine and other miotics, and/or epinephrine, and/or systemically administered carbonic anhydrase inhibitors, such as acetazolamide, can be instituted.

How is Betimol Supplied

Betimol® (timolol ophthalmic solution) is a clear, colorless solution.

Betimol® 0.25% is supplied in a white, opaque, plastic, ophthalmic dispenser bottle with a controlled drop tip as follows:

NDC 68669-522-05	5.0mL	fill in 5 cc container
NDC 68669-522-10	10mL	fill in 11 cc container
NDC 68669-522-15	15mL	fill in 15 cc container

Betimol® 0.5% is supplied in a white, opaque, plastic, ophthalmic dispenser bottle with a controlled drop tip as follows:

NDC 68669-525-05	5.0mL	fill in 5 cc container
NDC 68669-525-10	10mL	fill in 11 cc contalner
NDC 68669-525-15	15mL	fill in 15 cc container

Rx Only

STORAGE

Store between 15-25°C (59-77°F). Do not freeze. Protect from light.

MARKETED BY:

VISTAKON® Pharmaceuticals, LLC

Jacksonville, FL 32256 USA

MANUFACTURED BY:

Santen Oy, P.O. Box 33

FIN-33721 Tampere, Finland

November 2006 Version

3220660/5

PRINCIPAL DISPLAY PANEL - 0.25% Carton

NDC 68669-522-05

Betimol®

(TIMOLOL OPHTHALMIC

SOLUTION) 0.25%

Timolol equivalent (timolol

hemihydrate 2.56 mg/mL)

Rx Only

5 mL

VISTAKON®

PHARMACEUTICALS, LLC

PRINCIPAL DISPLAY PANEL - 5 mL Bottle Label

NDC 68669-525-05

Betimol®

(TIMOLOL OPHTHALMIC

SOLUTION) 0.5%

Timolol equivalent (timolol

hemihydrate 5.12 mg/mL)

5 mL

VISTAKON®

PHARMACEUTICALS, LLC

Betimol  timolol  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68669-522 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength timolol (timolol) timolol 2.5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength benzalkonium chloride 0.1 mg  in 1 mL sodium phosphate, monobasic, dihydrate 10.53 mg  in 1 mL sodium phosphate, dibasic, dihydrate 12.01 mg  in 1 mL water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68669-522-05 5 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020439	10/01/2000

Betimol  timolol  solution

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 68669-525 Route of Administration OPHTHALMIC DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength timolol (timolol) timolol 5 mg  in 1 mL

Inactive Ingredients Ingredient Name Strength benzalkonium chloride 0.1 mg  in 1 mL sodium phosphate, monobasic, dihydrate 10.53 mg  in 1 mL sodium phosphate, dibasic, dihydrate 12.01 mg  in 1 mL water

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 68669-525-99 2.5 mL In 1 BOTTLE None 2 68669-525-05 5 mL In 1 BOTTLE None 3 68669-525-10 10 mL In 1 BOTTLE None 4 68669-525-15 15 mL In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA020439	10/01/2000

Labeler - Vistakon Pharmaceuticals LLC (004060273)

Revised: 03/2010Vistakon Pharmaceuticals LLC

More Betimol resources

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

• Betimol Advanced Consumer (Micromedex) - Includes Dosage Information


• Betimol Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Istalol Consumer Overview


• Istalol Drops MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Betimol with other medications

• Glaucoma, Open Angle
• Intraocular Hypertension

Captopril / Hydrochlorothiazide Teva

Captopril/Hydrochlorothiazide Teva may be available in the countries listed below.

Ingredient matches for Captopril/Hydrochlorothiazide Teva

Captopril

Captopril is reported as an ingredient of Captopril/Hydrochlorothiazide Teva in the following countries:

• France

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Captopril/Hydrochlorothiazide Teva in the following countries:

• France

International Drug Name Search

Oflovid

Oflovid may be available in the countries listed below.

Ingredient matches for Oflovid

Ofloxacin

Ofloxacin is reported as an ingredient of Oflovid in the following countries:

• Taiwan

International Drug Name Search

Amoxicilina + ácido clavulânico Alpharma

Amoxicilina + ácido clavulânico Alpharma may be available in the countries listed below.

Ingredient matches for Amoxicilina + ácido clavulânico Alpharma

Amoxicillin

Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicilina + ácido clavulânico Alpharma in the following countries:

• Portugal

Clavulanate

Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Amoxicilina + ácido clavulânico Alpharma in the following countries:

• Portugal

International Drug Name Search

Toprol XL

Ingredient matches for Toprol XL

Metoprolol

Metoprolol succinate (a derivative of Metoprolol) is reported as an ingredient of Toprol XL in the following countries:

• Australia


• United States

International Drug Name Search

Buconif

Buconif may be available in the countries listed below.

Ingredient matches for Buconif

Nifedipine

Nifedipine is reported as an ingredient of Buconif in the following countries:

• Austria

International Drug Name Search

Delepsine

Delepsine may be available in the countries listed below.

Ingredient matches for Delepsine

Valproic Acid

Valproic Acid semisodium (a derivative of Valproic Acid) is reported as an ingredient of Delepsine in the following countries:

• Denmark

International Drug Name Search

Tylvalosin Tartrate

Tylvalosin Tartrate may be available in the countries listed below.

Ingredient matches for Tylvalosin Tartrate

Tylvalosin

Tylvalosin Tartrate (USAN) is also known as Tylvalosin (Rec.INN)

International Drug Name Search

Glossary

Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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

Glutamic Acid

In the US, Glutamic Acid is a member of the following drug classes: miscellaneous GI agents, nutraceutical products.

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0000056-86-0

Chemical Formula

C5-H9-N-O4

Molecular Weight

147

Therapeutic Category

Amino acid

Chemical Name

Glutamic acid

Foreign Names

• Acidum glutamicum (Latin)
• Glutaminsäure (German)
• Acide glutamique (French)
• Acido glutamico (Spanish)

Generic Names

• Acide glutamique (OS: DCF)
• Acido glutamico (OS: DCIT)
• Glutamic Acid (OS: USAN)
• 10549-13-0 (IS)
• 138-16-9 (IS)
• 6899-05-4 (IS)
• Acido glutammico (IS)
• E 620 (IS: E Number)
• Glu (IS)
• Acidum glutamicum (PH: Ph. Eur. 6)
• Glutamic Acid (PH: BP 2010, USP 30, Ph. Eur. 6)
• Glutaminsäure (PH: Ph. Eur. 6)
• Glutamique (acide) (PH: Ph. Eur. 6)
• Acigluminum (IS)
• Glutamic Acid Hydrochloride (PH: NF XIII)
• Glutaminsäurehydrochlorid (PH: DAB 2007)
• Magnesium Glutamate (IS)
• Magnesium L-hydrogenglutamate (IS)
• Magnesiumbis (IS: hydrogen-L-glutamat)

Brand Names

• Glutamin Verla
  Verla, Germany



• Gluti-Agil
  Riemser, Germany



• Hypochylin
  Recip, Finland



• Neuroglutamin Dr. Fischer
  Pharmonta, Austria



• Hypochylin
  Recip, Sweden



• Pepsaletten
  Cheplapharm, Germany



• Psicosoma Solucion (Glutamic Acid and Promethazine)
  Ferrer, Spain



• Magnesium Verla i.v./i.m.
  Verla, Germany

International Drug Name Search

Glossary

DCF	Dénomination Commune Française
DCIT	Denominazione Comune Italiana
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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

Lanarif

Lanarif may be available in the countries listed below.

Ingredient matches for Lanarif

Rifampicin

Rifampicin is reported as an ingredient of Lanarif in the following countries:

• Indonesia

International Drug Name Search

Glycerinzäpfchen Sanova

Glycerinzäpfchen Sanova may be available in the countries listed below.

Ingredient matches for Glycerinzäpfchen Sanova

Glycerol

Glycerol is reported as an ingredient of Glycerinzäpfchen Sanova in the following countries:

• Austria

International Drug Name Search

Flunixin

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

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0038677-85-9

Chemical Formula

C14-H11-F3-N2-O2

Molecular Weight

296

Therapeutic Categories

Analgesic, antipyretic and anti-inflammatory agent

Non-steroidal anti-inflammatory drug, NSAID

Chemical Name

3-Pyridinecarboxylic acid, 2-[[2-methyl-3-(trifluoromethyl)phenyl]amino]-

Foreign Names

• Flunixinum (Latin)
• Flunixin (German)
• Flunixine (French)
• Flunixino (Spanish)

Generic Names

• Flunixin (OS: BAN, USAN)
• Sch 14714 (IS: Schering)
• Flunixin Meglumine (OS: USAN, BANM)
• Flunixine, comp. with N-methylglucamine (IS)
• Sch 14714 Meglumine (IS: Schering)
• Flunixin Meglumine (PH: USP 32, BP vet. 2007)
• Flunixin Meglumine for vet. use (PH: Ph. Eur. 6)
• Flunixini megluminum ad usum veterinarium (PH: Ph. Eur. 6)

Brand Names

• Cronyxin (veterinary use)
  Cross Vetpharm, Poland



• Flunixin Norbrook (veterinary use)
  Norbrook, Austria



• Flunixina (veterinary use)
  Norbrook, Portugal



• Alivios (veterinary use)
  Fatro, Italy



• Avlezan (veterinary use)
  Virbac, France



• Banamine (veterinary use)
  Schering-Plough Animal Health, United States



• Bedozane (veterinary use)
  Eurovet, Belgium; Eurovet, Netherlands



• Binixin (veterinary use)
  Bayer Animal, Netherlands; Bayer Animal Health, Belgium; Bayer Animal Health, United Kingdom; Bayer Animal Health, Luxembourg



• Covunil (Flunixin and Oxytetracycline (veterinary use))
  Merial, France



• Cronyxin (veterinary use)
  Bimeda, United Kingdom; Bimeda, Ireland; CEVA Vetpharma, Sweden



• Equibos (veterinary use)
  Serumber, Germany



• Finadyne (veterinary use)
  Essex, Austria; Essex Tierarzneimittel, Germany; Galena, Finland; Intervet, France; Schering-Plough, Ireland; Schering-Plough, Sweden; Schering-Plough Animal, Luxembourg; Schering-Plough Animal, Norway; Schering-Plough Animal Health, Australia; Schering-Plough Animal Health, Belgium; Schering-Plough Animal Health, South Africa; Schering-Plough Vet, Italy; Schering-Plough Vet, Netherlands; Schering-Plough Veterinária, Lda, Portugal; Schering-Plough Veterinary, United Kingdom; Veterinaria, Switzerland



• Finoxaline (Flunixin and Oxytetracycline (veterinary use))
  Intervet, France



• Flogend (veterinary use)
  Intervet, Italy



• Flumav (veterinary use)
  Mavlab, Australia



• Flumeg (veterinary use)
  Selecta, Germany



• Flunamine (veterinary use)
  Bayer Sanità Animale, Italy



• Flunazine (veterinary use)
  Cross Vetpharm, United States



• Flunidol (veterinary use)
  CP-Pharma, Germany



• Flunifen (veterinary use)
  Vetem, Italy



• Fluniveto (veterinary use)
  Norbrook, Luxembourg; V.M.D, Belgium



• Flunix (veterinary use)
  Bomac, New Zealand; Bomac Animal Health, Australia



• Flunixil (veterinary use)
  Ilium Veterinary Products, Australia



• Fluniximin (veterinary use)
  Gräub, Switzerland



• Flunixin Meglumine (veterinary use)
  Agri Laboratories, United States; Fort Dodge Animale Health, United States; IVX, United States



• Flunixin N-Vet (veterinary use)
  N-vet, Sweden



• Flunixin (veterinary use)
  Axience, France; Biovet, Norway; Norbrook, United Kingdom; Norbrook, Ireland; Norbrook, New Zealand; Norbrook, United States; VAAS, Italy; Vet Medic, Finland



• Flunixine Biokema (veterinary use)
  Biokema, Switzerland



• Flunixine (veterinary use)
  Norbrook, Netherlands



• Flunixon (veterinary use)
  Norbrook Laboratories Australia, Australia



• Fluximine (veterinary use)
  Bomac, New Zealand; Bomac Animal Health, Australia



• Hexasol (Flunixin and Oxytetracycline (veterinary use))
  Norbrook, South Africa; Norbrook Laboratories Australia, Australia



• Meflosyl (veterinary use)
  Fort Dodge, Belgium; Fort Dodge, Germany; Fort Dodge, United Kingdom; Fort Dodge, Italy; Fort Dodge, Netherlands; Fort Dodge, Portugal; Fort Dodge Animal Health, Austria; Fort Dodge Santé Animale, France; Interchem, Ireland; Scanvet, Finland



• Niglumine (veterinary use)
  Bio98, Italy; Calier, Portugal



• Paraflunixin (veterinary use)
  IDT, Germany



• Pyroflam (veterinary use)
  Norbrook, South Africa



• Resflor (Flunixin and Florfenicole (veterinary use))
  Essex Tierarzneimittel, Germany; Intervet, Austria; Intervet, France; Veterinaria, Switzerland



• Resprixin (veterinary use)
  Intervet, United Kingdom

International Drug Name Search

Glossary

BAN	British Approved Name
BANM	British Approved Name (Modified)
IS	Inofficial Synonym
OS	Official Synonym
PH	Pharmacopoeia Name
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name

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

Sertralin Copyfarm

Sertralin Copyfarm may be available in the countries listed below.

Ingredient matches for Sertralin Copyfarm

Sertraline

Sertraline hydrochloride (a derivative of Sertraline) is reported as an ingredient of Sertralin Copyfarm in the following countries:

• Denmark


• Finland

International Drug Name Search

Azitromin

Azitromin may be available in the countries listed below.

Ingredient matches for Azitromin

Azithromycin

Azithromycin is reported as an ingredient of Azitromin in the following countries:

• Brazil

Azithromycin dihydrate (a derivative of Azithromycin) is reported as an ingredient of Azitromin in the following countries:

• Venezuela

International Drug Name Search

Miltefosine

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

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

L01XX09

CAS registry number (Chemical Abstracts Service)

0058066-85-6

Chemical Formula

C21-H46-N-O4-P

Molecular Weight

407

Therapeutic Category

Antineoplastic agent

Chemical Name

Choline hydroxide, hexadecyl hydrogen phosphate, inner salt

Foreign Names

• Miltefosinum (Latin)
• Miltefosin (German)
• Miltefosine (French)
• Miltefosina (Spanish)

Generic Names

• Miltefosine (OS: BAN)
• D-18506 (IS)
• HDPC (IS)
• Hexadecylphosphocholine (IS)

Brand Names

• Impavido
  Paladin Labs, Germany; Tecnofarma, Colombia



• Milteforan (veterinary use)
  Virbac, Switzerland



• Miltex
  Baxter, Austria; Baxter, Chile; Baxter, France; Baxter, Israel; Baxter, Romania; Baxter, Sweden; Baxter Oncology, Germany; Baxter Oncology, Singapore; Baxter-RM, Italy; Irinol Farma, Spain

International Drug Name Search

Glossary

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

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

Socatil

Socatil may be available in the countries listed below.

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

Ingredient matches for Socatil

Formosulfathiazole

Formosulfathiazole is reported as an ingredient of Socatil in the following countries:

• Italy

International Drug Name Search

Mixobar

Mixobar may be available in the countries listed below.

Ingredient matches for Mixobar

Barium Sulfate

Barium Sulfate is reported as an ingredient of Mixobar in the following countries:

• Finland

International Drug Name Search

Streptocombin

Streptocombin may be available in the countries listed below.

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

Ingredient matches for Streptocombin

Benzylpenicillin

Benzylpenicillin monohydrate (a derivative of Benzylpenicillin) is reported as an ingredient of Streptocombin in the following countries:

• Germany

Dihydrostreptomycin

Dihydrostreptomycin sulfate (a derivative of Dihydrostreptomycin) is reported as an ingredient of Streptocombin in the following countries:

• Germany

International Drug Name Search

Desorelle

Desorelle may be available in the countries listed below.

Ingredient matches for Desorelle

Desogestrel

Desogestrel is reported as an ingredient of Desorelle in the following countries:

• Belgium


• Denmark

Ethinylestradiol

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

• Belgium


• Brazil


• Denmark

International Drug Name Search

Suxa

Suxa may be available in the countries listed below.

Ingredient matches for Suxa

Suxamethonium Chloride

Suxamethonium Chloride is reported as an ingredient of Suxa in the following countries:

• Bangladesh

International Drug Name Search

Aspen Ceftriaxone

Aspen Ceftriaxone may be available in the countries listed below.

Ingredient matches for Aspen Ceftriaxone

Ceftriaxone

Ceftriaxone is reported as an ingredient of Aspen Ceftriaxone in the following countries:

• South Africa

International Drug Name Search

Asmolex

Asmolex may be available in the countries listed below.

Ingredient matches for Asmolex

Salbutamol

Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Asmolex in the following countries:

• Bangladesh

International Drug Name Search

Terbano

Terbano may be available in the countries listed below.

Ingredient matches for Terbano

Terbinafine

Terbinafine is reported as an ingredient of Terbano in the following countries:

• Lithuania

International Drug Name Search

Hexachlorophene

Scheme

Rec.INN

ATC (Anatomical Therapeutic Chemical Classification)

D08AE01

CAS registry number (Chemical Abstracts Service)

0000070-30-4

Chemical Formula

C13-H6-Cl6-O2

Molecular Weight

406

Therapeutic Categories

Antiseptic

Disinfectant

Chemical Name

Phenol, 2,2'-methylenebis[3,4,6-trichloro-

Foreign Names

• Hexachlorophenum (Latin)
• Hexachlorophen (German)
• Hexachlorophène (French)
• Hexaclorofeno (Spanish)

Generic Names

• Hexachlorophene (OS: BAN)
• Hexachlorophène (OS: DCF)
• Hexachlorophane (IS)
• Surofene (IS)
• Hexachlorophene (PH: USP 32, BP 2010)

Brand Names

• Dermisan
  Armoxindo, Indonesia



• pHisoHex
  sanofi-aventis, Canada; sanofi-aventis, United States



• Pre-Op
  Davis and Geck, United States

International Drug Name Search

Glossary

BAN	British Approved Name
DCF	Dénomination Commune Française
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.

Asthma

Asthma may be available in the countries listed below.

Ingredient matches for Asthma

Diprophylline

Diprophylline is reported as an ingredient of Asthma in the following countries:

• Japan

Methoxyphenamine

Methoxyphenamine is reported as an ingredient of Asthma in the following countries:

• Japan

International Drug Name Search

Cleiton

Cleiton may be available in the countries listed below.

Ingredient matches for Cleiton

Hydrocortisone

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

• Japan

International Drug Name Search

Clarifast

Clarifast may be available in the countries listed below.

Ingredient matches for Clarifast

Clarithromycin

Clarithromycin is reported as an ingredient of Clarifast in the following countries:

• Myanmar

International Drug Name Search

Acnisal

In the US, Acnisal is a member of the following drug classes: topical acne agents, topical keratolytics and is used to treat Acne and Dermatological Disorders.

UK matches:

• Acnisal (SPC)

Ingredient matches for Acnisal

Salicylic Acid

Salicylic Acid is reported as an ingredient of Acnisal in the following countries:

• Ireland


• United Kingdom

International Drug Name Search

Glossary

SPC	Summary of Product Characteristics (UK)

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

Deratin

Deratin may be available in the countries listed below.

Ingredient matches for Deratin

Chlorhexidine

Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Deratin in the following countries:

• Spain

International Drug Name Search

Co-Trimoxazol Merck

Co-Trimoxazol Merck may be available in the countries listed below.

Ingredient matches for Co-Trimoxazol Merck

Sulfamethoxazole

Sulfamethoxazole is reported as an ingredient of Co-Trimoxazol Merck in the following countries:

• Netherlands

Trimethoprim

Trimethoprim is reported as an ingredient of Co-Trimoxazol Merck in the following countries:

• Netherlands

International Drug Name Search

Mucolitic

Mucolitic may be available in the countries listed below.

Ingredient matches for Mucolitic

Carbocisteine

Carbocisteine is reported as an ingredient of Mucolitic in the following countries:

• Argentina


• Brazil

International Drug Name Search

Atormin

Atormin may be available in the countries listed below.

Ingredient matches for Atormin

Atenolol

Atenolol is reported as an ingredient of Atormin in the following countries:

• Bahrain


• Oman

International Drug Name Search

Adco-Loperamide

Adco-Loperamide may be available in the countries listed below.

Ingredient matches for Adco-Loperamide

Loperamide

Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Adco-Loperamide in the following countries:

• South Africa

International Drug Name Search

Esonide

Esonide may be available in the countries listed below.

Ingredient matches for Esonide

Budesonide

Budesonide is reported as an ingredient of Esonide in the following countries:

• Greece


• Malta


• Singapore

International Drug Name Search

Mequitolide

Mequitolide may be available in the countries listed below.

Ingredient matches for Mequitolide

Mexiletine

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

• Japan

International Drug Name Search

Salilax

Salilax may be available in the countries listed below.

Ingredient matches for Salilax

Magnesium Oxide

Magnesium Oxide is reported as an ingredient of Salilax in the following countries:

• Denmark

Magnesium Oxide light (a derivative of Magnesium Oxide) is reported as an ingredient of Salilax in the following countries:

• Sweden

International Drug Name Search

Subsalicilato de Bismuto

Subsalicilato de Bismuto may be available in the countries listed below.

Ingredient matches for Subsalicilato de Bismuto

Bismuth Subsalicylate

Bismuth Subsalicylate is reported as an ingredient of Subsalicilato de Bismuto in the following countries:

• Peru

International Drug Name Search

Fluor Crinex

Fluor Crinex may be available in the countries listed below.

Ingredient matches for Fluor Crinex

Sodium Fluoride

Sodium Fluoride is reported as an ingredient of Fluor Crinex in the following countries:

• France

International Drug Name Search

Carmellose Sodium

Carmellose Sodium may be available in the countries listed below.

Ingredient matches for Carmellose Sodium

Carmellose

Carmellose Sodium (BANM, JAN) is also known as Carmellose (Rec.INN)

International Drug Name Search

Glossary

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

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

Razoxane

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0021416-87-5

Chemical Formula

C11-H16-N4-O4

Molecular Weight

268

Therapeutic Category

Antineoplastic agent, antimitotic

Chemical Name

(±)-4,4'-Propylenedi-2,6-piperazinedione

Foreign Names

• Razoxanum (Latin)
• Razoxan (German)
• Razoxane (French)
• Razoxano (Spanish)

Generic Names

• Razoxane (OS: BAN)
• ICI 59118 (IS)
• ICRF 159 (IS)
• NSC 129943 (IS)
• Propylendiamintetraessigsäure-diimid (IS)

Brand Name

• Cardioxane
  Tecnofarma, Chile

International Drug Name Search

Glossary

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

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

Normix

Normix may be available in the countries listed below.

Ingredient matches for Normix

Rifaximin

Rifaximin is reported as an ingredient of Normix in the following countries:

• Czech Republic


• Hungary


• Italy


• Romania


• Russian Federation


• Slovakia


• Tunisia

International Drug Name Search

Alendronat 1A Pharma

Alendronat 1A Pharma may be available in the countries listed below.

Ingredient matches for Alendronat 1A Pharma

Alendronic Acid

Alendronic Acid is reported as an ingredient of Alendronat 1A Pharma in the following countries:

• Slovakia

International Drug Name Search

Wokadine

Wokadine may be available in the countries listed below.

Ingredient matches for Wokadine

Povidone Iodine

Povidone-Iodine is reported as an ingredient of Wokadine in the following countries:

• Botswana


• Ghana


• India


• Kenya


• Malawi


• Myanmar


• Namibia


• Russian Federation


• Sri Lanka


• Sudan


• Tanzania


• Uganda


• Zambia

International Drug Name Search

Renvela Powder Packets

Pronunciation: se-VEL-a-mer
Generic Name: Sevelamer
Brand Name: Renvela

Renvela Powder Packets are used for:

Reducing the amount of phosphorus in the blood in patients with chronic kidney disease who are on dialysis.

Renvela Powder Packets are a phosphate binder. It works by binding with phosphate in the digestive tract, which decreases the amount of phosphate absorbed into the body.

Do NOT use Renvela Powder Packets if:

• you are allergic to any ingredient in Renvela Powder Packets


• you have a blockage of your bowels

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

Before using Renvela Powder Packets:

Some medical conditions may interact with Renvela Powder Packets. 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 difficulty swallowing, certain stomach or bowel problems (eg, severe constipation), or you have had stomach or bowel surgery


• if you have low blood phosphate levels


• if you take medicines for irregular heartbeat, seizures, or thyroid problems

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

• Ciprofloxacin because its effectiveness may be decreased by Renvela Powder Packets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Renvela Powder Packets 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 Renvela Powder Packets:

Use Renvela Powder Packets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Renvela Powder Packets with meals.


• Place the entire contents of each powder packet in a cup and mix thoroughly with the correct amount of water. Multiple packets may be mixed together with the appropriate amount of water. Check with your doctor if you have questions about how much water to add.


• The powder does not dissolve and, therefore, it should be stirred vigorously just before drinking. The entire preparation should be consumed within 30 minutes.


• Renvela Powder Packets may bind with other medicines, reducing the amount your body can absorb and use. If you are taking other medicines, your doctor may want you to take them 1 hour before or 3 hours after taking Renvela Powder Packets. Contact your doctor if you have questions about when to take your dose.


• Continue to take Renvela Powder Packets even if you feel well. Do not miss any doses.


• If you miss a dose of Renvela Powder Packets, 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 Renvela Powder Packets.

Important safety information:

• Renvela Powder Packets may reduce certain vitamins in your body. Check with your doctor about whether or not you should take a vitamin supplement while you take Renvela Powder Packets.


• Follow the diet program given to you by your health care provider.


• Lab tests, including calcium, bicarbonate, phosphate, and chloride blood levels, may be performed while you use Renvela Powder Packets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.


• Renvela Powder Packets should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Renvela Powder Packets while you are pregnant. It is not known if Renvela Powder Packets are found in breast milk. If you are or will be breast-feeding while you use Renvela Powder Packets, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Renvela Powder Packets:

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; gas; indigestion; mild stomach pain; nausea; vomiting.

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); severe or persistent constipation or stomach pain.

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. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Renvela 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.

Proper storage of Renvela Powder Packets:

Store Renvela Powder Packets at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Do not use after the expiration date. Keep Renvela Powder Packets out of the reach of children and away from pets.

General information:

• If you have any questions about Renvela Powder Packets, please talk with your doctor, pharmacist, or other health care provider.


• Renvela Powder Packets are 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 Renvela Powder Packets. 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

Copyright © 2012 Wolters Kluwer Health, Inc.

More Renvela resources

• Renvela Side Effects (in more detail)
• Renvela Use in Pregnancy & Breastfeeding
• Drug Images
• Renvela Drug Interactions
• Renvela Support Group
• 1 Review for Renvela - Add your own review/rating

Compare Renvela with other medications

• Hyperphosphatemia of Renal Failure

Starpod-Kid

Starpod-Kid may be available in the countries listed below.

Ingredient matches for Starpod-Kid

Cefpodoxime

Cefpodoxime is reported as an ingredient of Starpod-Kid in the following countries:

• India

International Drug Name Search

Ceruletide Diethylamine

Ceruletide Diethylamine may be available in the countries listed below.

Ingredient matches for Ceruletide Diethylamine

Ceruletide

Ceruletide Diethylamine (BANM, USAN) is also known as Ceruletide (Rec.INN)

International Drug Name Search

Glossary

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

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

Bisoprolol comp. AbZ

Bisoprolol comp. AbZ may be available in the countries listed below.

Ingredient matches for Bisoprolol comp. AbZ

Bisoprolol

Bisoprolol fumarate (a derivative of Bisoprolol) is reported as an ingredient of Bisoprolol comp. AbZ in the following countries:

• Germany

Hydrochlorothiazide

Hydrochlorothiazide is reported as an ingredient of Bisoprolol comp. AbZ in the following countries:

• Germany

International Drug Name Search