Chemiderm may be available in the countries listed below.
Terbinafine hydrochloride (a derivative of Terbinafine) is reported as an ingredient of Chemiderm in the following countries:
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Orazole may be available in the countries listed below.
Omeprazole is reported as an ingredient of Orazole in the following countries:
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PMS-Chloral Hydrate may be available in the countries listed below.
Chloral Hydrate is reported as an ingredient of PMS-Chloral Hydrate in the following countries:
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Bezafibrat-CT may be available in the countries listed below.
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Brimonidine tartrate ophthalmic solution, 0.2% is a relatively selective alpha-2 adrenergic agonist for ophthalmic use. The chemical name of Brimonidine tartrate is 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate. It has a molecular weight of 442.24 as the tartrate salt and is water soluble (34 mg/mL) at pH 6.5. The structural formula is:
In solution, Brimonidine tartrate ophthalmic solution, 0.2% has a clear, greenish-yellow color. It has an osmolality of 280-330 mOsml/kg and a pH of 5.6-6.6.
Each mL of Brimonidine tartrate ophthalmic solution, 0.2% contains: Active ingredient: Brimonidine tartrate: 0.2% (2 mg/mL). Preservative: benzalkonium chloride (0.05 mg). Inactives: citric acid; polyvinyl alcohol; sodium chloride; sodium citrate; and purified water. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.
Brimonidine tartrate ophthalmic solution, 0.2% is an alpha adrenergic receptor agonist. It has a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that Brimonidine tartrate has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow.
After ocular administration of a 0.2% solution, plasma concentrations peaked within 1 to 4 hours and declined with a systemic half-life of approximately 3 hours. In humans, systemic metabolism of Brimonidine is extensive.
It is metabolized primarily by the liver. Urinary excretion is the major route of elimination of the drug and its metabolites. Approximately 87% of an orally-administered radioactive dose was eliminated within 120 hours, with 74% found in the urine.
Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. Brimonidine tartrate has the action of lowering intraocular pressure with minimal effect on cardiovascular and pulmonary parameters.
In comparative clinical studies with timolol 0.5%, lasting up to one year, the IOP lowering effect of Brimonidine tartrate was approximately 4-6 mm Hg compared with approximately 6 mm Hg for timolol. In these studies, both patient groups were dosed BID; however, due to the duration of action of Brimonidine tartrate ophthalmic solution, 0.2%, it is recommended that Brimonidine tartrate ophthalmic solution, 0.2% be dosed TID. Eight percent of subjects were discontinued from studies due to inadequately controlled intraocular pressure, which in 30% of these patients occurred during the first month of therapy.
Approximately 20% were discontinued due to adverse experiences.
Brimonidine tartrate ophthalmic solution, 0.2% is indicated for lowering intraocular pressure in patients with open-angle glaucoma or ocular hypertension. The IOP lowering efficacy of Brimonidine tartrate ophthalmic solution, 0.2% diminishes over time in some patients. This loss of effect appears with a variable time of onset in each patient and should be closely monitored.
Brimonidine tartrate ophthalmic solution, 0.2% is contraindicated in patients with hypersensitivity to Brimonidine tartrate or any component of this medication. It is also contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.
Although Brimonidine tartrate ophthalmic solution, 0.2% had minimal effect on blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.
Brimonidine tartrate ophthalmic solution, 0.2% has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.
Brimonidine tartrate ophthalmic solution, 0.2% should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension or thromboangiitis obliterans.
During the studies there was a loss of effect in some patients. The IOP-lowering efficacy observed with Brimonidine tartrate ophthalmic solution, 0.2% during the first month of therapy may not always reflect the long-term level of IOP reduction. Patients prescribed IOP-lowering medication should be routinely monitored for IOP.
The preservative in Brimonidine tartrate ophthalmic solution, 0.2%, benzalkonium chloride, may be absorbed by soft contact lenses. Patients wearing soft contact lenses should be instructed to wait at least 15 minutes after instilling Brimonidine tartrate ophthalmic solution, 0.2% to insert soft contact lenses.
As with other drugs in this class, Brimonidine tartrate ophthalmic solution, 0.2% may cause fatigue and/or drowsiness in some patients. Patients who engage in hazardous activities should be cautioned of the potential for a decrease in mental alertness.
Although specific drug interaction studies have not been conducted with Brimonidine tartrate ophthalmic solution, 0.2%, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered. Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in using concomitant drugs such as beta-blockers (ophthalmic and systemic), antihypertensives and/or cardiac glycosides is advised.
Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with Brimonidine tartrate ophthalmic solution, 0.2% in humans can lead to resulting interference with the IOP lowering effect. No data on the level of circulating catecholamines after Brimonidine tartrate ophthalmic solution, 0.2% are available. Caution, however, is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.
No compound-related carcinogenic effects were observed in either mice or rats following a 21-month and 24-month study, respectively. In these studies, dietary administration of Brimonidine tartrate at doses up to 2.5 mg/kg/day in mice and 1.0 mg/kg/day in rats achieved ~77 and 118 times, respectively, the plasma drug concentration estimated in humans treated with one drop Brimonidine tartrate ophthalmic solution, 0.2% into both eyes 3 times per day.
Brimonidine tartrate was not mutagenic or cytogenic in a series of in vitro and in vivo studies including the Ames test, chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells, a host-mediated assay and cytogenic studies in mice, and dominant lethal assay.
Reproductive studies performed in rats with oral doses of 0.66 mg base/kg revealed no evidence of harm to the fetus due to Brimonidine tartrate ophthalmic solution, 0.2%.
Pregnancy Category B.
Reproduction studies performed in rats with oral doses of 0.66 mg base/kg revealed no evidence of harm to the fetus due to Brimonidine tartrate ophthalmic solution, 0.2%. Dosing at this level produced 100 times the plasma drug concentration level seen in humans following multiple ophthalmic doses.
There are no adequate and well-controlled studies in pregnant women. In animal studies, Brimonidine crossed the placenta and entered into the fetal circulation to a limited extent. Brimonidine tartrate ophthalmic solution, 0.2% should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
It is not known whether this drug is excreted in human milk; in animal studies, Brimonidine tartrate was excreted in breast milk. 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.
In a well-controlled clinical study conducted in pediatric glaucoma patients (ages 2 to 7 years) the most commonly observed adverse events with Brimonidine tartrate ophthalmic solution, 0.2% dosed three times daily were somnolence (50%-83% in patients ages 2 to 6 years) and decreased alertness. In pediatric patients 7 years of age or older (>20kg), somnolence appears to occur less frequently (25%). The most commonly observed adverse event was somnolence. Approximately 16% of patients on Brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence.
The safety and effectiveness of Brimonidine tartrate ophthalmic solution, 0.2% have not been studied in pediatric patients below the age of 2 years. Brimonidine tartrate ophthalmic solution, 0.2% is not recommended for use in pediatric patients under the age of 2 years. (Also refer to Adverse Reactions section).
No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Adverse events occurring in approximately 10-30% of the subjects, in descending order of incidence, included oral dryness, ocular hyperemia, burning and stinging, headache, blurring, foreign body sensation, fatigue/drowsiness, conjunctival follicles, ocular allergic reactions, and ocular pruritus.
Events occurring in approximately 3-9% of the subjects, in descending order included corneal staining/erosion, photophobia, eyelid erythema, ocular ache/pain, ocular dryness, tearing, upper respiratory symptoms, eyelid edema, conjunctival edema, dizziness, blepharitis, ocular irritation, gastrointestinal symptoms, asthenia, conjunctival blanching, abnormal vision and muscular pain.
The following adverse reactions were reported in less than 3% of the patients: lid crusting, conjunctival hemorrhage, abnormal taste, insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal dryness and syncope.
The following events have been identified during post-marketing use of Brimonidine tartrate ophthalmic solution, 0.2% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to Brimonidine tartrate ophthalmic solution, 0.2%, or a combination of these factors, include: bradycardia; hypotension; iritis; miosis; skin reactions (including erythema, eyelid pruritus, rash, and vasodilation); and tachycardia. Apnea, bradycardia, hypotension, hypothermia, hypotonia, and somnolence have been reported in infants receiving Brimonidine tartrate ophthalmic solution, 0.2%.
No information is available on overdosage in humans. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.
The recommended dose is one drop of Brimonidine tartrate ophthalmic solution, 0.2% in the affected eye(s) three times daily, approximately 8 hours apart.
Brimonidine tartrate ophthalmic solution, 0.2% may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.
Brimonidine tartrate ophthalmic solution, 0.2% is supplied sterile in white opaque LDPE plastic dropper bottles with tips with purple polypropylene caps as follows:
5 mL in 5 mL bottle NDC 61314-143-05
10 mL in 10 mL bottle NDC 61314-143-10
15 mL in 15 mL bottle NDC 61314-143-15
NOTE: Store between 15°-25°C (59°-77°F).
Rx Only
9002760-0707
Mfd for:
FALCON Pharmaceuticals, Ltd.
Fort Worth, Texas 76134
Mfd by:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134
NDC 61314-143-10 Rx Only
FALCON PHARMACEUTICALS®
Brimonidine
Tartrate
Ophthalmic
Solution
FOR TOPICAL OPHTHALMIC
USE ONLY
0.2%
10 mL STERILE
AFFILIATE OF
ALCON LABORATORIES, INC.
QUALITY RX
| Brimonidine TARTRATE Brimonidine tartrate solution | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| ANDA | ANDA076254 | 09/17/2003 | |
| Labeler - Falcon Pharmaceuticals, Ltd. (874345820) |
| Registrant - Alcon Laboratories, Inc. (008018525) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Alcon Laboratories, Inc. | 008018525 | MANUFACTURE | |
Antalgin Corsa may be available in the countries listed below.
Metamizole sodium anhydrous (a derivative of Metamizole) is reported as an ingredient of Antalgin Corsa in the following countries:
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Doridon may be available in the countries listed below.
Domperidone is reported as an ingredient of Doridon in the following countries:
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Migränin Phenazon may be available in the countries listed below.
Phenazone is reported as an ingredient of Migränin Phenazon in the following countries:
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Gevit may be available in the countries listed below.
Ascorbic Acid is reported as an ingredient of Gevit in the following countries:
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Diclofenac AL may be available in the countries listed below.
Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Diclofenac AL in the following countries:
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Generic Name: tolnaftate topical (toll NAF tate)
Brand Names: Absorbine Athletes Foot, Absorbine Jr. Antifungal, Aftate For Athletes Foot, Blis-To-Sol, Desenex Spray, Fungatin, Fungi-Guard, Genaspor, Hongos, NP 27, Podactin, T-Athlete, Tinactin, Tinaspore, Ting
Tolnaftate topical is an antifungal medication. Tolnaftate topical prevents fungus from growing on the skin.
Tolnaftate topical is used to treat skin infections such as athlete's foot, jock itch, and ringworm infections. Tolnaftate is also used, along with other antifungals, to treat infections of the nails, scalp, palms, and soles of the feet. The powder and powder aerosol may be used to prevent athlete's foot.
Tolnaftate topical may also be used for purposes other than those listed in this medication guide.
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).
Do not use tolnaftate topical if you have had an allergic reaction to it in the past.
Wash your hands before and after using this medication.
Clean and dry the affected area. Apply the gel, cream, lotion, spray, or powder twice daily as directed for 2 to 6 weeks.
If the infection does not clear up in 10 days 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.
Apply the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the dose you missed and apply only the regular amount of tolnaftate topical. Do not use a double dose unless otherwise directed by your doctor.
An overdose of tolnaftate topical is unlikely to occur. If you do suspect that a much larger than normal dose has been used or that tolnaftate topical has been ingested, contact an emergency room or a poison control center.
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.
Serious side effects of tolnaftate topical use are not expected to occur. Stop using tolnaftate 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.
Other skin medications may affect the absorption or effectiveness of tolnaftate topical. Avoid using other topicals at the same time except under the direction of a doctor.
See also: Desenex side effects (in more detail)
Ramol may be available in the countries listed below.
Paracetamol is reported as an ingredient of Ramol in the following countries:
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Lorin may be available in the countries listed below.
Loratadine is reported as an ingredient of Lorin in the following countries:
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Insuman Infusat may be available in the countries listed below.
Insulin Injection, Soluble human (a derivative of Insulin Injection, Soluble) is reported as an ingredient of Insuman Infusat in the following countries:
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