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Brimopress

Al-Tinez Visions Limited
9, Olowogbowo Str off Obokun Str by Coker Rd, Ilupeju, Lagos
Email: altinezvisions@gmail.com
Tel: 01-7418609, 08296588658, 0708900917

Brand Name

Brimopress

Manufacturer

CENTAUR PHARMACEUTICALS PVT. LTD. Plant 1, Plot No. 3, Tivim Industrial Estate, Karaswada, Mapusa Goa-403 S26, INDIA.

Therapeutic Class

Antiglaucoma preparations and Miotics

Dosage Form, Composition & NAFDAC Registration Number (NRN)

Drops (NRN:B4-3082): Brimonidine Tartrate 0.2% w/v Polyvinyl Alcohol USP 1.4% w/v Preservative Benzalkonium Chloride Solution BP 0.01% w/v Water for Injection BP q.s.

Pack size: Brimopress supplied sterile in 5 mL plastic (lupolen) dropper bottles

Brimopress

Pharmacology

Mechanism of action:

Brimopress is an alpha-adrenergic receptor agonist. It has a peak ocular hypotensive effect occurring at two hours post-doing. 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.

Pharmacokinetics:

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. Primarily the liver metabolizes it.

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.

Indications

Brimopress is indicated for lowering intraocular pressure in patients with open angle glaucoma or ocular hypertension.

The IOP lowering efficacy of Brimopress Eye Drops diminishes over time in some patients.

This loss or effect appears with a variable time of onset in each patient and should be closely monitored.

Contra-indications

Brimopress 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.

Precautions/Warnings

General:

Although Brimopress had minimal effect on blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.

Brimopress has not been studied in patients with hepatic or renal impairment; caution should be taken in treating such patients.

Brimopress 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 toss of effect in some patients.

The IOP-lowering efficacy observed with Brimopress, Eye Drops during the first month of therapy may not always reflect the long-term level of IOP reduction. Patient’s prescribed IOP-lowering medication should be routinely monitored for IOP.

Information for Patients:

The preservable in Brimoprees, 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.

Brimopress to insert soft contact lenses.

As with other drugs in this Class, Brimopress 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.

Interactions

Although specific drug interaction studies have not been conducted with Brimopress, 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 Brimopress, in humans can lead to resulting interference with the IOP lowering effect. No date on the level of circulating catecholamines after Brimopress instillation are available.

Caution, however, is advised in patients taking tricyclic antidepressants, which can affect the metabolism and uptake of circulating amines.

Carcinogenesis, Mutagenesis, impairment of fertility: 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 ofBrimonidine Tartrate at doses up to 2.5 mg/kg/day in mice and 1.0 day in rats achieved -77 and 118 times, respectively, the plasma drug concentration estimated in humans treated with one drop Brimopress into both eyes 3 times per day.

Brimonidine Tartrate was not mutagenic or cytogenic in a series of in vitro in vivo studies including the Ames test, chromosomal aberration assay in Chinese Hamster Ovary (CHO) cell, 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 impaired fertility due to Brimopress.

Pregnancy: Teratogenic Effects: Reproductive studies performed in rats with oral doses of 0.66 mg base/kg revealed no evidence of harm to the fetus due to Brimopress. 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 woman. In animal studies, Brimonidine crossed the placenta and entered into fetal circulation to a limited extent.

Brimopress should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

Nursing Mothers: It is not known whether Brimonidine is excreted in human milk; but in animal studies it 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.

Pediatric Use: The safety and effectiveness of Brimopress have not been studied in pediatric patients below the age of 2 years. Brimopress is not recommended for use in pediatric patients under the age of 2 years.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Adverse Effects

ADVERSE REACTIONS:

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: Iid crusting, conjunctival hemorrhage, abnormal taste, insomnia, conjunctival discharge, depression, hypertension, anxiety, palpitations/arrhythmias, nasal dryness and syncope.

Dosage & Administration

The recommended dose is one drop of Brimopress in the affected eye(s) two times daily.

If the IOP peaks in the afternoon, one additional drop can be instilled in the afternoon.

OVERDOSAGE:

No information is available on overdosage in humans Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

Storage/Handling Recommendations

Store at temperature between 15 - 30°C in a dark place.

Do not freeze.

Keep medicines out of the reach of children.

Review Date

2016-05-10 10:30:13