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Brimonidine Tartrate 0.15% Drops 15 Ml By Sandoz Falcon.

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Brimonidine Tartrate 0.15% Drops 15 Ml By Sandoz Falcon.

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Brimonidine Tartrate 0.15% Drops 15 Ml By Sandoz Falcon. This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXD4252854/RXB10004737/RXA600481
Size : 15 ML
Selling UoM : EA
NDC: 61314-0144-15
UPC Barcode : 361314144157Supplier: 0050001955 SANDOZ/FALCON PHARMA LTD
Supplier Material : 014415
Generic Code : 048333 BRIMONIDINE TARTRATE OPHTHALMIC DROPS 0.
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
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Product Description.:

ALPHAGAN? P (brimonidine tartrate ophthalmic solution) 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 is an off-white to pale yellow powder. It has a molecular weight of 442.24 as the tartrate salt, and is both soluble in water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7.

Active ingredient: brimonidine tartrate 0.1% (1.0 mg/mL) or 0.15% (1.5 mg/mL).

Inactives: sodium carboxymethylcellulose sodium borate boric acid sodium chloride potassium chloride calcium chloride magnesium chloride Purite? 0.005% (0.05mg/mL) as a preservative purified water with hydrochloric acid and/or sodium hydroxide to adjust pH.

INDICATIONS

ALPHAGAN? P is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
DOSAGE AND ADMINISTRATION

The recommended dose is one drop of ALPHAGAN? P in the affected eye(s) three times daily, approximately 8 hours apart.

ALPHAGAN? P ophthalmic solution 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.

SIDE EFFECTS

Adverse events occurring in approximately 10-20% of the subjects receiving brimonidine ophthalmic solution (0.1-0.2%) included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritus. Adverse events occurring in approximately 5-9% included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.

Adverse events occurring in approximately 1-4% of the subjects receiving brimonidine ophthalmic solution (0.1-0.2%) included: allergic reaction, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, fatigue, flu syndrome, follicular conjunctivitis, foreign body sensation, gastrointestinal disorder, headache, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), insomnia, keratitis, lid disorder, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, somnolence, stinging, superficial punctate keratopathy, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity.

The following events were reported in less than 1% of subjects: corneal erosion, hordeolum, nasal dryness, and taste perversion.

The following events have been identified during post-marketing use of brimonidine tartrate ophthalmic solutions 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 solutions, or a combination of these factors, include: bradycardia depression iritis keratoconjunctivitis sicca miosis nausea 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 solutions.
DRUG INTERACTIONS

Although specific drug interaction studies have not been conducted with ALPHAGAN? P , 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 anti-hypertensives and/or cardiac glycosides is advised.