Brimonidine Tartrate (Alphagan P)

Trade Name : ALPHAGAN P

Allergan, Inc.

SOLUTION/ DROPS

Strength 1.5 mg/mL

BRIMONIDINE TARTRATE Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Brimonidine Tartrate (Alphagan P) which is also known as ALPHAGAN P and Manufactured by Allergan, Inc.. It is available in strength of 1.5 mg/mL per ml. Read more

Brimonidine Tartrate (Alphagan P) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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No data

ALPHAGAN
P
1

The recommended dose is one drop of n n in the affected eye(s) three times daily, approximately 8 hours apart. n n ophthalmic solution may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure.u00a0If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart.
One drop in the affected eye(s), three times daily, approximately 8 hours apart. ()

Solution containing 1 mg/mL or 1.5 mg/mL brimonidine tartrate.
Solution containing 1 or 1.5 mg/mL brimonidine tartrate. ()

Neonates and infants (under the age of 2 years). ()

Potentiation of vascular insufficiency. ()nttu00a0u00a0u00a0u00a0u00a0nt

Most common adverse reactions occurring in approximately 5% to 20% of patients receiving brimonidine ophthalmic solution (0.1%-0.2%) included allergic conjunctivitis, burning sensation, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, hypertension, ocular allergic reaction, oral dryness, and visual disturbance. ()

No data

Antihypertensives/cardiac glycosides may lower blood pressure. ()n
Use with CNS depressants may result in an additive or potentiating effect. ()n
Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ()n
Monoamine oxidase inhibitors may result in increased hypotension. ()

Use with caution in children u2265 2 years of age. ()

Very limited information exists on accidental ingestion of brimonidine in adults; the only adverse reaction reported to date has been hypotension. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving n n as part of medical treatment of congenital glaucoma or by accidental oral ingestion (see , 8.4).u00a0Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

ALPHAGANn- Arrayn- P
nttu00a0u00a0u00a0u00a0u00a0nt
The structural formula of brimonidine tartrate is:
5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24
In solution, n n (brimonidine tartrate ophthalmic solution) has a clear, greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a pH of 7.4-8.0 (0.1%) or 6.9-7.4 (0.15%).
Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7.
Each mL of n n contains the active ingredient brimonidine tartrate 0.1% (1 mg/mL) or 0.15% (1.5 mg/mL) with the inactive ingredients sodium carboxymethylcellulose; sodium borate; boric acid; sodium chloride; potassium chloride; calcium chloride; magnesium chloride; PURITE 0.005% (0.05 mg/mL) as a preservative; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH.

No data

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 mg/kg/day in rats achieved 150 and 120 times or 90 and 80 times, respectively, the plasma C drug concentrationu00a0in humans treated with one drop of n n 0.1% oru00a00.15% into both eyes 3 times per day, the recommended daily human dose.
nttu00a0u00a0u00a0u00a0u00a0nt
Brimonidine tartrate was not mutagenic or clastogenic in a series of and studies including the Ames bacterial reversion test, chromosomal aberration assay in Chinese Hamster Ovary (CHO) cells, and three studies in CD-1 mice: a host-mediated assay, cytogenetic study, and dominant lethal assay.
Reproduction and fertility studies in rats with brimonidine tartrate demonstrated no adverse effect on male or female fertility at doses which achieve up to approximately 125 and 90 times the systemic exposure following the maximum recommended human ophthalmic dose of n n 0.1% or 0.15%,respectively.u00a0

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 tartratehas the action of lowering intraocular pressure with minimal effect on cardiovascular and pulmonary parameters.
Clinical studies were conducted to evaluate the safety, efficacy, and acceptability of ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.15% compared with ALPHAGAN administered three-times-daily in patients with open-angle glaucoma or ocular hypertension. Those results indicated that ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.15% is comparable in IOP lowering effect to ALPHAGAN (brimonidine tartrate ophthalmic solution) 0.2%, and effectively lowers IOP in patients with open-angle glaucoma or ocular hypertension by approximately 2-6 mmHg.
A clinical study was conducted to evaluate the safety, efficacy, and acceptability of ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% compared with ALPHAGAN administered three-times-daily in patients with open-angle glaucoma or ocular hypertension. Those results indicated that ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% is equivalent in IOP lowering effect to ALPHAGAN (brimonidine tartrate ophthalmic solution) 0.2%, and effectively lowers IOP in patients with open-angle glaucoma or ocular hypertension by approximately 2-6 mmHg.

ALPHAGANn- Arrayn- P
0.1%
5 mL in 10 mL bottlenttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-9321-05
10 mL in 10 mL bottlenttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-9321-10
15 mL in 15 mL bottlenttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-9321-15
0.15%
5 mL in 10 mL bottlenttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-9177-05
10 mL in 10 mL bottlenttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-9177-10
15 mL in 15 mL bottlenttu00a0u00a0u00a0u00a0u00a0ntNDC 0023-9177-15
Storage:

Patients should be instructed that ocular solutions, if handled improperly or if the tip of the dispensing container contacts the eye or surrounding structures, 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 ,5.3). Always replace the cap after using. If solution changes color or becomes cloudy, do not use. Do not use the product after the expiration date marked on the bottle.
Patients also should be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician's advice concerning the continued use of the present multidose container.
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
As with other similar medications, n n 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.
u00a9 2013 Allergan, Inc.
Irvine, CA 92612, U.S.A.
Patented. See: www.allergan.com/products/patent_notices
Made in the U.S.A.
71816US16

NDC 0023-9321-10Alphagan P(brimonidine tartrate ophthalmic solution) 0.1%10 mLRx Only Sterile

NDC 0023-9177-10Alphagan P(brimonidine tartrate ophthalmic solution) 0.15%10 mLRx Only Sterile

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Brimonidine Tartrate (Alphagan P)

Trade Name : ALPHAGAN P

SOLUTION/ DROPS

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Brimonidine Tartrate (Alphagan P)

Trade Name : ALPHAGAN P

SOLUTION/ DROPS

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

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CONTACT US

Can’t find what
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