BRIMONIDINE TARTRATE - brimonidine tartrate solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BRIMONIDINE TARTRATE (UNII: 4S9CL2DY2H) (BRIMONIDINE - UNII:E6GNX3HHTE)

Available from:

Osmotica Pharmaceutical Corp.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Brimonidine Tartrate Ophthalmic Solution, 0.2% is supplied in white LDPE bottle with natural LDPE nozzle and purple HDPE cap. 5 mL in 5mL bottle        NDC 42843-501-05 10 mL in 10 mL bottle   NDC 42843-501-10 15 mL in 15 mL bottle   NDC 42843-501-15. STORAGE: Store between 15°-  25°C (59°-  77°F). KEEP OUT OF THE REACH OF CHILDREN. Do not use if seal on the bottle is missing or broken. Rx only Manufactured by: Indoco Remedies Limited, L-32, 33, 34, Verna Industrial Area, Verna, Goa – 403722. India. Distributed by: Osmotica Pharmaceutical Corp. Wilmington, NC 28405 Revised:11/2014

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

BRIMONIDINE TARTRATE - BRIMONIDINE TARTRATE SOLUTION/ DROPS
OSMOTICA PHARMACEUTICAL CORP.
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BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION, 0.2%
DESCRIPTION:
Brimonidine Tartrate Ophthalmic Solution, 0.2% is a relatively
selective alpha-2 adrenergic agonist for
ophthalmic use. 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. The structural formula is
C
H BrN •C H O
Mol. Wt. 442.24 (as the tartrate salt)
Chemical Name: 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline
L-tartrate.
CAS Number: 59803-98-4
CONTAINS:
ACTIVE: Brimonidine Tartrate 0.2% (2 mg/mL).
INACTIVES: Citric Acid, Polyvinyl Alcohol, Sodium Chloride, Sodium
Citrate, Water for injection,
Hydrochloric acid and/or Sodium hydroxide may be added to adjust pH.
PRESERVATIVES: Benzalkonium Chloride 0.005% (0.05 mg)
CLINICAL PHARMACOLOGY:
MECHANISM OF ACTION:
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.
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. 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.
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CLINICAL EVALUATIONS:
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 intraocul