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ALPHAGAN P OPHTHALMIC SOLUTION 0.15% W/V

Product Information

Registration Status: Active

SIN12336P

ALPHAGAN P OPHTHALMIC SOLUTION 0.15% W/V is approved to be sold in Singapore with effective from 2003-06-26. It is marketed by ALLERGAN SINGAPORE PTE LTD, with the registration number of SIN12336P.

This product contains Brimonidine 0.15% w/v in the form of SOLUTION. It is approved for OPHTHALMIC use.

This product is manufactured by ALLERGAN SALES LLC in UNITED STATES.

It is a Prescription Only Medicine that can only be obtained from a doctor or a dentist, or a pharmacist with a prescription from a Singapore-registered doctor or dentist.

Product Reference
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Description

Brimonidine is a drug used to treat glaucoma. It acts via decreasing aqueous humor synthesis. A topical gel formulation, marketed under the name Mirvaso, was FDA approved on August 2013 for the treatment of rosacea.

Indication

The ophthalmic solution is indicated for patients with open-angle glaucoma or ocular hypertension to lower intraocular pressure. The topical gel is indicated for the treatment of persistent (nontransient) facial erythema of rosacea in adults 18 years or older.

Mechanism of Action

Brimonidine is an alpha adrenergic receptor agonist (primarily alpha-2). It has a peak ocular hypotensive effect occurring at two hours post-dosing. Fluorophotometric studies in animals and humans suggest that Brimonidine has a dual mechanism of action by reducing aqueous humor production and increasing uveoscleral outflow. The topical gel reduces erythema through direct vasocontriction.

Pharmacokinetics

Absorption
Minimal systemic absorption occurs after ocular insertion. When the topical gel was applied to adult patients with facial erythema associated with rosacea, the plasma maximum concentration (Cmax) and area under the concentration-time curve (AUC) were 46 ± 62 pg/mL and 417 ± 264 pg.hr/mL, respectively. These values were reached on Day 15 of treatment.
Distribution
Metabolism
Metabolized primarily by the liver.
Elimination

Toxicity

Oral LD50 is 50 mg/kg in mice and 100 mg/kg in rats. Common adverse reactions of the topical gel formulation include erythema, flushing, skin burning sensation, and contact dermatitis.

Active Ingredient/Synonyms

5-Bromo-6-(2-imidazolin-2-ylamino)quinoxaline | Brimonidina | Brimonidine | Brimonidinum | Bromoxidine | Brimonidine |


Source of information: Drugbank (External Link). Last updated on: 3rd July 18. *Trade Name used in the content below may not be the same as the HSA-registered product.

References

  1. Health Science Authority of Singapore - Reclassified POM
  2. Drugbank

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