Alphagan P Ophthalmic Solution

Brimonidine Tartrate 0.025% relieves redness of the eye due to minor eye irritations.

Brimonidine is an alpha-2 adrenoreceptor agonist that is more selective for the alpha-2 adrenoreceptor than alpha-1. Topical administration of low concentration of Brimonidine Tartrate eye drops reduces ocular redness in humans by constricting the venule, alleviating the potential decrease of blood and oxygen through the eye. It has minimal to no activity on the alpha-1 receptor, which has a low risk of redness rebound of loss of efficacy over time when used as directed.

Adults and children 5 years of age and over: Instill 1 drop in the affected eye(s) every 6-8 hours. Do not use more than 4 times daily. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart.

Although specific drug interaction studies have not been conducted with Brimonidine Tartrate eye drops, the possibility of an additive effect with CNS depressants (alcohol, barbiturates, opiates, sedatives or anesthetics) should be considered.

Brimonidine Tartrate sterile eye drops is contraindicated in patients with hypersensitivity to Brimonidine Tartrate or any component of this medication and Neonates and infants (under the age of 5).

In clinical studies, most adverse events were usually transient and not commonly of a severity requiring discontinuation of treatment. The most frequently reported adverse events were:

• Ocular: ocular hyperemia, dryness, tearing, burning and stinging, blurring and foreign body sensation, upper respiratory symptoms.
• Systemic: oral dryness, headache, fatigue, drowsiness.

There are no studies of Brimonidine Tartrate eye drops in pregnant women, however in animal studies, Brimonidine Tartrate crossed the placenta and entered into the fetal circulation to a related extent. Brimonidine Tartrate eye drops should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.

It is not known whether Brimonidine Tartrate is excreted in human milk, although in animal studies, Brimonidine Tartrate has been shown to be 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.

Although Brimonidine Tartrate had minimal effects on blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease. It has not been studied in patients with hepatic or renal impairment; caution should be used in treating such patients.

No information is available on overdose in humans. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained. In the event of a topical overdosage, flush eye with a topical ocular irrigant.

Other ophthalmic preparations

Store at below 30°C in a dry place protected from light. Do not touch dropper tip to any surface. It is desirable that the contents should not be used more than one month after first opening of the bottle.