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  • Alphagan P
    / Allergan


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Suspension

    5 ml

    partial basket chart 12494 1940

    Dosage

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


    Indications

    For the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.


    Contra-Indications

    Neonates and infants (under the age of 2 years). Patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.  


    Special Precautions

    Although brimonidine tartrate ophthalmic solution had minimal effect on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease. Ithas not been studied in patients with hepatic impairment. This producthas not been studied in patients with renal impairment. The effect of dialysis on brimonidine pharmacokinetics in patients with renal failure is not known. It may potentiate syndromes associated with vascular insufficiency. This productshould be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans. There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products. These containers had been inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface.
    See prescribing information for full details.


    Side Effects

    Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adverse reactions occurring in approximately 10-20% of the subjects receiving brimonidine ophthalmic solution (0.1-0.2%) included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritis. Adverse reactions occurring in approximately 5-9% of the subjects included: burning sensation, conjunctival foliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.
    See prescribing information for full details.


    Drug interactions

    Although specific drug interaction studies have not been conducted with this product, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered. Because this productmay reduce blood pressure, caution in using drugs such as anti-hypertensives and/or cardiac glycosides with this productis advised.
    Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents in humans can lead to resulting interference with the IOP lowering effect. Caution is advised in patients taking tricyclic antidepressants which can affect the metabolism and uptake of circulating amines.
    Monoamine oxidase (MAO) inhibitors may theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side-effect such as hypotension.
    Caution is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Pregnancy Category B. Teratogenicity studies have been performed in animals. It should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus.
    Lactation: 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. Because of the potential for serious adverse reactions from this productin nursing infants, 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.
    See prescribing information for full details.


    Overdose

    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 this productas part of medical treatment of congenital glaucoma or by accidental oral ingestion. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.


    Important notes

    Shelf life after first openning: 28 days, or expiry date which ever comes first. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
    See prescribing information for full details.


    Manufacturer
    Allergan
    Licence holder
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