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ALPHAGAN® P 0.1% may benefit patients by providing a favorable safety profile: No cardiopulmonary contraindications
No label warnings or precautions regarding patients with:
CONTRAINDICATIONS ALPHAGAN® P 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. 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. ALPHAGAN® P has not been studied in patients with hepatic or renal impairment. Caution should be used in treating such patients. ALPHAGAN® P should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans. Patients prescribed IOP-lowering medication should be routinely monitored for IOP. INFORMATION FOR PATIENTS As with other drugs in this class, ALPHAGAN® P 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.ADVERSE REACTIONS Adverse events occurring in approximately 10%-20% of the subjects receiving brimonidine ophthalmic solution (0.1%-0.2%) included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritus. Adverse events occurring in approximately 5%-9% included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance. Adverse events occurring in approximately 1%-4% of the subjects receiving brimonidine ophthalmic solution (0.1%-0.2%) included: allergic reaction, asthenia, blepharitis, blepharoconjunctivitis, blurred vision, bronchitis, cataract, conjunctival edema, conjunctival hemorrhage, conjunctivitis, cough, dizziness, dyspepsia, dyspnea, epiphora, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, fatigue, flu syndrome, follicular conjunctivitis, foreign body sensation, gastrointestinal disorder, headache, hypercholesterolemia, hypotension, infection (primarily colds and respiratory infections), insomnia, keratitis, lid disorder, pharyngitis, photophobia, rash, rhinitis, sinus infection, sinusitis, somnolence, stinging, superficial punctuate keratopathy, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity. |
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ALPHAGAN® P ophthalmic solution is indicated for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Important Safety InformationALPHAGAN® P (brimonidine tartrate ophthalmic solution) 0.1% is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy. Although ALPHAGAN® P 0.1% 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. Adverse events occurring in approximately 10% to 20% of the subjects included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritus. Please click here for full Prescribing Information. |



