Alphagan P ALPHAGAN P - Prescribing Info PDF
Font SizeSize 1Size 2Size 3right
Get Adobe Acrobat Reader
Safety and Tolerability
 

Safety and Tolerability

No cardiopulmonary contraindications
No label warnings or precautions regarding patients with:
green dot Diabetes
green dot Sexual dysfunction
green dot Obstructive pulmonary disease

CONTRAINDICATION
ALPHAGAN® P 0.1% is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.

PRECAUTIONS
General:
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.

ALPHAGAN® P 0.1% has not been studied in patients with hepatic or renal impairment. Caution should be used in treating such patients.

ALPHAGAN® P 0.1% 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 0.1% 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% to 20% of the subjects included: allergic conjunctivitis, conjunctival hyperemia, and eye pruritus. Adverse events occurring in approximately 5% to 9% included: burning sensation, conjunctival folliculosis, hypertension, ocular allergic reaction, oral dryness, and visual disturbance.

Adverse events occurring in approximately 1% to 4% of the subjects 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 punctate keratopathy, tearing, visual field defect, vitreous detachment, vitreous disorder, vitreous floaters, and worsened visual acuity.

 
Indication: ALPHAGAN® P 0.1% ophthalmic solution is indicated for the lowering of intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.
Important Safety Information
Contraindication: ALPHAGAN® P 0.1% is contraindicated in patients receiving monoamine oxidase (MAO) inhibitor therapy.
Precautions: 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. ALPHAGAN® P 0.1% should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud's phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
Adverse reactions: 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.