Alphagan Purite Ophthalmic solution

ALPHAGAN u00ae Purite u00ae is indicated for the lowering of intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

The recommended dose is one drop of ALPHAGAN u00ae Purite u00ae in the affected eye(s) twice daily, approximately 12 hours apart. ALPHAGAN u00ae Purite u00ae ophthalmic solution may be used concomitantly with other topical ophthalmic medicinal products to lower intraocular pressure. If more than one topical ophthalmic product is being used, the product should be administered at least 5 minutes apart.

ALPHAGAN u00ae Purite u00ae is contraindicated in patients who have exhibited a hypersensitivity reaction to brimonidine tartrate or any component of ALPHAGAN u00ae Purite u00ae . ALPHAGAN u00ae Purite u00ae is contraindicated in neonates and infants (under the age of 2 years).

Severe cardiovascular disease
Although ALPHAGAN u00ae Purite u00ae ophthalmic solution had minimal effects on the blood pressure of patients in clinical studies, caution should be exercised in treating patients with severe cardiovascular disease.
Potentiation of vascular insufficiency
ALPHAGAN u00ae Purite u00ae may potentiate syndromes associated with vascular insufficiency. ALPHAGAN u00ae Purite u00ae should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaudu2019s phenomenon, orthostatic hypotension, or thromboangiitis obliterans. Patients using IOP-lowering medication should be routinely monitored for IOP.
Contamination of ALPHAGAN u00ae Purite u00ae after use
There have been reports of bacterial keratitis associated with the use of multiple-dose containers of topical ophthalmic products such as ALPHAGAN u00ae Purite u00ae . 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 u201cInformation for patientsu201d).
Paediatric use
ALPHAGAN u00ae Purite u00ae is contraindicated in children under the age of 2 years (see u2018CONTRA - INDICATIONSu2019). The safety and efficacy of brimonidine tartrate have not been studied in children below the age of 2 years. During post-marketing surveillance, apnoea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine either for congenital glaucoma or by accidental ingestion. Children 2 years of age and above, especially those weighing u2264 20 kg, should be treated with caution and closely monitored due to the high incidence and severity of somnolence. In a clinical study conducted in paediatric glaucoma patients (ages 2 to 7 years) the most commonly observed adverse reactions with brimonidine tartrate ophthalmic solution 0,2 % dosed three times daily were somnolence (50 - 83 % in patients ages 2 to 6 years) and decreased alertness. In paediatric patients 7 years of age (> 20 kg), somnolence appears to occur less frequently (25 %). Approximately 16 % of patients on brimonidine tartrate ophthalmic solution discontinued from the study due to somnolence.
Geriatric use
No overall differences in safety or efficacy have been observed between elderly and other adult patients.
Special populations
ALPHAGAN u00ae Purite u00ae has not been studied in patients with hepatic impairment. ALPHAGAN u00ae Purite u00ae has not been studied in patients with renal impairment. The effect of dialysis on brimonidine pharmacokinetics in patients with renal failure is not known.

Antihypertensives
Because ALPHAGAN u00ae Purite u00ae may reduce blood pressure, caution in using antihypertensives with ALPHAGAN u00ae Purite u00ae is advised.
Digoxin
Caution is advised when using ALPHAGAN u00ae Purite u00ae with digoxin.
CNS depressants
Although specific interaction studies have not been conducted with ALPHAGAN u00ae Purite u00ae , the possibility of an additive or potentiating effect with CNS-depressants (alcohol, barbiturates, opiates, sedatives, or anaesthetics) should be considered. Alpha-agonists, as a class, may reduce pulse and blood pressure. Caution in using concomitant medicines such as beta-blockers (ophthalmic and systemic), anti-hypertensives and/or digoxin is advised.
Tricyclic antidepressants
Tricyclic antidepressants have been reported to blunt the hypotensive effects of systemic clonidine. It is not known whether the concurrent use of these agents with ALPHAGAN u00ae Purite u00ae ophthalmic solution 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 inhibitors
Monoamine oxidase (MAO) inhibitors may interfere with the metabolism of ALPHAGAN u00ae Purite u00ae 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 amine.

Pregnancy
Safety and/or efficacy for ALPHAGAN u00ae Purite u00ae use during pregnancy have not been established.
Lactation
It is not known whether ALPHAGAN u00ae Purite u00ae is excreted in breastmilk. Because of the potential for serious adverse reactions from ALPHAGAN u00ae Purite u00ae in nursing infants, patients should not breastfeed while using ALPHAGAN u00ae Purite u00ae .

ALPHAGAN u00ae Purite u00ae 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. ALPHAGAN u00ae Purite u00ae may also cause blurred vision or visual disturbance in some patients. The patient should wait until these symptoms have cleared before driving or using machinery.

For each indication the frequency of adverse reactions arising from clinical experience is given as follows: Very common (u22651/10); Common (u22651/100, <1/10); Uncommon (u22651/1 000, <1/100); Rare (u22651/10 000, <1/1 000); Very rare (<1/10 000).
Eye disorders
Very common : Allergic conjunctivitis, conjunctival hypaeremia, eye pruritus
Common : Blepharitis, burning sensation, conjunctival folliculosis, conjunctival oedema, conjunctival haemorrhage, conjunctivitis, epiphora, eye discharge, eye dryness, eye irritation, eye pain, follicular conjunctivitis, foreign body sensation, photophobia, stinging, superficial punctuate keratopathy, visual disturbance, visual field defects, vitreous floaters, worsened visual acuity, blepharoconjunctivitis, blurred vision, cataract, keratitis, lid disorder, tearing, vitreous detachment, vitreous disorder, ocular allergic reaction, eyelid oedema, eyelid erythema
Uncommon : Corneal erosion, hordeolum
Nervous system disorders
Common : Dizziness, headache
Uncommon : Somnolence, taste perversion
Vascular disorders
Common : Hypertension, hypotension
Psychiatric disorders
Uncommon : Insomnia
Respiratory, thoracic and mediastinal disorders
Common : Cough, dyspnoea
Uncommon : Nasal dryness
Gastrointestinal disorders
Common : Dyspepsia, oral dryness, gastrointestinal disorder
Skin and subcutaneous tissue disorders
Common : Rash
Immune system disorders
Common : Allergic reaction
Infections and infestations
Common : Bronchitis, flu syndrome, pharyngitis, rhinitis, sinus infection, sinusitis
General disorders and administration site conditions
Common : Asthenia, fatigue
Blood and lymphatic system disorders
Common: Hypercholesterolaemia
The following events have been identified during post-marketing use of ALPHAGAN u00ae Purite u00ae ophthalmic solution in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to ALPHAGAN u00ae Purite u00ae , or a combination of these factors, include: bradycardia, depression, hypersensitivity, iritis, keratoconjunctivitis sicca, miosis, nausea, skin reactions (including erythema, eyelid pruritus, rash and vasodilatation), syncope, and tachycardia.

Very limited information exists on accidental ingestion of brimonidine in adults and children; the only adverse reaction reported to date has been hypotension. Treatment of an oral overdose includes supportive and symptomatic therapy; a patient airway should be maintained.