Brimonidine Tartrate / Timolol Maleate

Trade Names:
Combigan
- Ophthalmic solution brimonidine tartrate 0.2%/timolol 0.5%

Indications and Usage

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Reduction of elevated IOP in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequate control of IOP.

Contraindications

Bronchial asthma; history of bronchial asthma; severe COPD; sinus bradycardia or cardiac shock; second- or third-degree AV block; overt cardiac failure; hypersensitivity to any component of the product.

Dosage and Administration

Ophthalmic One drop in affected eye(s) twice daily approximately 12 h apart. If more than 1 topical ophthalmic product is to be used, separate the instillation times by at least 5 min.

Storage/Stability

Store at 59° to 77°F. Protect from light.

Drug Interactions

Use with caution because of increased risk of hypotension.

Possible additive effects systemically and on IOP. Coadministration is not recommended.

Risk of atrioventricular conduction disturbances, left ventricular failure, and hypotension may be increased with coadministration of oral or IV calcium antagonists. Concurrent use should be avoided.

Possible additive or synergistic effects.

Systemic beta-blockade (eg, decreased heart rate) may be potentiated.

Possible additive effects, prolonging AV conduction time.

Use with caution because data are insufficient to determine if tricyclic antidepressants will blunt the IOP-lowering effect.

Use with caution because MAOIs may theoretically interfere with brimonidine metabolism, resulting in an increase in systemic adverse reactions (eg, hypotension).

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypertension (1% to 5%).

Bradycardia, hypotension, tachycardia.

CNS

Asthenia, depression, headache, somnolence (1% to 5%).

Dermatologic

Eyelid pruritus, skin reactions including erythema, rash, and vasodilation (postmarketing).

EENT

Allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, epiphora, eye pruritus, ocular burning and stinging (5% to 15%); blepharitis, corneal erosion, eye discharge, eye dryness, eye irritation, eye pain, eyelid edema, eyelid erythema, eyelid pruritus, foreign body sensation, superficial punctate keratitis, visual disturbance (1% to 5%).

Iritis, keratoconjunctivitis sicca, miosis.

GI

Oral dryness (1% to 5%).

Nausea (postmarketing).

Miscellaneous

Hypothermia, hypotonia (postmarketing).

Precautions

Pregnancy

Category C.

Lactation

Excreted in breast milk.

Undetermined.

Children

Safety and efficacy not established in children younger than 2 yr of age.

Elderly

No overall differences in safety and efficacy have been observed between elderly patients and other adult patients.

Allergens

Patients with a history of atopy or severe anaphylactic reactions may be more reactive to repeated exposures to allergens (eg, therapeutic challenge).

Bronchospasm

May be precipitated in susceptible patients.

Cardiac failure

Beta-adrenergic blockade may exacerbate cardiac failure.

Diabetic patients

Beta-adrenergic blockers may mask signs and symptoms of hypoglycemia (eg, tachycardia).

Muscle weakness

Beta-adrenergic blockers may potentiate muscle weakness consistent with myasthenic symptoms (eg, generalized weakness).

Surgery

Beta-adrenergic blockade may impair the ability of the heart to respond to beta-adrenergic reflex stimuli. Consider withdrawal of the beta-blocking agent during general anesthesia.

Vascular insufficiency

Syndromes associated with vascular insufficiency (eg, cerebral or coronary insufficiency) may be potentiated.

Overdosage

Symptoms

Bradycardia, bronchospasm, cardiac arrest, dizziness, headache, shortness of breath.

Patient Information

• Inform patients that if more than 1 topical ophthalmic drug is being used, the administration times should be separated by at least 5 min.
• Inform patient that product contains benzalkonium chloride, which may be absorbed by soft contact lenses. Remove lenses before instilling drops. Lenses may be reinserted 15 min following administration.
• Advise patient that the drug may cause drowsiness, and to use caution while driving or performing other tasks requiring mental alertness.

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