COMBIGAN

BRIMONIDINE TARTRATE, TIMOLOL MALEATE

Manufacturer: Allergan, Inc.

Score: 141.66

Quick Summary

Brimonidine Tartrate/Timolol Maleate ophthalmic solution is used for the reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension. It is a combination of an alpha-adrenergic receptor agonist and a beta-adrenergic receptor inhibitor. The recommended dose is one drop in the affected eye(s) twice daily, approximately 12 hours apart. The solution is contraindicated in patients with bronchial asthma, severe chronic obstructive pulmonary disease, sinus bradycardia, atrioventricular block, overt cardiac failure, cardiogenic shock, and in neonates and infants under the age of 2 years.

Key Clinical Findings and Indications

Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension
Alpha-adrenergic receptor agonist and beta-adrenergic receptor inhibitor
Peak ocular hypotensive effect seen at 2 hours post-dosing for brimonidine and 1-2 hours for timolol

Important Safety Information

Warning

Brimonidine Tartrate/Timolol Maleate ophthalmic solution may cause systemic beta-blockade, and caution should be exercised when using it in patients with cardiovascular disease.

Contraindications

Bronchial asthma
Severe chronic obstructive pulmonary disease
Sinus bradycardia
Atrioventricular block
Overt cardiac failure
Cardiogenic shock
Neonates and infants under the age of 2 years
Hypersensitivity to any component of the product

Adverse Reactions

Allergic conjunctivitis
Conjunctival folliculosis
Conjunctival hyperemia
Eye pruritus
Ocular burning
Stinging
Asthenia
Blepharitis
Corneal erosion
Depression
Epiphora
Eye discharge
Eye dryness
Eye irritation
Eye pain
Eyelid edema
Eyelid erythema
Eyelid pruritus
Foreign body sensation
Headache
Hypertension
Oral dryness
Somnolence
Superficial punctate keratitis
Visual disturbance

Dosing Recommendations

General Guidance

None specified

Glaucoma or ocular hypertension

Adult Dose

One drop in the affected eye(s) twice daily, approximately 12 hours apart

Pediatric Dose

Not recommended for children under the age of 2 years

Special Population Considerations

Pregnancy

Brimonidine Tartrate/Timolol Maleate ophthalmic solution should be used during pregnancy only if the potential benefit to the mother justifies the potential risk to the fetus
Teratogenicity studies have been performed in animals, but there are no adequate and well-controlled studies in pregnant women

Nursing Mothers

Timolol has been detected in human milk following oral and ophthalmic drug administration
It is not known whether brimonidine tartrate is excreted in human milk
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

Pediatric Use

Brimonidine Tartrate/Timolol Maleate ophthalmic solution is contraindicated in children under the age of 2 years
The safety and effectiveness of the solution have been established in the age groups 2-16 years of age