COMBIGAN 2 mg/mL
brimonidine tartrate, timolol maleate · SOLUTION/ DROPS · Allergan, Inc.
COMBIGAN is a solution/ drops containing brimonidine tartrate, timolol maleate at 2 mg/mL, taken ophthalmic. Manufactured by Allergan, Inc..
Key Facts
- Brand Name
- COMBIGAN
- Generic Name
- brimonidine tartrate, timolol maleate
- NDC Code (Product)
0023-9211- Manufacturer
- Allergan, Inc.
- Strength
- 2 mg/mL
- Dosage Form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Marketing Status
- Application #
- NDA021398
- Marketing Start
- 11/14/2007
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE COMBIGAN ® is indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of COMBIGAN dosed twice a day was slightly less than that seen with the concomitant administration of 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day. COMBIGAN is a combination of brimonidine tartrate, an alpha-adrenergic receptor agonist, and timolol maleate, a beta-adrenergic receptor inhibitor, indicated for the reduction of elevated intraocular pressure (IOP) in patients with glaucoma or ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP. The IOP-lowering of COMBIGAN dosed twice a day was slightly less than that seen with the concomitant administration of timolol maleate ophthalmic solution, 0.5% dosed twice a day and brimonidine tartrate ophthalmic solution, 0.2% dosed three times per day. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dosage is one drop in the affected eye(s) twice daily approximately 12 hours apart. If more than one topical ophthalmic product is to be used, the different products should be instilled at least 5 minutes apart. One drop in the affected eye(s), twice daily approximately 12 hours apart. ( 2 )
Contraindications
4 CONTRAINDICATIONS Bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease. ( 4.1 , 5.1 , 5.3 ) Sinus bradycardia, atrioventricular block, overt cardiac failure, cardiogenic shock. ( 4.2 , 5.2 ) Neonates and infants (pediatric patients younger than 2 years old). ( 4.3 ) Hypersensitivity to any component of this product. ( 4.4 ) 4.1 Reactive Airway Disease I ncluding Asthma, COPD COMBIGAN is contraindicated in patients with reactive airway disease including bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [ see Warnings and Precautions ( 5.1 , 5.3 ) ] . 4.2 Sinus Bradycardia, AV Block, Cardiac Failure, Cardiogenic Shock COMBIGAN is contraindicated in patients with sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure [see Warnings and Precautions ( 5.2 )] ; cardiogenic shock. 4.3 Neonates and Infants ( Pediatric Patients Younger than 2 Years Old ) COMBIGAN is contraindicated in neonates and infants (pediatric patients younger than 2 years old) [see Use in Specific Populations ( 8.4 )] . 4.4 Hypersensitivity Reactions Local hypersensitivity reactions have occurred fol…
Drug Interactions
7 D RUG INTERACTIONS Antihypertensives/cardiac glycosides may lower blood pressure. ( 7.1 ) Concomitant use with systemic beta-blockers may potentiate systemic beta blockade. ( 7.2 ) Oral or intravenous calcium antagonists may cause atrioventricular conduction disturbances, left ventricular failure, and hypotension. ( 7.3 ) Catecholamine-depleting drugs may have additive effects and produce hypotension and/or marked bradycardia. ( 7.4 ) Use with CNS depressants may result in an additive or potentiating effect. ( 7.5 ) Digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time. ( 7.6 ) CYP2D6 inhibitors may potentiate systemic beta-blockade. ( 7.7 ) Tricyclic antidepressants may potentially blunt the hypotensive effect of systemic clonidine. ( 7.8 ) Monoamine oxidase inhibitors may result in increased hypotension. ( 7.9 ) 7.1 Antihypertensives/Cardiac Glycosides Because COMBIGAN may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with COMBIGAN is advised. 7.2 Beta-adrenergic Blocking Agents Patients who are receiving a beta-adrenergic blocking agent either orally or intravenously and CO…
Adverse Reactions
6 A DVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hypersensitivity Reactions [see Contraindications ( 4.4 )] Potential for Severe Respiratory or Cardiac Reactions [see Warnings and Precautions ( 5.1 )] Cardiac Failure [see Warnings and Precautions ( 5.2 )] Potentiation of Vascular Insufficiency [see Warnings and Precautions ( 5.4 )] Increased Reactivity to Allergens [see Warnings and Precautions ( 5.5 )] Potentiation of Muscle Weakness [see Warnings and Precautions ( 5.6 )] Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus [see Warnings and Precautions ( 5.7 )] Masking of Thyrotoxicosis [see Warnings and Precautions ( 5.8 )] Ocular Hypersensitivity [see Warnings and Precautions ( 5.9 )] Contamination of Topical Ophthalmic Products after Use [see Warnings and Precautions ( 5.10 )] Impairment of Beta-adrenergically Mediated Reflexes During Surgery [see Warnings and Precautions ( 5.11 )] Most common adverse reactions occurring in approximately 5% to 15% of patients included allergic conjunctivitis, conjunctival folliculosis, conjunctival hyperemia, eye pruritus, ocular burning, and stinging. ( 6.1 ) To report SUSPEC…
Frequently Asked Questions
What is COMBIGAN used for?
COMBIGAN contains brimonidine tartrate, timolol maleate. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.
Is COMBIGAN a controlled substance?
COMBIGAN is not classified as a controlled substance by the DEA.
What is the generic name for COMBIGAN?
The generic name for COMBIGAN is brimonidine tartrate, timolol maleate. There are no other listed brand versions of brimonidine tartrate, timolol maleate.
What is the NDC code for COMBIGAN 2 mg/mL?
The NDC (National Drug Code) for COMBIGAN 2 mg/mL is 0023-9211, listed by Allergan, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)