Combigan

(Brimonidine Tartrate, Timolol Maleate)

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Dosage & Administration

The recommended dose is one drop of

COMBIGAN

^®

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.

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Combigan Prescribing Information

COMBIGAN

^®

(brimonidine tartrate/timolol maleate ophthalmic solution) 0.2%/0.5% is an alpha-adrenergic receptor agonist with 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 0.5% timolol maleate ophthalmic solution dosed twice a day and 0.2% brimonidine tartrate ophthalmic solution dosed three times per day.

Not for use in children below the age of 2 years. Use with caution in children ≥ 2 years of age. (

8.4
Pediatric Use

COMBIGAN

^®

is contraindicated in children under the age of 2 years

[see Contraindications (

4.3

)]

. During post-marketing surveillance, apnea, bradycardia, coma, hypotension, hypothermia, hypotonia, lethargy, pallor, respiratory depression, and somnolence have been reported in infants receiving brimonidine. The safety and effectiveness of brimonidine tartrate and timolol maleate have not been studied in children below the age of 2 years.

The safety and effectiveness of

COMBIGAN

^®

have been established in the age groups 2 – 16 years of age. Use of

COMBIGAN

^®

in these age groups is supported by evidence from adequate and well-controlled studies of

COMBIGAN

^®

in adults with additional data from a study of the concomitant use of brimonidine tartrate ophthalmic solution 0.2% and timolol maleate ophthalmic solution in pediatric glaucoma patients (ages 2 to 7 years). In this study, brimonidine tartrate ophthalmic solution 0.2% was dosed three times a day as adjunctive therapy to beta-blockers. The most commonly observed adverse reactions were somnolence (50%-83% in patients 2 to 6 years) and decreased alertness. In pediatric patients 7 years of age or older (>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.

)

Bronchial asthma, a history of bronchial asthma, severe chronic obstructive pulmonary disease. (
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
)
]
.
,
5.1
Potenti
a
l
for Severe
Respiratory
or Cardiac
Reactions
COMBIGAN
^®
contains timolol maleate; and although administered topically can be absorbed systemically. Therefore, the same types of adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure have been reported following systemic or ophthalmic administration of timolol maleate
[see
Contraindications (
4.1
)]
. Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension.
,
5.3
Obstructive Pulmonary Disease
Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma or a history of bronchial asthma, in which
COMBIGAN
^®
is contraindicated
[see Contraindications (
4.1
)]
should, in general, not receive beta-blocking agents, including
COMBIGAN
^®
.
)
Sinus bradycardia, atrioventricular block, overt cardiac failure, cardiogenic shock. (
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.
,
5.2
Cardiac Failure
Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure.
In patients without a history of cardiac failure, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure,
COMBIGAN
^®
should be discontinued
[see Contraindications (
4.2
)]
.
)
Neonates and infants (under the age of 2 years). (
4.3
Neonates and Infants (Under the Age of 2 Years)
COMBIGAN
^®
is contraindicated in neonates and infants (under the age of 2 years).
)
Hypersensitivity to any component of this product. (
4.4
Hypersensitivity Reactions
Local hypersensitivity reactions have occurred following the use of different components of
COMBIGAN
^®
.
COMBIGAN
^®
is contraindicated in patients who have exhibited a hypersensitivity reaction to any component of this medication in the past.
)

Potential for Severe Respiratory or Cardiac Reactions (
5.1
Potenti
a
l
for Severe
Respiratory
or Cardiac
Reactions
COMBIGAN
^®
contains timolol maleate; and although administered topically can be absorbed systemically. Therefore, the same types of adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. For example, severe respiratory reactions and cardiac reactions including death due to bronchospasm in patients with asthma, and rarely death in association with cardiac failure have been reported following systemic or ophthalmic administration of timolol maleate
[see
Contraindications (
4.1
)]
. Additionally, ophthalmic beta-blockers may impair compensatory tachycardia and increase risk of hypotension.
)
Cardiac Failure (
5.2
Cardiac Failure
Sympathetic stimulation may be essential for support of the circulation in individuals with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may precipitate more severe failure.
In patients without a history of cardiac failure, continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of cardiac failure,
COMBIGAN
^®
should be discontinued
[see Contraindications (
4.2
)]
.
)
Obstructive Pulmonary Disease (
5.3
Obstructive Pulmonary Disease
Patients with chronic obstructive pulmonary disease (e.g., chronic bronchitis, emphysema) of mild or moderate severity, bronchospastic disease, or a history of bronchospastic disease (other than bronchial asthma or a history of bronchial asthma, in which
COMBIGAN
^®
is contraindicated
[see Contraindications (
4.1
)]
should, in general, not receive beta-blocking agents, including
COMBIGAN
^®
.
)
Potentiation of Vascular Insufficiency (
5.4
Potentiation of Vascular Insufficiency
COMBIGAN
^®
may potentiate syndromes associated with vascular insufficiency.
COMBIGAN
^®
should be used with caution in patients with depression, cerebral or coronary insufficiency, Raynaud’s phenomenon, orthostatic hypotension, or thromboangiitis obliterans.
)
Increased Reactivity to Allergens (
5.5
Increased Reactivity to Allergens
While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reactions to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.
)
Potentiation of Muscle Weakness (
5.6
Potentiation of Muscle Weakness
Beta-adrenergic blockade has been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness). Timolol has been reported rarely to increase muscle weakness in some patients with myasthenia gravis or myasthenic symptoms.
)
Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus (
5.7
Masking of Hypoglycemic Symptoms in Patients with Diabetes Mellitus
Beta-adrenergic blocking agents should be administered with caution in patients subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may mask the signs and symptoms of acute hypoglycemia.
)
Masking of Thyrotoxicosis (
5.8
Masking of Thyrotoxicosis
Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic blocking agents that might precipitate a thyroid storm.
)
Ocular Hypersensitivity (
5.9
Ocular Hypersensitivity
Ocular hypersensitivity reactions have been reported with brimonidine tartrate ophthalmic solutions 0.2%, with some reported to be associated with an increase in intraocular pressure
[see Contraindications (
4.4
)]
.
)

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