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Combigan (Brimonidine Tartrate / Timolol Maleate Ophthalmic) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Antihypertensives/Cardiac Glycosides

Because COMBIGAN® may reduce blood pressure, caution in using drugs such as antihypertensives and/or cardiac glycosides with COMBIGAN® is advised.

Beta-adrenergic Blocking Agents

Patients who are receiving a beta-adrenergic blocking agent orally and COMBIGAN® should be observed for potential additive effects of beta-blockade, both systemic and on intraocular pressure. The concomitant use of two topical beta-adrenergic blocking agents is not recommended.

Calcium Antagonists

Caution should be used in the co-administration of beta-adrenergic blocking agents, such as COMBIGAN®, and oral or intravenous calcium antagonists because of possible atrioventricular conduction disturbances, left ventricular failure, and hypotension. In patients with impaired cardiac function, co-administration should be avoided.

Catecholamine-depleting Drugs

Close observation of the patient is recommended when a beta blocker is administered to patients receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or marked bradycardia, which may result in vertigo, syncope, or postural hypotension.

CNS Depressants

Although specific drug interaction studies have not been conducted with COMBIGAN®, the possibility of an additive or potentiating effect with CNS depressants (alcohol, barbiturates, opiates, sedatives, or anesthetics) should be considered.

Digitalis and Calcium Antagonists

The concomitant use of beta-adrenergic blocking agents with digitalis and calcium antagonists may have additive effects in prolonging atrioventricular conduction time.

CYP2D6 Inhibitors

Potentiated systemic beta-blockade (e.g., decreased heart rate, depression) has been reported during combined treatment with CYP2D6 inhibitors (e.g., quinidine, SSRIs) and timolol.

Tricyclic Antidepressants

Tricyclic antidepressants have been reported to blunt the hypotensive effect of systemic clonidine. It is not known whether the concurrent use of these agents with COMBIGAN® in humans can lead to resulting interference with the IOP-lowering effect. Caution, however, 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 theoretically interfere with the metabolism of brimonidine and potentially result in an increased systemic side effect such as hypotension. Caution, however, is advised in patients taking MAO inhibitors which can affect the metabolism and uptake of circulating amines.

OVERDOSAGE

There have been reports of inadvertent overdosage with timolol ophthalmic solution resulting in systemic effects similar to those seen with systemic beta-adrenergic blocking agents such as dizziness, headache, shortness of breath, bradycardia, bronchospasm, and cardiac arrest. Very limited information exists on accidental ingestion of brimonidine in adults alone or in combination. Symptoms of brimonidine overdose have been reported in neonates, infants, and children receiving brimonidine ophthalmic solutions as part of medical treatment of congenital glaucoma or by accidental oral ingestion [see Use in Specific Populations]. Treatment of an oral overdose includes supportive and symptomatic therapy; a patent airway should be maintained.

CONTRAINDICATIONS

Asthma, COPD

COMBIGAN® is contraindicated in patients with bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease [see Warnings and Precautions (5.1, 5.3)].

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]; cardiogenic shock.

Neonates and Infants (Under the Age of 2 Years)

COMBIGAN® is contraindicated in neonates and infants (under the age of 2 years).

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.

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