DUOTRAV

What it is

DuoTrav is a combination eye drop containing a topical prostaglandin analogue, travoprost and a topical beta-adrenergic receptor blocking agent, timolol maleate. Each mL of DuoTrav Eye Drops contains 40 micrograms (0.004%) travoprost and 5 mg (0.5%) timolol (as timolol maleate 6.83 mg). The product is benzalkonium chloride (BAK) free and uses polyquaternium-1 (POLYQUAD) as a preservative.

Approved indications

— Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension for whom single agent therapy provides insufficient intraocular pressure reduction.

Dosing overview

The recommended dosage for adults (including the elderly) is to instil one drop of DuoTrav Eye Drops once daily at about the same time each day in the conjunctival sac of the affected eye(s). DuoTrav Eye Drops should not be given more than once daily because travoprost is most effective at this dosage. If more than one topical ophthalmic product is being used, the eye drop products should be administered at least five minutes apart.

Key safety warnings

Like other topically applied ophthalmic agents, DuoTrav may be absorbed systemically. Due to the beta-adrenergic component timolol, the same types of adverse reactions seen with systemic beta-blockers may occur including aggravation of Prinzmetal angina, aggravation of severe peripheral and central circulatory disorders, bradycardia and hypotension. Respiratory and cardiac reactions, including death due to bronchospasm in patients with asthma and rarely death associated with cardiac failure have been reported following administration of timolol. Travoprost may gradually change the eye colour by increasing the number of melanosomes (pigment granules) in melanocytes. Before treatment is instituted patients must be informed of the possibility of these changes. Unilateral treatment can result in permanent heterochromia. Eyelash changes occurred in over a third of patients treated with DuoTrav Eye Drops. These changes include: increased length, thickness, pigmentation, and/or number of lashes. While taking beta-blockers patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens, whether accidental, diagnostic or therapeutic. In addition, such patients may be unresponsive to the usual doses of adrenaline used to treat anaphylactic reactions.

Contraindications

DuoTrav Eye Drops are contraindicated in patients with a known hypersensitivity to travoprost, timolol or any of the excipients in DuoTrav. DuoTrav Eye Drops are also contraindicated in pregnant women or women attempting to become pregnant. Reactive airway disease including bronchial asthma, a history of bronchial asthma, or severe chronic obstructive pulmonary disease. Sinus bradycardia, sick sinus syndrome, including sino-atrial block, second or third degree atrioventricular block, overt cardiac failure or cardiogenic shock.

Regulatory history

DuoTrav (travoprost 0.004% and timolol 0.5% as maleate eye drop solution) was first registered on the ARTG on 15 March 2012.