TIMOPTIC 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC SOLUTION) in OCUDOSE

Timoptic in Ocudose
Timoptic in OcudoseFor patients who are sensitive to the preservative in TIMOPTIC (timolol maleate ophthalmic solution), benzalkonium chloride (BAK), TIMOPTIC in OCUDOSE is a preservative-free eye drop for reducing intraocular pressure.1 It is supplied in a sterile, single-use container that should be used immediately upon opening, and then discarded.







Clinical support

In an epidemiologic survey, patients who were switched to a preservative-free timolol experienced fewer ocular symptoms, such as pain and discomfort upon instillation.2


INDICATIONS AND USAGE

Preservative-free TIMOPTIC in OCUDOSE is indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma. It may be used when a patient is sensitive to the preservative in TIMOPTIC (timolol maleate ophthalmic solution), benzalkonium chloride, or when use of a preservative-free topical medication is advisable.

IMPORTANT SAFETY INFORMATION

Preservative-free TIMOPTIC in Ocudose is contraindicated in patients with: bronchial asthma; a history of bronchial asthma; severe chronic obstructive pulmonary disease; sinus bradycardia; second or third degree atrioventricular block; overt cardiac failure; cardiogenic shock; hypersensitivity to any component of this product.

The same adverse reactions found with systemic administration of beta-adrenergic blocking agents may occur with topical administration. 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.

In patients undergoing elective surgery, some authorities recommend gradual withdrawal of beta-adrenergic receptor blocking agents because these agents impair the ability of the heart to respond to beta-adrenergically mediated reflex stimuli.

Beta-adrenergic blocking agents may mask signs and symptoms of acute hypoglycemia or certain clinical signs of hyperthyroidism. Patients subject to spontaneous hypoglycemia, or diabetic patients receiving either insulin or oral hypoglycemic agents, or patients suspected of developing thyrotoxicosis, should be managed carefully, with caution.

The most frequently reported adverse experiences have been burning and stinging upon instillation (approximately one in eight patients).

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TIMOPTIC 0.25% AND 0.5% (TIMOLOL MALEATE OPHTHALMIC SOLUTION) in OCUDOSE : Additional information


References:

1. Timoptic in Ocudose [package insert]. Valeant Pharmaceuticals, Bridgewater, NJ 2009.
2. Jaenen N. Ocular symptoms and signs with preserved and preservative-free glaucoma medications. Eu J Ophthamol. 2007:17(3)341-349

US/TOP/14/0016(1)