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2.2 Introduction International Nonproprietary Name (rINN): Travoprost Structural formula: Molecular formula:

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Travoprost/ Pharmathen 40 micrograms/mL preservative free eye drops, solution in multi dose container

2.2 Introduction, p.1

2.2 Introduction

International Nonproprietary Name (rINN): Travoprost Structural formula:

Molecular formula:

Molecular weight:

Chemical names:

Travoprost decrease the elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Data on adjunctive administration of Travoprost with timolol 0.5% and limited data with brimonidine 0.2% were collected during clinical trials that showed an additive effect of Travoprost with these glaucoma medications. No clinical data are available on adjunctive use with other ocular hypotensive medications.

Travoprost significantly increased optic nerve head blood flow in rabbits following 7 days of topical ocular administration ( )

Travoprost is

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Travoprost/ Pharmathen 40 micrograms/mL preservative free eye drops, solution in multi dose container

2.2 Introduction, p.2

Following topical ocular administration of Travoprost to healthy volunteers, low systemic exposure to active free acid was demonstrated. Peak active free acid plasma concentrations of 25 pg/ml or less were observed between 10 and 30 minutes post- dose. Thereafter, plasma levels declined rapidly to below the 10 pg/ml assay quantitation limit before 1 hour post-administration. Due to the low plasma concentrations and rapid elimination following topical dosing, the elimination half- life of active free acid in man could not be determined.

Metabolism is the major route of elimination of both travoprost and the active free acid.

Travoprost free acid and its metabolites are mainly excreted by the kidneys.

Travoprost has been studied in patients with mild to severe hepatic impairment and in patients with mild to severe renal impairment (creatinine clearance as low as ml/min). No dosage adjustment is necessary in these patients.

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