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TRAVATAN (TRAVOPROST): PRESCRIBING INFORMATION
Travoprost is a synthetic prostaglandin F analogue. Its chemical name is [1R-[1alpha(Z),2beta(1E,3R*),3alpha,5alpha]]-7-[3,5Dihydroxy-2-[3-hydroxy-4-[3(
trifluoromethyl)phenoxy]-1-butenyl]cyclopentyl]-5heptenoic acid, 1-methylethylester. It has a molecular formula of C26H35F3O6 and a molecular weight of 500.55.
Travoprost is a clear, colorless to slightly yellow oil that is very soluble in acetonitrile, methanol, octanol, and chloroform. It is practically insoluble in water.
Travoprost (Travatan) ophthalmic solution is supplied as sterile, buffered aqueous solution of travoprost with a pH of approximately 6.0 and an osmolality of approximately 290 mOsmol / kg.
Travatan contains Active: travoprost 0.04 mg / ml;
Preservative: benzalkonium chloride 0.15 mg / ml;
Inactives: tromethamine, polyoxyl 40 hydrogenated castor oil, boric acid, edetate disodium, mannitol, sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water.
INDICATIONS AND USAGE
Travatan (Travoprost) ophthalmic solution 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.
DOSAGE AND ADMINISTRATION
The recommended dosage is one drop in the affected eye(s) once daily in the evening. Travatan should not be administered more than once daily since it has been shown that more frequent administration of prostaglandin analogs may decrease the intraocular pressure lowering effect.
Reduction of the intraocular pressure starts approximately 2 hours after the first administration with maximum effect reached after 12 hours.
Travatan (Travoprost) may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure. If more than one topical ophthalmic drug is being used, the drugs should be administered at least five minutes apart.
DOSAGE FORMS AND STRENGTHS
Ophthalmic solution containing travoprost 0.04 mg / ml.
WARNINGS AND PRECAUTIONS
Travatan warnings and precautions
Travatan adverse reactions
USE IN SPECIFIC POPULATIONS
Travatan use in specific populations
Travatan clinical pharmacology
Travatan nonclinical toxicology
In clinical studies, patients with open-angle glaucoma or ocular hypertension and baseline pressure of 25-27 mm Hg who were treated with Travatan dosed once-daily in the evening demonstrated 7-8 mm Hg reductions in intraocular pressure. In subgroup analyses of these studies, mean IOP reduction in black patients was up to 1.8 mm Hg greater than in non-black patients. It is not known at this time whether this difference is attributed to race or to heavily pigmented irides.
In a multi-center, randomized, controlled trial, patients with mean baseline intraocular pressure of 24-26 mm Hg on Timoptic 0.5% BID who were treated with Travatan (Travoprost) dosed QD adjunctively to Timoptic 0.5% BID demonstrated 6-7 mm Hg reductions in intraocular pressure.
HOW SUPPLIED / STORAGE AND HANDLING
Travatan (Travoprost) ophthalmic solution is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg / ml) supplied in Alcon's oval Drop Tainerr package system.
Travatan (Travoprost) ophthalmic solution 0.004% is supplied as a 2.5 mL solution in a 4 mL and a 5 mL solution in a 7.5 mL natural polypropylene dispenser bottle with a natural
polypropylene dropper tip and a turquoise polypropylene or high density polyethylene overcap. Tamper evidence is provided with a shrink band around the closure and neck area of the package.
2.5 mL fill; 2 units, 2.5 mL fill; 5 mL fill
Store at 2° - 25°C (36°‹ - 77°F).
Manufactured and distributed by Alcon pharmaceutical company and its divisions.
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