Travoprost (Travatan Z)

Trade Name : Travatan Z

Alcon Laboratories, Inc

SOLUTION/ DROPS

Strength 0.04 mg/mL

TRAVOPROST Prostaglandin Analog [EPC],Prostaglandins [CS]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Travoprost (Travatan Z) which is also known as Travatan Z and Manufactured by Alcon Laboratories, Inc. It is available in strength of 0.04 mg/mL per ml. Read more

Travoprost (Travatan Z) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

TRAVATAN Z (travoprost ophthalmic solution) 0.004% is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.
TRAVATAN Z is a prostaglandin analog indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension n

The recommended dosage is one drop in the affected eye(s) once daily in the evening. TRAVATAN Z (travoprost ophthalmic solution) 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 Z may be used concomitantly with other topical ophthalmic drug products to lower intraocular pressure (IOP). If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes apart.
One drop in the affected eye(s) once daily in the evening n

Ophthalmic solution containing travoprost 0.04 mg/mL.
Ophthalmic solution containing travoprost 0.04 mg/mL n

None.
None n

No data

Pigmentation: Pigmentation of the iris, periorbital tissue (eyelid) and eyelashes can occur. Iris pigmentation likely to be permanent n
Eyelash Changes: Gradual change to eyelashes including increased length, thickness and number of lashes. Usually reversible n

Most common adverse reaction (30% to 50%) is conjunctival hyperemia n
To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories Inc. at 1-800-757-9195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Use in pediatric patients below the age of 16 years is not recommended because of potential safety concerns related to increased pigmentation following long-term chronic use n

Travoprost is a synthetic prostaglandin F analog. Its chemical name is [1-[1u03b1(),2u03b2(1,3*),3u03b1,5u03b1]]-7-[3,5-Dihydroxy-2-[3-hydroxy-4-[3-(trifluoromethyl) phenoxy]-1-butenyl]cyclopentyl]-5-heptenoic acid, 1-methylethylester. It has a molecular formula of CHFO and a molecular weight of 500.55. The chemical structure of travoprost is:
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.
TRAVATAN Zu00ae (travoprost ophthalmic solution) 0.004% is supplied as sterile, buffered aqueous solution of travoprost with a pH of approximately 5.7 and an osmolality of approximately 290 mOsmol/kg.
TRAVATAN Zu00ae contains travoprost 0.04 mg/mL; polyoxyl 40 hydrogenated castor oil, Ziau00ae (boric acid, propylene glycol, sorbitol, zinc chloride), sodium hydroxide and/or hydrochloric acid (to adjust pH) and purified water, USP. Preserved in the bottle with an ionic buffered system, Ziau00ae.

No data

Two-year carcinogenicity studies in mice and rats at subcutaneous doses of 10, 30, or 100 mcg/kg/day did not show any evidence of carcinogenic potential. However, at 100 mcg/kg/day, male rats were only treated for 82 weeks, and the maximum tolerated dose (MTD) was not reached in the mouse study. The high dose (100 mcg/kg) corresponds to exposure levels over 400 times the human exposure at the maximum recommended human ocular dose (MRHOD) of 0.04 mcg/kg, based on plasma active drug levels.
Travoprost was not mutagenic in the Ames test, mouse micronucleus test or rat chromosome aberration assay. A slight increase in the mutant frequency was observed in one of two mouse lymphoma assays in the presence of rat S-9 activation enzymes.
Travoprost did not affect mating or fertility indices in male or female rats at subcutaneous doses up to 10 mcg/kg/day (250 times the MRHOD of 0.04 mcg/kg/day on a mcg/kg basis). At 10 mcg/kg/day, the mean number of corpora lutea was reduced, and the post-implantation losses were increased. These effects were not observed at 3 mcg/kg/day (75 times the MRHOD).

In clinical studies, patients with open-angle glaucoma or ocular hypertension and baseline pressure of 25-27 mmHg who were treated with TRAVATANu00ae (travoprost ophthalmic solution) 0.004% or TRAVATAN Z (travoprost ophthalmic solution) 0.004% dosed once-daily in the evening demonstrated 7-8 mmHg reductions in intraocular pressure. In subgroup analyses of these studies, mean IOP reduction in black patients was up to 1.8 mmHg 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 mmHg on TIMOPTIC* 0.5% twice daily who were treated with TRAVATAN (travoprost ophthalmic solution) 0.004% dosed daily adjunctively to TIMOPTIC* 0.5% twice daily demonstrated 6-7 mmHg reductions in intraocular pressure.

TRAVATAN Zu00ae (travoprost ophthalmic solution) 0.004% is a sterile, isotonic, buffered, preserved, aqueous solution of travoprost (0.04 mg/mL) supplied in Alcon's oval DROP-TAINERu00ae package system.
TRAVATAN Zu00ae is supplied as a 2.5 mL solution in a 4u00a0mL 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 fillu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0065-0260-25
5 mL fillu00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0NDC 0065-0260-05
Storage:

Potential for Pigmentation
Advise the patient about the potential for increased brown pigmentation of the iris, which may be permanent. Inform the patient about the possibility of eyelid skin darkening, which may be reversible after discontinuation of TRAVATAN Z (travoprost ophthalmic solution) 0.004%.
Potential for Eyelash Changes
Inform the patient about the possibility of eyelash and vellus hair changes in the treated eye during treatment with TRAVATAN Z. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.
Handling the Container
Instruct the patient to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
When to Seek Physician Advice
Advise the patient that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of TRAVATAN Z.
Use with Contact Lenses
Contact lenses should be removed prior to instillation of TRAVATAN Z and may be reinserted 15 minutes following its administration.
Use with Other Ophthalmic Drugs
If more than one topical ophthalmic drug is being used, the drugs should be administered at least 5 minutes between applications.
Rx only
TIMOPTIC* is a registered trademark of Merck & Co., Inc.
Distributed by:Alcon Laboratories, Inc. Fort Worth, Texas 76134
ALCONn A Novartis company
u00a9 2006, 2010, 2011, 2013, 2017 Novartis
T2017-96

No data

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Travoprost (Travatan Z)

Trade Name : Travatan Z

SOLUTION/ DROPS

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Travoprost (Travatan Z)

Trade Name : Travatan Z

SOLUTION/ DROPS

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?