TRAVA – MAX

  • Therapeutic Category
    • OPHTHALMOLOGICAL DRUGS
    • MIOTICS AND ANTIGLAUCOMA DRUGS
  • Pharmaceutical Form : Eye Drops
  • Composition : Travoprost 0.04 mg / 1 ml
  • Active Substance : Travoprost

CLINICAL PHARMACOLOGY:

Travoprost free acid is a selective FP prostanoid receptor agonist which is believed to reduce intraocular pressure by increasing uveoscleral outflow. The exact mechanism of action is unknown at this time.

Absorption:    Travoprost is absorbed through the cornea. In humans, peak plasma concentrations of travoprost free acid (25 pg/mL or less) were reached within 30 minutes following topical ocular administration and was rapidly eliminated.

Metabolism:    Travoprost, an isopropyl ester prodrug, is hydrolyzed by esterases in the cornea to its biologically active free acid. Systemically, travoprost free acid is metabolized to inactive metabolites via beta-oxidation of the (alpha)(carboxylic acid) chain to give the 1,2-dinor and 1,2,3,4-tetranor analogs, via oxidation of the 15-hydroxyl moiety, as well as via reduction of the 13,14 double bond.

Excretion:    Elimination of travoprost free acid from human plasma is rapid. Plasma levels are below the limit of quantization (<10 pg/mL) within one hour following ocular instillation.

INDICATIONS AND USAGE:

TRAVA – MAX Ophthalmic Solution is indicated for the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension who are intolerant of other intraocular pressure lowering medications or insufficiently responsive (failed to achieve target IOP determined after multiple measurements over time) to another intraocular pressure lowering medication

CONTRAINDICATIONS:

Known hypersensitivity to travoprost, benzalkonium chloride or any other ingredients in this product.

 WARNINGS:

– TRAVA – MAX has been reported to cause changes to pigmented tissues. The most frequently reported changes have been increased pigmentation of the iris and periorbital tissue (eyelid) and increased pigmentation and growth of eyelashes. These changes may be permanent.

– TRAVA – MAX may gradually change eye color, increasing the amount of brown pigmentation in the iris by increasing the number of melanosomes (pigment granules) in melanocytes.

– TRAVA – MAX may gradually change eyelashes in the treated eye; these changes include increased length, thickness, pigmentation, and/or number of lashes.

PRECAUTIONS:

  • TRAVA – MAX should be used with caution in patients with active intraocular inflammation

 (iritis/uveitis).

  • Macular edema, including cystoid macular edema, has been reported during treatment with prostaglandin F2a analogues. These reports have mainly occurred in aphakic patients, pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema. TRAVA – MAX should be used with caution in these patients.
  • TRAVA – MAX has not been evaluated for the treatment of angle closure, inflammatory or neovascular glaucoma.
  • TRAVA – MAX has not been studied in patients with renal or hepatic impairment and should be used with caution in such patients.
  • Contact lenses should be removed prior to the administration of the solution. Lenses may be reinserted 15 minutes following administration of TRAVA – MAX.

Pregnancy: Pregnancy Category C: Since prostaglandins are biologically active and may be absorbed through the skin, women who are pregnant or attempting to become pregnant should exercise appropriate precautions to avoid direct exposure to the contents of the bottle. In case of accidental contact with the contents of the bottle, thoroughly cleanse the exposed area with soap and water immediately.

Nursing Mothers: It is not known whether this drug or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRAVA – MAX is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established. 

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

Information For Patients:

  • Patients should be advised concerning all the information contained in the Warnings and Precautions sections.
  • Patients should also be instructed to avoid allowing the tip of the dispensing container to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
  • Patients also should be advised that if they develop an intercurrent ocular condition (e.g., trauma, or infection) or have ocular surgery, they should immediately seek their physician’s advice concerning the continued use of the multi-dose container.
  • Patients should be advised that if they develop any ocular reactions, particularly conjunctivitis and lid reactions, they should immediately seek their physician’s advice.
  • If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes apart.

DOSAGE AND ADMINISTRATION:

The recommended dosage is one drop in the affected eye(s) once-daily in the evening. The dosage of TRAVA – MAX should not exceed once-daily since it has been shown that more frequent administration may decrease the intraocular pressure lowering effect.

Reduction of intraocular pressure starts approximately 2 hours after administration, and the maximum effect is reached after 12 hours.

TRAVA – MAX 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 (5) minutes apart.

STORAGE:

  • Store between 2° – 25°C .
  • Discard the container within 6 weeks of removing it from the sealed pouch.

How Supplied: Plastic bottle 2.5-5 ml