TRAVATAN Z
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVATAN Z (TRAVATAN Z).
Selective FP prostanoid receptor agonist; increases uveoscleral outflow of aqueous humor by binding to FP receptors in the ciliary muscle and trabecular meshwork, leading to matrix metalloproteinase activation and remodeling of extracellular matrix.
| Metabolism | Primarily hydrolyzed by esterases in the cornea and other ocular tissues to the active acid form; subsequent metabolism via beta-oxidation and reduction reactions; minimal hepatic metabolism. |
| Excretion | Primarily eliminated via hepatic metabolism; renal excretion of metabolites accounts for approximately 20% of the dose; fecal excretion is minimal. |
| Half-life | Terminal elimination half-life is 45 minutes; due to rapid hydrolysis to active acid, the clinical effect duration is longer than the half-life suggests. |
| Protein binding | Approximately 99% bound to human plasma proteins, primarily albumin. |
| Volume of Distribution | 0.26 L/kg; indicates distribution into total body water, consistent with hydrophilic nature. |
| Bioavailability | Ocular: Systemic bioavailability is low due to extensive ocular and hepatic first-pass metabolism; precise ocular bioavailability not determined. |
| Onset of Action | Ocular: Reduction of intraocular pressure begins within 2-4 hours after instillation. |
| Duration of Action | Ocular: Intraocular pressure reduction persists for at least 24 hours following a single dose, supporting once-daily dosing. |
One drop in the affected eye(s) once daily in the evening. Ophthalmic solution 0.004% (travoprost 0.04 mg/mL).
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dose adjustment required for renal impairment. Travoprost is extensively metabolized and renal clearance is minimal. |
| Liver impairment | No dose adjustment required for mild to moderate hepatic impairment (Child-Pugh A or B). Not studied in severe hepatic impairment (Child-Pugh C); use with caution. |
| Pediatric use | Safety and efficacy not established. Use in pediatric patients is not recommended. |
| Geriatric use | No dose adjustment necessary. Elderly patients may have increased risk of ocular adverse effects; monitor intraocular pressure and ocular surface status. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVATAN Z (TRAVATAN Z).
| Breastfeeding | It is not known whether travoprost is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRAVATAN Z is administered to a nursing woman. M/P ratio: not available. Consider risk of systemic exposure to the infant; avoid use or discontinue nursing if drug is needed. |
| Teratogenic Risk | Travoprost (TRAVATAN Z) is classified as FDA Pregnancy Category C. In animal studies, fetal toxicity including skeletal abnormalities and malformations occurred at doses 5-10 times the human dose. There are no adequate and well-controlled studies in pregnant women. The drug should be used during pregnancy only if potential benefit justifies potential risk to the fetus. First trimester: caution due to potential teratogenic effects. Second and third trimesters: increased risk of preterm labor and uterine contractions due to prostaglandin analog activity. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to travoprost or any component of the formulation","Active herpes simplex keratitis"]
| Precautions | ["May gradually change eyelashes and periocular pigmentation (reversible upon discontinuation)","May cause iris pigmentation changes (likely permanent)","Use with caution in patients with intraocular inflammation (e.g., iritis/uveitis)","May reactivate herpetic keratitis; contraindicated in patients with active herpes simplex keratitis","Risk of macular edema, especially in aphakic, pseudophakic with torn posterior lens capsule, or with known risk factors for macular edema","Contains benzalkonium chloride which may be absorbed by soft contact lenses; remove lenses before administration"] |
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| Fetal Monitoring | Monitor intraocular pressure (IOP) regularly. Assess for adverse effects including increased iris pigmentation, eyelash changes, and ocular inflammation. In pregnancy, monitor for any signs of uterine hyperstimulation or preterm labor. For breastfeeding, observe infant for ocular or systemic effects such as apnea or bradycardia if accidental exposure. |
| Fertility Effects | No specific human data on fertility effects. In animal studies, there was no impairment of fertility at doses up to 8 times the human dose. Theoretical concern due to prostaglandin analog activity; may affect uterine contractility and implantation, but clinical significance unknown. |