TRAVATAN
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVATAN (TRAVATAN).
Selective FP prostanoid receptor agonist; increases uveoscleral outflow of aqueous humor by relaxing the ciliary muscle and remodeling the extracellular matrix in the ciliary body.
| Metabolism | Hydrolyzed by esterases in the cornea and plasma to the active free acid, which is further metabolized via beta-oxidation and phase II conjugation. |
| Excretion | Renal (primarily as metabolites): ~70%; Fecal: ~25%; Unchanged drug in urine: <1% |
| Half-life | Terminal elimination half-life is approximately 45 minutes for travoprost acid (active metabolite). Clinical context: due to rapid systemic clearance, ocular hypotensive effect persists for 24 hours from corneal tissue binding. |
| Protein binding | 99.8% bound to plasma proteins (primarily albumin) |
| Volume of Distribution | 0.17 L/kg (active metabolite); small Vd consistent with extensive protein binding and limited tissue distribution |
| Bioavailability | Ocular topical: minimal systemic absorption (plasma concentrations below 10 pg/mL after therapeutic dose); systemic bioavailability not assessed due to low systemic exposure |
| Onset of Action | Ocular topical: 2 hours (maximal intraocular pressure reduction seen at 12 hours) |
| Duration of Action | 24 hours with once-daily dosing; sustained IOP reduction for up to 35 hours post single dose |
One drop of 0.004% ophthalmic solution in the affected eye(s) once daily in the evening.
| Dosage form | SOLUTION/DROPS |
| Renal impairment | No dosage adjustment required. Use with caution in severe renal impairment (CrCl < 15 mL/min). |
| Liver impairment | No dosage adjustment recommended for mild to moderate hepatic impairment. Not studied in severe hepatic impairment. |
| Pediatric use | Safety and efficacy not established. Not recommended for use in pediatric patients. |
| Geriatric use | No specific dose adjustment required. Elderly patients may have increased risk of ocular adverse events; monitor closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVATAN (TRAVATAN).
| Breastfeeding | Excretion in human milk unknown; however, travoprost and its metabolites have been detected in milk of rats. Caution advised. M/P ratio not established. Benefit-risk assessment recommended. |
| Teratogenic Risk | FDA Pregnancy Category C. No adequate studies in pregnant women. In animal studies, intravenously administered travoprost caused teratogenic effects (e.g., skeletal abnormalities, hydrocephalus) at doses 1.2-6 times the clinical ocular dose. Risk cannot be ruled out; use only if potential benefit justifies risk. First trimester: theoretical risk of teratogenicity due to prostaglandin analog activity. Second and third trimesters: potential for increased uterine contractility; avoid use during labor due to possible augmentation. |
■ FDA Black Box Warning
None.
| Common Effects | Eye pain Foreign body sensation Eye discomfort Eye itching Ocular hyperemia Decreased vision |
| Serious Effects |
["Hypersensitivity to travoprost or any component of the formulation"]
| Precautions | ["Pigmentation changes (iris, periorbital tissue, eyelashes)","Eyelash changes (increased length, thickness, number)","Potential for intraocular inflammation (iritis/uveitis)","Macular edema, especially in aphakic/pseudophakic patients with torn posterior lens capsule","Contamination risk from multiple-dose container","Bacterial keratitis if tip touches eye","Use with caution in patients with active intraocular inflammation","May increase rebound IOP if discontinued abruptly"] |
Loading safety data…
| Fetal Monitoring | Monitor intraocular pressure (IOP) regularly. Assess for ocular adverse effects (e.g., iris pigmentation changes, eyelash changes). No specific fetal monitoring required; however, consider fetal ultrasound if systemic exposure suspected. |
| Fertility Effects | No human data. In animal studies, travoprost did not impair fertility at doses up to 1.2 times the clinical ocular dose. Theoretical risk of disruption of tubal motility due to prostaglandin analog activity; avoid in women attempting conception if unexplained infertility. |