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TRAVATAN (TRAVOPROST): USE IN SPECIFIC POPULATIONS
Pregnancy Category C
Teratogenic effects: Travatan (Travoprost) was teratogenic in rats, at an intravenous (IV) dose up to 10 mcg / kg per day (250 times the maximal recommended human ocular dose (MRHOD), evidenced by an increase in the incidence of skeletal malformations as well as external and visceral malformations, such as fused sternebrae, domed head and hydrocephaly. Travoprost was not teratogenic in rats at IV doses up to 3 mcg / kg per day (75 times the MRHOD), or in mice at subcutaneous doses up to 1 mcg / kg per day (25 times the MRHOD). Travoprost produced an increase in post-implantation losses and a decrease in fetal viability in rats at IV doses > 3 mcg / kg per day (75 times the MRHOD) and in mice at subcutaneous doses > 0.3 mcg / kg per day (7.5 times the MRHOD).
In the offspring of female rats that received travoprost subcutaneously from Day 7 of pregnancy to lactation Day 21 at doses of >= 0.12 mcg / kg per day (3 times the MRHOD), the incidence of postnatal mortality was increased, and neonatal body weight gain was decreased. Neonatal development was also affected, evidenced by delayed eye opening, pinna detachment and preputial separation, and by decreased motor activity.
There are no adequate and well-controlled studies of Travatan (Travoprost) ophthalmic solution administration in pregnant women. Because animal reproductive studies are not always predictive of human response, Travatan (Travoprost) ophthalmic solution 0.004% should administered during pregnancy only if the potential benefit justifies the potential risk to the fetus.
A study in lactating rats demonstrated that radiolabeled travoprost and/or its metabolites were excreted in milk. 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 Travatan (Travoprost) eye drops is administered to a nursing woman.
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.
No overall clinical differences in safety or effectiveness have been observed between elderly and other adult patients.
Hepatic and Renal Impairment
Travoprost (Travatan) has been studied in patients with hepatic impairment and also in patients with renal impairment. No clinically relevant changes in hematology, blood
chemistry, or urinalysis laboratory data were observed in these patients.
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