Pregnancy: Teratogenic Effects: Pregnancy Category C: There was no evidence of teratogenicity in rats or rabbits at oral terfenadine doses up to 300 mg/kg; these doses produced fexofenadine plasma AUC values that were up to 4, 30 and 37 times the human therapeutic value (based on a 60-mg twice-daily fexofenadine HCl dose), respectively.
There are no adequate and well-controlled studies in pregnant women. Telfast should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nonteratogenic Effects: Dose-related decreases in pup weight gain and survival were observed in rats exposed to oral doses ≥150 mg/kg of terfenadine; at these doses, the plasma AUC values of fexofenadine were ≥3 times the human therapeutic values (based on a 60-mg twice-daily fexofenadine HCl dose).
Oral suspension: Risk category in pregnancy: category C.
This medication must not be used by pregnant women without a physician or surgeon dentist's advice.
No studies of TELFAST (ORAL SUSPENSION) have been conducted in pregnant women.
TELFAST (ORAL SUSPENSION) should not be used during pregnancy unless the potential benefits exceed the potential risks to the fetus.
In studies that assessed reproductive toxicity conducted in mice, fexofenadine did not impair fertility, was not teratogenic and did not impair pre- or postnatal development.
Lactation: It is not known if fexofenadine is excreted in human milk. Because many drugs are excreted in human milk, caution should be used when fexofenadine HCl is administered to a nursing woman.
Oral suspension: No studies of TELFAST (ORAL SUSPENSION) have been conducted in breast feeding women.
TELFAST (ORAL SUSPENSION) must only be used by lactating women if the potential benefits exceed the potential risks to the child.