Telfast/Telfast Oral Suspension Special Precautions

Film-coated tablet: As with most new medicinal products, there is only limited data in the elderly and renally or hepatically impaired patients. Fexofenadine hydrochloride should be administered with care in these special groups.
Patients with a history of or ongoing cardiovascular disease should be warned that, antihistamines as a medicine class, have been associated with the adverse reactions, tachycardia and palpitations (see Adverse Reactions).
Effects on ability to drive and use machines: On the basis of the pharmacodynamic profile and reported adverse reactions, it is unlikely that fexofenadine hydrochloride tablets will produce an effect on the ability to drive or use machines. In objective tests, Telfast has been shown to have no significant effects on central nervous system function. This means that patients may drive or perform tasks that require concentration. However, in order to identify sensitive people who have an unusual reaction to medicinal products, it is advisable to check the individual response before driving or performing complicated tasks.
Oral suspension: Effects on Fertility: In rat fertility studies, dose-related reductions in implants and increases in post-implantation losses were observed at oral doses equal to or greater than 150 mg/kg of terfenadine, respectively; these doses produced plasma AUC values of fexofenadine that were equal to or greater than three times the human therapeutic value, respectively (based on a 60 mg twice daily fexofenadine HCl dose).
Carcinogenicity: The carcinogenic potential and reproductive toxicity of fexofenadine HCl were assessed using terfenadine studies. No evidence of carcinogenicity was observed when mice and rats were given daily oral doses of 50 and 150 mg/kg of terfenadine for 18 and 24 months, respectively; these doses resulted in plasma AUC values of fexofenadine that were two to four times the human therapeutic value (based on a 60 mg twice daily fexofenadine HCl dose).
Fexofenadine showed no genotoxic activity in a series of assays for gene mutations and chromosomal damage.
Use in Pregnancy: Category B2. Reproductive toxicity of fexofenadine in animals was assessed through terfenadine exposure. No evidence of teratogenicity was observed in animal reproduction studies (rat and rabbit) when terfenadine was given at oral doses of up to 300 mg/kg/day throughout organogenesis, which corresponds to levels of systemic fexofenadine exposure 4- and 32-fold higher, respectively, than those anticipated in clinical use. Decreased pup weight and survival occurred in rats when terfenadine was given at oral doses of 150 mg/kg/day and above throughout pregnancy and lactation.
There are no studies in pregnant women exposed to fexofenadine alone or through the administration of terfenadine.
Use in Lactation: Telfast is not recommended for nursing women unless, in the physician's judgment, the potential benefit to the patient outweighs the potential risk to the infant. There are no data on the content of human milk after administering fexofenadine. However, when terfenadine was administered to nursing mothers, fexofenadine was found to cross into human breast milk.
Exposure of rats to fexofenadine and terfenadine through the administration of terfenadine at dietary doses of 150 and 300 mg/kg/day throughout pregnancy and lactation (corresponding to systemic exposure at levels (AUC) approximately 3- and 6-fold higher than those anticipated in clinical use) caused decreased pup weight gain and survival. The relative risks of these effects from terfenadine or fexofenadine are unknown. Effects on pups exposed to fexofenadine only during lactation are unknown.
Use in Children: Safety and effectiveness of Telfast has not been established in children under 2 years of age for allergic rhinitis and under 6 years of age for chronic idiopathic urticaria.
Telfast Oral Suspension Pediatric is intended for children from 2 years of age.