Quốc gia: Nam Phi
Ngôn ngữ: Tiếng Anh
Nguồn: South African Health Products Regulatory Authority (SAHPRA)
Aspen-p
TELLERGE 120 mg (film-coated tablets) TELLERGE 180 mg (film-coated tablets) SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): TELLERGE 120 mg (film-coated tablets) TELLERGE 180 mg (film-coated tablets) COMPOSITION: Each TELLERGE 120 mg tablet contains Fexofenadine Hydrochloride 120 mg equivalent to Fexofenadine 112 mg base. Each TELLERGE 180 mg tablet contains Fexofenadine Hydrochloride 120 mg equivalent to Fexofenadine 168 mg base PHARMACOLOGICAL CLASSIFICATION: A 5.7.1 Antihistaminics. PHARMACOLOGICAL ACTION: Fexofenadine hydrochloride is a pharmacologically active metabolite of terfenadine and is a non-sedating, selective histamine H 1 -receptor antagonist. Fexofenadine exhibits an antihistaminic effect beginning within one hour, achieving maximum effect at 6 hours and lasting 24 hours. Pharmacokinetics Fexofenadine is absorbed into the body following oral administration, with Tmax occurring at approximately 1-3 hours post dose. The mean Cmax value was approximately 427 ng/mL and 494 ng/mL following the administration of a 120 mg and 180 mg dose once daily, respectively. The volume of distribution is 5.4-5.8 L/kg. Fexofenadine does not cross the blood brain barrier. Fexofenadine is 60-70% plasma protein bound. Fexofenadine undergoes negligible metabolism (about 5% of the total dose is metabolized, mostly by the intestinal mucosa, with only 0.5-1.5% of the dose undergoing hepatic biotransformation), as it was the only major compound identified in urine and faeces of animals and man. The plasma concentration profiles of Fexofenadine follow a bi-exponential decline with a terminal elimination half-life ranging from 11 to 15 hours, after multiple dosing. The single and multiple dose pharmacokinetics of Fexofenadine are linear between 40 mg and 240 mg taken daily. The major route o Đọc toàn bộ tài liệu