Land: Sør-Afrika
Språk: engelsk
Kilde: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
INDICATIONS [/za_1030.html#1] [/za_1030.html#1] [/za_1030.html#1] CONTRA-INDICATIONS [/za_1030.html#1] [/za_1030.html#1] DOSAGE [/za_1030.html#1] [/za_1030.html#1] SIDE-EFFECTS [/za_1030.html#1] [/za_1030.html#1] [/za_1030.html#1] PREGNANCY [/za_1030.html#1] [/za_1030.html#1] OVERDOSE [/za_1030.html#1] IDENTIFICATION [/za_1030.html#1] [/za_1030.html#1] PATIENT INFORMATION FASTWAY 120 (TABLETS) FASTWAY 180 (TABLETS) SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): FASTWAY 120 (TABLETS) FASTWAY 180 (TABLETS) COMPOSITION: FASTWAY 120: Each tablet contains 120 mg FEXOFENADINE hydrochloride FASTWAY 180: Each tablet contains 180 mg fexofenadine hydrochloride 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 T max 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 is5,4-5,8 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 metabolised, 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 Les hele dokumentet