Ország: Dél-afrikai Köztársaság
Nyelv: angol
Forrás: 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 Olvassa el a teljes dokumentumot