Država: Južnoafrička Republika
Jezik: engleski
Izvor: South African Health Products Regulatory Authority (SAHPRA)
Dr-reddy
BIGSENS 500 (film coated tablets) BIGSENS 850 (film coated tablets) BIGSENS 1000 (film coated tablets) SCHEDULING STATUS: S3 PROPRIETARY NAME (and dosage form): BIGSENS 500 (film coated tablets) BIGSENS 850 (film coated tablets) BIGSENS 1000 (film coated tablets) COMPOSITION Per film coated tablet: BIGSENS 500: Metformin hydrochloride 500 mg BIGSENS 850: Metformin hydrochloride 850 mg BIGSENS 1000: Metformin hydrochloride 1000 mg PHARMACOLOGICAL CLASSIFICATION A.21.2 Oral Hypoglycaemic PHARMACOLOGICAL ACTION Metformin is a biguanide oral anti-hyperglycaemic agent. Its mode of action is thought to be increased peripheral glucose utilization mediated by increased insulin sensitivity and inhibition of increased hepatic and renal gluconeogenesis. Absorption: After an oral dose of metformin, Tmax is reached in 2,5 hours. Absolute bioavailability of a 500 mg or 850 mg metformin tablet is approximately 50-60% in healthy subjects. After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%. After oral administration, metformin absorption is saturable and incomplete. It is assumed that the pharmacokinetics of metformin absorption is non-linear. At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24 to 48 hours and are generally less than 1 micrograms/mL. In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 micrograms/mL, even at maximum doses. Food decreases the extent and slightly delays the absorption of metformin; following administration of a dose of 850 mg, a 40% lower plasma peak concentration, a 25% decrease in AUC (area under the curve) and a 35 minute prolongation of time to peak plasma concentration were observed. The clinical relevance of these decreases is unknown. Distribution: Pla Pročitajte cijeli dokument