País: Sudáfrica
Idioma: inglés
Fuente: South African Health Products Regulatory Authority (SAHPRA)
Bm_squib
AMIKIN injection 100 mg AMIKIN injection 250 mg AMIKIN injection 500 mg AMIKIN injection 1g SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): AMIKIN injection 100 mg AMIKIN injection 250 mg AMIKIN injection 500 mg AMIKIN injection 1g COMPOSITION: Vials containing amikacin sulphate equivalent to 100 mg, 250 mg and 500 mg amikacin base per 2 mL and 1g/4 mL sterile water respectively. Contains sodium bisulphite. PHARMACOLOGICAL CLASSIFICATION: A 20.1.1 - Broad spectrum antibiotics. PHARMACOLOGICAL ACTION: AMIKIN (amikacin sulphate) is a semi-synthetic aminoglycoside antibiotic which is active against a broad spectrum of Gram-negative organisms, including Pseudomonas and some Gram-positive organisms. Chemically, the medicine consists of 2 amino sugars glycosidically linked to deoxy-streptamine whose 1-amino group has been acylated by S-4- amino-2-hydroxy-butyric acid. AMIKIN is rapidly absorbed after intramuscular administration. In normal adult volunteers, average peak serum concentrations of about 12 and 21 micrograms/mL are obtained 1 hour after intramuscular administration of 250 mg (3,7 mg/kg) and 500 mg (7,5 mg/kg), single doses, respectively. At 10 hours, serum levels are about 0,3 micrograms/mL and 2,1 micrograms/mL, respectively. Mean urine concentrations for 6 hours are 563 micrograms/mL following a 250 mg dose and 832 micrograms/mL following a 500 mg dose. Clinical Pharmacology: Intravenous administration Single doses of 500 mg (7,5 mg/kg) administered to normal adults as an infusion over a period of 30 minutes produced a mean peak serum concentration of 38 micrograms/mL at the end of the infusion. Repeat infusions of 7,5 mg/kg every 12 hours in normal adults were well tolerated and caused no drug accumulation. Single doses of 15 mg/kg administered intravenously over 3 Leer el documento completo