Quốc gia: Nam Phi
Ngôn ngữ: Tiếng Anh
Nguồn: South African Health Products Regulatory Authority (SAHPRA)
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AMPICLOX 500 (capsules) AMPICLOX S (syrup) AMPICLOX 500 I (injection) AMPICLOX 75 I (neonatal injection) AMPICLOX D (neonatal drops) SCHEDULING STATUS: S4 PROPRIETARY NAME (and dosage form): AMPICLOX 500 (capsules) AMPICLOX S (syrup) AMPICLOX 500 I (injection) AMPICLOX 75 I (neonatal injection) AMPICLOX D (neonatal drops) COMPOSITION: (a) Oral: Ampicillin trihydrate B.P. and cloxacillin sodium B.P. available as: AMPICLOX 500 : Gelatin capsules containing the equivalent of 250 mg ampicillin and 250 mg cloxacillin. AMPICLOX S : Powder for preparing fruit-flavoured suspension. When dispensed as directed each 5 mL of the suspension contains the equivalent of 125 mg ampicillin and 125 mg cloxacillin. The powder contains 0,13% m/m of sodium benzoate B.P. as a preservative. AMPICLOX D : Powder for preparing neonatal drops. When dispensed as directed, each 0,6 mL of the suspension contains the equivalent of 60 mg ampicillin and 30 mg cloxacillin. The powder contains 0,525% m/m sodium benzoate B.P. as a preservative. (b) Parenteral Ampicillin sodium B P. and cloxacillin sodium B.P. available as: AMPICLOX 75 I : Sterile powder for preparing the equivalent of 50 mg ampicillin and 25 mg cloxacillin per neonatal vial. AMPICLOX 500 I : Sterile powder for preparing the equivalent of 250 mg ampicillin and 250 mg cloxacillin per vial. PHARMACOLOGICAL CLASSIFICATION: A.20.1.2 Penicillins PHARMACOLOGICAL ACTION: (a) Bacteriology: AMPICLOX exhibits in vivo and in vitro bactericidal activity against Gram-positive and Gram-negative organisms. In vitro sensitivity does not necessarily imply in vivo activity. (b) Absorption: Both ampicillin and cloxacillin are acid stable and well absorbed orally, giving peak serum levels about two hours after dosing. As there is a linear dose/response in peak serum le Đọc toàn bộ tài liệu