Amsulvex

Amsulvex Dosage/Direction for Use

ampicillin + sulbactam

Manufacturer:

North China Pharma

Distributor:

Sannovex
Full Prescribing Info
Dosage/Direction for Use
1.5-12 g/day in divided doses: Mild infection 1.5-3 g, moderate infection: Up to 6 g, severe infection Up to 12 g. Neonate 150 mg/kg/day. Prophylaxis of surgical infections 1.5-3 g at the induction of anesthesia and may be repeated 6-8 hourly.
Directions for Use: General Dissolution Procedures: Ampicillin and Sulbactam for Injection sterile powder for intravenous and intramuscular use may be reconstituted with any of the compatible diluents described in this insert. Solutions should be allowed to stand after dissolution to allow any foaming to dissipate in order to permit visual inspection for complete solubilization.
Preparation for Intravenous Use: 1.5 Gram and 3 Gram Vials of Sterile Powder: Initially, vials for intravenous use may be reconstituted with Sterile Water for Injection to yield solutions containing 375 mg ampicillin and sulbactam per mL (250 mg ampicillin/125 mg sulbactam per mL). An appropriate volume should then be immediately diluted with any of the following suitable parenteral diluents to yield solutions containing 3 to 45 mg ampicillin and sulbactam per mL (2 to 30 mg ampicillin/1 to 15 mg sulbactam per mL). Reconstitution of AMSULVEX, at the specified concentrations, with these diluents provide stable solutions for the time periods indicated in the following table: (After the indicated time periods, any unused portions of solutions should be discarded.) (See Table 1.)

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Preparation for Intramuscular Injection: 1.5 G and 3 G Vials: Vials for intramuscular use may be reconstituted with Sterile Water for Injection USP, 0.5% Lidocaine Hydrochloride Injection USP or 2% Lidocaine Hydrochloride Injection USP. Consult the following table for recommended volumes to be added to obtain solutions containing 375 mg Ampicillin and Sulbactam per mL (250 mg ampicillin/125 mg sulbactam per mL). Note: Use only freshly prepared solutions and administer within one hour after preparation.
*There is sufficient excess present to allow withdrawal and administration of the stated volumes. (See Table 2.)

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While reversible glycogenosis was observed in laboratory animals, this phenomenon was dose- and time-dependent and is not expected to develop at the therapeutic doses and corresponding plasma levels attained during the relatively short periods of combined ampicillin/sulbactam therapy in man.
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