SUMMARY OF PRESCRIBING INFORMATION FOR MAGNEX/MAGNEX FORTE

Magnex/Magnex Forte injection (Sulbactam/Cefoperazone 1:1 and 1:2)
 

Sulbactam/Cefoperazone 1:1 and 1:2 – Magnex/Magnex Forte injection (Trademark Proprietor – Pfizer  Products Inc., USA) 

Indications: Monotherapy- Sulbactam/cefoperazone is indicated for the treatment of the following infections when caused by susceptible organisms: Respiratory Tract Infections, Urinary Tract  Infections (Upper and Lower), Intra-abdominal Infections, Septicemia, Meningitis, Skin and Soft Tissue  Infections, Bone and Joint Infections, Endometritis, other Infections of the Genital Tract. Magnex Forte  indicated for specific subset of patients (immunocompromised febrile neutropenic cancer patients, bone  marrow transplant). 

Pharmaceutical Form: Sulbactam sodium I.P./cefoperazone sodium I.P. combination is  available as a dry powder for reconstitution in a 1:1 and 1:2 ratio in terms of free Sulbactam /Cefoperazone. Sulbactam sodium I.P. is a derivative of the basic penicillin nucleus. Chemically it is sodium penicillinate sulfone. It contains 92 mg sodium (4 mEq) per gram. Sulbactam is an off-white crystalline powder which is highly soluble in water. The molecular weight is 255.22. Cefoperazone sodium I.P. is a semisynthetic broad-spectrum cephalosporin antibiotic for parenteral use only. It contains 34 mg sodium (1.5 mEq) per gram.
Cefoperazone is a white crystalline powder which is freely soluble in water. The molecular weight is 667.65.  

Dosage and Method of Administration: Vials of the 1:1 product contain the equivalent of 500 mg + 500 mg  and 1000 mg + 1000 mg of sulbactam and cefoperazone, respectively. Vials of the 1:2 product contain the  equivalent of 500 mg + 1000 mg and 1000 mg + 2000 mg of sulbactam and cefoperazone, respectively.

Dosage in adults: The usual adult dose of Sulbactam/Cefoperazone is 2 to 4 g per day (i.e. 1 to 2 g per day  cefoperazone activity) given intravenously or intramuscularly in equally divided doses every 12 hours. In  severe or refractory infections, the daily dosage of sulbactam/cefoperazone may be increased up to 8 g (i.e. 4  g cefoperazone activity) given intravenously in equally divided doses or 12 g of the 1:2 ratio. The  recommended maximum daily dosage of sulbactam is 4 g (i.e. 8 g of sulbactam/cefoperazone). In febrile  neutropenia, total daily dose can be administered twice or thrice a day in equally divided doses. Dosage in  pediatric population: The usual dosage of sulbactam/cefoperazone in children is 40 to 80 mg/kg/day (i.e. 20-  40 mg/kg/day cefoperazone) in 2 to 4 equally divided doses. In serious or refractory infections, these dosages  may be increased up to 160 mg/kg/day (80 mg/kg/day of cefoperazone) of the 1:1 ratio or 240 mg/kg/day  (160 mg/kg/day cefoperazone activity) of the 1:2 ratio. Doses should be administered in 2 to 4 equally divided  doses. Dosage in neonates: For neonates in the first week of life, the drug should be given every 12 hours. The maximum daily dosage of sulbactam in pediatrics should not exceed 80 mg/kg/day. For doses of  sulbactam/cefoperazone requiring more than 80 mg/kg/day cefoperazone activity the 1:2 ratio product must  be used. Dosage in renal impairment: Dosage regimens of sulbactam/cefoperazone should be adjusted in  patients with marked decrease in renal function (creatinine clearance of less than 30 ml/min) to compensate  for the reduced clearance of sulbactam. Patients with creatinine clearances between 15 and 30 ml/min  should receive a maximum of 1 g of sulbactam administered every 12 hours (maximum daily dosage of 2 g  sulbactam), while patients with creatinine clearances of less than 15 ml/min should receive a maximum of  500 mg of sulbactam every 12 hours (maximum daily dosage of 1 g sulbactam). Dosage in hepatic  dysfunction: Dose modification may be necessary in cases of severe biliary obstruction, severe hepatic  disease or in cases of renal dysfunction coexistent with either of those conditions. In patients with hepatic  dysfunction and concomitant renal impairment, cefoperazone serum concentrations should be monitored  and dosage adjusted as necessary. In these cases, dosage should not exceed 2 g/day of cefoperazone without  close monitoring of serum concentrations. 

Contraindications: Hypersensitivity to the active substances  (sulbactam, cefoperazone), to beta-lactams or to any excipients listed in the Pharmaceutical form section. 

Warnings and Precautions: Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been  reported in patients receiving beta-lactam or cephalosporin therapy, including sulbactam/cefoperazone. Before therapy with sulbactam/cefoperazone is instituted, careful inquiry should be made to determine  whether the patient has had previous hypersensitivity reactions to cephalosporins, penicillins or other drugs.  If an allergic reaction occurs, the drug should be discontinued, and the appropriate therapy instituted. Severe  and occasionally fatal skin reactions such as toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome  (SJS), and dermatitis exfoliative have been reported in patients on sulbactam/cefoperazone therapy. If a  severe skin reaction occurs sulbactam/cefoperazone should be discontinued and appropriate therapy should  be initiated. Haemorrhage cases, sometimes fatal including fatalities, have been reported with the use of  cefoperazone/sulbactam. As with other antibiotics, a vitamin K deficiency has occurred in patients treated  with sulbactam/cefoperazone which has generated coagulopathy. The mechanism is most likely connected with the suppression of the intestinal bacterial flora that normally synthesizes this vitamin. Those  at risk include patients with poor diet, malabsorption conditions and patients, and in patients receiving oral  anticoagulants, prothrombin time (or INR) on prolonged intravenous alimentation regimens. In these patients  should be monitored (for signs of bleeding, thrombocytopenia and hypoprothrombinemia) and exogenous  vitamin K should be given as indicated. Discontinue sulbactam/cefoperazone in case of persistent bleeding  and no alternative explanation is identified. Clostridium difficile associated diarrhea (CDAD) has been  reported with use of nearly all antibacterial agents, including sulbactam sodium/cefoperazone sodium, and  may range in severity from mild diarrhea to fatal colitis. CDAD must be considered in all patients who present  with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to  occur over two months after the administration of antibacterial agents. Sulbactam/cefoperazone has not  been extensively studied in premature infants or neonates. Therefore, in treating premature infants and  neonates potential benefits and possible risks involved should be considered before instituting therapy. 

Adverse reactions: Very common: Neutropenia, Leukopenia, Coombs direct test positive, haemoglobin  decreased, hematocrit decreased, thrombocytopenia, alanine aminotransferase increased, aspartate  aminotransferase increased, blood alkaline phosphatase increased. Common: Coagulopathy, eosinophilia,  diarrhea, nausea, vomiting, blood bilirubin increased. Reporting suspected adverse reactions after  authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk  balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse  reactions. 

Drug interactions: A reaction characterized by flushing, sweating, headache, and tachycardia has  been reported when alcohol was ingested during and as late as the fifth day after cefoperazone  administration. For patients requiring artificial feeding orally or parenterally, solutions containing ethanol  should be avoided. 

Overdose: Limited information is available on the acute toxicity of cefoperazone sodium  and sulbactam sodium in humans. Overdosage of the drug would be expected to produce manifestations that  are principally extensions of the adverse reactions reported with the drug. The fact that high CSF  concentrations of beta-lactam antibiotics may cause neurologic effects, including seizures, should be  considered. Because cefoperazone and sulbactam are both removed from the circulation by hemodialysis,  these procedures may enhance elimination of the drug from the body if overdosage occurs in patients with impaired renal function. 

Storage condition: Till reconstitution, store below 25°C and protect from light.  Reconstituted solutions are stable for 7 days at 2°C-8°C and for 24 hours at 8°C-25°C. All unused solutions  should be discarded after those time periods respectively.

 

Adapted from local product document. LPD version LPDMGX042020. 
Full prescribing Information available on  request
^®Trademark– Pfizer Products Inc., USA 
Licensed User – Pfizer Limited, India
Last Updated on 22.09.2020

Reference:

1. Magnex. Local product document. Pfizer; 2020. Version LPDMGX042020. ​​​​​​

Please click the Prescribing Information link to view the safety and adverse events information of MAGNEX^®.
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