MAGNEX® Summary of Product Information

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 cephalospor in 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 anti coagulants, 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 amino transferase 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 over dosage 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   Proprietor–   Pfizer
Products Inc., USA Licensed User –
Pfizer Limited, India
Last Updated on 22.09.2020

Reference:
1. Local Product Document. Magnex®. version LPDMGX042020.

PP-MGX-IND-0399. 09 December 2021
Please click on Prescribing Information link to view safety and adverse events information of MAGNEX® 
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