SUDOPEN 500 MG is a sterile, lyophilized powder for intravenous (IV) or intramuscular (IM) administration, combining Cefoperazone (3rd-generation cephalosporin) and Sulbactam (beta-lactamase inhibitor). It is effective against multidrug-resistant Gram-negative and some Gram-positive infections.
Composition
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Active Ingredients per vial:
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Cefoperazone Sodium (equivalent to 500 mg Cefoperazone).
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Sulbactam Sodium (equivalent to 500 mg Sulbactam).
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Excipients:Â Sodium carbonate (for pH adjustment).
Mechanism of Action
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Cefoperazone:
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Inhibits bacterial cell wall synthesis by binding to penicillin-binding proteins (PBPs).
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Broad-spectrum activity against Gram-negative (Pseudomonas, Enterobacteriaceae) and some Gram-positive bacteria.
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Sulbactam:
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Irreversibly inhibits beta-lactamase enzymes, enhancing Cefoperazone’s efficacy against resistant strains.
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Dosage & Administration
Standard Adult Dose:
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1–2 g (1:1 ratio) every 12 hours (IV/IM).
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Severe Infections: Up to 2 g every 8 hours (max 8 g/day).
Pediatric Dose (≥1 year):
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40–80 mg/kg/day (divided every 6–12 hours).
Renal/Hepatic Dose Adjustment:
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Renal Impairment (CrCl <30 mL/min): Reduce dose by 50%.
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Hepatic Dysfunction:Â Monitor closely (Cefoperazone is bile-excreted).
Administration:
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IV: Reconstitute with 2–5 mL sterile water, then dilute in 50–100 mL NS/D5W; infuse over 30–60 minutes.
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IM:Â Deep injection (use lidocaine for pain relief).
Uses (Indications)
✔ Intra-abdominal infections (with metronidazole for anaerobes).
✔ Respiratory tract infections (pneumonia, bronchitis).
✔ Skin/soft tissue infections.
✔ UTIs and gynecological infections.
✔ Septicemia.
Storage
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Unreconstituted powder: Store below 25°C; protect from light/moisture.
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Reconstituted solution:
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Stable for 24 hours at 2–8°C (discard unused portions).
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Do not freeze.
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Recommendations
✔ Monitor CBC, liver/renal function during prolonged therapy.
✔ Not effective against MRSA or Enterococci.
✔ Avoid alcohol (disulfiram-like reaction possible).
Important Note
Contraindications:
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Hypersensitivity to cephalosporins/penicillins.
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History of severe allergic reactions to beta-lactams.
Side Effects:
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Common:Â Diarrhea, rash, elevated liver enzymes.
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Serious:
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Bleeding (vitamin K-dependent coagulopathy).
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C. difficile colitis.
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Drug Interactions:
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Anticoagulants: ↑ Bleeding risk (monitor PT/INR).
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Alcohol:Â Disulfiram-like reaction (flushing, tachycardia).
Pregnancy & Lactation:
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Category BÂ (use if benefits outweigh risks).
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Breastfeeding:Â Low excretion in milk (caution advised).
Presentation
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Single-dose vial (500 mg + 500 mg powder for reconstitution).
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