SUDOPEN 500 MGĀ is a sterile, lyophilized powder forĀ intravenous (IV) or intramuscular (IM)Ā administration, combiningĀ CefoperazoneĀ (3rd-generation cephalosporin) andĀ SulbactamĀ (beta-lactamase inhibitor). It is effective againstĀ multidrug-resistant Gram-negative and some Gram-positive infections.
Composition
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Active Ingredients per vial:
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Cefoperazone SodiumĀ (equivalent toĀ 500 mg Cefoperazone).
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Sulbactam SodiumĀ (equivalent toĀ 500 mg Sulbactam).
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Excipients:Ā Sodium carbonate (for pH adjustment).
Mechanism of Action
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Cefoperazone:
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InhibitsĀ bacterial cell wall synthesisĀ by binding toĀ penicillin-binding proteins (PBPs).
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Broad-spectrum activity againstĀ Gram-negative (Pseudomonas, Enterobacteriaceae)Ā and someĀ Gram-positive bacteria.
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Sulbactam:
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Irreversibly inhibitsĀ beta-lactamase enzymes, enhancing Cefoperazoneās efficacy against resistant strains.
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Dosage & Administration
Standard Adult Dose:
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1ā2 g (1:1 ratio) every 12 hoursĀ (IV/IM).
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Severe Infections:Ā Up toĀ 2 g every 8 hoursĀ (maxĀ 8 g/day).
Pediatric Dose (ā„1 year):
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40ā80 mg/kg/dayĀ (divided every 6ā12 hours).
Renal/Hepatic Dose Adjustment:
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Renal Impairment (CrCl <30 mL/min):Ā Reduce dose byĀ 50%.
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Hepatic Dysfunction:Ā Monitor closely (Cefoperazone is bile-excreted).
Administration:
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IV:Ā Reconstitute withĀ 2ā5 mL sterile water, then dilute inĀ 50ā100 mL NS/D5W; infuse overĀ 30ā60 minutes.
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IM:Ā Deep injection (use lidocaine for pain relief).
Uses (Indications)
āĀ Intra-abdominal infectionsĀ (with metronidazole for anaerobes).
āĀ Respiratory tract infectionsĀ (pneumonia, bronchitis).
āĀ Skin/soft tissue infections.
āĀ UTIs and gynecological infections.
āĀ 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 2ā8°CĀ (discard unused portions).
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Do not freeze.
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Recommendations
ā MonitorĀ CBC, liver/renal functionĀ during prolonged therapy.
āĀ Not effective against MRSA or Enterococci.
ā AvoidĀ alcoholĀ (disulfiram-like reaction possible).
Important Note
Contraindications:
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Hypersensitivity toĀ cephalosporins/penicillins.
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History ofĀ severe allergic reactionsĀ to beta-lactams.
Side Effects:
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Common:Ā Diarrhea, rash, elevated liver enzymes.
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Serious:
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Bleeding (vitamin K-dependent coagulopathy).
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C. difficileĀ colitis.
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Drug Interactions:
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Anticoagulants:Ā ā Bleeding risk (monitor PT/INR).
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Alcohol:Ā Disulfiram-like reaction (flushing, tachycardia).
Pregnancy & Lactation:
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Category BĀ (use if benefits outweigh risks).
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Breastfeeding:Ā 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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