TIGEBAX INJ is a broad-spectrum glycylcycline antibiotic containing Tigecycline, used for complicated infections caused by multi-drug resistant (MDR) bacteria when other treatments fail.
Composition
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Active Ingredient: Tigecycline 50 mg (as lyophilized powder).
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Inactive Ingredients: Hydrochloric acid, sodium hydroxide, lactose monohydrate.
Mechanism of Action
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Bacteriostatic (inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit).
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Covers:
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Gram-positive (MRSA, VRE*, Streptococcus)
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Gram-negative (E. coli, Klebsiella, Acinetobacter)
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Anaerobes (Bacteroides fragilis)
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Atypicals (Mycoplasma, Legionella)
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Not effective against: Pseudomonas aeruginosa, Proteus spp.
(Limited activity against some Enterococcus faecium strains)*
Dosage & Administration
Adults:
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Loading dose: 100 mg IV (single dose).
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Maintenance: 50 mg IV every 12 hours (infuse over 30–60 minutes).
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Duration: Typically 5–14 days (based on infection severity).
Hepatic Impairment (Child-Pugh C):
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Reduce maintenance dose to 25 mg every 12 hours.
Renal Impairment:
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No dose adjustment needed (not renally excreted).
Pediatrics:
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Not recommended (risk of tooth discoloration & bone growth issues).
Indications (Approved Uses)
1️⃣ Complicated Skin & Soft Tissue Infections (cSSTI)
2️⃣ Complicated Intra-Abdominal Infections (cIAI)
3️⃣ Community-Acquired Bacterial Pneumonia (CABP)
4️⃣ Severe MDR infections (when alternatives fail).
(Not approved for diabetic foot infections or bacteremia due to higher mortality risk.)
Storage & Stability
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Unreconstituted vials: Store at 20–25°C, protect from light.
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Reconstituted solution:
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Stable for 6 hrs at room temp or 24 hrs if refrigerated (2–8°C).
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Do not freeze or shake vigorously.
Key Recommendations
✔ Last-line antibiotic (use only when other options fail).
✔ Monitor liver enzymes (risk of hepatotoxicity).
✔ Watch for superinfections (C. difficile, fungal).
✔ Avoid in pregnancy (Category D) – fetal risks.
Black Box Warning (FDA Alert)
⚠ Higher mortality risk observed in clinical trials (especially in HAP).
⚠ Use only when no safer alternatives exist.
Side Effects
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Common: Nausea, vomiting, diarrhea, headache.
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Serious:
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Acute pancreatitis.
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Liver toxicity.
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Severe hypersensitivity.
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Drug Interactions
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Warfarin → Increased bleeding (monitor INR).
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Oral contraceptives → Reduced efficacy (use backup).
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PPIs → May affect absorption if switching to oral therapy.
Conclusion
TIGEBAX INJ (Tigecycline) is a critical reserve antibiotic for MDR infections. Strict monitoring is essential due to safety risks.
Reviews
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