ZUTIG is an injectable antibiotic containing Tigecycline (50 mg/vial), a broad-spectrum glycylcycline used for complicated infections caused by multidrug-resistant (MDR) bacteria.
Composition
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Active Ingredient: Tigecycline 50 mg (as lyophilized powder).
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Excipients: Hydrochloric acid, sodium hydroxide, lactose monohydrate.
Mechanism of Action
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Bacteriostatic (inhibits protein synthesis by binding to the 30S ribosomal subunit).
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Effective against:
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Gram-positive (MRSA, VRE*, Streptococcus spp.)
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Gram-negative (E. coli, Klebsiella, Acinetobacter baumannii)
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Anaerobes (Bacteroides fragilis)
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Atypical bacteria (Mycoplasma, Legionella)
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Not effective against: Pseudomonas aeruginosa, Proteus spp.
(Limited efficacy against some Enterococcus faecium strains)*
Dosage & Administration
Standard Adult Dose:
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Loading dose:Â 100 mg IVÂ (single dose).
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Maintenance: 50 mg every 12 hours (infused over 30–60 minutes).
Dosage Adjustments:
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Severe hepatic impairment (Child-Pugh C):Â 25 mg every 12 hours.
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No renal dose adjustment needed (primarily liver metabolism).
Pediatric Use:
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Not recommended for children <18 years (risk of tooth/bone abnormalities).
Indications (Approved Uses)
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Complicated Skin & Soft Tissue Infections (cSSTI)
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Complicated Intra-Abdominal Infections (cIAI)
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Community-Acquired Bacterial Pneumonia (CABP)
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Resistant bacterial infections (when other options fail).
(Not approved for diabetic foot infections or bacteremia due to higher mortality risk.)
Storage & Stability
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Unreconstituted vials: Store below 25°C, protect from light.
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Reconstituted solution:
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Stable for 6 hours at room temperature or 24 hours if refrigerated (2–8°C).
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Do not freeze or shake vigorously.
Key Recommendations
✔ Use as a last-resort antibiotic (due to mortality risks in certain infections).
✔ Monitor for superinfections (C. difficile, fungal infections).
✔ Avoid in pregnancy (Category D) – risk of fetal harm.
✔ Assess liver function before/during therapy.
Black Box Warning (FDA)
⚠ Increased mortality risk observed in clinical trials (especially in hospital-acquired pneumonia).
âš Â Use only when no alternative treatments are available.
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 enzyme elevations.
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Severe allergic reactions.
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Drug Interactions
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Warfarin → Increased bleeding risk (monitor INR).
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Oral contraceptives → Reduced efficacy (use backup contraception).
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Proton pump inhibitors → May reduce absorption (if switching to oral therapy).
Conclusion
ZUTIG (Tigecycline) is reserved for MDR infections when standard antibiotics fail. Strict monitoring is required due to safety concerns.
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