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TIGABIO

TIGECYCLINE · by BIO-LABS

TETRACYCLINES Glycylcycline, Antibacterials, Tetracyclines BIO-LABS

Composition

Inj 50 mg: Per ml: Tigecycline 10 mg; 5 ml (50mg); powder in vial.

Indications & Dosage

Treatment of complicated skin & soft-tissue infections and complicated abdominal infections caused by multiple-antibacterial resistant organisms: BY IV INF: Adult: Initially 100 mg, then 50 mg every 12 hours for5-14 days, Children: Not recommended.

Administration

Administered by IV infusion over 30 to 60 min after dilution of the reconstituted solution in 100 ml of Dextrose 5% or NaCI 0.9 %.Reconstitute the vials with 5.3 ml of NaCI0.9% or D5W. The concentration should not exceed 1 mg/ ml. The solution should be yellow to orange.

Compatibility

Dextrose 5%, NaCI 0.9%.

Stability

Reconstituted vial at room temperature for up to 6 hours with an additional 18 hours after dilution in the infusion solution or 48 hours in refrigerator.

Contraindications

Tetracycline hypersensitivity, not recommended for the treatment of foot infections in patients with diabetes. Children under 12 years (deposition in growing bone and teeth, by binding to calcium, causes staining and occasionally dental hypoplasia)

Precautions

Severe hepatic impairment, cholestasis, monitor for signs of acute pancreatitis, consider withdrawal if suspected, myasthenia gravis (muscle weakness may be increased), systemic lupus erythematosus (may be exacerbated), avoid exposure to sunlight or UV light, risk of super-infection.

Interactions

Anticoagulants.

Pregnancy

Contraindicated in pregnancy.

Lactation

Contraindicated avoid

Side Effects

Abdominal pain, anorexia, bilirubinaemia, diarrhoea, dizziness, dyspepsia, headache, hypoglycaemia, injection-site reactions, nausea, prolonged activated partial thromboplastin time, prolonged prothrombin time, pruritus, rash, vomiting, antibiotic-associated colitis, hepatic failure, Stevens-Johnson syndrome, thrombocytopenia. Rare: Cholestatic jaundice, hypoproteinaemia, pancreatitis