Tigebac Powder for IV Infusion 50 mg/vial

Uses of Tigebac Powder for IV Infusion: - Severe bacterial infections Complicated intra-abdominal infections; Complicated skin and skin structure infections, Community-acquired pneumonia Hypersensitivity. Hospital-acquired pneumonia and ventilator-associated pneumonia. Use during tooth development.

Tetracycline group of drugs

Tigecycline, a glycylcycline, inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into the A site of the ribosome. This prevents incorporation of amino acid residues into elongating peptide chains. Tigecycline carries a glycylamido moiety attached to the 9-position of minocycline. The substitution pattern is not present in any naturally occurring or semisynthetic tetracycline and imparts certain microbiologic properties to tigecycline. Tigecycline is not affected by the two major tetracycline resistance mechanisms, ribosomal protection and efflux. Accordingly, tigecycline has demonstrated in vitro and in vivo activity against a broad spectrum of bacterial pathogens. There has been no cross resistance observed between tigecycline and other antibiotics. Tigecycline is not affected by resistance mechanisms such as beta-lactamases (including extended spectrum beta-lactamases), target site modifications, macrolide efflux pumps or enzyme target changes (e.g. gyrase/topoisomerase). In vitro studies have not demonstrated antagonism between tigecycline and other commonly used antibacterial drugs. In general, tigecycline is considered bacteriostatic.

How to use Tigecycline: Your doctor or nurse will give you this medicine. Kindly do not self administer. Administration: IV Preparation Reconstitute each vial with 5.3 mL NS or D5W to achieve a conc of 10 mg/mL IV Administration Infuse over 30-60 min Adult Dose: The recommended daily dose is as follows: Adults: The recommended dosage regimen for Tigecycline is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous (IV) infusions of Tigecycline should be administered over approximately 30 to 60 minutes every 12 hours. The duration of therapy should be guided by the severity and site of the infection and the patient's clinical and bacteriological progress. The recommended duration of treatment with Tigecycline for complicated skin and skin structure infections or for complicated intra-abdominal infections is 5 to 14 days and for Community-acquired pneumonia is 7-14 days. Hepatic impairment: Mild to moderate: No dosage adjustment. Severe: 100 mg as a single dose, then 25 mg 12 hrly. Child Dose: <18 years: Safety and efficacy not established Renal Dose: Renal impairment: No dosage adjustment needed.

Increased warfarin serum levels. May decrease efficacy of oral contraceptives.

Hypersensitivity. Hospital-acquired pneumonia and ventilator-associated pneumonia. Use during tooth development.

Common - Headache - Vomiting - Nausea - Increased liver enzymes - Stomach pain - Diarrhea >10% Nausea (29.5%),Vomiting (19.7%),Diarrhea (12.7%) 1-10% Infection (8.3%),Fever (7.1%),Abd pain (6.8%),Headache (5.9%),HTN (4.9%),Anemia (4.2%),Dizziness (3.5%),Dyspnea (2.9%),Pruritus (2.6%),Rash (2.4%),Hypotension (2.3%),Insomnia (2.3%)

Pregnancy: Tigecycline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: Caution should be exercised when Tigecycline is administered to a nursing woman.

Precaution: Hypersensitivity to tetracyclines. Use tigecycline in situations when alternative treatments are not suitable. Patients w/ complicated intra-abdominal infections secondary to clinically apparent intestinal perforation. Hepatic impairment. Pregnancy and lactation.

No specific information is available on the treatment of overdosage with Tigecycline. Intravenous administration of Tigecycline at a single dose of 300 mg over 60 minutes in healthy volunteers resulted in an increased incidence of nausea and vomiting.

Prior to reconstitution, Tigecycline should be stored at 20°C to 25°C. Once reconstituted, Tigecycline may be stored at room temperature for up to 24 hours (up to 6 hours in the vial and the remaining time in the intravenous bag). Reconstituted solution may be stored refrigerated at 2°C to 8°C for up to 48 hours following immediate transfer of reconstituted solution into the intravenous bag.

Tetracycline group of drugs

Tigecycline is a glycylcycline antibiotic which prevents protein synthesis of the susceptible bacteria by binding to its 30s ribosomal subunit. It is generally considered as bacteriostatic agent; w/ bactericidal activity against S. pneumonia and L. pneumophilia. Tigecycline antibacterial activity covers facultative gm+ve (including MRSA, vancomycin-susceptible Enterococcus faecalis) and gm-ve bacteria, and anaerobic bacteria.

Pregnancy: Tigecycline should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Lactation: Caution should be exercised when Tigecycline is administered to a nursing woman.