TYGACIL 50 MG 1 VIAL
ACTIVE INGREDIENT OF TYGACIL 50 MG 1 VIAL
THERAPEUTIC INDICATIONS OF TYGACIL 50 MG 1 VIAL
- Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections.
- Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections.
- Complicated intra-abdominal infections (cIAI).
- Tygacil should be used only in situations where other alternative antibiotics are not suitable.
- Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Method of Administration and Dose of Tygacil
The recommended dose for adults is an initial dose of 100 mg followed by 50 mg every 12 hours for 5 to 14 days.
The duration of therapy should be guided by the severity, site of the infection, and the patient’s clinical response.
Children and adolescents (8 to 17 years of age)
Tigecycline is only to be used to treat patients aged 8 years and older after consultation with a physician with appropriate experience in the management of infectious diseases.
Pregnancy and TYGACIL 50 MG 1 VIAL
There are no or limited amount of data from the use of tigecycline in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. As it is known for tetracycline class antibiotics, tigecycline may also induce permanent dental defects (discoloration and enamel defects) and a delay in ossification processes in foetuses, exposed in utero during the last half of gestation, and in children under eight years of age due to the enrichment in tissues with a high calcium turnover and formation of calcium chelate complexes. Tigecycline should not be used during pregnancy unless the clinical condition of the woman requires treatment with tigecycline.
BREASTFEEDING AND TYGACIL 50 MG
It is unknown whether tigecycline/metabolites are excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of tigecycline/metabolites in milk. A risk to the newborns/infants cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from tigecycline therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
MECHANISM OF ACTION OF TYGACIL
Tigecycline, a glycylcycline antibiotic, 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.
In general, tigecycline is considered bacteriostatic. At 4 times the minimum inhibitory concentration (MIC), a 2-log reduction in colony counts was observed with tigecycline against Enterococcus spp., Staphylococcus aureus, and Escherichia coli.