Posology : מינונים

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Adult Dosage
The recommended dosage regimen for Tigecycline S.K.is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous infusions of Tigecycline S.K.should be administered over approximately 30 to 60 minutes every 12 hours.
The recommended duration of treatment with Tigecycline S.K.for complicated skin and skin structure infections or for complicated intra-abdominal infections is 5 to 14 days. The recommended duration of treatment with Tigecycline S.K.for community-acquired bacterial pneumonia is 7 to 14 days. The duration of therapy should be guided by the severity and site of the infection and the patient’s clinical and bacteriological progress.

2.2 Dosage in Patients with Hepatic Impairment
No dosage adjustment is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B). In patients with severe hepatic impairment (Child Pugh C), the initial dose of Tigecycline S.K.should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours.
Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response [see Clinical Pharmacology (11.3) and Use in Specific Populations (8.5)].


2.3 Dosage in Pediatric Patients
The safety and efficacy of the proposed pediatric dosing regimens have not been evaluated due to the observed increase in mortality associated with Tigecycline S.K.in adult patients. Avoid use of Tigecycline S.K.in pediatric patients unless no alternative antibacterial drugs are available. Under these circumstances, the following doses are suggested:
• Pediatric patients aged 8 to 11 years should receive 1.2 mg/kg of Tigecycline S.K.every 12 hours intravenously to a maximum dose of 50 mg of Tigecycline S.K.every 12 hours.
• Pediatric patients aged 12 to 17 years should receive 50 mg of Tigecycline S.K.every 12 hours.

The proposed pediatric doses of Tigecycline S.K.were chosen based on exposures observed in pharmacokinetic trials, which included small numbers of pediatric patients [see Use in Specific Populations (8.3) and Clinical Pharmacology (11.3)].

There are no data to provide dosing recommendations in pediatric patients with hepatic impairment.
2.4 Monitoring of Blood Coagulation Parameters

Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with Tigecycline S.K. [see Warnings and Precautions (5.6)].


2.5 Preparation and Administration
Each vial of Tigecycline S.K.should be reconstituted with 5.3 mL of 0.9% Sodium Chloride Injection, USP, 5% glycose 50 mg/ml (5%) solution for Injection, USP, or Lactated Ringer’s solution for Injection, USP to achieve a concentration of 10 mg/mL of tigecycline. (Note: Each vial contains a 6% overage. Thus, 5 mL of reconstituted solution is equivalent to 50 mg of the drug.) The vial should be gently swirled until the drug dissolves. Reconstituted solution must be transferred and further diluted for intravenous infusion.
Withdraw 5 mL of the reconstituted solution from the vial and add to a 100 mL intravenous bag for infusion (for a 100 mg dose, reconstitute two vials; for a 50 mg dose, reconstitute one vial). The maximum concentration in the intravenous bag should be

1 mg/mL. The reconstituted solution should be orange to orange-red in color; if not, the solution should be discarded. Parenteral drug products should be inspected visually for particulate matter and discoloration (e.g., green or black) prior to administration. Once reconstituted and diluted in the bag or other suitable infusion container (e.g. glass bottle),tigecycline should be used immediately.

Tigecycline S.K.may be administered intravenously through a dedicated line or through a Y-site. If the same intravenous line is used for sequential infusion of several drugs, the line should be flushed before and after infusion of Tigecycline S.K.with 0.9% Sodium Chloride Injection, USP, 5% glycose 50 mg/ml Injection, USP or Lactated Ringer’s Injection, USP. Injection should be made with an infusion solution compatible with tigecycline and with any other drug(s) administered via this common line.

2.6 Drug Compatibilities
Compatible intravenous solutions include 0.9% Sodium Chloride Injection, USP, 5% glycose 50 mg/ml Injection, USP, and Lactated Ringer’s Injection, USP. When administered through a Y-site, Tigecycline S.K.is compatible with the following drugs or diluents when used with either 0.9% Sodium Chloride Injection, USP or 5% glycose 50 mg/ml Injection, USP: amikacin, dobutamine, dopamine HCl, gentamicin, haloperidol, Lactated Ringer’s, lidocaine HCl, metoclopramide, morphine, norepinephrine, piperacillin/tazobactam (EDTA formulation), potassium chloride, propofol, ranitidine HCl, theophylline, and tobramycin.

2.7 Drug Incompatibilities
The following drugs should not be administered simultaneously through the same Y-site as Tigecycline S.K.: amphotericin B, amphotericin B lipid complex, diazepam, esomeprazole and omeprazole.