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TIGECYCLINE FOR is a brand name for Tigecycline, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TIGECYCLINE FOR INJECTION (tigecycline) is indicated for the treatment of the following infections when caused by susceptible strains of the designated microorganisms in patients 18 years of age and older: Complicated skin and skin structure infections (cSSSI) caused by Escherichia coli, Enterococcus faecalis…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Based on pharmacokinetic data in patients with severe hepatic impairment (Child Pugh C), the dose of TIGECYCLINE FOR INJECTION (tigecycline) should be altered. 2 Recommended Dose and Dosage Adjustment. 2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use.
The recommended dosage regimen of TIGECYCLINE FOR INJECTION is an initial dose of 100 mg, followed by 50 mg every 12 hours. Intravenous (IV) infusions of TIGECYCLINE FOR INJECTION should be administered over approximately 30 to 60 minutes every 12 hours.
The recommended duration of treatment with TIGECYCLINE FOR INJECTION for cSSSI or for cIAI is 5 to 14 days. The recommended duration of treatment with TIGECYCLINE FOR INJECTION for CAP (mild to moderate infections only) 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. Patients with Hepatic Insufficiency No dosage adjustment of TIGECYCLINE FOR INJECTION is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).
3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency. Patients with Severe Hepatic Impairment Based on the pharmacokinetic profile of tigecycline in patients with severe hepatic impairment (Child Pugh C), the dose of TIGECYCLINE FOR INJECTION should be altered to 100 mg followed by 25 mg every 12 hours.
Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency. Patients with Renal Insufficiency Based on the pharmacokinetic data, no dosage adjustment of TIGECYCLINE FOR INJECTION is necessary in patients with renal impairment or in patients undergoing hemodialysis.
3, Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency. Other No dosage adjustment of TIGECYCLINE FOR INJECTION is necessary based on age (adults 18 years of age or more), gender or race. 3 Pharmacokinetics, Special Populations and Conditions.
5. 9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, or, Lactated Ringer’s Injection, USP to achieve a concentration of 10 mg/mL of tigecycline. (Note: Each vial contains a 6% overage. ) The vial should be gently swirled until the drug dissolves.
2 Clinical Trial Adverse Reactions, Adverse events with outcome of Death. General Anaphylaxis/anaphylactoid reactions have been reported with tigecycline and may be life- threatening. Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics and may have similar adverse events.
Such effects may include photosensitivity, pseudotumor cerebri, pancreatitis, and anti-anabolic action (which has led to increased BUN, azotemia, acidosis, and hyperphosphatemia). Acute pancreatitis, including fatal cases, have occurred in association with tigecycline treatment.
5 Post-Market Adverse Reactions. The diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of acute pancreatitis. Cases have been reported in patients without known risk factors for pancreatitis.
Patients usually improve after tigecycline discontinuation. Consideration should be given to the cessation of the treatment with tigecycline in cases suspected of having developed pancreatitis. Tigecycline may be associated with permanent tooth discoloration in humans during tooth development (last half of pregnancy, infancy, and childhood to the age of 8 years).
Results of studies in rats with tigecycline have shown bone discoloration. During antibiotic therapy, colonization or superinfection with Candida, Proteus or Pseudomonas spp may occur in the GI, genitourinary, and respiratory tracts.
Patients should be carefully monitored during therapy. If superinfection occurs, appropriate measures should be taken. The use of tigecycline with other drugs may lead to drug-drug interactions and require dose adjustment and monitoring.
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, General. To reduce the development of drug-resistant bacteria and maintain the effectiveness of TIGECYCLINE FOR INJECTION and other antibacterial drugs, TIGECYCLINE FOR INJECTION should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Appropriate specimens for bacteriological examination should be obtained in order to isolate and identify the causative organisms and to determine their susceptibility to tigecycline. Once these results are available, antimicrobial therapy should be adjusted if necessary.
TIGECYCLINE FOR INJECTION may be initiated as empiric therapy before results of these tests are known. , and Morganella spp. Pseudomonas aeruginosa is inherently resistant to TIGECYCLINE FOR INJECTION. 1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
3 Pediatrics. 2 Geriatrics Geriatrics (≥ 65 years of age): Evidence from clinical studies and experience suggests that use in the geriatric population is not associated with differences in safety or effectiveness. 4 Geriatrics. 2 CONTRAINDICATIONS TIGECYCLINE FOR INJECTION (tigecycline) is contraindicated in patients who are hypersensitive to tigecycline or tetracycline class of antibiotics or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 1 Dosing Considerations Based on pharmacokinetic data in patients with severe hepatic impairment (Child Pugh C), the dose of TIGECYCLINE FOR INJECTION (tigecycline) should be altered.
TIGECYCLINE FOR INJECTION (tigecycline) is contraindicated in patients who are hypersensitive to tigecycline or tetracycline class of antibiotics or to any ingredient in the formulation, including any non- medicinal ingredient, or component of the container.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tigecycline in Canada.
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Dilution:
Withdraw 5 mL of the reconstituted solution from the vial and add to a 100 mL IV bag for infusion (for a 100 mg dose, reconstitute two vials; for a 50 mg dose, reconstitute one vial). The maximum concentration in the IV bag should be 1 mg/mL.
The reconstituted solution should be yellow to orange in color; if not, the solution should be discarded. , green or black) prior to administration, whenever solution and container permit. 9% Sodium Chloride Injection, USP, 5% Dextrose Injection USP, and Lactated Ringer’s Injection, USP.
Once reconstituted, TIGECYCLINE FOR INJECTION may be stored at room temperature (not to exceed 25C/ 77F) for up to 24 hours (up to 6 hours in the vial and the remaining time in the IV bag). 9% Sodium Chloride Injection, USP, or 5% Dextrose Injection USP may be stored refrigerated at 2 to 8C (36 to 46F) for up to 48 hours following immediate transfer of the reconstituted solution into the IV bag.
See 11 STORAGE, STABILITY AND DISPOSAL. If the storage conditions exceed 25C/ 77F after reconstitution, tigecycline should be used immediately. 5 mg/mL (50 mg dose in 100 mL). 4 Administration Intravenous (IV) infusions of TIGECYCLINE FOR INJECTION should be administered over approximately 30 to 60 minutes every 12 hours.
TIGECYCLINE FOR INJECTION (tigecycline) Product Monograph Page 7 of 59 TIGECYCLINE FOR INJECTION may be administered intravenously through a dedicated line or through a Y-site. 9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP.
Injection should be made with an infusion solution compatible with TIGECYCLINE FOR INJECTION and with any other drug(s) administered via this common line. 9% Sodium Chloride Injection) Gentamicin […]
2 Recommended Dose and Dosage Adjustment. 2 Recommended Dose and Dosage Adjustment Health Canada has not authorized an indication for pediatric use. The recommended dosage regimen of TIGECYCLINE FOR INJECTION is an initial dose of 100 mg, followed by 50 mg every 12 hours.
Intravenous (IV) infusions of TIGECYCLINE FOR INJECTION should be administered over approximately 30 to 60 minutes every 12 hours. The recommended duration of treatment with TIGECYCLINE FOR INJECTION for cSSSI or for cIAI is 5 to 14 days.
The recommended duration of treatment with TIGECYCLINE FOR INJECTION for CAP (mild to moderate infections only) 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.
Patients with Hepatic Insufficiency No dosage adjustment of TIGECYCLINE FOR INJECTION is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B). 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency.
Patients with Severe Hepatic Impairment Based on the pharmacokinetic profile of tigecycline in patients with severe hepatic impairment (Child Pugh C), the dose of TIGECYCLINE FOR INJECTION should be altered to 100 mg followed by 25 mg every 12 hours.
Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response. 3 Pharmacokinetics, Special Populations and Conditions, Hepatic Insufficiency. Patients with Renal Insufficiency Based on the pharmacokinetic data, no dosage adjustment of TIGECYCLINE FOR INJECTION is necessary in patients with renal impairment or in patients undergoing hemodialysis.
3, Pharmacokinetics, Special Populations and Conditions, Renal Insufficiency. Other No dosage adjustment of TIGECYCLINE FOR INJECTION is necessary based on age (adults 18 years of age or more), gender or race. 3 Pharmacokinetics, Special Populations and Conditions.
5. 9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, or, Lactated Ringer’s Injection, USP to achieve a concentration of 10 mg/mL of tigecycline. (Note: Each vial contains a 6% overage. ) The vial should be gently swirled until the drug dissolves.
Dilution:
Withdraw 5 mL of the reconstituted solution from the vial and add to a 100 mL IV bag for infusion (for a 100 mg dose, reconstitute two vials; for a 50 mg dose, reconstitute one vial). The maximum concentration in the IV bag should be 1 mg/mL.
The reconstituted solution should be yellow to orange in color; if not, the solution should be discarded. , green or black) prior to administration, whenever solution and container permit. 9% Sodium Chloride Injection, USP, 5% Dextrose Injection USP, and Lactated Ringer’s Injection, USP.
Once reconstituted, TIGECYCLINE FOR INJECTION may be stored at room temperature (not to exceed 25C/ 77F) for up to 24 hours (up to 6 hours […]