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TIGECYCLINE 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 (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 (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 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 recommended duration of treatment with TIGECYCLINE for cSSSI or for cIAI is 5 to 14 days.
The recommended duration of treatment with TIGECYCLINE 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 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 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 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 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. Glycylcycline antibiotic class effects 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). Superinfection 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. Cardiovascular An effect on cardiac repolarization following tigecycline administration cannot be definitively excluded from the clinical data.
3 Pharmacokinetics, Special Populations and Conditions, Cardiovascular. g. , amiodarone, sotalol) antiarrhythmic agents, or in other pro- arrhythmic conditions. Pharmacokinetic studies between tigecycline and drugs that prolong the QTc interval such as cisapride, erythromycin, antipsychotics, and tricyclic antidepressants have not been performed.
The effect of tigecycline has also not been studied in patients with congenital prolongation of the QT interval. It is expected that these individuals may be more susceptible to drug-induced QT prolongation. The magnitude of QTc prolongation may increase with increasing concentrations of drugs; therefore, the recommended dose and the recommended infusion rate for TIGECYCLINE should not be exceeded.
See 4 DOSAGE AND ADMINISTRATION. TIGECYCLINE (Tigecycline for Injection) Page 12 of 74 Patients should be instructed to contact their physician if they experience palpitations or fainting spells while taking TIGECYCLINE. Driving and Operating Machinery Tigecycline can cause dizziness.
, General. 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 (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. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • All-cause mortality has been observed in a meta-analysis of clinical trials in tigecycline-treated patients.
2) has not been established. TIGECYCLINE should be reserved for use in situations when alternative treatments are not suitable (See Section 7 WARNINGS AND PRECAUTIONS, General). 1 Dosing Considerations Based on pharmacokinetic data in patients with severe hepatic impairment (Child Pugh C), the dose of TIGECYCLINE (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 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 recommended duration of treatment with TIGECYCLINE for cSSSI or for cIAI is 5 to 14 days. The recommended duration of treatment with TIGECYCLINE 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 is warranted in patients with mild to moderate hepatic impairment (Child Pugh A and Child Pugh B).
TIGECYCLINE (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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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 may be stored at room temperature (not to exceed 25°C/77°F) 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°C to 8°C (36°F to 46°F) for up to 48 hours TIGECYCLINE (Tigecycline for Injection) Page 8 of 74 following immediate transfer of the reconstituted solution into the IV bag.
See 11 STORAGE, STABILITY AND DISPOSAL. If the storage conditions exceed 25°C/77°F after reconstitution, tigecycline should be used immediately. 5 mg/mL (50 mg dose in 100 mL). 4 Administration Intravenous (IV) infusions of TIGECYCLINE should be administered over approximately 30 to 60 minutes every 12 hours.
TIGECYCLINE 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 and with any other drug(s) administered via this common line.
9% Sodium Chloride […]
Exercise caution when driving or operating a vehicle or potentially dangerous machinery. Gastrointestinal Clostridium difficile-associated disease Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including tigecycline.
CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic megacolon, or perforation of colon subsequent to the administration of any antibacterial agent.
CDAD has been reported to occur over 2 months after the administration of antibacterial agents. Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. Clostridium difficile produces toxins A and B, which contribute to the development of CDAD.
CDAD may cause significant morbidity and mortality. CDAD can be refractory to antimicrobial therapy. If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile.
In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridium difficile. Surgical evaluation should be instituted as clinically indicated, as surgical intervention may be required in certain severe cases.
See 8 ADVERSE REACTIONS. Intra-abdominal infections Caution should be exercised when considering tigecycline monotherapy in patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation.
See 8 ADVERSE REACTIONS. In Phase 3 cIAI studies (n=1642), 6 patients treated with tigecycline and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/septic shock. The 6 patients treated with tigecycline had higher APACHE II scores (median = 13) vs the 2 patients treated with imipenem/cilastatin (APACHE II scores = 4 and 6).
Due to differences in baseline APACHE II scores between treatment groups and small overall numbers, the relationship of this outcome to treatment cannot be established. TIGECYCLINE (Tigecycline for Injection) Page 13 of 74 Hepatic/Biliary/Pancreatic Increases in total bilirubin concentration, prothrombin time and transaminases have been seen in patients treated with tigecycline.
Isolated cases of significant hepatic dysfunction and hepatic failure have been reported in patients treated with tigecycline. Patients who develop abnormal liver function tests during tigecycline therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing tigecycline therapy.
Adverse events may occur after the drug has been discontinued. 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.
Immune Hypersensitivity Anaphylaxis/anaphylactoid reactions have been reported with tigecycline and may be life- threatening. Monitoring and Laboratory Tests The use of tigecycline with other drugs may lead to drug-drug interactions and require dose […]
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 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 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 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 may be stored at room temperature (not to exceed 25°C/77°F) 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°C to 8°C (36°F to 46°F) for up to 48 hours TIGECYCLINE (Tigecycline for Injection) Page 8 of 74 following immediate transfer of the reconstituted solution into the IV bag.
See 11 STORAGE, STABILITY AND DISPOSAL. If the storage conditions exceed 25°C/77°F after reconstitution, tigecycline should be used immediately. 5 mg/mL (50 mg dose in 100 mL). 4 Administration Intravenous (IV) infusions of TIGECYCLINE should be administered over approximately 30 to 60 minutes every 12 hours.
TIGECYCLINE may be administered intravenously through a dedicated line or through a Y-site. If the same intravenous line […]