Loading…
TYGACIL 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.
Verbatim from this product's HC label. Tap a section to expand.
Patients should be instructed to contact their physician if they experience palpitations or fainting spells while taking TYGACIL. Driving and Operating Machinery Tigecycline can cause dizziness. 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 TYGACIL. 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 TYGACIL (tigecycline) Product Monograph Page 12 of 41 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 TYGACIL 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 TYGACIL and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/septic shock. The 6 patients treated with TYGACIL 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. 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.
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, fixed eruption, 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 TYGACIL should not be exceeded.
See 4 DOSAGE AND ADMINISTRATION. Patients should be instructed to contact their physician if they experience palpitations or fainting spells while taking TYGACIL. Driving and Operating Machinery Tigecycline can cause dizziness. Exercise caution when driving or operating a vehicle or potentially dangerous machinery.
, General 11/2025 Table of Contents Sections or subsections that are not applicable at the time of authorization are not listed. Recent Major Label Changes .................................................................................................
2 Table of Contents ................................................................................................................. 2 Part 1: Healthcare Professional Information..........................................................................
5 1 Indications ................................................................................................................ 1 Pediatrics .......................................................................................................
2 Geriatrics ....................................................................................................... 6 2 Contraindications ......................................................................................................
6 3 Serious Warnings and Precautions Box ...................................................................... 6 4 Dosage and Administration ....................................................................................... 1 Dosing Considerations ....................................................................................
2 Recommended Dose and Dosage Adjustment ................................................. 3 Reconstitution ............................................................................................... 4 Administration ...............................................................................................
5 Missed Dose................................................................................................... 9 5 Overdose ................................................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Tigecycline in Canada.
Know a brand we are missing in Canada? Suggest a brand →
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.
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 TYGACIL (tigecycline) and may be life- threatening. TYGACIL (tigecycline) Product Monograph Page 13 of 41 Monitoring and Laboratory Tests The use of tigecycline with other drugs may lead to drug-drug interactions and require dose adjustment and monitoring.
See 9 DRUG INTERACTIONS. Monitoring of blood coagulation parameters, including blood fibrinogen, is recommended prior to treatment initiation with tigecycline and regularly while on treatment. Prothrombin time or other suitable anticoagulation test should be monitored if tigecycline is administered with warfarin.
Monitoring of calcineurin inhibitor (tacrolimus, cyclosporine) blood levels before, during and following treatment with tigecycline, together with appropriate dose adjustment, is recommended. 1 Drug Interactions Overview. Reproductive Health • Fertility The effects of tigecycline on fertility in humans have not been studied.
Respiratory Mortality imbalance and lower cure rates in hospital-acquired pneumonia TYGACIL is not indicated for treatment of hospital acquired pneumonia (HAP). The safety and efficacy of TYGACIL in patients with HAP have not been established.
3%]) than the comparator. 7%]) than the comparator. TYGACIL is not indicated for the treatment of severe community acquired pneumonia. Safety and efficacy of TYGACIL in severe community acquired pneumonia have not been studied. See 14 CLINICAL TRIALS.
TYGACIL has not been evaluated in clinical trials for use against suspected or documented multiple drug resistant pathogens in pneumonia. Sensitivity/Resistance Development of Drug Resistant Bacteria Prescribing TYGACIL in the absence of a proven or strongly suspected bacterial infection is unlikely to […]
Gastrointestinal Clostridium difficile-associated disease Clostridium difficile-associated disease (CDAD) has been reported with use of many antibacterial agents, including TYGACIL. 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 TYGACIL (tigecycline) Product Monograph Page 12 of 41 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 TYGACIL 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 TYGACIL and 2 patients treated with imipenem/cilastatin presented with intestinal perforations and developed sepsis/septic shock. The 6 patients treated with TYGACIL 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. 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 TYGACIL (tigecycline) and may be life- threatening. TYGACIL (tigecycline) Product Monograph Page 13 of 41 Monitoring and Laboratory Tests The use of tigecycline with other drugs may lead to drug-drug interactions and require dose […]
10 6 Dosage Forms, Strengths, Composition and Packaging ............................................. 10 7 Warnings and Precautions ....................................................................................... 10 General… ................................................................................................................
10 Cardiovascular......................................................................................................... 11 Driving and Operating Machinery ............................................................................
11 Gastrointestinal ...................................................................................................... 11 Hepatic/Biliary/Pancreatic ......................................................................................
12 Immune.. ................................................................................................................ 12 Monitoring and Laboratory Tests .............................................................................
13 Reproductive Health................................................................................................ 13 TYGACIL (tigecycline) Product Monograph Page 3 of 41 Respiratory .............................................................................................................
13 Sensitivity/Resistance ............................................................................................. 13 Skin……… .................................................................................................................
1 Special Populations ...................................................................................... 1 Pregnancy ................................................................................................. 2 Breastfeeding ............................................................................................
3 Pediatrics .................................................................................................. 4 Geriatrics .................................................................................................. 14 8 Adverse Reactions ...................................................................................................
1 Adverse Reaction Overview .......................................................................... 2 Clinical Trial Adverse Reactions .................................................................... 1 Clinical Trial Adverse Reactions – Pediatrics ...............................................
3 Less Common Clinical Trial Adverse Reactions .............................................. 1 Less Common Clinical Trial Adverse Reactions – Pediatrics ......................... 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data....................................................................................................
5 Post-Market Adverse Reactions .................................................................... 18 9 Drug Interactions .................................................................................................... 2 Drug Interactions Overview ..........................................................................
3 Drug-Behavioural Interactions ...................................................................... 4 Drug-Drug Interactions ................................................................................. 5 Drug-Food Interactions.................................................................................
6 Drug-Herb Interactions ................................................................................. 7 Drug-Laboratory Test Interactions ................................................................ 20 10 Clinical Pharmacology .............................................................................................
1 Mechanism of Action […]