Tigecycline is an injection that is usually given by a healthcare professional. The person responsible for giving you your medicine will make sure that you get the right dose. If you feel that the medicine is making you feel unwell or you think it is not working, you should talk to someone who is involved in your care.

Your prescriber may only prescribe this medicine with special care or may not prescribe it at all if you:

-are allergic or sensitive to or have had a reaction to any of the ingredients in the medicine or to medicines similar to Tigecycline such as tetracyclines

-have biliary problems

-have liver problems

Furthermore the prescriber may only prescribe Tigecycline with special care or may not prescribe it at all for someone under 18 years of age.

As part of the process of assessing suitability to take Tigecycline a prescriber may also arrange tests:

-to determine whether or not the medicine is suitable and whether it must be prescribed with extra caution

-to check that this medicine is not having any undesired effects

Posology

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.

Hepatic insufficiency

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 dose of Tigecycline should be reduced to 25 mg every 12 hours following the 100 mg loading dose. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response.

Renal insufficiency

No dosage adjustment is necessary in patients with renal impairment or in patients undergoing haemodialysis.

Elderly patients

No dosage adjustment is necessary in elderly patients.

Pediatric patients

Tigecycline is not recommended for use in children and adolescents below 18 years due to the lack of data on safety and efficacy.

Method of administration:

What happens if I overdose?

Anaphylaxis/anaphylactoid reactions, potentially life-threatening, have been reported with tigecycline.

Glycylcycline class antibiotics are structurally similar to tetracycline class antibiotics. Tigecycline may have adverse reactions similar to tetracycline class antibiotics. Such reactions may include photosensitivity, pseudotumor cerebri, pancreatitis, and anti-anabolic action which has led to increased BUN, azotaemia, acidosis, and hyperphosphataemia.

Acute pancreatitis, which can be serious, has occurred (frequency: uncommon) in association with tigecycline treatment. The diagnosis of acute pancreatitis should be considered in patients taking tigecycline who develop clinical symptoms, signs, or laboratory abnormalities suggestive of acute pancreatitis. Most of the reported cases developed after at least one week of treatment. 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.

Experience in the use of tigecycline for treatment of infections in patients with severe underlying diseases is limited.

In clinical trials in complicated skin and soft tissue infections, the most common type of infection in tigecycline treated-patients was cellulitis (59 %), followed by major abscesses (27.5 %). Patients with severe underlying disease, such as those that were immunocompromised, patients with decubitus ulcer infections, or patients that had infections requiring longer than 14 days of treatment (for example, necrotizing fasciitis), were not enrolled. Few patients with diabetic foot infections (5%) were enrolled. A limited number of patients were enrolled with co-morbid factors such as diabetes (20 %), peripheral vascular disease (7 %), intravenous drug abuse (2 %), and HIV-positive infection (1 %). Limited experience is also available in treating patients with concurrent bacteraemia (3 %). Therefore, caution is advised when treating such patients.

In clinical trials in complicated intra-abdominal infections, the most common type of infection in tigecycline treated-patients was complicated appendicitis (51 %), followed by other diagnoses less commonly reported such as complicated cholecystitis (14 %), intra-abdominal abscess (10 %), perforation of intestine (10 %) and gastric or duodenal ulcer perforation less than 24 hours (5 %). Of these patients, 76 % had associated diffuse peritonitis (surgically-apparent peritonitis). There were a limited number of patients with severe underlying disease such as immunocompromised patients, patients with APACHE II scores > 15 (4 %), or with surgically apparent multiple intra-abdominal abscesses (10 %). Limited experience is also available in treating patients with concurrent bacteraemia (6 %). Therefore, caution is advised when treating such patients.

Consideration should be given to the use of combination antibacterial therapy whenever tigecycline is to be administered to severely ill patients with complicated intra-abdominal infections (cIAI) secondary to clinically apparent intestinal perforation or patients with incipient sepsis or septic shock.

The effect of cholestasis in the pharmacokinetics of tigecycline has not been properly established. Biliary excretion accounts for approximately 50 % of the total tigecycline excretion. Therefore, patients presenting with cholestasis should be closely monitored.

Prothrombin time or other suitable anticoagulation test should be used to monitor patients if tigecycline is administered with anticoagulants.

Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life threatening. Therefore, it is important to consider this diagnosis in patients who present with diarrhea during or subsequent to the administration of any antibacterial agent.

The use of tigecycline may result in overgrowth of non-susceptible organisms, including fungi. Patients should be carefully monitored during therapy. If super infection occurs, appropriate measures should be taken.

Results of studies in rats with tigecycline have shown bone discoloration. Tigecycline may be associated with permanent tooth discoloration in humans if used during tooth development.

Tigecycline should not be used in children under 8 years of age because of teeth discoloration, and is not recommended in adolescents below 18 years due to the lack of data on safety and efficacy.

Very common: More than 10% of people who take Tigecycline

-diarrhea - seek medical advice if you get diarrhea

-nausea

-vomiting

Common: Between 1% and 10% of people who take Tigecycline

-abnormal laboratory test results

-abscess

-changes in blood clotting time

-death

-dizziness

-headaches

-indigestion

-infections

-itching

-loss of appetite

-phlebitis

-skin rash or rashes

-stomach pain

Uncommon: Between 0.1% and 1% of people who take Tigecycline

-injection site problems such as pain, inflammation or edema

-jaundice

-liver problems

-metabolic problems

-pancreatitis

-sepsis

-septic shock

-thrombophlebitis

The frequency of these side-effects is unknown

-anaphylactic reactions - this may be fatal

-discoloration of teeth

-overgrowth of micro-organisms that are not affected by Tigecycline

-pseudomembranous colitis - this may be fatal

-thrombocytopenia

The frequency of these side-effects is unknown and have been reported in people who have had medicines similar to Tigecycline

-photosensitivity skin reaction

-raised intracranial pressure

The following medicines may interact with Tigecycline:

-warfarin

The following types of medicine may interact with Tigecycline:

-anticoagulants

-oral contraceptives

Interaction studies have only been performed in adults.

Concomitant administration of tigecycline and warfarin (25 mg single-dose) to healthy subjects resulted in a decrease in clearance of R-warfarin and S-warfarin by 40 % and 23 %, and an increase in AUC by 68 % and 29 %, respectively. The mechanism of this interaction is still not elucidated. Available data does not suggest that this interaction may result in significant INR changes. However, since tigecycline may prolong both prothrombin time (PT) and activated partial thromboplastin time (aPTT), the relevant coagulation tests should be closely monitored when tigecycline is co-administered with anticoagulants. Warfarin did not affect the pharmacokinetic profile of tigecycline.

Tigecycline is not extensively metabolised. Therefore, clearance of tigecycline is not expected to be affected by active substances that inhibit or induce the activity of the CYP450 isoforms. In vitro, tigecycline is neither a competitive inhibitor nor an irreversible inhibitor of CYP450 enzymes.

Tigecycline in recommended dosage did not affect the rate or extent of absorption, or clearance of digoxin (0.5 mg followed by 0.25 mg daily) when administered in healthy adults. Digoxin did not affect the pharmacokinetic profile of tigecycline. Therefore, no dosage adjustment is necessary when tigecycline is administered with digoxin.

In in vitro studies, no antagonism has been observed between tigecycline and other commonly used antibiotic classes.

Concurrent use of antibiotics with oral contraceptives may render oral contraceptives less effective.

It is not known whether this medicinal product is excreted in human milk. In animal studies tigecycline is excreted into milk of lactating rats. Because a potential risk to the breast-feeding infant cannot be ruled out, when treating with tigecycline, caution should be exercised and interruption of breast-feeding should be considered.

Disclaimer:

Information on this page is provided for general information purposes. You should not make a clinical treatment decision based on information contained in this page without consulting other references including the package insert of the drug, textbooks and where relevant, expert opinion. We cannot be held responsible for any errors you make in administering drugs mentioned on this page, nor for use of any erroneous information contained on this page.