Drugs List

Therapeutic Indications

Uses

Complicated intra-abdominal infections: treatment
Complicated skin and soft tissue infections

Administration

For intravenous infusion.

Contraindications

Children under 8 years
Diabetic foot infections
Pregnancy

Precautions and Warnings

Bacteraemia
Breastfeeding
Cholestasis
Diabetes mellitus
Drug misuse
Peripheral vascular disease
Positive HIV status
Severe hepatic impairment - Child-Pugh score greater than or equal to 10

Advise patient dizziness may affect ability to drive or operate machinery
Consult national/regional policy on the use of anti-infectives
Monitor coagulation values before and during treatment
Monitor periodically for overgrowth of non-susceptible organisms
Monitor prothrombin times closely in patients on anticoagulant therapy
Consider pseudomembranous colitis if patient presents with diarrhoea
May cause anaphylactic / anaphylactoid reactions
Prolonged use may result in superinfection with non-susceptible organisms
Risk of pancreatitis
Discontinue if overgrowth of resistant organisms occurs
Advise patient not to take St John's wort concurrently

Combination antibacterial therapy should be considered in severely ill patients with complicated intra-abdominal infections secondary to clinically apparent intestinal perforation, or patients with incipient sepsis or septic shock.

Liver injury with predominantly cholestatic pattern in patients receiving tigecycline has been reported. Some cases of hepatic failure with a fatal outcome have also been reported. Hepatic failure may occur in patients treated with tigecycline due to the underlying conditions or concomitant medications, although a possible contribution of tigecycline should be considered.

Pregnancy and Lactation

Pregnancy

Tigecycline is contraindicated in pregnancy.

The manufacturer does not recommend the use of tigecycline during pregnancy unless the clinical condition of the mother requires treatment with tigecycline.

Tetracycline class antibiotics, administered during the last half of pregnancy, have been known to produce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses, exposed in utero. There is no adequate data from the use of tigecycline during human pregnancy, but animal studies have shown evidence of foetal harm and miscarriage. However, it is not known if the drug crosses human placenta but Briggs (2015) suggest that tigecycline would cross to the embryo/foetus due to molecular weight and prolonged half-life.

Lactation

Use tigecycline with caution in breastfeeding.

Manufacturer recommends that a decision should be made whether to discontinue breastfeeding or discontinue treatment with tigecycline, taking into consideration the potential benefits and risk to both the mother and infant.

It is not known whether tigecycline is excreted in human milk. Briggs (2015) suggests due to tigecycline's limited bioavailability, it would be unlikely that the infant would absorb clinically relevant levels over brief exposure. The potential of modification of infant's bowel flora or other effects on the infant cannot be ruled out.

Side Effects

Abdominal pain
Abscess
Acidosis
Acute pancreatitis
Anaphylactoid reaction
Anaphylaxis
Anorexia
Azotaemia
Cholestatic jaundice
Dental discolouration
Diarrhoea
Dizziness
Dyspepsia
Elevated amylase levels
Headache
Hepatic failure
Hyperbilirubinaemia
Hyperphosphataemia
Hypofibrinogenaemia
Hypoglycaemia
Hypoproteinaemia
Increase in blood urea nitrogen
Increase in serum ALT/AST
Increased partial thromboplastin time
Infections
Inflammation (injection site)
Jaundice
Liver damage
Local pain (injection site)
Nausea
Oedema (injection site)
Pancreatitis
Phlebitis
Phlebitis (injection site)
Photosensitivity
Pneumonia
Prothrombin time increased
Pruritus
Pseudomembranous colitis
Pseudotumour cerebri
Rash
Sepsis
Septic shock
Skin reactions
Stevens-Johnson syndrome
Thrombocytopenia
Thrombophlebitis
Vomiting

Presentation

Powder for solution for infusion containing tigecycline.

Drugs List

Therapeutic Indications

Uses

Complicated intra-abdominal infections: treatment
Complicated skin and soft tissue infections

Dosage

The duration of therapy should depend on the severity, site of infection, and the patient's clinical response to therapy.

Consideration should be given to official local guidance on the appropriate use of antibacterial agents.

Adults

Elderly

Children

Patients with Hepatic Impairment

Administration

For intravenous infusion.

Contraindications

Children under 8 years
Diabetic foot infections
Pregnancy

Precautions and Warnings

Bacteraemia
Breastfeeding
Cholestasis
Diabetes mellitus
Drug misuse
Peripheral vascular disease
Positive HIV status
Severe hepatic impairment - Child-Pugh score greater than or equal to 10

Advise patient dizziness may affect ability to drive or operate machinery
Consult national/regional policy on the use of anti-infectives
Monitor coagulation values before and during treatment
Monitor periodically for overgrowth of non-susceptible organisms
Monitor prothrombin times closely in patients on anticoagulant therapy
Consider pseudomembranous colitis if patient presents with diarrhoea
May cause anaphylactic / anaphylactoid reactions
Prolonged use may result in superinfection with non-susceptible organisms
Risk of pancreatitis
Discontinue if overgrowth of resistant organisms occurs
Advise patient not to take St John's wort concurrently

Combination antibacterial therapy should be considered in severely ill patients with complicated intra-abdominal infections secondary to clinically apparent intestinal perforation, or patients with incipient sepsis or septic shock.

Liver injury with predominantly cholestatic pattern in patients receiving tigecycline has been reported. Some cases of hepatic failure with a fatal outcome have also been reported. Hepatic failure may occur in patients treated with tigecycline due to the underlying conditions or concomitant medications, although a possible contribution of tigecycline should be considered.

Pregnancy and Lactation

Pregnancy

Tigecycline is contraindicated in pregnancy.

The manufacturer does not recommend the use of tigecycline during pregnancy unless the clinical condition of the mother requires treatment with tigecycline.

Tetracycline class antibiotics, administered during the last half of pregnancy, have been known to produce permanent dental defects (discolouration and enamel defects) and a delay in ossification processes in foetuses, exposed in utero. There is no adequate data from the use of tigecycline during human pregnancy, but animal studies have shown evidence of foetal harm and miscarriage. However, it is not known if the drug crosses human placenta but Briggs (2015) suggest that tigecycline would cross to the embryo/foetus due to molecular weight and prolonged half-life.

Lactation

Use tigecycline with caution in breastfeeding.

Manufacturer recommends that a decision should be made whether to discontinue breastfeeding or discontinue treatment with tigecycline, taking into consideration the potential benefits and risk to both the mother and infant.

It is not known whether tigecycline is excreted in human milk. Briggs (2015) suggests due to tigecycline's limited bioavailability, it would be unlikely that the infant would absorb clinically relevant levels over brief exposure. The potential of modification of infant's bowel flora or other effects on the infant cannot be ruled out.

Side Effects

Abdominal pain
Abscess
Acidosis
Acute pancreatitis
Anaphylactoid reaction
Anaphylaxis
Anorexia
Azotaemia
Cholestatic jaundice
Dental discolouration
Diarrhoea
Dizziness
Dyspepsia
Elevated amylase levels
Headache
Hepatic failure
Hyperbilirubinaemia
Hyperphosphataemia
Hypofibrinogenaemia
Hypoglycaemia
Hypoproteinaemia
Increase in blood urea nitrogen
Increase in serum ALT/AST
Increased partial thromboplastin time
Infections
Inflammation (injection site)
Jaundice
Liver damage
Local pain (injection site)
Nausea
Oedema (injection site)
Pancreatitis
Phlebitis
Phlebitis (injection site)
Photosensitivity
Pneumonia
Prothrombin time increased
Pruritus
Pseudomembranous colitis
Pseudotumour cerebri
Rash
Sepsis
Septic shock
Skin reactions
Stevens-Johnson syndrome
Thrombocytopenia
Thrombophlebitis
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: June 2019

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia

Summary of Product Characteristics: Tygacil 50 mg powder for solution for infusion. Pfizer Ltd. Revised April 2019.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 06 June 2019