Tigecycline - Tigecycline injection, Powder, Lyophilized, For Solution

Contraindications (

Initial dose of 100 mg, followed by 50 mg every 12 hours administered intravenously over approximately 30 to 60 minutes. (2.1)

• Severe hepatic impairment (Child Pugh C): Initial dose of 100 mg followed by 25 mg every 12 hours. (
  5.6 Monitoring of Blood Coagulation Parameters

  Hypofibrinogenemia has been reported in patients treated with tigecycline for injection

  [see Adverse Reactions ]

  . Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with tigecycline for injection.
  )
• Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with tigecyclineetracycline. (
  2.4 Monitoring of Blood Coagulation Parameters

  Obtain baseline blood coagulation parameters, including fibrinogen, and continue to monitor regularly during treatment with tigecycline for injection

  [see Warnings and Precautions ].
  ,
  2.2 Dosage in Patients With Hepatic Impairment

  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 initial dose of tigecycline for injection should be 100 mg followed by a reduced maintenance dose of 25 mg every 12 hours. Patients with severe hepatic impairment (Child Pugh C) should be treated with caution and monitored for treatment response

  [see Clinical Pharmacology and Use in Specific Populations ]

  .
  )

For Injection: Each single-dose 5 mL glass vial contains 50 mg of tigecycline, USP as an orange lyophilized powder for reconstitution.

• Lactation:
  Avoid breastfeeding for longer than 3 weeks while taking tigecycline for injection. A lactating woman may also pump and discard breast milk during treatment and for 9 days after the last dose of tigecycline for injection (
  8.2 Lactation

  Risk Summary

  There are no data on the presence of tigecycline in human milk; however, tetracycline-class antibacterial drugs are present in breast milk. It is not known whether tigecycline has an effect on the breastfed infant or on milk production. Tigecycline has low oral bioavailability; therefore, infant exposure is expected to be low. Tigecycline is present in rat milk with little or no systemic exposure to tigecycline in nursing pups as a result of exposure via maternal milk. When a drug is present in animal milk, it is likely that the drug will be present in human milk.

  The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tigecycline for injection and any potential adverse effects on the breastfed child from tigecycline for injection or from the underlying maternal condition (see Clinical Considerations).

  Clinical Considerations

  Because of the theoretical risk of dental discoloration and inhibition of bone growth, avoid breastfeeding if taking tigecycline for injection for longer than three weeks. A lactating woman may also consider interrupting breastfeeding and pumping and discarding breastmilk during administration of tigecycline for injection and for 9 days (approximately 5 half-lives) after the last dose in order to minimize drug exposure to a breastfed infant.
  )
• Pediatrics:
  Use in patients under 18 years of age is not recommended. Pediatric trials were not conducted because of the higher risk of mortality seen in adult trials (
  8.4 Pediatric Use

  Use in patients under 18 years of age is not recommended. Safety and effectiveness in pediatric patients below the age of 18 years have not been established. Because of the increased mortality observed in tigecycline-treated adult patients in clinical trials, pediatric trials of tigecycline to evaluate the safety and efficacy of tigecycline were not conducted.

  In situations where there are no other alternative antibacterial drugs, dosing has been proposed for pediatric patients 8 to 17 years of age based on data from pediatric pharmacokinetic studies

  [see Dosage and Administration and Clinical Pharmacology ].

  Because of effects on tooth development, use in patients under 8 years of age is not recommended

  [see Warnings and Precautions ].
  )