Usual Adult Dose for Pneumonia

IV: 150 mg IV every 12 hours for 5 to 7 days
Oral: 600 mg orally every 12 hours for 5 days

Comments:

• May switch from IV to oral dosing to complete the course of therapy

Use: For the treatment of community-acquired bacterial pneumonia due to susceptible Streptococcus pneumoniae, Staphylococcus aureus (methicillin-susceptible isolates), Haemophilus influenzae, Legionella pneumophila, Mycoplasma pneumoniae, Chlamydophila pneumoniae

Renal Dose Adjustments

No adjustment recommended.

Liver Dose Adjustments

IV:

• Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
• Severe liver dysfunction (Child-Pugh C): 150 mg IV every 24 hours

Oral:

• Mild liver dysfunction (Child-Pugh A): No adjustment recommended.
• Moderate or severe liver dysfunction (Child-Pugh B or C): Not recommended.

Comments:

• Patients with liver dysfunction should be monitored for drug-related side effects throughout therapy.

Precautions

CONTRAINDICATIONS:

• Known hypersensitivity to the active component, any of the ingredients, or pleuromutilin class drugs
• Tablets: Coadministration with sensitive CYP450 3A4 substrates that prolong the QT interval (e.g., pimozide)

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis: No adjustment recommended.

Other Comments

Administration advice:

• IV: Administer via IV infusion over 60 minutes.
• IV: Do not use the diluent bag in series connections.
• Oral: Administer at least 1 hour before a meal or 2 hours after a meal.
• Oral: Swallow tablets whole with water (6 to 8 ounces); do not crush or divide tablets.
• Consult the manufacturer product information regarding missed doses.

Storage requirements:

• Injection (before dilution): Store vials in refrigerator at 2C to 8C (36F to 46F); do not freeze. Store diluent bags in barrier overwrap at 2C to 25C (36F to 77F) until ready to use.
• Injection (after dilution): Can store up to 24 hours at room temperature and up to 48 hours when refrigerated at 2C to 8C (36F to 46F)
• Tablets: Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).

Reconstitution/preparation techniques:

• Injection: Must dilute into the supplied diluent bag (containing a solution of 10 mM citrate buffered 0.9% sodium chloride for injection) before use.
• The manufacturer product information should be consulted.

IV compatibility:

• Do not add other additives to the diluent bag; compatibility not established.

General:

• To reduce the development of drug-resistant organisms and maintain effective therapy, this drug should be used only to treat or prevent infections proven or strongly suspected to be caused by susceptible bacteria.
• Culture and susceptibility information should be considered when selecting/modifying antibacterial therapy or, if no data are available, local epidemiology and susceptibility patterns may be considered when selecting empiric therapy.

Monitoring:

• General: For drug-related side effects in patients with liver dysfunction (throughout therapy)

Patient advice:

• Avoid missing doses and complete the entire course of therapy.
• Contact healthcare provider as soon as possible if watery stools (with or without stomach cramps and fever) develop.
• Females of reproductive potential: Avoid pregnancy while using this drug; use effective contraception during therapy and for 2 days after the last dose.