Usual Adult Dose for Pneumonia

800 mg orally once a day for 7 to 10 days

Use: For the treatment of mild to moderate community-acquired pneumonia due to Streptococcus pneumoniae (including multi-drug resistant S pneumoniae), Haemophilus influenzae, Moraxella catarrhalis, Chlamydophila pneumoniae, or Mycoplasma pneumoniae

Renal Dose Adjustments

Mild or moderate renal dysfunction (CrCl at least 30 mL/min): No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min): 600 mg orally once a day

• Severe renal dysfunction with liver dysfunction: 400 mg orally once a day

Liver Dose Adjustments

Liver dysfunction: No adjustment recommended.

• Liver dysfunction with severe renal dysfunction: 400 mg orally once a day

Precautions

US BOXED WARNING:

• CONTRAINDICATION IN MYASTHENIA GRAVIS: Reports of fatal and life-threatening respiratory failure in patients with myasthenia gravis associated with use of this drug.

Dialysis

Severe renal dysfunction (CrCl less than 30 mL/min), including dialysis patients: 600 mg orally once a day

• Severe renal dysfunction with liver dysfunction: 400 mg orally once a day

• This drug should be administered after the hemodialysis session on dialysis days.

Other Comments

Administration advice:

• May administer without regard to food
• Because the risks outweigh the benefits, this drug is no longer approved by the US FDA for the treatment of acute bacterial sinusitis, acute bacterial exacerbation of chronic bronchitis, or tonsillitis/pharyngitis; do not use this drug for these indications.

• Multi-drug resistant S pneumonia includes penicillin-resistant isolates that are resistant to at least 2 of the following antibacterials: penicillin, second generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and sulfamethoxazole-trimethoprim.
• 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.

• Hepatic: Signs/symptoms of hepatitis

• Read the US FDA-approved patient labeling (Medication Guide).
• Stop this drug and seek medical attention at once if nausea, fatigue, anorexia, jaundice, dark urine, light-colored stools, pruritus, or tender abdomen occurs.
• Limit driving or other hazardous activities during therapy; if visual difficulties, loss of consciousness, confusion, or hallucinations occur, do not drive, operate heavy machinery, or engage in other hazardous activities. If any of these side effects occur, consult physician.
• Avoid missing doses and complete the entire course of therapy.