Usual Adult Dose for Bronchitis

320 mg orally once a day for 5 days

Comments:

• Since fluoroquinolones (including this drug) have been associated with serious side effects and acute bacterial exacerbation of chronic bronchitis (ABECB) is self-limiting for some patients, this drug should be saved for treatment of ABECB in patients with no alternative treatment options.

Use: For the treatment of ABECB due to susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, H parainfluenzae, or Moraxella catarrhalis

Usual Adult Dose for Pneumonia

320 mg orally once a day

Duration of therapy:

• Due to known/suspected S pneumoniae, H influenzae, Mycoplasma pneumoniae, or Chlamydophila pneumoniae infection: 5 days
• Due to known/suspected multi-drug resistant S pneumoniae (MDRSP), Klebsiella pneumoniae, or M catarrhalis infection: 7 days

Comments:

• MDRSP isolates are isolates resistant to at least 2 of the following antibacterials: penicillin (MIC at least 2 mcg/mL), second-generation cephalosporins (e.g., cefuroxime), macrolides, tetracyclines, and sulfamethoxazole-trimethoprim.

Use: For the treatment of mild to moderate community-acquired pneumonia due to susceptible isolates of S pneumoniae (including MDRSP), H influenzae, M catarrhalis, M pneumoniae, C pneumoniae, or K pneumoniae

Renal Dose Adjustments

CrCl 40 mL/min or less: 160 mg orally every 24 hours

Liver Dose Adjustments

No adjustment recommended.

Precautions

US BOXED WARNING:
SERIOUS SIDE EFFECTS INCLUDING TENDINITIS, TENDON RUPTURE, PERIPHERAL NEUROPATHY, CNS EFFECTS, AND EXACERBATION OF MYASTHENIA GRAVIS:

• Fluoroquinolones (including this drug) have been associated with disabling and potentially irreversible serious side effects that have occurred together (including tendinitis and tendon rupture, peripheral neuropathy, CNS effects). This drug should be discontinued immediately and use of fluoroquinolones (including this drug) should be avoided in patients with any of these serious side effects.
• Fluoroquinolones (including this drug) may exacerbate muscle weakness in patients with myasthenia gravis. This drug should be avoided in patients with known history of myasthenia gravis.
• Since fluoroquinolones (including this drug) have been associated with serious side effects, this drug should be reserved for use in patients with no alternative treatment options for acute bacterial exacerbation of chronic bronchitis.

CONTRAINDICATIONS:
History of hypersensitivity to the active component, other fluoroquinolone antibacterial agents, or any of the ingredients

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

Consult WARNINGS section for additional precautions.

Dialysis

Hemodialysis or CAPD: 160 mg orally every 24 hours

Other Comments

Administration advice:

• May administer without regard to food
• Swallow tablet whole with plenty of liquid.
• Do not exceed recommended dose and duration of therapy.
• Administer this drug at least 2 hours before or 3 hours after aluminum-, magnesium-, iron-, zinc-, or other metal cation-containing products (e.g., antacids, mineral supplements/multivitamins, buffered didanosine).
• Administer this drug at least 2 hours before sucralfate.

Storage requirements:

• Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
• Protect from light.

General:

• 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.
• Initial sputum culture should guide clinical decision regarding use of 5-day or 7-day regimen.

Patient advice:

• Read the US FDA-approved patient labeling (Medication Guide).
• Drink plenty of fluids.
• Avoid missing doses and complete the entire course of therapy.
• Stop this drug immediately and contact healthcare provider if a serious side effect occurs.
• Seek medical attention immediately in an emergency room or call 911 if sudden, severe, constant pain in the stomach, chest, or back occurs.
• Stop this drug and contact healthcare provider if tendon pain, swelling, or inflammation develops or you have weakness or are unable to use 1 of your joints; rest and do not exercise.
• Stop this drug at once and contact physician if symptoms of peripheral neuropathy develop.
• Contact physician immediately if any muscle weakness worsens or respiratory problems develop or if watery and bloody stools occur; contact physician if you have palpitations or fainting spells.
• Stop this drug immediately at first sign of rash or other allergic reaction and seek medical care; stop this drug and contact healthcare provider if rash develops.
• Dizziness reported; do not drive, operate machinery, or engage in other tasks that require mental alertness or coordination if dizziness occurs.
• Avoid or minimize exposure to natural or artificial sunlight; use sun protection (e.g., protective clothing, sunscreen) if sun exposure cannot be avoided. Contact physician if sunburn-like reaction or skin eruption develops.