Praxinstad 400

Rx

Indications:

• Acute bacterial sinusitis
• Mild to moderate community-acquired pneumonia
• Skin and skin structure infections
• Acute bacterial exacerbations of chronic bronchitis.

Dosage:

Adults: 400 mg once daily.

Time of treatment:

• 10 days in patients with acute bacterial sinusitis, mild to moderate community-acquired pneumonia;
• 7 days in patients with skin and skin structure infections;
• 5 days in patients with acute bacterial exacerbations of chronic bronchitis.

Usage:

Praxinstad 400 is administered orally, during or after meals.

• Hypersensitivity to moxifloxacin, other quinolones or to any of the excipients.
• Children below 18 years of age because experimental data show that moxifloxacin can cause damage to the cartilage in weight-bearing joints.
• Patients with known prolongation of the QT interval, patients receiving class IA (quinidine, procainamide) or III (amiodarone, sotalol) antiarrhythmic agents.
• It is not recommended to use Praxinstad 400 for pregnant and breast-feeding women.

• Disabling and potentially irreversible serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects.
• Common: Vomiting, diarrhea; dizziness.
• Uncommon: Abdominal pain, dry mouth, dyspepsia, mild taste disorders; headache, convulsions, depression, confusion, tremor, insomnia, restlessness, nervousness, somnolence; pruritus, erythema; arthralgia, myalgia.

• Avoid the use of Praxinstad 400 in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones. Discontinue this medicine immediately at the first signs or symptoms of any serious adverse reactions.
• Extreme caution should be exercised when use Praxinstad 400 for:
  • Patients with known or suspected CNS disorders e.g. seizures, cerebral arteriosclerosis
  • Patients with known risk factors for prolongation of the QT interval: Congenital long QT syndrome, concomitant use of class IA and III antiarrhythmic, tricyclic antidepressants, macrolides), uncorrected electrolyte imbalance (e.g. hypokalemia, hypomagnesaemia), elderly, cardiac disease (e.g. heart failure, myocardial infarction, bradycardia).
• It is not recommended to use Praxinstad 400 for pregnant and breast-feeding women. In cases, administration of moxifloxacin is necessary, after taking into account the benefit/risk, a decision should be made to discontinue nursing during treatment.
• Patients should be aware of how they react to drug before driving or operating machinery. Praxinstad 400 including moxifloxacin may result in an impairment of the patient’s ability to drive or operate machinery due to CNS reactions (e.g. dizziness) or acute and short lasting loss of consciousness (syncope).