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Antibiotics

Praxinstad 400


Pack size:  

Box of 2 blisters x 5 tablets.


Composition:

Each film-coated tablet contains:

Moxifloxacin (as moxifloxacin hydrochloride) 400 mg


Shelf-life:            

24 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Do not store above 30oC.
 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

  • Treatment of mild to moderate community-acquired pneumonia caused by  susceptible Streptococcus pneumoniae, H. influenzae, Chlamydia pneumoniae,  Mycoplasma pneumoniae or Moraxella catarrhalis.
  • Treatment of uncomplicated skin and skin structure infections caused by  susceptible Staphylococcus aureus and Streptococcus pyogenes. Effective for the  treatment of uncomplicated subcutaneous abscesses, furuncles, impetigo and  cellulitis.
  • Acute bacterial exacerbations of chronic bronchitis caused by  susceptible Streptococcus pneumoniae, Haemophilus influenzae, H. Parainfluenzae, Klebsiella pneumoniae, Staphylococcus aureus, Moraxella catarrhalis: Because fluoroquinolones, including moxifloxacin, have been  associated with serious adverse reactions (see PRECAUTIONS) and for some  patients acute bacterial exacerbations of  chronic bronchitis is self-limiting,  reserve moxifloxacin for treatment of acute bacterial exacerbations of chronic bronchitis in  patients who have no alternative treatment options.
  • Acute bacterial sinusitis caused by susceptible isolates of Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis: Because fluoroquinolones, including moxifloxacin, have been associated with serious adverse reactions (see PRECAUTIONS) and for some patients acute bacterial  sinusitis is self-limiting, reserve moxifloxacin for treatment of acute bacterial sinusitis in patients who have no alternative treatment options.
     
  • Administered orally before, during or after meals.
     
  • 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.
  • Renal/hepatic impairment:
    No adjustment of dosage is required in patients with mild, moderate renal/hepatic impairment and elderly. Moxifloxacin has not been evaluated in patients with renal impairment undergoing haemodialysis or in patients with severe hepatic impairment.


Or as prescribed by physicians.

 

  • Hypersensitivity to moxifloxacin, other quinolones or to any ingredient of the drug.
  • 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.

     

Common

  • Vomiting, diarrhea.
  • Dizziness.

Uncommon

  • Abdominal pain, dry mouth, dyspepsia, mild taste disorders.
  • Headache, convulsions, depression, confusion, tremor, insomnia, restlessness, nervousness, somnolence.
  • Pruritus, erythema.
  • Amylase and lactic dehydrogenase increased.
  • Arthralgia, myalgia.

Rare

  1. QT interval prolonged.
  2. Rupture of the Achilles tendon and other tendons.
  3. Diarrhea by C.difficile.
  4. Hallucination, visual disturbances, asthenia, suicidal thoughts.

     

  • Moxifloxacin has been shown to prolong the QT interval on the electrocardiogram. Use with caution in patients receiving other drugs that prolong the QT interval such as cisapride, erythromycin, tricyclic antidepressants, antipsychotic agents. Use with caution in patients with ongoing cardiac arrhythmia including bradycardia and acute myocardial ischaemia.
  • Use with caution in patients with CNS disorders such as severe cerebral arteriosclerosis, epilepsy because convulsions may occur.
  • Disabling and potentially irreversible serious adverse reactions including tendinitis, tendon rupture, peripheral neuropathy, central nervous system effects.
  • Fluoroquinolones have been associated with disabling and potentially irreversible serious adverse reactions from different body systems that can occur together in the same patient. Commonly seen adverse reactions include tendinitis, tendon rupture, arthralgia, myalgia, peripheral neuropathy, and central nervous system effects (hallucinations, anxiety, depression, insomnia, severe headaches, and confusion). These reactions can occur within hours to weeks after starting fluoroquinolones. Patients of any age or without pre-existing risk factors have experienced these adverse reactions.
  • Discontinue Praxinstad 400 immediately at the first signs or symptoms of any serious adverse reactions. In addition, avoid the use of fluoroquinolones, in patients who have experienced any of these serious adverse reactions associated with fluoroquinolones.
  • Pregnancy: Because of serious risks on fetus, use in pregnancy is therefore not  recommended moxifloxacin.
  • Lactation: Rat experiments have shown excretion of moxifloxacin in breast milk,  therefore administration of moxifloxacin is not recommended in breast- feeding patients  because of the potential for serious adverse effects in  infants. In cases, administration of moxifloxacin is necessary, after taking  into account the benefit/risk, a decision should be made to discontinue  nursing during treatment.
  • Effects on ability to drive and use machines: No studies on the effects of moxifloxacin on the ability to drive and use machines have been performed. However, fluoroquinolones 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). Patients should be advised to see how they react to moxifloxacin before driving or operating machinery.

     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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