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Antibiotics

Azicine

 

Pack size:

Box of 1 blister x 6 capsules.

 

Composition:

Each capsule contains azithromycin 250 mg.

 

Shelf-life:

36 months from the date of manufacturing.

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

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

  • Pharyngitis and tonsillitis caused by Streptococcus pyogenes.
  • Acute bacterial sinusitis caused by H.influenzae, M. catarrhalis or S.pneumoniae.
  • Acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD) caused by H.influenzae, M. catarrhalis or S.pneumoniae.
  • Mild to moderate community - acquired pneumonia (CAP) caused by susceptible S.pneumoniae, H.influenzae, Mycoplasma pneumoniae or Chlamydophila pneumoniae.
  • Uncomplicated skin and skin structure infections caused by susceptible Staphylococcus aureus, S.pyogenes, or S.agalactiae.
  • Chancroid (genital ulcers caused by Haemophilus ducreyi).
  • Urethritis and cervicitis caused by Neisseria gonorrhoeae or Chlamydia trachomatis.
  • Treament of disseminated infections caused by MAC in patients with HIV infection.
  • Prevention of disseminated MAC infection (both primary and secondary prophylaxis) in HIV-infected individuals.
  • MAC infections in HIV-negative patients (treatment of pulmonary infections).

 

  • Azithromycin is administered orally, should be given at least 1 hour before or 2 hours after a meal.

Adults
Treatment of individuals 16 years of age and older with mild to moderate acute bacterial exacerbations of COPD, CAP, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections due to the indicated organisms: 500 mg as a single dose on the first day followed by 250 mg once daily on days 2 through 5 for a total dose of 1.5 g of azithromycin.

  • Treatment of acute sinusitis: 500 mg once daily for 3 days.
  • Treatment of chancroid: 1g administered as a single dose.
  • Treatment of urethritis and cervicitis due to C. trachomatis: 1 g as a single dose.
  • Treatment of urethritis and cervicitis due to N. gonorrhoeae: 2 g as a single dose.

MAC infections in patients with HIV infections:

  • Primary prophylaxis: 1.2 g once weekly. Azithromycin can be given alone or in conjunction with rifabutin (300 mg once daily).
  • Treatment of disseminated MAC infection: 600 mg once daily in conjunction with ethambutol (15 mg/kg daily).
  • Prevention of recurrence (secondary prophylaxis or chronic maintenance therapy) of disseminated MAC infection: 500 mg once daily in conjunction with ethambutol (15 mg/kg once daily) with or without rifabutin (300 mg once daily).

MAC infections in HIV-negative patients (treatment of pulmonary infections): 250 mg daily or 500 mg 3 times weekly in conjunction with rifabutin (300 mg daily) or rifampin (600 mg daily) and ethambutol (25 mg/kg daily for 2 months, then 15 mg/kg daily).

Children

  • The dose in children is 10 mg/kg as a single daily dose for day 1, then 5 mg/kg once daily on days 2 through 5.


Or as prescribed by physicians.

 

  • Hypersensitivity to azithromycin, erythromycin, or any macrolide antibiotic, or to any ingredient of the drug.

     

  • As for erythromycin, azithromycin is well tolerated with a low incidence of side effects (approximately 13% of all treated patients). The most frequent adverse reactions of azithromycin are gastrointestinal disturbances (10%) in origin with nausea, abdominal discomfort (pain/cramps), vomiting, flatulence, diarrhoea, and loose stools being occasionally observed, but they are usually mild and less frequent than with erythromycin. Transient elevations of liver enzyme values have been reported. Rashes, headache, and dizziness may occur. Transient alterations in neutrophil counts have been seen in patients receiving azithromycin.
  • Hearing impairment: In investigational studies where higher doses were used for prolonged periods of time, reversible hearing impairment was seen in some patients.

Common

  • Nausea, diarrhoea, pain, vomiting.

Less common

  • Fatigue, headache, vertigo, somnolence.
  • Flatulence, dyspepsia, appetite loss.
  • Skin eruptions, itch.
  • Vaginosis, colpitis.

Rare

  • Anaphylactic reaction.
  • Angioedema.
  • Elevated transaminase.
  • Slight transient decrease of neutrophils.

     

  • Serious hypersensitivity reactions, including angioedema, anaphylaxis, and dermatologic reactions, have occurred rarely in patients receiving azithromycin.
  • Because azithromycin is eliminated principally via the liver, the drug should be used with caution in patients with impaired hepatic function.
  • Because of limited data regarding use of azithromycin in patients with renal impairment, the drug should be used with caution in patients with glomerular filtration rates less than 10 ml/minute.
  • Prolonged cardiac repolarization and QT interval with risk of cardiac arrhythmia and torsades de pointes has been reported rarely with macrolides. The possibility of such effects with azithromycin cannot be completely ruled out in patients at increased risk for prolonged cardiac repolarization.
  • To reduce development of drug-resistant bacteria and maintain effectiveness of azithromycin and other antibacterials, the drug should be used only for the treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.
  • Pregnancy: There are no adequate and controlled studies to date using azithromycin in pregnant women, and the drug should be used during pregnancy only when clearly needed.
  • Lactation: Azithromycin has been detected in human milk. The drug should be used with caution in nursing women.
  • There is no evidence to suggest that azithromycin may have an effect on a patient's ability to drive or operate 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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