Azicine 500

Azicine 500 contains azithromycin, a first macrolide antibiotic. It blocks protein synthesis by inhibiting the transpeptidation/translocation step of protein synthesis of bacteria and by inhibiting the assembly of the 50S ribosomal subunit. Azicine 500 is indicated for infections caused by susceptible organisms.

Pack size Box of 3 tablets, 6 tablets, 8 tablets, 10 tablets.
Shelf-life 24 months
Composition Azithromycin (as azithromycin dihydrate)
Dosage forms and strengths Film-coated tablet: 500 mg
Product Code : HK1NP19-08-2-1

Prescribing Information

Indications, usage, dosage and administration

Indications:

  • Treatment of infections caused by susceptible organisms; in lower respiratory tract infections including bronchitis and pneumonia, in oral and dental infections, in skin and soft tissue infections, in acute otitis media and in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis.
  • Treatment of uncomplicated genital infections due to Chlamydia trachomatis. It is also indicated in the treatment of chancroid due to Haemophilus ducreyi and uncomplicated genital infections due to non-multiresistant Neisseria gonorrhoeae.
  • Prophylaxis against Mycobacterium avium-intracellulare complex (MAC) infection or use in combination with ethambutol for the treatment of disseminated MAC (DMAC) infection in patients with advanced HIV infection.

Dosage:

Adults and children weighing > 45 kg:

Treatment of sexually transmitted diseases caused by

  • Chlamydia trachomatis and Haemophilus ducreyi: 1000 mg as a single oral dose.
  • Susceptible Neisseria gonorrhoeae: 1000 mg or 2000 mg of azithromycin + 250 mg or 500 mg ceftriaxone.

In patients with advanced HIV infection:

  • Prophylaxis against MAC infections: 1200 mg once per week.
  • Treatment of DMAC infections: 600 mg once a day, in combination with other antimycobacterial agents against MAC.

For all other indications, the total dosage of 1500 mg should be given as 500 mg daily for 3 days or for 5 days with 500 mg given on the first day, then 250 mg daily from 2nd to 5th day.

In patients with renal impairment:

  • Mild to moderate renal impairment (GFR 10 – 80 ml/min): No dose adjustment is necessary
  • Severe renal impairment (GFR < 10 ml/min): Caution should be exercised.

Usage:

Azicine 500 should be given as a single daily dose. Azithromycin tablets can be taken with or without food

Contraindications

Known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any of the excipients.

Adverse reactions

  • Reversible hearing impairment (associated with prolonged use of high doses); nausea, vomiting, diarrhea, loose stools, abdominal discomfort (pain/cramps) and flatulence; abnormal liver function; allergic reactions including rash and angioedema; moniliasis and vaginitis.
  • Prophylaxis for DMAC: Diarrhea, abdominal pain, nausea, loose stools, flatulence, vomiting, dyspepsia, rash, pruritus, headache and arthralgia.
  • Treatment of DMAC infection for prolonged periods: Abdominal pain, nausea, vomiting, diarrhea, flatulence, headache, abnormal vision and hearing impairment.

Precautions

Use with caution in patients with severe hepatic/renal impairment.

There were reports about:

  • Rare serious allergic reactions. If an allergic reaction occurs, the drug should be discontinued and appropriate therapy should be instituted. Physicians should be aware that reappearance of the allergic symptoms may occur when symptomatic therapy is discontinued.
  • Abnormal liver function, hepatitis, cholestatic jaundice, hepatic necrosis, and hepatic failure have been reported, some of which have resulted in death. Discontinue azithromycin immediately if signs and symptoms of hepatitis occur.
  • Acute exacerbations of the symptoms of myasthenia gravis.
  • Infantile hypertrophic pyloric stenosis (IHPS) in neonates (treatment up to 42 days of life), contact physician if vomiting or irritability with feeding occurs.
  • Clostridium difficile-associated diarrhea (CDAD) must be considered in all patients who present with diarrhea following antibiotic use. CDAD may range in severity from mild diarrhea to fatal colitis.

Observation for signs of super infection with non-susceptible organisms, including fungi is recommended.

Azithromycin and ergot derivatives should not be co-administered.

Consider the risk of QT prolongation, which can be fatal when prescribe for at-risk groups including:

  • Patients with congenital or documented QT prolongation.
  • Patients currently receiving treatment with other active substances known to prolong QT interval, such as antiarrhythmics of Classes IA and III, antipsychotic agents, antidepressants, and fluoroquinolones.
  • Patients with electrolyte disturbance, particularly in cases of hypokalemia and hypomagnesemia.
  • Patients with clinically relevant bradycardia, cardiac arrhythmia or cardiac insufficiency.
  • Elderly patients.

Azithromycin should be used during pregnancy only if clearly needed. Caution should be exercised when azithromycin is administered to a nursing woman.

Patients should be aware of how they react to drug before driving or operating machinery.