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Azikil

Azithromycin

Presentation

Azikil 500 Tablet: Each film coated tablet contains Azithromycin Dihydrate USP 524.03 mg equivalent to Azithromycin 500 mg.

Azikil 35 ml Powder for Suspension: After reconstitution, each 5 ml suspension contains Azithromycin Dihydrate USP 209.65 mg equivalent to Azithromycin 200 mg.

Azikil 50 ml Powder for Suspension: After reconstitution, each 5 ml suspension contains Azithromycin Dihydrate USP 209.65 mg equivalent to Azithromycin 200 mg.

 

Description

Azithromycin is an azalide antibiotic, a subclass of macrolide antibiotic. It acts by binding to the 50s ribosomal subunit of susceptible microorganisms and thus interfering with microbial protein synthesis. Azithromycin has been shown to be active against most strains in the following microorganisms, both In vitro and in clinical infections:

Gram-positive microorganisms: Staphylococcus aureus, Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes.

Gram-negative microorganisms: Haemophilus ducreyi, Haemophilus influenzae, Moraxella catarrhalis, Neisseria gonorrhoeae, Escherichia coli.

 

Indications and Uses

  • Azithromycin is indicated for infections caused by susceptible organisms in-
  • Upper respiratory tract infections including sinusitis, pharyngitis and tonsillitis
  • Lower respiratory tract infections including bronchitis, acute bacterial exacerbations of chronic obstructive pulmonary disease (COPD)
  • Otitis media
  • Skin and soft tissue infections including cellulitis, pyoderma, erysipelas, wound infections
  • Diarrhea, Shigellosis
  • Sexually transmitted diseases, especially in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis
  • Genital ulcer disease in men due to Haemophilus ducreyi (chancroid)
  • Mild or moderate typhoid due to multiple-antibacterial resistant organisms
  • Prophylaxis against a-hemolytic (viridans group) streptococcal bacterial endocarditis
  • Other infections including odontogenic infections, bartonella infections, toxoplasmosis, babesiosis

 

Dosage and Administration

Azithromycin tablet can be taken with or without food. Azithromycin suspension should be taken at least 1 hour before or 2 hours after meal.

Adult

For respiratory tract infections, otitis media and skin & soft tissue infections: 500 mg once daily for 3 days or an alternative to this as 500 mg once on day 1, followed by 250 mg once daily for next 4 days. For sexually transmitted diseases like genital ulcer, non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis : a single 1 gm (1000 mg) dose. For the treatment of urethritis and cervicitis due to Neisseria gonorrhoeae : a single 2 gm (2000 mg) dose. In typhoid, 500 mg once daily for 7 days. In Cholera, a single 1 gm (1000 mg) dose. In Shigellosis, 500 mg once on day 1, followed by 250 mg once daily for next 4 days.

Children:

Elderly:  same as for adults.

Side effects

Azithromycin is well tolerated with a low incidence of side efects. The side effects include nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhea, headache, dizziness, and skin rashes and are reversible upon discontinuation of therapy. Reversible elevations in liver transaminases have been observed occasionally. Transient mild reductions in neutrophil counts have occasionally been observed in clinical trials, although causal relationship to Azithromycin has not been established.

 

Contraindications

Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivative and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.

 

Precautions

As with any antibiotic, observation for signs of super infection with non-susceptable organisms, including fungi, is recommended. Precaution should be taken in patients with more severe renal impairment.

 

Use in pregnancy & lactation

Pregnancy: US FDA pregnancy category B. In the animal studies, no evidence of harm to the fetus due to Azithromycin was found. Because animal reproduction studies are not always predictive of human response, Azithromycin should be used during pregnancy only if clearly needed.

Lactation: It is not known whether Azithromycin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Azithromycin is administered to nursing mother.

 

Drug interactions

Peak serum levels but not the total extent of absorption were reduced by the presence of magnesium and aluminum-containing antacids. Azithromycin should be taken at least 1 hr before or 2 hrs after these antacids. In patients receiving ergot alkaloids, Azithromycin should be avoided concurrently because of the possibilty of ergotism result in from interaction of Azithromycin with the cytochrome P-450 system However, no cases of such interaction have been reported. Macrolides have been known to increase the plasma concentration of digoxin and cyclosporine. Therefore, if co-administration is necessary caution should be exercised and serum levels of digoxin and cyclosporine should be checked. There have been no pharmacokinetic drug interactions between Azithromycin and warfarin, theophylline, carbamazepine, methylprednisolone and cimetidine.

 

Direction for reconstitution of suspension

Shake the bottle to loosen powder.

35 ml: Add 23 ml (with the help of supplied cup) of boiled and cooled water for 35 ml, to the dry powder of the bottle.

50 ml: Add 33 ml (with the help of supplied cup) of boiled and cooled water for 50 ml, to the dry powder of the bottle.

For ease of preparation, add water to the bottle in two proportions. Shake well after each addition until all the powder is in suspension.

Note: Shake the suspension well before each use. Keep the bottle tightly closed. The reconstituted suspension should be stored in a cool and dry place, preferably in refrigerator.

 

Overdosage

There are no data available on overdose with Azithromycin. Typical symptoms of overdosage with macrolide antibiotics include hearing loss, severe nausea, vomiting and diarrhoea. Gastric lavage and general supportive measures are indicated.

 

Commercial Pack

Azikil 500 Tablet: Each box contains 1 Alu-Alu blister strips of 8 tablets.

Azikil 35 ml Powder for Suspension: Bottle containing dry powder for 35 ml suspension.

Azikil 50 ml Powder for Suspension: Bottle containing dry powder for 50 ml suspension.

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