Composition:
Azisol 500 Tablet: Each film-coated tablet contains Azithromycin Dihydrate USP equivalent to Azithromycin 500 mg.
Pharmacology:
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:
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:
- Adults: 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 the next 4 days.
- For sexually transmitted diseases: A single 1 gm (1000 mg) dose for genital ulcer, non-gonococcal urethritis, and cervicitis due to Chlamydia trachomatis.
- For 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 the next 4 days.
Children Dosage:
- From 1 month: 10 mg/kg for 3 days
- 15-25 kg: 200 mg for 3 days
- 26-35 kg: 300 mg for 3 days
- 36-45 kg: 400 mg for 3 days
Contra-indications:
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.
Warning & Precautions:
As with any antibiotic, observation for signs of superinfection with non-susceptible organisms, including fungi, is recommended. Precaution should be taken in patients with more severe renal impairment.
Side Effects:
- Common: Nausea, vomiting, abdominal discomfort (pain/cramps), flatulence, diarrhea, headache, dizziness, and skin rashes are reversible upon discontinuation of therapy.
- Rare: Reversible elevations in liver transaminases and transient mild reductions in neutrophil counts have occasionally been observed.
Use in Pregnancy & Lactation:
Pregnancy Category B. No evidence of harm to the fetus in animal studies. Caution should be exercised when administered to a nursing mother.
Drug Interactions:
- Magnesium and aluminum-containing antacids reduce the peak serum levels of Azithromycin.
- Azithromycin may increase the plasma concentration of digoxin and cyclosporine.
Overdose:
Symptoms include hearing loss, severe nausea, vomiting, and diarrhea. Gastric lavage and general supportive measures are indicated.
Storage:
Keep below 30° C, protect from light and moisture.
Commercial Pack:
Azisol 500 Tablet: Each box contains 12 (2x6’s) tablets in blister pack.
