Tridosil(Azithromycin)

Therapeutic Group: Anti Bacterial

Presentation

Tridosil 250 Tablet: Each tablet contains Azithromycin Dihydrate USP 262.015 mg equivalent to Azithromycin 250 mg.

Tridosil 500 Tablet: Each tablet contains Azithromycin Dihydrate USP 524.03 mg equivalent to Azithromycin 500 mg.

Tridosil 15 ml Powder for Suspension: After reconstitution, each 5 ml suspension contains Azithromycin Dihydrate USP 209.65 mg equivalent to Azithromycin 200 mg.

Tridosil 30 ml Powder for Suspension: After reconstitution, each 5 ml suspension contains Azithromycin Dihydrate USP 209.65 mg equivalent to Azithromycin 200 mg.

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

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

Tridosil IV Infusion: Each vial contains lyophilized powder of Azithromycin Dihydrate USP equivalent to Azithromycin 500 mg and each normal saline bottle contains 250 ml 0.9% Sodium Chloride solution. After reconstitution with 250 ml 0.9% Sodium Chloride solution according to direction, each ml contains Azithromycin Dihydrate USP equivalent to Azithromycin 2 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.

Other microorganisms: Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Bacteroides fragilis, Legionella pneumophila, oxoplasma gondii.

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 & 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.

Oral:

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:

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.

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.