Thromax ®

Azithromycin USP

Thromax® 250 tablet : Each film coated tablet contains Azithromycin Dihydrate USP equivalent to Azithromycin 250 mg.

Thromax® 500 tablet : Each film coated tablet contains Azithromycin Dihydrate USP equivalent to Azithromycin 500 mg.

Thromax® suspension: After reconstitution each 5 ml suspension contains Azithromycin Dihydrate USP equivalent to Azithromycin 200 mg.

Azithromycin is a semi-synthetic  macrolide antibiotic chemically related to Erythromycin and Clarithromycin. It is an azalide, a subclass of macrolide antibiotics. Azithromycin, like all macrolide antibiotics, prevents bacteria from growing by interfering with their ability to make proteins. The mode of action of Azithromycin is inhibition of protein synthesis in bacteria by binding to the 50s ribosomal subunit and preventing translocation of peptides. Nucleic acid synthesis is not affected. Due to the differences in the way proteins are made in bacteria and humans, the macrolide antibiotics do not interfere with humans' ability to make proteins.

Thromax® is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia (CAP), in upper respiratory tract infections including sinusitis and pharyngitis/tonsillitis, in otitis media, and in skin and soft tissue infections. Thromax® is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis or non multi-resistant Neisseria gonorrhoeae in sexually transmitted diseases in men and women, paediatric cholera and typhoid fever.

Adults: For most indications, the total dose is 1.5 g, which should be given as 500 mg once daily for 3 consecutive days, or, alternatively, a single dose of 500 mg on day 1 followed by 250 mg once daily on days 2-5. For sexually transmitted diseases, the dose is 1 g as a single dose.


Elderly: Normal adult dosage is recommended.


Children: The dose in children over 6 months of age is 10 mg/kg/day as a single dose for 3 days. If body-weight 15-25 kg, 200 mg once daily for 3 days; body-weight 26-35 kg, 300 mg once daily for 3 days; body-weight 36-45 kg, 400 mg once daily for 3 days. 

Azithromycin was found effective in typhoid fever in different clinical studies. In case of adults the dose is 1 gm in the first day followed by 500 mg once daily on the next 6 days and for children 10 mg/kg/day once daily for 7 days or 20 mg/kg/day once for 5 days. For paediatric cholera, 20 mg/kg as single dose. 

There is no information on children less than six months of age.


More common side effects may include: Abdominal pain, diarrhea or loose stools, nausea or vomiting.

Less common side effects may include: 

Blood in the stools, chest pain, dizziness, drowsiness, fatigue, gas, headache, palpitations, indigestion, itching, jaundice (yellowing of the skin and the whitening of the eyes), kidney infection, light sensitivity, rash, severe allergic reaction including swelling (as in hives), vaginal inflammation, vertigo and yeast infection.

The single and large dose of Thromax® that is prescribed to treat sexually transmitted infection of the cervix or urinary tract is more likely to cause stomach and bowel side effects than the smaller doses prescribed for a skin or respiratory tract infection.


Pregnancy: There are no adequate studies of Azithromycin in pregnant women. However, studies in animals suggest no important effects on the fetus. Azithromycin therefore can be used in pregnancy if the physician feels that it is clearly necessary.


Nursing Mothers: It is not known if Azithromycin is secreted in breast milk.

Overdose

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




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




Azithromycin is contraindicated in patients with known hypersensitivity to Azithromycin, Erythromycin, or any macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated. Azithromycin is contraindicated in patients with hepatic diseases.




Because Azithromycin is principally eliminated via the liver, caution should be exercised when Azithromycin is administered in patients with impaired hepatic function.No dose adjustment is needed in patients with mild renal impairment (creatinine clearance > 40 ml/min), but there is no data regarding Azithromycin usage in patients with more severe renal impairment, thus cautions should be exercised in using Azithromycin in these patients. As with any antibiotic, observations for signs of super infection with nonsusceptible organisms, including fungi, is recommended. Azithromycin should not be concomitantly used with Astemizole or Terfenadine.




Shake the bottle well to loosen the contents.

(†evZjwU fvjfv‡e SuvwK‡q wbb hv‡Z cvDWvi RgvU †eu‡a bv _v‡K|)

 

1. With supplied spoon add boiled and cooled water into the bottle. For ease,

add in two proportions.

For 15 ml suspension : 10 ml (2 spoon full)

       25 ml suspension : 15 ml (3 spoon full)

       35 ml suspension : 25 ml (5 spoon full)

 

mieivnK…Z Pvg‡Pi  mvnv‡h¨ dzUv‡bv  VvÛv cvwb †evZ‡j  Xvjyb| cÖ¯‘‡Zi myweav‡_© `yÕev‡i †gkvb|  

      15 wgwj mvm‡cbkb Gi Rb¨: 10 wgwj (2 PvgP)

      25 wgwj mvm‡cbkb Gi Rb¨: 15 wgwj (3 PvgP)

      35 wgwj mvm‡cbkb Gi Rb¨: 25 wgwj (5 PvgP)

 

2. Close the bottle tightly and shake gently until suspension is prepared.

    ( †evZ‡ji gyL wVKgZ eÜ K‡i fv‡jvfv‡e SvuwK‡q mvm‡cbkb ˆZwi Kiæb|)

 

3. The suspension is ready for use and contains microcapsules.

    (mvm‡cbkb GLb †me‡bi Rb¨ ˆZix| ˆZixK…Z mvm‡cbk‡b  gvB‡µvK¨vcmyjm Av‡Q|)

 

4. Do  not chew the microcapsules. Use spoon for administration.

   ( gvB‡µvK¨vcmyjm wPwe‡q Lv‡eb  bv| †me‡bi Rb¨ mieivnK…Z PvgP e¨envi Kiæb|)

 

Prepare the suspension at least 15 minutes before first administration.

(cÖ_gevi †me‡bi Kgc‡¶ 15 wgwbU c~‡e© mvm‡cbkb ˆZix Kiæb|)




Azithromycin should not be taken with antacids containing Aluminium or Magnesium. Azithromycin should be taken at least 1 hr before or 2 hr after these antacids.

If Azithromycin is taken with certain other drugs, the effects could be increased, decreased, or altered. Such drugs are Nelfinavir, Warfarin, Digoxin, Ergot-containing drugs such as Cafergot and D.H.E. Cyclosporine, Hexobarbital, Phenytoin.





Store in a cool, dry place, away from light. Keep out of the reach of children. Prepare the suspension at least 15 minutes before first administration. After reconstitution the suspension contains Microcapsules. Do not chew the microcapsules. The suspension is formulated ensuring proper dose and desired therapeutic efficacy. Store un-reconstituted product at room temperature. After reconstitution, the suspension may be stored at room temperature. Do not freeze. Keep bottles tightly closed and shake well before every use. The 15 ml suspension can be used for 5 days, 25 ml and 35 ml suspension for 10 days without significant loss of potency. Discard any unused portion after this period. 




Availability


Thromax® 250 mg tablet : Box containing 2 strips of 3 film coated tablets each. 

Thromax® 500 mg tablet : Box containing 4 strips of 3 film coated tablets each.          

Thromax® 15 ml suspension : Bottle containing  powder for the preparation of 15 ml suspension.

Thromax® 25 ml suspension : Bottle containing  powder for the preparation of 25 ml suspension.

Thromax® 35 ml suspension : Bottle containing  powder for the preparation of 35 ml suspension.