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Azithromax 500mg

Tablet
Azithromycin
Ziska Pharmaceuticals Limited

Other Strength:

Alternative:
- Azithrocin 500mg
- Zimax 500mg
- Rozith 500mg
- Zibac 500mg
- Odazyth 500mg
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- Benzith 500mg



Azithromax
Presentation
Azithromax 500 mg Tablet: Each film coated tablet contains Azithromycin USP 500 mg.
Azithromax Powder for Suspension: Each 5 ml reconstituted suspension contains Azithromycin USP 200 mg

Description
Azithromax is an azalide antibiotic, subclass of the macrolide class of antibiotics.
Azithromax acts by binding to the 50s ribosomal subunit of susceptible organisms and thus interferes with microbial protein synthesis. Azithromax demonstrated activity in vitro, against a wide range of Gram-positive and Gram-negative bacteria including: Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes (Group A) and other Streptococcal species, Haemophilus influenza and parainfluenzae, Moraxella catarrhalis, anaerobes including Bacteroides fragilis, Escherichia coli, Bordetella pertussis, Bordetella parapertussis, Borrelia burgdorferi, Haemophilus ducreyi, Neisseria
gonorrhoeae and Chlamydia trachomatis. Azithromax also demonstrates activity in vitro against Legionella pneumophila, Mycoplasma pneumoniae and hominis, Campylobacter sp., Toxoplasma gondii and Treponema pallidu

Indications
Azithromax is indicated for infections (caused by susceptible organisms) in lower respiratory tract infections including bronchitis and pneumonia, in upper respiratory tract infections including sinusitis and pharyngitis / tonsillitis, in otitis media and in skin and soft tissue infections. In sexually transmitted diseases in men and women,Azithromax is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

Dosage & Administration
Azithromax tablet and suspension should be taken at least 1 hour before or 2 hours after meal.However,Azithromax500 tablet can be taken with or without food.Adults:For lower respiratory tractinfections including bronchitis and pneumonia, upper respiratory tract infections including sinusitisand pharyngitis/tonsillitis, otitis media and skin and soft tissue infections, the total dose ofAzithromaxis 1.5 gm given as 500 mg once daily for 3 days. An alternative to this dosage scheduleis that 500 mg once daily on day 1, followed by 250 mg once daily for next 4 days. For sexuallytransmitted diseases caused by Chlamydia trachomatis, the dose ofAzithromaxis 1 gm given as asingle dose. Alternatively, 500 mg once daily on day 1, followed by 250 mg once daily for next 2 daysmay also be given. For the treatment of cholera caused by Vibrio cholerae, the dose ofAzithromaxis 1 gm as a single dose. For the treatment of uncomplicated gonorrhea (urethritis or cervicitis)caused by Neisseria gonorrhoeae, a single 2 g dose ofAzithromaxmay be given. Taking the dosewith food may minimize adverse effects. For non-gonococcal urethritis, shigella infection, traveler'sdiarrhea, the usual oral dosage is 1 gm administered as a single dose. For typhoid fever caused bysusceptible salmonella, the dose is 500 mg once daily for 7 days. Use in the elderly: Normal adultdosage is recommended.Children:The dose of Azithromaxin children over 6 months of age is 10 mg/kg body weight oncedaily for 3-5 days. Alternatively, 10 mg/kg on day 1, followed by 5 mg/kg for next 4 days is alsorecommended. Safety and effectiveness in the treatment of children under 6 months of age have notbeen established. For children the dose ofAzithromax suspension is as follows:

Body weight (age) Dose Dosage & Duration
15-25 kg (3-7 years) 200 mg 5 ml daily for 3-5 days
26-35 kg (8-11 years) 300mg 7.5 ml daily for 3-5 days
36-45 kg (12-14 years) 400 mg 10 ml daily for 3-5 days

For children having body weight over 45 kg, normal adult dosage is recommended.

Side Effects
Azithromycin is well tolerated with a low incidence of side effects. The side effects include nausea,vomiting, abdominal discomfort (pain / cramps), flatulence, diarrhoea, headache, dizziness and skin rashes are reversible upon discontinuation of therap

Precautions
Because of the theoretical possibility of ergotism, Azithromycin and ergotderivatives should not be co-administered. As liver is the principal route of excretion o f Azithromycin, itshould not be used in patients with hepatic disease. Avoid concomitant administration with terfenadine or astemizole recaution should be taken in patients with more severe renal impairment.

Contraindications
Azithromycin is contraindicated in patients with a known hypersensitivity to Azithromycin or any of the macrolide antibiotics.

Use in Pregnancy & Lactation
Recent clinical studies have recommended that Azithromycin should be considered for the initial treatment of chlamydial cervicitis in pregnancy. In other infections, Azithromycin should be used only when clearly needed. It is not known whether Azithromycin is excreted in breast milk. Exercise caution when administering to a nursing woman

Commercial Packaging
Azithromax 500 mg Tablet: Each carton contains 2×5's tablet in Alu-Alu blister pack.
Azithromax Powder for Suspension: Each carton contains a bottle containing Azithromycin dry powder for reconstituting 15 ml or 35 ml or 50 ml of suspension and a bottle containing diluent along with a measuring cup, a spoon and a dropper

Packaging
Azithromax 500 mg Tablet: Each carton contains 2×5's tablet in Alu-Alu blister pack.
Azithromax Powder for Suspension: Each carton contains a bottle containing Azithromycin dry powder for reconstituting 15 ml or 35 ml or 50 ml of suspension and a bottle containing diluent along with a measuring cup, a spoon and a dropper

Storage after reconstitution
To reconstitute Azithromax 15 ml powder for suspension, add 10 ml of supplied diluent to the content of the bottle and shake well to mixuniformly. To reconstitute Azithromax 35 ml powder for suspension, add 25 ml of supplied diluent to the content of the bottle and shake well to mix uniformly.To reconstitute Azithromax 50 ml powder for suspension, add 35 ml of supplied diluent to the content of the bottle and shake well to mix uniforml

Drug Interaction
Antacids: Peak serum levels but not the total extent of absorption are reduced by aluminium and magnesium containing antacids in the stomach. Azithromycin should therefore be taken at least 1 hour before or 2 hours after taking these antacids. Ergot Derivatives: Because of the theoretical possibility of ergotism, concomitant administration of ergot derivatives and Azithromycin should be avoided. Digoxin & Cyclosporin: Macrolides have been known to increase the plasma concentration of Digoxin & Cyclosporin. So, caution should be exercised while co-administration is necessary.

Overdose
There is no data on overdosage 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.

Storage
Store in a cool and dry place, protected from light. Any unused portion of reconstituted Azithromax suspension should be discarded after 14 days


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