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Amzith 500mg

Tablet
Azithromycin
Amulet Pharmaceuticals

Other Strength:

Alternative:
- Azithrocin 500mg
- Zimax 500mg
- Rozith 500mg
- Zibac 500mg
- Odazyth 500mg
- Azithromax 500mg
- Verizith 500mg
- Odaz 500mg
- Alzith 500mg
- Zinex 500mg
- AZ 500mg
- Azithro 500mg
- Benzith 500mg



Amzith
DESCRIPTION:
AMZITH is an azalide antibiotic, subclass of the macrolide class of antibiotics. AMZITH acts by binding to the 50s ribosomal subunit of susceptible organisms and thus interferes with microbial protein synthesis. AMZITH 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 influenzae and parainfluenzae, Moraxella catarrhalis, anaerobes including Bacteroides fragilis, Escherichia coli, Bordetella pertussis, Bordetella parapertussis, Borrelia burgdorferi, Haemophilus ducreyi, Neisseria gonorrhoeae and Chlamydia trachomatis. AMZITH also demonstrates activity in vitro against Legionella pneumophila, Mycoplasma pneumoniae and hominis, Campylobacter sp., Toxoplasma gondii and Treponema pallidum.

Following oral administration, Azithromycin is widely distributed through out the body; bioavailability is approximately 37%. The time taken to reach peak plasma levels is 2-3 hours. Plasma terminal elimination half life closely reflects the tissue depletion half life of 2 to 4 days. Kinetic studies have shown markedly higher Azithromycin levels in tissue then in plasma ( upto 50 time the maximum observe concentration in plasma) indicating that the drug is highly tissue bound. Concentrations in target tissues such as lung, tonsil and prostate exceed the MIC 90 for likely pathogens after a single dose of 500 mg.

COMPOSITION:
AMZITH 250 Capsule: Each capsules contains Azithromycin USP 250 mg as Azithromycin Dihydrate USP.

INDICATION:
AMZITH 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, AMZITH is indicated in the treatment of non-gonococcal urethritis and cervicitis due to Chlamydia trachomatis.

DOSAGE & ADMINISTRATION:
AMZITH is common with many other antibiotics should be taken at least 1 hour before or 2 hours after food.
Adult: For sexually transmitted disease caused by Chlamydia tracomatis, the dose is 1g as a single dose. For all other indications, the total dose is 1.5 g, which should be given as 500 mg daily for 3 days, alternatively, initially, 500 mg as a single dose followed by a 250 mg single daily dose for the next 4 days. Elderly: Normal adult dose is recommended.
Children > 6 months: The dose is 10 mg/Kg body weight as a single dose for 3 days;
for body weight 15-25 Kg, 200 mg or 5 ml/day for 3 days:
for body weight 26-35 Kg, 300 mg or 7.5 ml/day for 3 days;
for body weight 36-46 Kg, 400 mg or 10 ml/day for 3 days.
Children < 6 months: Not recommended.

CONTRAINDICATION & PRECAUTION:
Azithromycin is contraindicated in patients hypersensitive to Azithromycin or any other macrolide antibiotic. Co-administration of ergot derivatives and Azithromycin is contraindicated.

SIDE EFFECT:
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 and are reversible upon discontinuation of therapy.

DRUG INTERACTION:
Azithromycin absorption is reduced in presence of food and antacid. In patients receiving ergot alkaloids, Azithromycin should be avoided concurrently because of the possibility of ergotism resulting from interaction of Azithromycin with the cytochrome P450 system. However, no cases of such interaction have been reported. Macrolides have been known to increase the plasma concentration of Digoxin and Cyclosporin. There have been no pharmacokinetic drug interactions between Azithromycin and Warfarin, Theophylline, Carbamazepine, Methylprednisolone and Cimetidine.

USE IN PREGNANCY AND 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 or not. Exercise caution when administering to a nursing woman.

STORAGE CONDITION:
AMZITH 250 tablet and dry powder suspension should be stored at below 30º C.

HOW SUPPLIED:
AMZITH 500 tablet: Box containing 2 x 6’s film coated tablets in Alu-Alu blister pack.
AMZITH 250 capsule: Box containing 1 x 6’s capsules in Alu-Alu blister pack.
AMZITH Dry Powder for Suspension: Dry powder for reconstituting 15 ml/30 ml suspension in an amber glass bottle with a measuring cup and a spoon.

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