AZITHROMYCIN 250

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COMPOSITION:
Azithromycin (as azithromycin dihydrate) ... 250 mg
Excipients q.s  .......................................... 1 tablet
(Dicalcium phosphate, HPMC K4M, pregelatinized starch, croscarmellose sodium,
magnesium stearate, sodium lauryl sulfate, HPMC 606, HPMC 615, PEG 6000, titanium dioxide, talc).
DOSAGE FORM: Film coated tablet.
PRESENTATION: Box of 1 blister x 6 film coated tablets.  Box of 10 blisters x 6 film coated tablets.
PHARMACODYNAMICS: Azithromycin is an azalide, belonging to the macrolide broad-spectrum antibiotics. Bactericidal activity of azithromycin is stronger by binding to the ribosomes of harmful bacteria and inhibiting protein synthesis.
Azithromycin is active against the following organisms:
Gram-positive bacteria: Streptococcus, Pneumococcus, Staphylococcus aureus, Corynebacterium diphtheriae, Clostridium perfringens, Peptostreptococcus and Propionibacterium acnes.
Gram-negative bacteria: Haemophilus influenzae, parainfluenzae and ducreyi, Moraxella catarrhalis, Acinetobacter, Yersinia, Legionella pneumophilia, Bordetella pertussis and parapertussis; Neisseria gonorrhoeae and Campylobacter sp.. Besides, azithromycin is also active against Listeria monocytogenes, Mycobacterium avium, Mycoplasma pneumoniae and hominis, Ureaplasma urealyticum, Toxoplasma gondii, Chlamydia trachomatis and Chlamydia pneumoniae, Treponema pallidum and Borrelia burgdorferi.
PHARMACOKINETICS: Following oral administration, azithromycin is widely distributed throughout the body. Its bioavailability is about 40%. Approximately 50% of absorption is reduced by food. Peak plasma concentrations are achieved 2 to 3 hours after oral administration. Azithromycin is mainly distributed to tissues, such as lungs, tonsil, prostate, granulocytes, macrophages. A small amount of azithromycin is demethylated in the liver, and it is excreted in bile as unchanged drug and metabolites. About 6% of an oral dose is excreted in urine as unchanged drug within 72 hrs.
INDICATIONS: Azithromycin is indicated in treatment of infections caused by susceptible bacteria e.g lower respiratory tract infections, including bronchitis, pneumonia; skin and soft tissue infections; otitis media; upper respiratory tract infections, including sinusitis, pharyngitis, tonsillitis.
Azithromycin is used to treat uncomplicated genital infections due to Chlamydia trachomatis or non-multiresistant Neisseria gonorrhoeae.
CONTRAINDICATIONS: Hypersensitivity to azithromycin or any macrolide antibiotics.
PRECAUTIONS: Hepatic impairment, renal impairment.
PREGNANCY AND LACTATION: There are no adequate data from the use of azithromycin in pregnant women and azithromycin excretion into human breast milk. The drug should only be given to the subjects if there is no proper medicament.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES: Cautions should be taken during driving and operating machinery.
INTERACTIONS: Due to the possibility of ergotism, concurrent use of azithromycin with ergot derivatives is not recommended.
Azithromycin should be taken at least 1 hour before or 2 hours after the antacids.
If co-administration of azithromycin and cyclosporin is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly.
If azithromycin and digoxin are administered concomitantly, the possibility of elevated serum concentrations of the digoxin should be considered.
ADVERSE EFFECTS: Gastrointestinal disturbances: vomiting, diarrhea, colic, nausea.
Whole body: fatigue, headache, dizziness, somnolence.
Skin: rash, pruritus.
Inform your physician about any adverse effects occur during the treatment.
OVERDOSAGE:
Overdosage symptoms: No documents have been reported about overdosage events of azithromycin. The typical overdosage symptoms of macrolide antibiotics usually are reduced hearing ability, nausea, vomiting and diarrhea. Treatment: Gastric lavage and supportive treatment.
DOSAGE & ADMINISTRATION: Azithromycin is administered a single dose daily, 1 hour prior to or 2 hours after a meal.
Adults:
- Upper and lower respiratory tract infections, skin and soft tissue infections: 500 mg (2 tablets) given as a single dose on the first day of therapy, followed 250 mg (1 tablet) daily on the next 4 days.
- Sexually transmitted diseases: single dose of 1 g (4 tablets).
Children:
- First day: 10 mg/kg body-weight/ day.
- From days 2 -5: 5 mg/kg body-weight/day.
Or as directed by the physician.
Read the directions carefully before use.           Shelf-life: 36 months from the manufacturing date.
Consult the physician for more information.           Storage conditions: Store in dry places, not exceeding 30oC, protect from light.
This drug is for prescriptions only.           Specifications: Manufacturer's.

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