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AZITHROMYCIN 200

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COMPOSITION:
Azithromycin (as azithromycin dihydrate) ... 200 mg
Excipients q.s  ......................................... 1 sachet
(Kyron T112B, orange-flavored powder, aerosil, sorbitol P60W).
DOSAGE FORM: Powder for oral suspension
PRESENTATION: Box of 24 sachets x 1.5 g
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: Azithromycin and other macrolides should be used with caution because allergic reactions including angioneurotic oedema and anaphylaxis (although rare) have been reported and are very dangerous. As with any antibiotic preparations, observation for signs of superinfection with non-susceptible organisms, including fungi is recommended.
Dose adjustment should be necessary in patients with renal impairment with creatinine clearances > 40 ml/ min.
Do not indicate to hepatic impairment patients because the drug is eliminated via the liver.
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: As with erythromycin, azithromycin is well tolerated; and the rate of adverse effects is low (approximately 13% of patients). The most frequent adverse effects of azithromycin involve the gastrointestinal tract (10%). While these adverse effects generally are mild and moderate in severity and occur less frequently than with oral erythromycin. It can be seen a temporary change of number of neutrophils or a temporary increase in liver enzymes; skin rash, headache and dizziness sometimes occur.
Otic effects: Reversible hearing loss has been reported in some patients receiving long-term high-dose azithromycin therapy.
Common: nausea, vomiting, colic, diarrhea.
Uncommon: fatigue, headache, drowsiness, dizziness. Rash, pruritis. Vaginitis, cervicitis.
Rare: Anaphylactoid reaction. Angioedema. Elevated transaminases. Transient decrease in neutrophils.
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:
The drug content should be dissolved in a sufficient amount of water (about 5-10 ml of water for a sachet), stirred well before use.
Azithromycin is administered as 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 given on the first day of therapy, followed by 250 mg daily on the next 4 days.
- Sexually transmitted diseases: a dose of 1 g.
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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