Odaz 500mg

Tablet
Azithromycin
Unimed Unihealth MFG. Ltd

Other Strength:
- Odazyth 500mg

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



Odaz
Presentation
Odaz-500 tablet: Yellow, oblong shaped, one side scored, film coated tablet; each tablet contains Azithromycin Dihydrate USP equivalent to Azithromycin 500 mg.

Odaz suspension: White, mixed fruits (strawberry and banana) flavoured suspension; after reconstitution each 5 ml suspension contains Azithromycin Dihydrate USP equivalent to Azithromycin 200 mg.

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

Dosage Recommendations
Odaz (azithromycin) should be given as a single daily dose. In common with many other antibiotics Odaz (azithromycin) tablet should be taken at least 1 hour before or 2 hours after food.

Adults: For the treatment of sexually transmitted diseases caused by Chlamydia trachomatis, the dose is 1 g (two Odaz-500 tablets) given as a single dose. For all other indications, the dose is 1.5 g (three Odaz-500 tablets), which should be given 500 mg (one Odaz-500 tablet) daily for 3 days.

In elderly: The same dose range as in adult patients may be used in the elderly.

In children: Odaz (azithromycin) suspension should be used for children under 45 kg. There is no ,information on children under 6 months of age. The dose in children is 10 mg/kg as a single daily dose for 3 days.

Up to 15 kg: 10 mg/kg as single daily dose for 3 days.
(< 3 years)
15-25 kg: 200 mg (5 ml Odaz suspension) once daily
(3-7 years) for 3 days.
26-35 kg: 300 mg (7.5 ml Odaz suspension) once daily
(8-11 years) for 3 days.
36-45 kg: 400 mg (10 ml Odaz suspension) once daily
(12-14 years) for 3 days.
Over 45 kg: Dose as per adults.

Contra-indications, warnings, etc.
Contra-indications: Azithromycin is contra-indicated in patients with a known hypersensitivity to azithromycin or any of the macrolide antibiotics. Because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be co-administered.

Warning and precautions: As with erythromycin and other macrolides, rare serious allergic reactions, including angioneurotic oedema and anaphylaxis, has been reported. Some of these reactions with azithromycin have resulted in recurrent symptoms and required a long period of observation and treatment.

Use in pregnancy and lactation: Azithromycin should be used during pregnancy only if adequate alternatives are not available. No data on secretion of azithromycin in breast milk are available, so azithromycin should only be used in lactating women where adequate alternatives are not available.

Use in renal impairment: No dose adjustment is needed in patients with mild renal impairment (creatinine clearance >40 ml/min), but there are no data regarding azithromycin in patients with more severe renal impairment, thus caution should be exercised in using azithromycin in these patients.

Use in hepatic impairment: As the liver is the principal route of excretion of azithromycin, it should not be used in patients with hepatic disease.

Effects on ability to drive and use machines: There is no evidence to suggest that azithromycin may have an effect on a patient’s ability to drive or operate machinery.

Drug interactions: Antacid: In patients receiving azithromycin and antacids, azithromycin should be taken at least 1 hour before or 2 hours after the antacid. Carbamazepine: In a pharmacokinetic interaction study in healthy volunteers, no significant effect was observed on the plasma levels of carbamazepine or its active metabolite. Cyclosporin: Some of the related macrolide antibiotics interfere with the metabolism of cyclosporin. In the absence of conclusive data from pharmacokinetic studies or clinical data investigating potential interactions between azithromycin and cyclosporine, caution should be exercised before co-administration of these two drugs. If coadministrations is necessary, cyclosporin levels should be monitored and the dose adjusted accordingly. Digoxin: Some of the macrolide antibiotics have been reported to impair the metabolism of digoxin (in the gut) in some patients. Therefore, in patients receiving concomitant azithromycin and digoxin the possibility of raised digoxin levels should be borne in mind and digoxin levels monitored. Ergot derivatives: Because of the theoretical possibility of ergotism, azithromycin and ergot derivatives should not be co-administered. Methylprednisolone: In a pharmacokinetic interaction study in healthy volunteers, azithromycin had no significant effect on the pharmacokinetics of methylprednisolone. Theophylline: There is no evidence of any pharmacokinetic interaction when azithromycin and theophylline are co-administered to healthy volunteers. In general, however, theophylline levels should be monitored. Warfarin: In a pharmacodynamic interaction study, azithromycin did not alter the anticoagulant effect of a single 15 mg dose of warfarin administered to healthy volunteers. Azithromycin and warfarin may be co-administered, but monitoring of the prothrombin time should be continued as routinely performed. Terfenadine: Azithromycin did not affect the pharmacokinetics of terfenadine administered at the recommended dose of 60 mg every 12 hours. Addition of azithromycin did not result in any significant changes in cardiac repolarisation (QTc interval) measured during the steady state dosing of terfenadine.

Side-effects: Azithromycin is well tolerated with a low incidence of side-effects. Most side-effects observed were mild to moderate in severity. The majority of side-effects were gastrointestinal in origin with nauseas, abdominal discomfort (pain/cramps), vomiting, flatulence, diarrhoea and loose stools being occasionally observed. Allergic reactions such as rash or photosensitivity have occurred and there have also been rare reports of serious hypersensitivity reactions. Reversible elevations in liver transaminases have been seen with a frequency similar to the comparative macrolides and penicillins used in clinical trials. Rarely, cases of cholestatic jaundice have been observed. Transient mild reductions in neutrofil counts have occasionally been observed in clinical trials, although a causal relationship to azithromycin has not been established. Hearing impairment: In investigational studies where higher doses were used for prolonged periods of time, reversible hearing impairment was seen in some patients.

Overdose: There are no data on over dosage 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.

Pharmaceutical precautions
Store in a cool and dry place, protected from light.

Packaging quantities
Odaz-500 tablet: Cartons of 6 tablets in alu alu blister.
Odaz suspension: Cartons containing powder to produce 15 or 30 ml suspension when reconstituted in bottle.

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