For the use of a Registered Medical Practitioner, a Hospital or a Laboratory only
After reconstitution each 5ml contains Azithromycin Dihydrate B.P equivalent to 200mg Azithromycin.
Azithromycin is a macrolide antibiotic belonging to the azalide group. The molecule is constructed by adding a nitrogen atom to the lactone ring of erythromycin A.
The mechanism of action of azithromycin is based upon the suppression of bacterial protein synthesis by binding to the ribosomal 50S sub-unit and inhibition of peptide translocation.
- The bioavailability of azithromycin after oral administration is approximately 37%. Peak plasma levels are achieved 2-3 hours after taking the medicinal product
- After oral administration, azithromycin is distributed throughout the entire body. Pharmacokinetic studies have shown clearly higher azithromycin levels in the tissues than in the plasma (up to 50 times the maximum observed concentration in plasma). This indicates that the substance is bound in the tissues in considerable quantities.
- The terminal plasma elimination half-life closely reflects the elimination half-life from tissues of 2-4 days.
Azithromycin is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible microorganisms:
– community-acquired pneumonia
– otitis media
– skin and soft tissue infections
– uncomplicated genital infections due to Chlamydia trachomatis
DOSAGE AND ADMINISTRATION:
- Children over 45kg body weight and adults, including elderly patients: The total dose of azithromycin is 1500mg which should be given over three days (500mg once daily).
- In children under 45kg body weight: Throza Suspension should be used for children under 45kg. There is no information on children less than 6 months of age. The dose in children is 10mg/kg as a single daily dose for 3 days:
- For 15 ml Bottles
- Tap bottle to dislodge powder. Add 10ml of freshly boiled and cooled water. Shake well until all the powder is dispersed.
- For 30 ml Bottles
- Tap the bottle to dislodge powder.
- Add 20 ml of freshly boiled and cooled water.Shake well until powder is dispersed. CONTRAINDICATIONS:
- In patients with hypersensitivity to azithromycin, erythromycin or any of the macrolide or ketolide antibiotics.
WARNING AND PRECAUTIONS:
- Prolonged cardiac repolarisation and QT interval, imparting a risk of developing cardiac arrhythmia and torsades de pointes, have been seen in treatment with other macrolides.
- Since the liver is the principal route of elimination for azithromycin, the use of azithromycin should be undertaken with caution in patients with significant hepatic disease.
- Keep all medicines out of reach of children.
PREGNANCY AND LACTATION:
- Pregnancy: There are no adequate and well controlled studies in pregnant women.
- Lactation: Azithromycin passes into breast milk. Because it is not known whether azithromycin may have adverse effects on the breast-fed infant, nursing should be discontinued during treatment with azithromycin.
- Antacids: When studying the effect of simultaneously administered antacids on the pharmacokinetics of azithromycin, no overall change has been observed in bioavailability. Azithromycin should be taken at least 1 hour before or 2 hours after the antacid.
- Digoxin: There is a possibility that the concomitant use of azithromycin with Digoxin could cause a rise in Digoxin concentrations. Digoxin levels should be monitored.
- Coumarin anticoagulants: An increased tendency towards haemorrhage has been reported in connection with the concurrent use of azithromycin and warfarin or coumarin-like oral anticoagulants. Attention should be paid to the frequency of prothrombin time monitoring.
- Ergot derivatives: Because of the theoretical possibility of ergotism, the concurrent use of azithromycin with ergot derivatives is not recommended
- Common: nausea, vomiting, diarrhoea, abdominal discomfort (pain/cramps)
- Uncommon: loose stools, flatulence, digestive disorders, anorexia
The typical symptoms of an overdose with macrolide antibiotics include reversible loss of hearing, severe nausea, vomiting and diarrhoea. In the event of overdose, the administration of medicinal charcoal and general symptomatic treatment and supportive measures are indicated.
Dry Powder Packed in 15ml and 30ml Pet and Glass Bottles.
- Do not Store Above 30OC. Store in a dry place, Protect from direct sunlight, Keep all medicines out of reach of children.
- After reconstitution the suspension should be stored below 30OC and should be discarded after 7 days.