Zithromax Powder for Oral Suspension 900mg/22,5 ml

Zithromax Powder for Oral Suspension 900mg/22,5 ml

Ingredients:
Zithromax Powder for Oral Suspension is a dry blend of azithromycin dihydrate 209.60 mg per 5 ml, containing the equivalent of 200 mg azithromycin base, on reconstitution with water.
Excipients with known effect:
Also contains 3.87 g sucrose per 5 ml.
Pharmaceutical form.
Powder for Oral Suspension.
A dry powder which reconstituted with water to give a cherry/banana flavored suspension with a slight vanilla odor.
Description:
Zithromax 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 means of binding to the ribosomal 50S sub-unit and inhibition of peptide translocation.
Indications:
Azithromycin is indicated for the treatment of the following infections when known or likely to be due to one or more susceptible microorganisms:
- bronchitis
- community-acquired pneumonia
- sinusitis
- pharyngitis/tonsillitis
- otitis media
- skin and soft tissue infections
- uncomplicated genital infections due to Chlamydia trachomatis and Neisseria gonorrhoeae.
Considerations should be given to official guidance regarding the appropriate use of antibacterial agent
Dosage and Administration:
Method of administration:
Zithromax Suspension is for oral administration only.
10 mg/kg as a single dose on Day 1 followed by 5 mg/kg once daily on.
Days 2 through 5.
12 mg/kg once daily for 5 days.
Azithromycin for oral suspension can be taken with or without food.
Zithromax should be given as a single daily dose.
Zithromax Suspension can be taken with or without food.
Children over 45 kg body weight and adults, including elderly patients:
The total dose of azithromycin is 1500 mg which should be given over three days (500 mg once daily).
In uncomplicated genital infections due to Chlamydia trachomatis, the dose is 1000 mg as a single oral dose.
For susceptible Neisseria gonorrhoeae the recommended dose is 1000 mg or 2000 mg of azithromycin in combination with 250 mg or 500 mg ceftriaxone according to local clinical treatment guidelines.
For patients who are allergic to penicillin and/or cephalosporins, prescribers should consult local treatment guidelines.
Paediatric population:
In children under 45 kg body weight:
Zithromax Suspension should be used for children under 45 kg.
There is no information on children less than 6 months of age.
The dose in children is 10 mg/kg as a single daily dose for 3 days:
Up to 15 kg (less than 3 years):
Measure the dose as closely as possible using the 10 ml oral dosing syringe provided.
The syringe is graduated in 0.25 ml divisions, providing 10 mg of azithromycin in every graduation.
For children weighing more than 15 kg, Zithromax Suspension should be administered using the spoon provided according to the following guidance:
15-25 kg (3-7 years): 5 ml (200 mg) given as 1 x 5 ml spoonful, once daily for 3 days.
26-35 kg (8-11 years): 7.5 ml (300 mg) given as 1 x 7.5 ml spoonful, once daily for 3 days.
36-45 kg (12-14 years): 10 ml (400 mg) given as 1 x 10 ml spoonful, once daily for 3 days.
Over 45 kg: Dose as per adults.
The specially supplied measure should be used to administer Zithromax suspension to children.
Contraindications:
Hepatic impairment:
Since azithromycin is metabolised in the liver and excreted in the bile, the drug should not be given to patients suffering from severe liver disease.
No studies have been conducted regarding treatment of such patients with azithromycin.
Zithromax is contra-indicated in patients with a known hypersensitivity to azithromycin, erythromycin, any macrolide or ketolide antibiotic, or to any of the excipients.
Pregnancy:
Animal reproduction studies have been performed at doses up to moderately maternally toxic dose concentrations.
In these studies, no evidence of harm to the foetus due to azithromycin was found.
There are, however, no adequate and well-controlled studies in pregnant women.
Therefore, azithromycin should only be used during pregnancy if clinically needed and the benefit of treatment is expected to outweigh any small increased risks which may exist.
Breast-feeding
Limited information available from published literature indicates that azithromycin is present in human milk at an estimated highest median daily dose of 0.1 to 0.7 mg/kg/day.
No serious adverse effects of azithromycin on the breast-fed infants were observed.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from azithromycin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Side Effects:
Uncommon:
Candidiasis, oral candidiasis, vaginal infection
Leukopenia, neutropenia
Thrombocytopenia, haemolytic anaemia
Angioedema, hypersensitivity
Nervousness
Agitation
Hypoaesethesia, somnolence, insomnia
Palpitations
Hearing impaired, tinnitus
Gastritis, constipation
Common:
Dizziness, headache, paraesthesia, dysgeusia
Pruritus and rash
Anorexia
Psychiatric Disorders
Visual impairment
Ear and Labyrinth Disorders
Deafness
Vomiting, dyspepsia
Very common:
Diarrhoea, abdominal pain, nausea, flatulence.
Instructions for the syringe:
- Filling the syringe with medicine.
Shake the bottle before use and remove the child-proof cap.
An adaptor for the syringe should have been fitted into the neck of the bottle of medicine by the pharmacist.
If this has not been done, take off the adaptor from the syringe and fit to the neck of the bottle as shown.
The adaptor is so that you can fill the syringe with medicine from the bottle.
Check the dispensing label attached by your pharmacist to see how much medicine needs to be taken.
While the bottle is sitting on a firm, flat surface, hold it steady with one hand.
With the other hand insert the tip of the syringe into the adaptor.
Turn the bottle upside down while holding the syringe in place.
Slowly pull back the plunger of the syringe so that the top edge  is level with the graduation mark corresponding to the quantity in the millilitres (ml) prescribed by your doctor.
If large bubbles can be seen in the syringe, slowly push the plunger back into the syringe.
This will force the medicine back into the bottle.
Repeat step 6 again.
Hold the syringe and bottle firmly.
Turn the bottle upright, with the syringe still in place.
Remove syringe from bottle.
Storage:
After reconstitution, the suspension should be stored below 30°C and any remaining suspension discarded after 10 days.
Package:
A Carton box contains plastic bottle with 22,5 ml powder for suspension.