Zithrokan 200 mg/5 ml Powder for oral suspension 15 ml

Zithrokan 200mg/5 ml Powder for oral suspension 15 ml

Composition:
Each 5 ml of reconstituted suspension contains:
Azithromycin dihydrate 209.624 mg (equivalent to 200 mg azithromycin).
Excipients:
Sucrose, aspartame, mannitol, sodium phosphate tribasic, Avicel RC-591, colloidal silicon dioxide, menthol, cocktail flavor, benzyl alcohol (0.135 mg / 5 ml).
Description:
A broad-spectrum macrolide antibiotic.
Before reconstitution: creamy, homogeneous granulated powder.
After reconstitution: white to off-white oral suspension.
Indicated for infections of the respiratory tract, ENT organs, skin and soft tissues, and uncomplicated genital infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae.
Indications:
- Bronchitis
- Community-acquired pneumonia
- Sinusitis
- Pharyngitis/tonsillitis
- Otitis media
- Skin and soft tissue infections
- Uncomplicated genital infections (C. trachomatis, N. gonorrhoeae).
Dosage and Administration:
- Once-daily administration. 
May be taken with or without food.
Adults and children > 45 kg:
- 500 mg once daily for 3 days (total 1500 mg)
- Chlamydial infection: 1000 mg single dose
- Gonorrhea: 1000-2000 mg + ceftriaxone (as per guidelines).
Children < 45 kg:
- 10 mg/kg once daily for 3 days
- 15-25 kg: 5 ml (200 mg) once daily for 3 days.
- Children under 6 months:
not recommended.
Renal impairment:
- GFR 10-80 ml/min: no adjustment
- GFR < 10 ml/min: caution.
Route of administration:
Oral.
Reconstitute before use.
Contraindications:
- Hypersensitivity to azithromycin, erythromycin, macrolides or ketolides
- Previous cholestatic jaundice or hepatic dysfunction with azithromycin
- Severe hepatic impairment
- Concomitant ergot derivatives.
Precautions:
- Severe hypersensitivity reactions (anaphylaxis, angioedema, DRESS, AGEP)
- Hepatotoxicity including fulminant hepatitis
- QT prolongation, arrhythmias
- Clostridium difficile-associated diarrhoea
- Hypertrophic pyloric stenosis in neonates
- Risk of exacerbation in myasthenia gravis
- Diabetes: 5 ml contains 3156.3 mg sucrose
- Aspartame: source of phenylalanine
- Benzyl alcohol toxicity risk in neonates and young children.
Side Effects:
Very common: Diarrhoea, abdominal pain, nausea, flatulence.
Common: Vomiting, dyspepsia, headache, dizziness, taste disturbance, somnolence, rash, pruritus, fatigue, laboratory changes.
Uncommon: Candidiasis, tinnitus, palpitations, hepatitis, anxiety, oedema, chest pain.
Rare: AGEP, DRESS, hepatic dysfunction.
Not known: Anaphylaxis, C. difficile colitis, seizures, arrhythmias (including torsades de pointes), hepatic failure, TEN, erythema multiforme, acute renal failure.
Pregnancy and Lactation:
Use only if benefit outweighs risk.
May be excreted in breast milk.
Storage Conditions:
Store unreconstituted powder below 30 °C in a dry place.
Reconstituted suspension stable for 10 days below 30 °C.
Keep out of reach of children.
Packaging:
Carton box containing bottle with 15 g powder (for 15 ml suspension), two ampoules with 4 ml water each, plastic measuring spoon, Instruction leaflet.