Azrolid Powder for oral suspension 30 ml

Azrolid Powder for oral suspension 30 ml

Composition:

Each 5 ml of prepared suspension contains:
Azithromycin dihydrate — 209.6 mg (equivalent to 200 mg azithromycin).
Excipients: sucrose, trisodium phosphate, hydroxypropyl methylcellulose, strawberry flavor, banana flavor.

Product Description:

• Azrolid is a macrolide antibiotic of the azalide group with a broad spectrum of antimicrobial activity.
• Its mechanism of action is based on inhibition of bacterial protein synthesis by binding to the 50S ribosomal subunit, blocking peptide translocation. 
• At therapeutic doses it acts bacteriostatically, while at higher concentrations it has bactericidal effects. 
• Active against gram‑positive, gram‑negative, anaerobic, intracellular, and other microorganisms.

Indications for Use:

• Infectious and inflammatory diseases caused by azithromycin‑sensitive microorganisms:
• Upper respiratory tract and ENT infections (tonsillitis, sinusitis, pharyngitis, otitis media).
• Lower respiratory tract infections (acute bronchitis, exacerbation of chronic bronchitis, pneumonia including atypical pathogens).
• Skin and soft tissue infections (moderate acne vulgaris, erysipelas, impetigo, secondary infected dermatoses).
• Uncomplicated urogenital infections caused by Chlamydia trachomatis (urethritis, cervicitis).
• Early stage of Lyme disease (migratory erythema).

Method of Administration and Dosage:

• Dosage regimen determined by physician.
• Children: administered as suspension.
• Children >15 kg: 10 mg/kg once daily.
• Children 15–25 kg: 5 ml once daily.
• Children 26–35 kg: 7.5 ml once daily.
• Children 36–45 kg: 10 ml once daily.
• Average treatment course: 3 days.

Contraindications:

• Hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides.
• Hypersensitivity to excipients.
• Severe hepatic impairment.
• Severe renal impairment.
• Concomitant use with ergotamine or dihydroergotamine.

Precautions:

Use with caution in mild to moderate hepatic impairment due to risk of fulminant hepatitis and severe liver failure.
Discontinue therapy if symptoms of liver dysfunction occur (rapid asthenia, jaundice, dark urine, bleeding tendency, hepatic encephalopathy).

Adverse Reactions / Side Effects:

• Allergic reactions: angioedema, hypersensitivity, rare anaphylaxis.
• Nervous system: headache, dizziness, taste disturbance, paresthesia, somnolence, insomnia, nervousness.
• Gastrointestinal: diarrhea (very common), nausea, vomiting, abdominal pain.

Pregnancy and Lactation:

Use only if prescribed by a physician, weighing benefits against risks.

Storage Conditions:

Store in a dry, cool place at temperatures not exceeding 30 °C.
After reconstitution, keep refrigerated.
Shelf life after reconstitution: 14 days.

Packaging:

Carton box containing a 30 ml plastic bottle and paper leaflet.