About Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL

Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL is a broad-spectrum macrolide antibiotic formulated as an oral suspension, specifically designed for pediatric use. Each 5mL contains 200mg of azithromycin, an antibiotic that works by inhibiting bacterial protein synthesis, preventing the growth and multiplication of susceptible bacteria. Its extended tissue penetration and long half-life allow for once-daily dosing, often for just 3 to 5 days, which improves adherence in children and other patients who may struggle with longer or more frequent antibiotic courses.

This suspension is ideal for treating infections of the respiratory tract, ears, skin, and other body systems caused by bacteria. Its pleasant taste and ease of administration make it especially suitable for children who have difficulty swallowing tablets or capsules. Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL is often prescribed when first-line antibiotics are ineffective or contraindicated.

Indications of Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL

Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL is indicated for the treatment of mild to moderate infections caused by susceptible strains of bacteria, including:

• Upper respiratory tract infections: pharyngitis, tonsillitis, and sinusitis

• Lower respiratory tract infections: bronchitis and mild to moderate community-acquired pneumonia

• Acute otitis media (middle ear infection) in pediatric patients

• Skin and soft tissue infections

• Gastrointestinal infections caused by Campylobacter jejuni

• Genitourinary infections due to Chlamydia trachomatis (in appropriate pediatric cases)

Dosage of Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL

The dosage of Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL depends on the child’s weight, the type of infection, and the doctor’s instructions. Typical pediatric regimens include:

• For otitis media or pneumonia:
  10 mg/kg on Day 1, followed by 5 mg/kg once daily on Days 2–5

• For pharyngitis or tonsillitis:
  12 mg/kg once daily for 5 days

• For mild skin infections:
  Dosing and duration may vary as directed by a healthcare provider

• Maximum dose: Should not exceed 500mg/day

Shake the bottle well before each use and administer the dose using a calibrated measuring device. Complete the full course of therapy even if symptoms improve before the end of the regimen.

Side Effects of Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL

While Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL is generally well tolerated, it may cause some side effects in certain individuals.

Common side effects:

• Diarrhea

• Abdominal pain

• Nausea or vomiting

• Headache

Less common or serious side effects:

• Allergic reactions (rash, itching, facial swelling, difficulty breathing)

• Liver dysfunction or elevated liver enzymes

• Heart rhythm disturbances (QT interval prolongation)

• Reversible hearing loss with high doses or prolonged use

• Secondary infections, such as oral thrush or yeast infections

Contact a healthcare professional immediately if severe reactions occur.

Contraindications of Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL

Use of Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL is contraindicated in the following cases:

• Known hypersensitivity to azithromycin, erythromycin, other macrolide antibiotics, or any excipient in the formulation

• History of cholestatic jaundice or hepatic dysfunction associated with prior azithromycin use

• Severe liver impairment, where azithromycin metabolism may be compromised

• Patients with a known history of QT prolongation, cardiac arrhythmias, or those taking medications that can prolong the QT interval (e.g., certain antiarrhythmics or antipsychotics)

• Concurrent use with ergotamine derivatives, due to the risk of ergot toxicity

Azithromycin should not be used to treat viral infections or when bacterial resistance is suspected.

Precautions for Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL

Before starting treatment with Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL, consult a doctor if the patient:

• Has liver or kidney disease

• Has a history of heart conditions or is on QT-prolonging drugs

• Has experienced antibiotic-associated colitis in the past

• Is immunocompromised

• Is taking antacids, which may interfere with drug absorption (should be spaced a few hours apart)

Avoid unnecessary or excessive use of antibiotics to help prevent bacterial resistance.

Storage of Azithromycin (ROZITAN) 200mg/5mL Suspension 15mL

• Store the dry powder at room temperature (below 25°C), away from moisture and sunlight

• Once reconstituted with water, refrigerate the suspension at 2–8°C

• Use the suspension within 5 days after preparation and discard any unused portion

• Keep tightly closed and out of reach of children

• Do not freeze the suspension