AZIMUL-200 – Azithromycin 200 mg/5 mL Oral Suspension

AZIMUL-200 by Amcare Pharmaceuticals is a prescription macrolide antibacterial oral suspension containing Azithromycin 200 mg per 5 mL. The product shown is specifically labelled “For Paediatric Use Only” and is supplied in a 30 mL pack.

Azithromycin oral suspension 200 mg/5 mL is an established pediatric dosage form used for selected bacterial infections caused by susceptible organisms.

Composition of AZIMUL-200

Each 5 mL contains:

• Azithromycin Dihydrate I.P.
• Equivalent to Azithromycin Anhydrous – 200 mg
• Excipients – q.s.
• Flavoured Base – q.s.
• Colour: Ponceau 4R

AZIMUL-200 Product Details

AZIMUL-200 Uses

Azithromycin oral suspension is used for selected bacterial infections caused by susceptible organisms. Pediatric labelled indications include acute otitis media and community-acquired pneumonia in appropriate age groups.

Acute Otitis Media

Azithromycin oral suspension may be prescribed for acute bacterial middle-ear infections caused by susceptible organisms in eligible pediatric patients.

Community-Acquired Pneumonia

Azithromycin may be used for community-acquired pneumonia in pediatric patients of eligible age when the causative organism is susceptible and oral therapy is appropriate.

Selected Bacterial Respiratory Infections

Azithromycin has activity against susceptible respiratory pathogens and may be prescribed for selected bacterial respiratory infections according to the applicable indication and patient’s age.

Other Approved Uses

Depending on the patient population and applicable prescribing information, azithromycin has additional indications in adults, including certain bacterial sinusitis, bronchitis exacerbations, skin infections and specific genital infections. These should not be interpreted as pediatric indications for AZIMUL-200 simply because the same active ingredient is used.

Benefits of AZIMUL-200

• Contains Azithromycin 200 mg per 5 mL.
• Pediatric oral suspension formulation.
• Suitable for oral administration.
• 200 mg/5 mL is an established azithromycin suspension strength.
• Flavoured-base formulation for pediatric administration.
• Provides macrolide antibacterial activity against susceptible organisms.

How Does AZIMUL-200 Work?

Azithromycin 200 mg

Azithromycin belongs to the macrolide class of antibacterials. It works primarily by inhibiting bacterial protein synthesis, thereby interfering with the growth of susceptible bacteria.

Its use should be limited to infections that are proven or strongly suspected to be bacterial to help reduce antimicrobial resistance.

AZIMUL-200 Dosage & Administration

AZIMUL-200 should be given to children only according to the dose prescribed by a qualified healthcare professional.

Pediatric dosing is generally determined according to factors such as:

• Child’s body weight
• Age
• Type and severity of infection
• Clinical indication
• Medical history
• Other medicines being used

The exact dose and duration should therefore be determined by the prescribing doctor rather than by the product strength alone.

How to Take AZIMUL-200

• Measure the prescribed quantity using an appropriate measuring device.
• Shake the suspension well before each dose.
• Give the medicine exactly as prescribed.
• Do not change the dose or treatment duration without medical advice.
• Do not use leftover antibiotic suspension for another illness.

If the product is supplied as a powder requiring reconstitution, follow the specific reconstitution and storage instructions on the approved product label.

AZIMUL-200 Side Effects

Possible adverse effects associated with azithromycin include:

• Diarrhea
• Nausea
• Abdominal pain
• Vomiting
• Headache

More serious reactions can include severe allergic or skin reactions, liver injury and abnormal heart rhythms.

Important Pediatric Warning

Azithromycin use in neonates up to 42 days of life has been associated with reports of infantile hypertrophic pyloric stenosis (IHPS). Parents/caregivers should contact a healthcare professional if a young infant develops vomiting or feeding-related irritability.

AZIMUL-200 Precautions & Warnings

• Do not use in patients with known hypersensitivity to azithromycin, erythromycin, other macrolides or ketolides.
• It is contraindicated in patients with a history of cholestatic jaundice or hepatic dysfunction associated with previous azithromycin use.
• Serious allergic and skin reactions have been reported.
• Severe, potentially life-threatening liver injury has been reported.
• Azithromycin can prolong the QT interval and has been associated with torsades de pointes; caution is required in patients with relevant cardiac risk factors or medicines that prolong QT.
• Antibiotic-associated Clostridioides difficile diarrhea can occur.
• Azithromycin may worsen muscle weakness in patients with myasthenia gravis.
• Unnecessary use of antibiotics can contribute to antimicrobial resistance.

AZIMUL-200 Drug Interactions

Inform the doctor about all medicines and supplements being taken before AZIMUL-200 is prescribed.

Particular attention may be required when the child is receiving medicines that can affect cardiac rhythm/QT interval or otherwise interact with azithromycin.

The healthcare professional should review the child’s complete medication history before treatment.

AZIMUL-200 Storage

Store AZIMUL-200 according to the storage conditions specified on the approved product packaging.

• Keep the bottle properly closed.
• Protect from excessive heat and moisture.
• Keep out of reach of children.
• Follow the product label for storage after opening or reconstitution, where applicable.
• Do not use after the expiry date.

Why Choose AZIMUL-200 by Amcare Pharmaceuticals?

AZIMUL-200 provides Azithromycin 200 mg/5 mL in a pediatric oral-suspension dosage form.