Azimac susp 200mg/5ml 15ml 37.5ml in vial #1

Azimac Powder for Oral Suspension 200 mg/5 ml, 37.5 ml Bottle

Composition:

Each 5 ml of the prepared suspension contains: 200 mg azithromycin dihydrate.
Each 1 ml of the prepared suspension contains 40 mg azithromycin dihydrate.
Excipients: Each 5 ml of the prepared suspension contains sucrose 3.87 g, aspartame (E951) 0.0125 g; also xanthan gum (E415), hydroxypropyl cellulose, anhydrous sodium phosphate, anhydrous colloidal silica (E551), lemon flavor, vanilla flavor, titanium dioxide (E171).

Indications:

Azithromycin is used for the treatment of infections caused by susceptible microorganisms, including:

• Bronchitis

• Community-acquired pneumonia

• Sinusitis

• Pharyngitis / tonsillitis

• Otitis media

• Skin and soft tissue infections

• Genital infections caused by Chlamydia trachomatis and Neisseria gonorrhoeae in uncomplicated stages

Special attention should be paid to official guidelines for the appropriate use of antibacterial agents.

Dosage and Administration:

Children weighing over 45 kg, adults, and elderly:
The total dose of azithromycin treatment is 1500 mg, administered over 3 days (500 mg once daily).
For uncomplicated genital infections caused by Chlamydia trachomatis, a single oral dose of 1000 mg is recommended.
For infections caused by Neisseria gonorrhoeae, 1000 or 2000 mg of azithromycin is prescribed in combination with 250 or 500 mg of ceftriaxone, according to local treatment guidelines.
In cases of allergy to penicillins or cephalosporins, treatment follows local recommendations.

Children weighing less than 45 kg:
Azithromycin suspension can be prescribed for children under 45 kg. There is no data for treatment in children under 6 months of age.
The single dose for children is 10 mg/kg, taken once daily for 3 days.

• Children under 15 kg (<3 years): Dosing should be precise, using the provided 5 ml dosing syringe, graduated in 0.1 ml increments (each increment corresponds to 4 mg azithromycin).

• Children over 15 kg: Precise dosing with the dosing syringe according to the following scheme:

• 15-25 kg (3-7 years): 5 ml (200 mg) once daily for 3 days

• 26-35 kg (8-11 years): 7.5 ml (300 mg) once daily for 3 days

• 36-45 kg (12-14 years): 10 ml (400 mg) once daily for 3 days

Children over 45 kg receive adult doses.

Patients with renal impairment:

No dose adjustment is required for mild to moderate renal impairment (GFR 10-80 ml/min).
In severe renal impairment (GFR < 10 ml/min), caution is advised (see section 4.4 for special warnings and precautions).

Patients with hepatic impairment:
Azithromycin is metabolized in the liver and excreted in bile; therefore, it is contraindicated in patients with severe liver disease. Clinical studies in such patients have not been conducted.

Administration:

Azimac is administered once daily.
It may be taken with or without food.
Azimac is for oral use only.

Preparation Instructions:

To prepare the suspension:

• Shake the dry powder.

• Add 16.5 ml of water to the bottle contents to make 37.5 ml of suspension (1500 mg azithromycin).

• Shake well until a white, homogeneous suspension is formed.

Storage:

• Store at temperatures not exceeding 25°C.

• Keep in the original packaging.

• After preparation, the suspension should be used within 5 days when stored at room temperature.