Expiration date: 10/2025

Composition and form of issue:

Powder for preparation of suspension for oral administration 5 ml of finished suspension

amoxicillin trihydrate (based on amoxicillin) 125 mg

potassium clavulanate (in terms of clavulanic acid) 31, 25 mg

excipients: lactulose (200 mg) aspartame silicon dioxide colloidal (Aerosil), xanthan gum crospovidone (kollidon CL-M) citric acid monohydrate sodium citrate dihydrate sodium benzoate talc mannitol (mannitol) orange flavor 

in dark glass bottles with a volume of 125 ml with 25 g complete with double sided dosing spoon in the paper cartons 1 a bottle.

Powder for preparation of suspension for oral administration 5 ml of finished suspension

amoxicillin trihydrate (based on amoxicillin) 250 mg

potassium clavulanate (in terms of clavulanic acid) 62, 5 mg

excipients: lactulose (400 mg) aspartame silicon dioxide colloidal (Aerosil), xanthan gum crospovidone (kollidon CL-M) citric acid monohydrate sodium citrate dihydrate sodium benzoate talc mannitol (mannitol) orange flavor 

in dark glass bottles with a volume of 125 ml with 25 g complete with double sided dosing spoon in the paper cartons 1 a bottle.

Method of application and doses:

Inside. Dosing regimen is set individually depending on the patient's body weight, the severity of the course and the localization of the infectious process, as well as the sensitivity of the pathogen.

Minimum course of antibacterial therapy for 5 days. Treatment should not last longer than 14 days without review of the clinical situation. The duration of treatment of uncomplicated acute otitis media is 5 to 7 days, children up to 2 years for 7-10 days.

A single dose is set depending on the age and body weight (calculation of amoxicillin):

• children up to 3 months-30 mg / kg / day in 2 admission
  
• children from 3 months and older:
  
• to treat infections of the skin and soft tissues, as well as chronic tonsillitis: low doses-20 mg / kg / day in 3 admission
  
• for the treatment of otitis media, sinusitis, lower respiratory tract infections, urinary tract infections: high doses-40 mg/kg / day in 3 admission.
  

Children weighing 40 kg or more should be prescribed doses as adults.

The suspension can be used in adults with difficulty swallowing.

Recommended dosage regimen for adults: 20 ml of suspension at 125+31, 25 mg/5 ml or 10 ml of suspension at 250+62, 5 mg/5 ml 2-3 times a day.

The maximum daily dose of amoxicillin for adults and children over 12 years — 6 g, for children under 12 years — 45 mg/kg body weight.

The maximum daily dose of clavulanic acid for adults and children over 12 years-600 mg, for children under 12 years-10 mg / kg. 

Patients with impaired renal function.Dose correction is based on the maximum recommended dose of amoxicillin and creatinine clearance.

Children

Creatinine Cl >30 ml / min-dose correction is not required

Cl creatinine 10-30 ml/min-15 mg/ 3, 75 mg / kg 2 times a day, the maximum dose-500 + 125 mg (20 ml of suspension 125 + 31, 25 mg / 5 ml or 10 ml of suspension 250+62, 5 mg/ 5 ml) 2 times a day

Creatinine Cl creatinine less than 10 ml / min-15 mg/ 3, 75 mg/ kg 1 time per day, maximum daily dose-500 + 125 mg (20 ml suspension 125+ 31, 25 mg / 5 ml or 10 ml suspension 250 + 62, 5 mg / 5 ml)

Adult

Creatinine Cl >30 ml / min-dose correction is not required

Cl creatinine 10-30 ml — min-500 + 125 mg (20 ml of suspension 125+31, 25 mg/5 ml or 10 ml of suspension 250 mg+62, 5 mg/5 ml) 2 times a day

Creatinine Cl <10 ml / min-500 mg + 125 mg (20 ml of suspension 125+31, 25 mg/5 ml or 10 ml of suspension 250 mg+62, 5 mg/5 ml) 1 time per day

For patients on hemodialysis, dose adjustment is based on the maximum recommended dose of amoxicillin.

Children-15 mg/3, 75 mg / kg 1 time per day.

Before a session of hemodialysis should receive one additional dose of 15 mg/3, 75 mg/kg. To restore the concentrations of the active components of the drug in the blood of the second additional dose of 15 mg/3, 75 mg/kg should be taken after hemodialysis.

Adults — 500+125 mg (20 ml of suspension 125+31, 25 mg/5 ml or 10 ml of suspension 250+62, 5 mg/5 ml) once every 24 hours.

Additionally, 1 dose during the dialysis session and another dose at the end of the dialysis session (to compensate for the decrease in serum concentrations of amoxicillin and clavulanic acid).

Method of preparation of the suspension

The suspension is prepared immediately before use.

The powder in the bottle is pre-shaken, then, adding a small amount of boiled and cooled to room temperature water, stirred to obtain a homogeneous suspension, then add water to the mark on the bottle. For accurate dosing of the suspension should be used dosing double-sided spoon, which should be well rinsed with water after each application. After dilution, the suspension should be stored for no more than 7 days in the refrigerator, but do not freeze.

Storage conditions:

The finished suspension is stored at 2-8 ° C, in a tightly closed bottle.