Amoxicillin, clavulanic acid | Amoxiclav powder d.prep. Suspen 250 mg + 62.5 mg / 5ml 100 ml

Release form

Powder for suspension for oral administration

Packing

Bottle 100 ml.

Pharmacological action

Amoxiclav - a broad-spectrum antibiotic contains semisynthetic penicillin amoxicillin and a b-lactamase inhibitor clavulanic acid. Clavulanic acid inhibits most clinically significant b-lactamases (types 2, 3, 4 and 5 according to the classification of Richmond Sykes) produced by Staphylococcus spp., Escherichia coli, Proteus mirabilis, Haemophilus influenzae, Moraxella catarrhalis, Bacteroides spp. Inactive against type 1 b-lactamases produced by Enterobacter spp., Morganella morganii, Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.

This combination provides a high bactericidal activity of Amoxiclav (including in relation to strains of microorganisms, amoxicillin resistant). Clavulanic acid, having a higher affinity for b-lactamase than amoxicillin, forms a stable deactivated complex with the enzyme, preventing the enzymatic degradation of amoxicillin under the action of b-lactamases.

Thus, Amoxiclav acts bactericidal on a wide range of gram-positive and gram-negative bacteria (including strains that have become resistant to beta-lactam antibiotics due to the production of b-lactamases).

Indications

Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - infections of the upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, pharyngeal abscess, tonsillitis, pharyngitis)

- infections of the lower respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia)

- urinary tract infections

- gynecological infections

- infections of the skin and soft tissues

- infections of the bones and joints

- infections of the biliary tract (cholecystitis, cholangitis)

- odontogenic infections.

Contraindications

- cholestatic jaundice or liver dysfunction caused by the administration of amoxicillin / clavulanic acid in the history of

- hypersensitivity to amoxicillin, clavulanic acid or penicillins.

With caution, the drug should be prescribed for allergic reactions to cephalosporins and pseudomembranous colitis in the anamnesis, liver failure, severe renal impairment.

Due to the fact that in a large number of patients with infectious mononucleosis and lymphocytic leukemia who received ampicillin, the appearance of an erythematous rash was observed, the use of ampicillin antibiotics in such patients is not recommended.

Use during pregnancy and lactation

Amoxicillin and clavulanic acid pass into breast milk in small amounts.

Amoxiclav can be used during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus.

Special instructions

During the course of treatment, the function of hematopoiesis, liver and kidneys should be monitored.

Patients with severe renal impairment require adequate dosage adjustment or increased dosing intervals.

In order to reduce the risk of adverse reactions from the gastrointestinal tract, the drug should be taken with meals.

When using Amoxiclav, a false-positive reaction is possible when determining the level of glucose in the urine when using Benedict's reagent or Felling's solution (enzymatic reactions with glucose oxidase are recommended).

Composition of

5 ml of the prepared suspension contain amoxicillin (as trihydrate) 250 mg and clavulanic acid (as potassium salt) 62.5 mg

excipients: citric acid anhydrous, sodium citrate anhydrous, sodium benzoate, microcrystalline cellulose, sodium salt carboxymethyl cellulose, xanthan gum, colloidal silicon dioxide, silicon dioxide, sodium saccharin, mannitol, flavorings.

Dosage and administration

Daily dosages of suspensions of 156.25 mg / 5 ml and 312.5 mg / 5 ml (to facilitate the correct dosage of 156.25 mg / 5 ml and 312 suspensions in each package. 5 mg / 5 ml is added a dosage spoon of 5 ml).

Newborns and children up to 3 months of age are prescribed 30 mg / kg (amoxicillin) / day, divided into 2 doses (every 12 hours) for children older than 3 months with moderate infections - 20 mg (amoxicillin) / kg / day, divided into 3 doses (every 8 hours),

for severe infections and respiratory infections - 40 mg / kg (amoxicillin) / day, divided into 3 doses (every 8 hours).

Recommended suspension doses (156.25 mg / 5 ml and 312.5 mg / 5 ml) are determined depending on the body weight of the child and the severity of the infection. Multiplicity of admission - 3 times / day.

Side effects of the

Digestive system: loss of appetite, nausea, vomiting, diarrhea rarely - abdominal pain, impaired liver function, increased liver enzyme activity (ALT or AST) in isolated cases - cholestatic jaundice, hepatitis, pseudomembranous colitis.

Allergic reactions: pruritus, urticaria, erythematous rash rarely - multiforme exudative erythema, angioedema, anaphylactic shock, allergic vasculitis in isolated cases - exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis.

From the hemopoietic system and lymphatic system: rarely - reversible leukopenia (including neutropenia), thrombocytopenia very rarely - hemolytic anemia, reversible increase in prothrombin time (when combined with anticoagulants), eosinophilia, pancytopenia.

From the nervous system: dizziness, headache very rarely - cramps (can occur in patients with impaired renal function when taking the drug in high doses), hyperactivity, anxiety, insomnia.

From the urinary system: very rarely - interstitial nephritis, crystalluria.

Other: rarely - development of superinfection, candidiasis.

Drug interaction

With the simultaneous use of Amoxiclav and indirect anticoagulants, an increase in prothrombin time is noted. Therefore, this combination is prescribed with caution.

With the simultaneous use of Amoxiclav with allopurinol, the risk of developing side effects such as exanthema increases.

With the simultaneous use of Amoxiclav enhances the toxicity of methotrexate.

The combination of amoxicillin with rifampicin is antagonistic (there is a mutual weakening of the antibacterial effect).

Amoxiclav should not be used simultaneously with bacteriostatic antibiotics (macrolides, tetracyclines), sulfonamides due to a possible decrease in the effectiveness of Amoxiclav.

With the simultaneous use of Amoxiclav reduces the effectiveness of oral contraceptives.



overdose There are no reports of fatal or life-threatening side effects due to drug overdose.

Symptoms: abdominal pain, diarrhea, vomiting may also cause anxiety, insomnia, dizziness in some cases - convulsions.

Treatment: in case of recent administration of the drug (less than 4 h) it is necessary to carry out gastric lavage and appoint activated charcoal to reduce the absorption of the drug, if necessary, carry out symptomatic therapy. Hemodialysis is effective.

Storage conditions

Store in a dry, out of reach of children at a temperature not exceeding 25 РC.

After preparation, the oral suspension should be stored at 2 ° to 8 РC in a tightly closed vial and used for 7 days.

Shelf life

2 years.

Deystvuyushtee substance

amoxicillin, Klavulanovaya Chisloth

Terms and conditions

prescription

dosage form

oral suspension

Appointment Appointment



children on prescription, Children over 3 months of age