Amoxiclav suspension for children: instruction manual
- Amoxiclav suspension for children: instruction manual
ATX code: J01CR02.
Form: powder for suspension for oral administration.
Dosage form: yellowish white or pure white powder, homogeneous suspension from white to yellow.
Clinico-pharmacological group: Antibacterial preparation of a broad spectrum of action of a group of penicillins with an inhibitor of beta-lactamases.
Pharmacotherapeutic group: amoxicillin in combination with enzyme inhibitors.
Packing: a bottle of dark glass (100 ml), a dosage spoon-pipette, a cardboard bundle.
Active ingredient: amoxicillin trihydrate, potassium salt of clavulanic acid.
Excipients: sodium citrate, citric acid, xanthan gum, sodium benzoate, colloidal silicon dioxide, sodium carmellose, sodium saccharinate, flavor (wild cherry, strawberry, lemon), mannitol.
Powder for the preparation of the suspension is a beta-lactam antibiotic that inhibits the penicillin-binding proteins of the integral structural component of the bacterial cell wall (peptidoglycan). Under the influence of this drug, the cell membrane loses its strength, which subsequently leads to lysis and death of microorganisms. The spectrum of Amoxicillin activity does not apply to resistant bacteria that produce beta-lactamases.
Clavulanic acid, which is a beta-lactam bound to penicillins, is able to inhibit certain beta-lactamases, expanding the spectrum of activity and preventing inactivation of the drug.
Amoxical has antibacterial activity against the following microorganisms:
Gram-positive anaerobes ( Staphylococcus aureus , pneumococcus, pyogenic streptococcus, other species of the genus Staphylococcus and streptococcus, Clostridia, Peptococci);
Gram-negative anaerobes (coli bacteria, bacteria of the genus enterobacter, klebsiella, moraxella cataris, bordetella, salmonella, shigella, cholera vibrio).
Due to the fact that some strains of the above bacteria produce beta-lactamase, this makes them insensitive to monotherapy with Amoxicillin.
Both active ingredients are well absorbed, regardless of food intake. The maximum concentration in the plasma is achieved one hour after taking the drug (Cmax for amoxicillin - 3-12 μg / ml, Cmax for clavulanic acid - 2 μg / ml.
Amoxiclav components are well distributed in pleural, parietal, synovial fluids, bronchial secretion, secretion of nasal sinuses, saliva, and also in the body tissues (in the lungs, palatine tonsils, middle ear, ovaries, uterus, liver, prostate, muscle tissue, gall bladder ). The drug is not able to penetrate the blood-brain barrier (with non-inflamed meninges). Penetrates through the placental barrier, in trace concentrations is excreted together with breast milk. Poorly binds to plasma proteins, amoxicillin trihydrate decomposes in part, clavulanic acid - completely.
The drug is excreted by the kidneys almost unchanged. Small amounts are excreted by the lungs and through the intestines. The half-life is 1-1.5 hours.
Amoxicillin is excreted by the kidneys practically unchanged through tubular secretion and glomerular filtration. Small amounts can be excreted through the intestines and lungs. T1 / 2 amoxicillin and clavulanic acid is 1-1.5 hours. In severe renal failure, it increases for amoxicillin up to 7.5 hours, for clavulanic acid - up to 4.5 hours. Both components are removed during hemodialysis.
Indications for use
- Upper respiratory tract infections;
- Infections of ENT organs (acute and chronic sinusitis, pharyngitis , tonsillitis , otitis, zaglugal abscess);
- Infections of the lower respiratory tract (acute and chronic bronchitis , pneumonia);
- Urogenital pathologies;
- Infection of the skin and soft tissues (including bites of animals and humans);
- Infectious inflammation of bone and connective tissue;
- Odontogenic infections;
- Infections of the biliary tract.
Dosage of Amoxiclav suspension for children and adults
Daily dosage of the suspension:
125 mg + 31.25 / 5 ml
250 mg + 62.5 mg. 5 ml.
Newborns and children under the age of 3 months - 30 mg / kg body weight per day, every 12 hours (divided into 2 admission);
Children older than 3 months - from 20 mg / kg per day (with mild disease) to 40 mg / kg (with severe form of the infection process) every 8 hours.
For adults, the maximum daily dose of amoxicillin is 6 g / kg of body weight, for children - 10 mg / kg. Clavulanic acid - 600 mg for adults, 10 mg / kg body weight - for children.
The duration of treatment with amoxiclav is determined individually by the attending physician. On average, it is 5-14 days.
To prepare the suspension, the boiled water of room temperature is added to the bottle with powder, after which the preparation is shaken thoroughly. The finished suspension is stored in the refrigerator for no more than two weeks. Before use, the product should be allowed to warm up to room temperature.
From the digestive tract - loss of appetite, diarrhea, nausea, vomiting. Very rarely pain in the abdomen, increased activity of hepatic enzymes, impaired liver function, pseudomembranous colitis, hepatitis, cholestatic jaundice.
From the hematopoietic and lymphatic system : thrombocytopenia, reversible leukopenia (rarely), hemolytic anemia, eosinophilia, increased prothrombin time, pancytopenia (very rarely).
From the side of the urinary system : crystalluria, interstitial nephritis (very rarely);
From the side of the central nervous system : headache, dizziness, insomnia, increased anxiety, hyperactivity, with violations of kidney function, cramps are possible.
On the part of the skin : itching, erythematous eruptions, in rare cases - exudative erythema, angioedema, allergic vasculitis , anaphylactic shock, generalized exanthematous pustulosis, Stephen-Jones syndrome.
Other : Candidiasis.
With the simultaneous use of Amoxiclav with glucosamines, aminoglycosides, laxatives and antacids, slow absorption is observed, when taken together with ascorbic acid, the metabolism rises.
Drugs that block tubular secretion, cause amokitsillina increase, while using methotrexate increases the toxicity of the latter.
Categorically contraindicated simultaneous use with disulfiramom. Special care should be taken with the simultaneous use of Amoxiclav and anticoagulants (this may cause prolongation of prothrombin time.
Interaction with probenecid increases the serum concentration of the antibiotic and reduces its excretion from the body. Amoxiclav, like other antibacterial drugs, reduces the effectiveness of oral contraceptives.
- Hypersensitivity to the components of the drug;
- Violations of the function of the liver and / or cholestatic jaundice caused by the taking of the drug (in the anamnesis);
- Lymphocytic leukemia;
- Infectious mononucleosis;
- Severe hepatic and renal insufficiency;
- Pseudomembranous colitis (in the anamnesis);
- Breastfeeding period.
If the renal function is impaired, the dose of the drug should be reduced and the intervals between doses should be increased. During the treatment, the liver, kidneys and hematopoiesis should be constantly monitored. To reduce the risk of complications from the digestive tract (nausea, vomiting, diarrhea, flatulence) Amoxiclav recommended during meals. Data on the negative effect of the drug on the ability to drive vehicles is not available.
Terms of implementation
Amoxiclav, a powder for the preparation of a suspension, refers to prescription drugs.
Store in a dark place, protected from light and moisture, out of reach of children, at a temperature not exceeding 25 ° C.
The drug is suitable for use within 3 years from the date of manufacture. Do not use the product beyond the expiry date printed on the package.
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Prices for Amoxiclav
Powder for the preparation of suspension for ingestion 125 mg + 31.25 mg / 5 ml; 25 grams - from 110 rubles.
Powder for suspension for oral administration 250 mg + 62.5 mg / 5 ml; 25 g - from 270 rubles.