Amoxiclav suspension for children: instructions for use
- Amoxiclav suspension for children: instructions for use
ATX Code: J01CR02.
Form release: powder for suspension for oral administration.
Dosage form: powder yellowish white or pure white color, homogeneous suspension from white to yellow.
Clinico-pharmacological group: A broad-spectrum antibacterial drug of the penicillin group with beta-lactamase inhibitor.
Pharmacotherapeutic group: Amoxicillin in combination with enzyme inhibitors.
Packaging: dark glass bottle (100 ml), dosing spoon-pipette, cardboard pack.
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, flavoring (wild cherry, strawberry, lemon), mannitol.
The suspension preparation powder is a beta-lactam antibiotic that inhibits 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-lactamase.
Clavulanic acid, which is a beta-lactam associated with penicillins, is able to inhibit some beta-lactamases, expanding the spectrum of activity and preventing inactivation of the drug.
Amoksikalv has antibacterial activity to the following microorganisms:
Gram-positive anaerobes ( Staphylococcus aureus , pneumococcus, pyogenic streptococcus, other species of the genus Staphylococcus and Streptococcus, clostridia, peptococcus);
Gram-negative anaerobes (Kolya bacterium, bacteria of the genus enterobacter, Klebsiella, Moraxella catarallis, Bordetella, Salmonella, Shigella, Vibrio cholerae).
Due to the fact that some strains of the bacteria listed above produce beta-lactamase, this makes them insensitive to Amoxicillin monotherapy.
Both active ingredients are well absorbed, regardless of the meal. The maximum plasma concentration is reached 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 secretions, secretions of the nasal sinuses, saliva, and also in the body tissues (in the lungs, palatine tonsils, middle ear, ovaries, uterus, liver, prostate gland, muscle tissue, gall bladder ). The drug is not able to penetrate the blood-brain barrier (with noninflammatory cerebral membranes). Penetrates through the placental barrier, in trace concentrations excreted along with breast milk. It binds poorly to plasma proteins, amoxicillin trihydrate partially decomposes, clavulanic acid completely.
The drug is excreted by the kidneys almost unchanged. Small amounts are excreted by the lungs and through the intestines. Half-life is 1-1.5 hours.
Amoxicillin is excreted by the kidneys practically unchanged by tubular secretion and glomerular filtration. Small amounts can be excreted through the intestines and lungs. T1 / 2 of amoxicillin and clavulanic acid is 1-1.5 hours. In severe renal insufficiency, it increases to 7.5 hours for amoxicillin, and 4.5 hours for clavulanic acid. Both components are removed during hemodialysis.
Indications for use
- Upper respiratory tract infections;
- ENT-organ infections (acute and chronic sinusitis, pharyngitis , tonsillitis , otitis media, pharyngeal abscess);
- Lower respiratory tract infections (acute and chronic bronchitis , pneumonia);
- Urogenital pathology;
- Infection of the skin and soft tissues (including animal and human bites);
- Infectious inflammation of bone and connective tissue;
- Odontogenic infections;
- Biliary tract infections.
Dosage of Amoxiclav suspension for children and adults
Daily dosage of 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 doses);
Children older than 3 months - from 20 mg / kg per day (with mild disease) to 40 mg / kg (with a severe form of infection) every 8 hours.
For adults, the maximum daily dose of amoxicillin is 6 g / kg 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, boiled water at room temperature is added to the powder vial, after which the preparation is thoroughly shaken. Ready suspension is stored in the refrigerator no more than two weeks. Before use, the product should be allowed to warm to room temperature.
From the digestive tract - loss of appetite, diarrhea, nausea, vomiting. Very rarely, abdominal pain, increased liver enzymes, abnormal liver function, pseudomembranous colitis, hepatitis, cholestatic jaundice.
On the part of the hematopoietic and lymphatic systems : thrombocytopenia, reversible leukopenia (fairly rare), hemolytic anemia, eosinophilia, an increase in prothrombin time, pancytopenia (very rare).
On the part of the urinary system : crystalluria, interstitial nephritis (very rarely);
From the side of the central nervous system : headache, dizziness, insomnia, increased anxiety, hyperactivity, with renal impairment, convulsions are possible.
On the part of the skin : itching, erythematous rash, in rare cases - exudative erythema, angioedema, allergic vasculitis , anaphylactic shock, generalized exanthematic pustus, Steven-Jones syndrome.
Other : candidiasis.
With simultaneous use of Amoxiclav with glucosamines, aminoglycosides, laxatives and antacids, slow absorption is noted, and when taken together with ascorbic acid, metabolism increases.
Drugs that block tubular secretion, cause an increase in amoxicillin, while the use of methotrexate increases the toxicity of the latter.
It is strictly contraindicated for simultaneous use with disulfiram. Special care should be taken when using Amoxiclav and anticoagulants at the same time (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 drug;
- Liver dysfunction and / or cholestatic jaundice caused by taking the drug (in history);
- Lymphocytic leukemia;
- Infectious mononucleosis;
- Severe hepatic and renal failure;
- Pseudomembranous colitis (in history);
- Breastfeeding period.
In case of impaired renal function, the dose of the drug should be reduced and the intervals between doses should be extended. During treatment, the liver, kidneys and blood-forming organs should be constantly monitored. To reduce the risk of developing complications of the digestive tract (nausea, vomiting, diarrhea, flatulence), Amoxiclav is recommended to be taken during meals. Data on the negative effect of the drug on the ability to manage vehicles is not available.
Terms of implementation
Amoxiclav, powder for suspension, refers to prescription drugs.
Store in a dark, protected from light and moisture, out of the reach of children, at a temperature not exceeding 25 C.
The drug is usable for 3 years from the date of issue. Use of the product after the expiration date indicated on the package is prohibited.
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Powder for suspension for oral administration 125 mg + 31.25 mg / 5 ml; 25 g - from 110 rubles.
Powder for suspension for oral administration 250 mg + 62.5 mg / 5 ml; 25 g - from 270 rubles.