AMOXIMED BABY [Amoxicillin + Clavulanic acid] 125 + 31,25 mg Powder for suspension
AMOXIMED
instructions for medical use of the medicinal product
Tradename
Amoximed, Amoximed
grouping name
Amoxicillin + Clavulanic acid, Amoxicillin + C lavulanic acid
Composition
Each film-coated tablet contains:
active substances: amoxicillin (as amoxicillin trihydrate) USP
875 mg
clavulanic acid (as potassium clavulanate) USP 125 mg
excipients: microcrystalline cellulose, sodium carboxymethylcellulose, magnesium stearate, silicon dioxide.
Dosage form
Tablets.
Pharmacotherapeutic group
Antibiotic, semi-synthetic penicillin + beta-lactamase inhibitor .
Pharmacological properties
Amoximed - a combined preparation of amoxicillin and clavulanic acid, a beta-lactamase inhibitor. It acts bactericidal, inhibits the synthesis of the bacterial wall.
Pharmacodynamics
Amoxicillin is active against aerobic gram-positive bacteria (including beta-lactamase producing strains): Staphylococcus aureus; aerobic gram-negative bacteria : Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis. The following pathogens are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; as well as aerobic gram-negative bacteria (including beta-lactamase producing strains): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida ( formerly Pasteurella), Campylobacter jejuni; anaerobic gram-negative bacteria (including beta-lactamase producing strains): Bacteroides spp., including Bacteroides fragilis.
Clavulanic acid inhibits II, III, IV and V types of beta-lactamases, is not active against type I beta-lactamases produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. It has a high tropism for penicillinases, due to which it forms a stable complex with the enzyme, which prevents the enzymatic degradation of amoxicillin under the influence of beta-lactamases.
Pharmacokinetics
After oral administration, both components are rapidly absorbed in the gastrointestinal tract. Simultaneous food intake does not affect absorption. T Cmax - 45 min. After oral administration at a dose of 250/125 mg every 8 hours C max amoxicillin - 2.18-4.5 mcg / ml, clavulanic acid - 0.8-2.2 mcg / ml, at a dose of 500/125 mg every 12 hours C max amoxicillin - 5.09-7.91 mcg / ml, clavulanic acid - 1.19-2.41 μg / ml, at a dose of 500/125 mg every 8 hours max amoxicillin - 8.82-14.38 mcg / ml, clavulanic acid - 1.21-3.19 mcg / ml.
The time to reach the maximum inhibitory concentration of 1 μg / ml for amoxicillin is similar when applied after 12 hours and 8 hours in both adults and children.
Plasma protein binding: amoxicillin - 17-20%, clavulanic acid - 22-30%.
Both components are metabolized in the liver: amoxicillin - 10% of the administered dose, clavulanic acid - 50% of the administered dose.
T 1/2 after taking a dose of 375 and 625 mg - 1 and 1.3 hours for amoxicillin, 1.2 and 0.8 hours for clavulanic acid, respectively. It is excreted mainly by the kidneys (glomerular filtration and tubular secretion): 50-78 and 25-40% of the administered dose of amoxicillin and clavulanic acid are excreted, respectively, unchanged during the first 6 hours after administration.
Indications for use
Treatment of infectious and inflammatory diseases caused by susceptible pathogens:
- infections of the lower respiratory tract (bronchitis, pneumonia, pleural empyema, lung abscess);
- infections of ENT organs (sinusitis, tonsillitis, otitis media);
- infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postpartum sepsis, pelvic peritonitis, soft chancre, gonorrhea);
- infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection); osteomyelitis;
- postoperative infections, prevention of infections in surgery.
Contraindications
- hypersensitivity to amoxicillin and other penicillins, clavulanic acid, to other beta-lactam antibiotics (cephalosporins, carbapenems, monobactams);
- cholestatic jaundice and / or other abnormal liver function caused by the use of amoxicillin / clavulanic acid in history;
- severe renal dysfunction (CC <30 ml / min) (for a dosage form intended for use in children from 3 months to 12 years old);
- children's age up to 3 months.
Dosage and administration
inside. Tablets should be swallowed whole, without chewing, with a sufficient amount of liquid, before meals .
The dosage regimen is set individually depending on the severity of the course and localization of the infection, the sensitivity of the pathogen.
Adults and children over 12 years of age (or >40 kg body weight)
The usual dose in case of mild to moderate infection is 1 tablet 250+125 mg every 8 hours or 1 tablet 500+125 mg every 12 hours, in case of severe infection and respiratory infections - 1 tablet 500+125 mg every 8 hours or 1 tablet 875+125 mg every 12 hours.
Children under 12
The recommended dosage regimen is 20-40 mg / kg / day in 2-3 doses.
For children aged ≤6 years, it is more preferable to take the drug in the form of a suspension.
The course of treatment is 5-14 days. The duration of the course of treatment is determined by the attending physician. Treatment should not continue for more than 14 days without a second medical examination.
In patients with impaired renal and hepatic function, the drug should be taken with caution. It is necessary to conduct regular monitoring of kidney and liver function.
Special instructions and precautions
When using high doses, it is necessary to maintain adequate fluid intake and diuresis.
This combination is not recommended for suspected infectious mononucleosis.
Use with caution in patients with impaired liver and kidney function.
During the course of treatment, it is necessary to monitor the state of the function of the hematopoietic organs, liver and kidneys.
Perhaps the development of superinfection due to the growth of microflora insensitive to it, which requires a corresponding change in antibiotic therapy.
In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.
Use during pregnancy and during breastfeeding
Caution should be used during pregnancy and during breastfeeding.
Interaction with other drugs
If you are taking any other medicines, be sure to inform your doctor, and if you are self-treating, consult your doctor about the possibility of using the drug.
Antacids, glucosamine, laxative drugs, aminoglycosides slow down and reduce absorption. Ascorbic acid increases absorption.
Bacteriostatic antibiotics (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect.
When combined with rifampicin , a mutual weakening of the antibacterial effect is observed.
Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). While taking anticoagulants, it is necessary to monitor the indicators of blood clotting.
Reduces the effectiveness of oral contraceptives .
Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).
Combined use with methotrexate increases the toxicity of methotrexate.
Allopurinol increases the risk of skin rashes.
Simultaneous use with probenecid is not recommended, it reduces the tubular secretion of amoxicillin. When used together, it is possible to increase and prolong the blood concentration of amoxicillin, but not clavulanic acid.
Side effect
On the part of the digestive system: nausea, vomiting, diarrhea, gastritis, stomatitis, glossitis, increased activity of hepatic transaminases, in isolated cases - cholestatic jaundice, hepatitis, liver failure, pseudomembranous and hemorrhagic colitis (may also develop after therapy), enterocolitis.
On the part of the hematopoietic organs: a reversible increase in prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolytic anemia.
From the nervous system: dizziness, headache, hyperactivity, anxiety, behavioral changes, convulsions.
From the urinary system: interstitial nephritis, crystalluria, hematuria.
Allergic reactions: urticaria, erythematous rashes, erythema multiforme exudative, anaphylactic shock, angioedema, exfoliative dermatitis, malignant exudative erythema (Stevens-Johnson syndrome), allergic vasculitis.
Others: candidiasis, development of superinfection.
Overdose
Symptoms: nausea, vomiting, diarrhea, symptoms of water and electrolyte imbalance.
Treatment: symptomatic treatment. Amoxicillin can be removed by hemodialysis.
Storage conditions
Store in a dry place at temperatures below 30 0 C. Keep out of the reach of children.
Best before date
3 years. Do not use after the expiry date stated on the package.
Holiday conditions
Released by prescription.
Release form
10 tablets in an aluminum foil blister. 1 blister with instructions for use in a cardboard box.