Amoxiclav 0.25 + 0.125 N15 pills
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Active ingredients
Amoxicillin + Clavulanic Acid
Release form
Pills
Composition
1 tablet contains: Amoxicillin (in the form of trihydrate) 250 mg Clavulanic acid (in the form of potassium salt) 125 mg Auxiliary substances: colloidal silicon dioxide - 5.4 mg, crospovidone - 27.4 mg, croscarmellose sodium - 27.4 mg, magnesium stearate - 12 mg, talc - 13.4 mg, microcrystalline cellulose - up to 650 mg. The composition of the film coating: hypromellose - 14.378 mg, ethylcellulose - 0.702 mg, polysorbate 80 - 0.78 mg, triethyl citrate - 0.793 mg, titanium dioxide - 7.605 mg, talc - 1.742 mg.
Pharmacological effect
Broad-spectrum antibiotic; contains semi-synthetic penicillin amoxicillin and β-lactamase inhibitor clavulanic acid. Clavulanic acid provides a stable inactivated complex with these enzymes and ensures the resistance of amoxicillin to the effects of β-lactamases produced by microorganisms. Clavulanic acid, similar in structure to beta-lactam antibiotics, has a weak intrinsic antibacterial activity. Amoxiclav has a broad spectrum of antibacterial action. It is active against amoxicillin-sensitive strains, including strains producing β-lactamase, including Aerobic gram-positive bacteria:. Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Enterococcus spp, Staphylococcus aureus (methicillin-apart resistant strains), Staphylococcus epidermidis (methicillin-apart resistant strains), Staphylococcus saprophyticus, Listeria spp .; aerobic managment; spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica, Eikenella corrodens; Gram-positive anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp., Gram-negative anaerobes: Bacteroides spp.
Pharmacokinetics
AbsorptionAfter taking the drug inside both components are well absorbed from the gastrointestinal tract, food intake does not affect the degree of absorption. Cmax in blood plasma is reached after 1 h after taking the drug and is (depending on the dose) for amoxicillin 3-12 μg / ml, for clavulanic acid - about 2 μg / ml. Distribution of both components are characterized by a good volume of distribution in body fluids and tissues ( lungs, middle ear, pleural and peritoneal fluids, uterus, ovaries). Amoxicillin also penetrates into the synovial fluid, liver, prostate gland, palatine tonsils, muscle tissue, gallbladder, the secret of the paranasal sinuses, saliva, bronchial secretions. Amoxicillin and clavulanic acid do not penetrate through the BBB with non-inflammatory brain membranes. and in trace concentrations are excreted in breast milk.The degree of binding to plasma proteins is low. Metabolism Amoxicillin is partially metabolized, clavulanic acid undergoes, apparently, an intensive metabolism. Excretion of Amoxicillin is excreted by the kidneys almost unchanged by tubular secretion and glomerular filtration. Clavulanic acid is excreted by glomerular filtration, partly in the form of metabolites. Small amounts can be excreted through the intestines and lungs. T1 / 2 amoxicillin and clavulanic acid is 1-1.5 hours. Pharmacokinetics in special clinical situations. In severe renal failure, T1 / 2 increases to 7.5 hours for amoxicillin and 4.5 hours for clavulanic acid. Both components are removed by hemodialysis and minor amounts of peritoneal dialysis.
Indications
Treatment of infectious and inflammatory diseases caused by microorganisms sensitive to the drug: - infections of the upper respiratory tract and upper respiratory tract (including acute and chronic sinusitis, acute and chronic otitis media, pharyngeal abscess, tonsillitis, pharyngitis) - lower infections parts of the respiratory tract (including acute bronchitis with bacterial superinfection, chronic bronchitis, pneumonia); urinary tract infections; gynecological infections; infections of the skin and soft tissues, including human and animal bites; ostnoy and connective tissue - biliary tract infection (cholecystitis, cholangitis) - odontogenic infection.
Contraindications
- an indication of a history of cholestatic jaundice or abnormal liver function caused by taking amoxicillin / clavulanic acid; - infectious mononucleosis; - lymphatic leukemia; to amoxicillin or clavulanic acid.
Precautionary measures
With caution, the drug is prescribed to patients with a pseudomembranous colitis in history, with liver failure, severe renal impairment, as well as during lactation.
Use during pregnancy and lactation
Amoxiclav can be used during pregnancy if the expected benefit to the mother outweighs the potential risk to the fetus. Amoxicillin and clavulanic acid in small quantities are excreted in breast milk.
Dosage and administration
Adults and children over 12 years old (or with a body weight of more than 40 kg) with a mild or moderate course of infection are prescribed 1 tab. (250 mg + 125 mg) every 8 hours or 1 tab. (500 mg + 125 mg) every 12 hours, in case of severe infection and respiratory infections - 1 tab. (500 mg + 125 mg) every 8 hours or 1 tab. (875 mg + 125 mg) every 12 hours. The drug in tablet form is not prescribed to children under 12 years old (with a body weight less than 40 kg). The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults, 10 mg / kg body weight. The maximum daily dose of amoxicillin is 6 g for adults and 45 mg / kg of body weight for children. The treatment course is 5-14 days. The duration of treatment is determined by the attending physician. Treatment should not continue for more than 14 days without re-medical examination. In case of odontogenic infections, 1 tab. (250 mg + 125 mg) every 8 hours or 1 tab. (500 mg + 125 mg) every 12 hours for 5 days. In case of moderate renal failure (CC 10-30 ml / min), 1 tab. (500 mg + 125 mg) every 12 hours, with severe renal failure (CC less than 10 ml / min) - 1 tab. (500 mg + 125 mg) every 24 hours. With anuria, the interval between doses should be increased to 48 hours or more.
Side effects
On the part of the digestive system: possible loss of appetite, nausea, vomiting, diarrhea; rarely - abdominal pain, transient increase in liver enzymes (ALT, AST), abnormal liver function; in rare cases - cholestatic jaundice, hepatitis, pseudomembranous colitis. Allergic reactions: erythematous rash, pruritus, urticaria; rarely - erythema multiforme exudative, angioedema, anaphylactic shock, allergic vasculitis; in rare cases, exfoliative dermatitis, Stevens-Johnson syndrome, acute generalized exantmatous pustus very rarely - hemolytic anemia, reversible increase in prothrombin time (when used together with anticoagulants), eosinophilia, pancytopenia. On the nervous system: dizziness, headache; very rarely - convulsions (may 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. . h.candidiasis). The side effects in most cases are mild and transient.
Overdose
There are no reports of death or life-threatening side effects due to overdose of the drug. Symptoms: abdominal pain, diarrhea, vomiting; it is also possible anxiety, insomnia, dizziness; in some cases - convulsions. Treatment: in the case of a recent administration of the drug (less than 4 hours), it is necessary to carry out a gastric lavage and to appoint activated charcoal to reduce the absorption of the drug; the patient should be under medical supervision, if necessary, conduct symptomatic therapy. Effective hemodialysis.
Interaction with other drugs
With simultaneous use of Amoxiclav with antacids, glucosamine, laxatives, aminoglycosides, absorption slows down, and with ascorbic acid it increases. ). With the simultaneous use of Amoxiclav and anticoagulants, an increase in prothrombin time is noted. Therefore, this combination is prescribed with caution. When used simultaneously, Amoxiclav enhances the toxicity of methotrexate. If Amoxiclav is used simultaneously with allopurinol, the risk of developing exanthema is increased. use simultaneously with bacteriostatic antibiotics (macrolides, tetracyclines), sulfanilam ides due to a possible decrease in the effectiveness of Amoksiklava. Probenecid reduces the excretion of amoxicillin, increasing its serum concentration. With simultaneous use, Amoxiclav reduces the effectiveness of oral contraceptives.
special instructions
Due to the fact that a large number of patients with infectious mononucleosis and lymphocytic leukemia who received ampicillin, have observed the appearance of an erythematous rash,use of antibiotics of the ampicillin group for these patients is not recommended. In the course of treatment, blood formation, liver and kidney functions should be monitored. In patients with severely impaired renal function, an adequate correction of the dosing regimen or an increase in the intervals between dosing is required. the drug should be taken with meals. Since the pills of amoxicillin and clavulanic acid combination, 250 mg each + 125 mg and 500 mg + 125 mg, contain the same amount of Aulanic Acid - 125 mg, then 2 pills of 250 mg + 125 mg are not equivalent to 1 tablet of 500 mg + 125 mg. When using Amoksiklav, a false positive reaction is possible when determining the level of glucose in the urine using Benedict reagent or Felling solution (recommend using enzymatic reactions with glucosidase). Impact on the ability to drive vehicles and control mechanisms There are no data on the negative impact of Amoksiklav at the recommended doses on the ability to drive vehicles and control mechanisms.