Medoklav - instructions for use, reviews, analogs and forms of release (tablets 250 mg, 500 mg, 875 mg, powder for the preparation of a suspension and solution for injections) of a drug for the treatment of otitis media, bronchitis, cystitis in adults, children and pregnancy. Composition

In this article, you can read the instructions for using the drug Medoklav. There are reviews of visitors to the site - consumers of this medication, as well as opinions of medical experts on the use of the Medoblava antibiotic in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues Medoblava in the presence of existing structural analogues.Use for the treatment of otitis, bronchitis, pneumonia and cystitis in adults, children, as well as during pregnancy and lactation. Composition of the preparation.

Medoklav - a combined preparation containing Amoxicillin and clavulanic acid. Amoxicillin is a semisynthetic antibiotic from the group of aminopenicillins with a broad spectrum of bactericidal action against many Gram-positive and Gram-negative microorganisms. Clavulanic acid is a natural beta-lactam and has the ability to inactivate a number of beta-lactamases produced by microorganisms resistant to the action of most penicillins and many cephalosporins.

The combination of two active ingredients, amoxicillin and clavulanic acid, provides stability of amoxicillin to the damaging effect of beta-lactamases, and effectively expands the spectrum of antimicrobial activity of amoxicillin, including bacteria that are usually resistant to it and many other beta-lactam antibiotics.

Clavulanic acid inhibits 2, 3, 4 and 5 types of beta-lactamases, is inactive for Type I beta-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.Clavulanic acid has high affinity for penicillinases, thereby forming a stable complex with the enzyme, thus preventing the enzymatic degradation of amoxicillin under the influence of beta-lactamase.

Spectrum of antibacterial activity

Gram-positive aerobic microorganisms: Enterococcus faecalis (enterococcus), Staphylococcus aureus (Staphylococcus aureus), Staphylococcus epidermidis (except methicillin-resistant strains), Staphylococcus saprophyticus (except methicillin-resistant strains), Streptococcus pneumoniae (streptococcus), Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Enterococcus spp., Listeria spp.

Gram-positive anaerobic microorganisms: Clostridium spp. (Except Clostridium difficile), Peptococcus spp., Peptostreptococcus spp., Propionibacterium spp., Actinomyces israelii.

Gram-negative aerobic microorganisms: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Campylobacter coli, Citrobacter spp. (Moderately sensitive), Enterobacter spr., Escherichia coli (E. coli), Eikenella corrodens, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori (H. pylori), Klebsiella spp. (Klebsiella), Legionella pneumophila (Legionella), Moraxella catarrhalis, Morganella spp. (moderately sensitive), Neisseria gonorrhoeae, Neisseria meningitidis, Yersinia multocida, Proteus spp. (Proteus), Salmonella spp. (salmonella), Shigella spp. (shigella), Vibrio cholerae, Yersinia enterocolitica (moderately sensitive).

Gram-negative anaerobic microorganisms: Bacteroides spp. (including Bacteroides fragilis), Fusobacterium spp.

Composition

Amoxicillin + Clavulanic acid + excipients.

Pharmacokinetics

The pharmacokinetic parameters of amoxicillin and clavulanic acid are similar.The combined use of amoxicillin and clavulanic acid does not affect the pharmacokinetic properties of each of these substances, as if they were applied separately. Both components are highly bioavailable. 80-90% of amoxicillin trihydrate taken internally is absorbed from the digestive tract. Amoxicillin maintains stability in the presence of hydrochloric acid, food does not affect the degree of absorption.

Both components of the drug quickly diffuse into most tissues and body fluids. High concentrations of active substances are found in sputum, bronchial secretion, pleural fluid, pulmonary and adipose tissue, prostate gland, etc. Amoxicillin and clavulanic acid penetrate the placental barrier and are released in small amounts with milk.

Binding to plasma proteins is low in both amoxicillin and clavulanic acid, amoxicillin binds to proteins by 17-21% (an average of 20%). When taken orally, it is usually excreted by the kidneys unchanged for the first 6 hours after ingestion. With parenteral administration, both components are metabolized in the liver: amoxicillin - 10% of the administered dose, clavulanic acid - by 50%.

Indications

Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:

• infection of the upper respiratory tract and ENT organs (sinusitis, pharyngitis, tonsillitis, otitis media, retropharyngeal abscess);
• infection of the lower respiratory tract (acute and chronic bronchitis, lobar and bronchopneumonia, empyema of the pleura, lung abscess);
• infections of the skin and soft tissues (erysipelas, impetigo, secondarily infected dermatoses, abscess, phlegmon, wound infection);
• infection of the biliary tract (cholangitis, cholecystitis);
• infections of the genitourinary system and pelvic organs (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingoophoritis, endometritis, bacterial vaginitis, septic abortion, chancroid, gonorrhea);
• intestinal infections (dysentery, salmonellosis, salmonella carcinoma);
• osteomyelitis.

Forms of release

Tablets coated with 250 mg + 125 mg, 500 mg + 125 mg, 875 mg + 125 mg.

Powder for the preparation of the suspension for ingestion 125 mg + 31.25 mg / 5 ml: 100 ml bottle.

Powder for the preparation of a solution for intravenous administration of 1000 mg + 200 mg: a bottle of 1, 5, 10 or 100 pieces (injections in ampoules for injection).

Instructions for use and dosing regimen

The drug is taken or injected intravenously. Doses are given in terms of amoxicillin. The dosage regimen is set individually, depending on the severity of the course and localization of the infection, the sensitivity of the pathogen.

Children under 12 years - in the form of a suspension, syrup or drops for oral administration. Single dose is established depending on the age: children under 3 months - 30 mg per kg per day in 2 divided doses; 3 months and older - with infections of mild severity - 25 mg per kg per day in 2 divided doses or 20 mg per kg per day in 3 doses, in severe infections - 45 mg / kg per day in 2 doses or 40 mg / kg per day in 3 admission.

Adults and children over 12 years of age or with a body weight of 40 kg or more: 500 mg 2 times a day or 250 mg 3 times a day. For infections of severe severity and infections of the respiratory tract - 875 mg 2 times a day or 500 mg 3 times a day.

The maximum daily dose of amoxicillin for adults and children over 12 years is 6 g, for children under 12 years - 45 mg per kg of body weight. The maximum daily dose of clavulanic acid for adults and children over 12 years is 600 mg, for children under 12 years, 10 mg per kg of body weight.

If swallowing is difficult in adults, the use of a suspension is recommended.When preparing the suspension, syrup and droplets, use water as the solvent. Duration of treatment - up to 14 days, acute otitis media - up to 10 days.

When administered intravenously, adults and adolescents over 12 years of age are given 1 g (for amoxicillin) 3 times a day, if necessary 4 times a day. The maximum daily dose is 6 g. For children 3 months - 12 years - 25 mg per kg 3 times a day; in severe cases - 4 times a day; for children under 3 months: premature and in the perinatal period - 25 mg per kg 2 times per day, in the postperinatal period - 25 mg per kg 3 times per day.

For the prevention of postoperative infections in operations lasting less than 1 hour, during introductory anesthesia administered at a dose of 1 g intravenously. With longer operations - 1 g every 6 hours during the day. With a high risk of infection, administration can be continued for several days.

In chronic renal insufficiency, dose adjustment and frequency of administration are carried out depending on KK (creatinine clearance): when QC is more than 30 ml per minute, dose adjustment is not required; with KK 10-30 ml per minute: inside - 250-500 mg per day every 12 hours; intravenously - 1 g, then 500 mg intravenously; with QC less than 10 ml per minute - 1 g,then 500 mg per day intravenously or 250-500 mg per day orally in a single dose. For children, the dose should be reduced in the same way. Patients on hemodialysis 250 mg or 500 mg orally in a single dose or 500 mg intravenously, an additional 1 dose during dialysis and another 1 dose at the end of a dialysis session.

Side effect

• nausea, vomiting;
• diarrhea;
• stomatitis (inflammation of the oral mucosa);
• glossitis (inflammation of the tongue);
• darkening of enamel;
• gastritis (inflammation of the gastric mucosa);
• increased activity of hepatic transaminases;
• Cholestatic jaundice (stagnation of bile in the bladder);
• hepatic insufficiency (usually in the elderly);
• colitis (inflammation of the large intestine);
• enterocolitis (simultaneous inflammation of the small and large intestine);
• reversible increase in prothrombin time and bleeding time (blood clotting temporarily slows down);
• thrombocytopenia (decrease in the number of platelets);
• thrombocytosis (increase in the number of platelets);
• leukopenia (decrease in the number of leukocytes);
• agranulocytosis (decrease in the number of granular leukocytes);
• eosinophilia (increase in the number of eosinophils);
• hemolytic anemia;
• headache, dizziness;
• behavior change;
• convulsions;
• anxiety, hyperactivity;
• hives;
• erythematous rashes;
• multiforme exudative erythema;
• anaphylactic shock, angioedema;
• Stevens-Johnson syndrome;
• exfoliative dermatitis;
• a syndrome similar to serum sickness;
• allergic vasculitis (inflammation of blood vessels);
• acute generalized eczematous pustulosis;
• phlebitis at the injection site (venous inflammation);
• candidiasis (thrush);
• interstitial nephritis (inflammation of the kidney);
• hematuria (blood in the urine);
• crystalluria (crystals in the urine);
• development of superinfection.

Contraindications

• hypersensitivity (including to cephalosporins and other beta-lactam antibiotics);
• infectious mononucleosis (including when there is a measles-like rash);
• phenylketonuria;
• episodes of jaundice or a violation of liver function as a result of the use of amoxicillin or clavulanic acid in the anamnesis;
• Creatinine clearance less than 30 ml per minute (for tablets 875 mg / 125 mg).

Carefully:

• pregnancy;
• lactation period;
• severe hepatic impairment;
• diseases of the digestive tract (including colitis in history, associated with the use of penicillins);
• chronic renal failure.

Application in pregnancy and lactation

During pregnancy and lactation, take Medonavra with caution. Cases of development of necrotizing enterocolitis in newborns, in pregnant women with premature rupture of membranes were revealed.

Use in children

Children under 12 years - in the form of a suspension, syrup or drops for oral administration. Single dose is established depending on the age: children under 3 months - 30 mg per kg per day in 2 divided doses; 3 months and older - with infections of mild severity - 25 mg per kg per day in 2 divided doses or 20 mg per kg per day in 3 doses, in severe infections - 45 mg / kg per day in 2 doses or 40 mg / kg per day in 3 admission. The maximum daily dose of amoxicillin for children under 12 years is 45 mg per kg of body weight. The maximum daily dose of clavulanic acid for children under 12 years is 10 mg per kg of body weight.

special instructions

In the course of treatment with Medoblava, it is necessary to monitor the status of the functions of the organs of hematopoiesis, liver and kidneys.

To reduce the risk of side effects from the gastrointestinal tract should take the drug during meals.

It is possible to develop superinfection due to the growth of insensitive microflora, which requires a corresponding change in antibacterial therapy.

Can give false positive results in determining glucose in the urine. In this case, it is recommended to use a glucose oxidant method for determining the concentration of glucose in the urine.

After reconstitution, the suspension should be stored for no more than 7 days in the refrigerator, but not frozen.

In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.

Cases of development of necrotizing enterocolitis in newborns, in pregnant women with premature rupture of membranes were revealed.

Since the tablets contain the same amount of clavulanic acid (125 mg), it should be noted that 2 tablets of 250 mg (for amoxicillin) are not equivalent to 1 tablet of 500 mg (for amoxicillin).

Impact on the ability to drive vehicles and service moving machinery:

Care should be taken when driving vehicles and engaging in other activities that require a high concentration of attention and speed of psychomotor reactions.

Drug Interactions

Antacids, glucosamine, laxative drugs, aminoglycosides slow down and reduce absorption; Ascorbic acid increases absorption.

Bacteriostatic medicinal products (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) have an antagonistic effect.

Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). With the simultaneous administration of anticoagulants, it is necessary to monitor blood coagulability.

Reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism which forms PABC, ethinyl estradiol - the risk of bleeding "breakthrough".

Diuretics, allopurinol, phenylbutazone, NSAIDs (non-steroidal anti-inflammatory drugs) and other drugs that block tubular secretion, increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

Allopurinol increases the risk of skin rash.

Analogues of medicinal product Medoklav

Structural analogs for the active substance:

• Amovicomb;
• Amoxivan;
• Amoxiclav;
• Arlette;
• Augmentin;
• Bactocklave;
• Betaclav;
• Verklav;
• Quixtab;
• Clamosar;
• Novaklav;
• Panklav;
• Ranklav;
• Rapiklav;
• Taromentine;
• Fibell;
• Flemoclav Solutab;
• Foraklav;
• Ecoclave.

Response of a therapist

As a broad-spectrum antibiotic, I prescribe Medoblava and its analogues in follicular tonsillitis and bronchitis, often without waiting for the results of bacapsov. The combination with clavulanic acid does its job: resistance to the drug is extremely rare, in the case of resistance of the causative agent, we replace Medoplast with a preparation of cephalosporin series. Of the shortcomings: frequent allergic rashes in the form of urticaria and diarrhea after the beginning of admission. Therefore always I appoint or nominate together with probiotikom and antihistamine.

Feedback from an otorhinolaryngologist

A quality generic, an excellent alternative to Augmentin, although it is not much cheaper than the original. I appoint or nominate at an average otitis, a purulent angina, sometimes at sinusitis. The effect does not make you wait, the temperature drops after one or two receptions. Microbial resistance has never been observed, serious allergic reactions also, a maximum of a small rash. I recommend to everyone as a drug of choice for acute inflammatory diseases of ENT organs.

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