Rapiklav - instructions for use, dose, side effects, contraindications

Active substances: amoxicillin trihydrate (equivalent to amoxicillin) 250 mg. Potassium clavulanate (equivalent to clavulanic acid) - 125 mg. Excipients: silicon dioxide colloidal, microcrystalline cellulose, sodium crosscarmellose, magnesium stearate, hypromelose, dibutyl phthalate, purified talc, titanium dioxide, isopropyl alcohol, methylene chloride.

The coated tablets are 500 mg + 125 mg.

Active substances: amoxicillin trihydrate (equivalent to amoxicillin) - 500 mg. Potassium clavulanate (equivalent to clavulanic acid) - 125 mg. Excipients: silicon dioxide colloidal, microcrystalline cellulose, sodium crosscarmellose, magnesium stearate, hypromelose, dibutyl phthalate, purified talc, titanium dioxide, isopropyl alcohol, methylene chloride.

Description:

Oval-shaped tablets covered with a film membrane, from white to almost white.

Pharmacotherapeutic group:Antibiotic - penicillin semisynthetic + beta-lactamase inhibitor.

ATX: & nbsp

J.01.C.R.02 Amoxicillin in combination with enzyme inhibitors

Pharmacodynamics:

Rapiklav is a combination of amoxicillin - semisynthetic penicillin with a broad spectrum of antibacterial activity and

clavulanic acid - an irreversible inhibitor of beta-lactamases (II, III, IV, V type; is inactive with respect to Type I). Clavulanic acid forms a stable inactivated complex with these enzymes and protects amoxicillin from the loss of antibacterial activity caused by the production of beta-lactamases, both the main pathogens and co-pathogens, and conditionally pathogenic microorganisms. This combination provides a high bactericidal activity Rapiklava.

Rapiklav has a broad spectrum of antibacterial action. It is active with respect to both amoxicillin-sensitive strains and against beta-lactamase producing strains:

Gram-positive aerobes: Streptococcus pneumoniae, S.pyogenes, S.viridans, S.bovis, Staphylococcus aureus (except methicillin-resistant strains), S.epidermidis (except methicillin-resistant strains), Listeria spp., Enteroccocus spp.

Gram-negative aerobes: Bordetella pertussis, Brucella spp., Campylobacter jejuni, E.coli, Gardnerella vaginalis, El.influenzae, H.ducreyi, Klebsiella spp., Moraxella catarrhalis, N. gonorrhoeae, N. meningitidis, Pasteurela multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersenia enterocolitica.

Anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinimyces israelii.

Pharmacokinetics:

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Both components are well absorbed after ingestion, eating does not affect the degree of absorption. The peak of plasma concentrations is reached approximately 1 hour after administration.

Both components are characterized by a good distribution in the fluids and tissues of the body (lungs, middle ear, pleural and peritoneal fluids, uterus, ovaries, etc.). Amoxicillin also penetrates into the synovial fluid, liver, prostate, palatine tonsils, muscle tissue, gall bladder, the secret of the paranasal sinuses, saliva and bronchial secretions.

Amoxicillin and clavulanic acid do not penetrate the blood-brain barrier in non-inflamed meninges.

Amoxicillin and clavulanic acid penetrate the placental barrier and in trace concentrations are excreted in breast milk.

Amoxicillin and clavulanic acid are characterized by low binding to plasma proteins.

Amoxicillin is partially metabolized, clavulanic acid undergoes, apparently, intensive metabolism.

Amoxicillin is excreted by the kidneys almost unchanged through 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. The half-life of amoxicillin and clavulanic acid is 1-1.5 hours. In patients with severe renal failure, the elimination half-life increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid.

Both components are removed by hemodialysis and minor amounts by peritoneal dialysis.

Indications:

Rapiklav is intended for the treatment of the following infections caused by susceptible combinations of amoxicillin / clavulanic acid strains:

Infections of ENT organs (acute and chronic sinusitis, acute and chronic otitis media, tonsillitis, pharyngitis)

Respiratory tract infections (acute and chronic bronchitis and pneumonia, empyema of the pleura)

Urinary tract infections (including cystitis, urethritis, pyelonephritis).

Infections in gynecology (including salpingitis, salpingoophoritis, endometritis, septic abortion, pelvioperitonitis).

Infections of bones and joints (including chronic osteomyelitis).

Infections of the skin and soft tissues (including phlegmon, wound infection). Infections of the biliary tract (cholecystitis, cholangitis).

Diseases transmitted sexually (gonorrhea, chancroid).

Odontogenic infections.

Contraindications:

Hypersensitivity (including to cephalosporins and other beta-lactam antibiotics), infectious mononucleosis (including when there is a measles-like rash), phenylketonuria (for forms containing as an auxiliary substance aspartame).

Carefully:

With caution - pregnancy, lactation, severe hepatic insufficiency, gastrointestinal diseases (including colitis in history, associated with the use of penicillins), CRF.

Dosing and Administration:

Tablets should be taken orally while eating, without chewing, with a small amount of water.

Adults and children over 12 years of age (or more than 40 kg of body weight), the usual dose in the case of a light and medium-heavy course of infection is one 250 mg / 125 mg tablet 3 times a day.

In severe infections, 2 tablets 250 mg / 125 mg 3 times a day or 1 tablet 500/125 mg 3 times a day are prescribed.

The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults and 10 mg / kg of body weight for children.

The maximum daily dose of amoxicillin is 6 g for adults and 45 mg / kg of body weight for children.

The course of treatment is 5-14 days. The duration of the course of treatment is determined by the attending physician. Treatment should not last more than 14 days without a second medical examination.

Dosage for odontogenic infections: 1 tablet 625 mg every 12 hours for 5 days.

Dosage with moderate renal insufficiency (creatinine clearance 10-30 ml / min) is 1 tablet 500/125 mg every 12 hours, with severe renal failure (creatinine clearance less than 10 ml / min) - 1 tablet 500/125 mg every 24 hours .

For anuria, the interval between dosing should be increased to 48 hours or more.

Side effects:

On the part of the digestive system: nausea, vomiting, diarrhea, impaired liver function, increased activity of "liver" transaminases, in isolated cases - cholestatic jaundice, hepatitis, pseudomembranous colitis.

Allergic reactions: urticaria, erythematous rashes, rarely - erythema multiforme, anaphylactic shock, Quincke's edema, Stevens-Johnson syndrome, extremely rarely - exfoliative dermatitis.

Local reactions: in some cases - phlebitis in the place of intravenous administration.

Other: Candidiasis, development of superinfection, reversible increase prothrombin time.

Overdose:Symptoms: a violation of the function of the gastrointestinal tract and water-electrolyte balance. Treatment is symptomatic. Hemodialysis is effective.

Interaction:

Antacids, glucosamine, laxatives, aminoglycosides - slow down and reduce absorption; ascorbic acid increases absorption. Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic. 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, and other drugs that block tubular secretion, increase the concentration Amoxicillin (clavulanic acid is excreted mainly by glomerular filtration). Allopurinol increases the risk of skin rash.

Special instructions:

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

In order to reduce the risk of side effects from the gastrointestinal tract, you should take the drug while eating.

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

With the appointment of patients with sepsis, the development of a bacteriolysis reaction (the Yarisch-Gerxheimer reaction) is possible.

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

Receiving Rapiklava leads to the appearance of amoxicillin in the urine. High concentrations of amoxicillin give a false positive response to urine glucose when using a Benedict reagent or Felling solution.It is recommended to use enzymatic reactions with glucose oxidase.

The drug does not affect the ability to concentrate.

Form release / dosage:Pills.

Packaging:3 tablets in a contour non-cellular package (strip) made of aluminum foil; for 5 or 7 strips in a pack of cardboard, complete with instructions for use.

Storage conditions:

List B. In a dry, protected from light, out of reach of children at a temperature below 25 ° C.

Shelf life:24 months. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N016024 / 01

Date of registration:30.11.2009

The owner of the registration certificate:Ipka Laboratories Ltd.Ipka Laboratories Ltd. India

Manufacturer: & nbsp

IPCA LABORATORIES, Ltd. India

Representation: & nbspIPKA LABORATORIES LTD. IPKA LABORATORIES LTD. India

Information update date: & nbsp17.07.2014

Illustrated instructions

Instructions

Rapiklav® (Rapiclav®)