Rapiklav
Rapiklav: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Rapiclav
ATX code: J01CR02
Active ingredient: amoxicillin (amoxicillin), clavulanic acid (clavulanic acid)
Manufacturer: IPKA Laboratories, Ltd. (IPCA Laboratories, Ltd.) (India)
Description and photo updated: 22.11.2018
Prices in pharmacies: from 287 rubles.
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Rapiklav is a broad-spectrum antibiotic.
Release form and composition
Dosage form Rapiklava - coated tablets: oval, white or almost white (tablets 250 mg + 125 mg and 500 mg + 125 mg - 3 pcs. In blisters / strips, in a cardboard box 5 or 7 blisters / strips; 21 pcs. In dark glass bottles, in a cardboard box 1 bottle; tablets 875 mg + 125 mg - 2 or 3 pcs. In contoured non-cell packs, 7 packs in a cardboard box).
Composition of 1 tablet:
- active substances: amoxicillin (in the form of trihydrate) - 250 mg and clavulanic acid (in the form of potassium salt) - 125 mg, or amoxicillin - 500 mg and clavulanic acid - 125 mg, or amoxicillin - 875 mg and clavulanic acid - 125 mg;
- auxiliary components: dibutyl phthalate, microcrystalline cellulose, colloidal silicon dioxide, purified talc, magnesium stearate, isopropanol, hypromellose, croscarmellose sodium, methylene chloride, titanium dioxide.
Pharmacological properties
Pharmacodynamics
Rapiklav is a combined preparation containing amoxicillin (semisynthetic penicillin with a broad spectrum of antimicrobial action) and clavulanic acid (irreversible inhibitor of type II, III, IV and V β-lactamases, inactive against type I β-lactamases).
Clavulanic acid forms a stable inactivated complex with β-lactamases and prevents the loss of antibacterial activity of amoxicillin due to the production of β-lactamases by the main pathogens and co-pathogens or opportunistic microorganisms. It is this combination that determines the high bactericidal property of the drug.
Rapiklav is active against the following microorganisms:
- gram-positive aerobes: Listeria spp., Streptococcus pyogenes, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus spp., Staphylococcus epidermidis (except methicillin-resistant strains), Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus aureus (except methicillin-resistant strains)
- gram-negative aerobes: Campylobacter jejuni, Klebsiella spp., Proteus spp., Brucella spp., Haemophilus ducreyi, Pasteurella multocida, Gardnerella vaginalis, Neisseria gonorrhoeae, Vibrio cholerae, Moraxella catarrhalis, Escinusella spp. meningitidis, Bordetella pertussis, Shigella spp.;
- anaerobes: Clostridium spp., Peptococcus spp., Actinomyces israelii, Bacteroides spp., Peptostreptococcus spp.;
- others: Borrelia burgdorferi, Treponema pallidum, Leptospira icterohaemorrhagiae.
The following bacteria are naturally resistant to the combination of active substances in the Rapiklav:
- gram-negative aerobes: Hafnia alvei, Serratia spp., Acinetobacter spp., Morganella morganii, Yersinia enterocolitica, Providencia spp., Stenotrophomonas maltophilia, Citrobacter freundii, Pseudomonas spp., Legionella pneumophila, Enterobacter spp.;
- others: Coxiella burnetii, Chlamydia psittaci, Chlamydia spp., Chlamydia pneumoniae, Mycoplasma spp.
Pharmacokinetics
The main pharmacokinetic parameters of both Rapiklav active substances are similar.
After ingestion, they are well absorbed from the gastrointestinal tract, regardless of food intake. The maximum plasma concentrations are reached after about 1 hour.
They are characterized by a good distribution volume. Distributed in body fluids and tissues, including the middle ear, lungs, uterus, ovaries, peritoneal and pleural fluids. Amoxicillin, in addition, penetrates into saliva, bronchial secretions, synovial fluid, palatine tonsils, secret of the paranasal sinuses, gallbladder, liver, muscle tissue, prostate gland.
Both substances do not penetrate the blood-brain barrier (provided there is no meningeal inflammation). They penetrate the placental barrier and in trace concentrations are excreted in breast milk.
They are characterized by a low degree of protein binding.
Amoxicillin is partially metabolized. Clavulanic acid is believed to be extensively metabolized.
Amoxicillin is excreted practically unchanged by the kidneys by glomerular filtration and tubular secretion. Clavulanic acid is excreted unchanged and partially as metabolites by glomerular filtration. Small amounts can be excreted by the lungs and through the intestines. The half-life of both substances is on the order of 1-1.5 hours.
In patients with concomitant severe renal failure, the half-life of Rapiklav's active substances increases: amoxicillin - up to 7.5 hours, clavulanic acid - up to 4.5 hours.
Both substances are removed by hemodialysis, slightly by peritoneal dialysis.
Indications for use
According to the instructions, Rapiklav is prescribed for the treatment of infectious inflammatory diseases caused by pathogens sensitive to the combination of its active substances. In particular, it is used for infections of the following organs and systems:
- ear, throat, nose: pharyngitis, acute and chronic sinusitis, tonsillitis, acute and chronic otitis media;
- respiratory organs: pleural empyema, acute and chronic bronchitis and pneumonia;
- bones and joints, including chronic osteomyelitis;
- biliary tract: cholecystitis, cholangitis;
- skin, soft tissues, including phlegmon and wound infections;
- urinary tract, including cystitis, pyelonephritis, urethritis;
- odontogenic infections;
- gynecological infections, including salpingitis, endometritis, salpingo-oophoritis, pelvioperitonitis, septic abortion;
- sexually transmitted infections, including chancroid, gonorrhea.
Contraindications
- infectious mononucleosis, including with a measles-like rash;
- previous episodes of jaundice or abnormal liver function with amoxicillin and / or clavulanic acid in history;
- impaired renal function (creatinine clearance <30 ml / min);
- children under 12 years of age (or body weight <40 kg);
- hypersensitivity to any component of Rapiclav, cephalosporins or other β-lactam antibiotics.
With care: chronic renal failure, severe hepatic failure, diseases of the gastrointestinal tract (including colitis due to the use of penicillins in the history).
Instructions for the use of Rapiklav: method and dosage
Rapiklav is taken orally with meals: the tablets are swallowed whole and washed down with plenty of water.
Adults and children over 12 years old (weighing more than 40 kg) with mild and moderate infectious diseases are usually prescribed 1 tablet 250 + 125 mg 3 times a day.
In severe infectious processes, 2 tablets of 250 + 125 mg are prescribed 3 times a day, or 1 tablet of 500 + 125 mg 3 times a day, or 1 tablet of 875 + 125 mg 2 times a day.
Maximum daily doses of Rapiklav:
- amoxicillin: 6000 mg for adults and 45 mg / kg for children;
- clavulanic acid: 600 mg for adults and 10 mg / kg for children.
The duration of treatment is set for each patient individually, usually from 5 to 14 days. Reception of Rapiklav without a second medical examination for more than 14 days is not allowed.
For odontogenic infections, 1 tablet of 500 + 125 mg is usually prescribed 2 times a day (at 12-hour intervals) for 5 days.
For patients with renal failure and creatinine clearance (CC) of 10-30 ml / min, the recommended dose of the drug is 1 tablet 500 + 125 mg 2 times a day (at 12-hour intervals), with CC <10 ml / min - 1 tablet 500 + 125 mg once a day (every 24 hours).
In case of anuria, the interval between Rapiklav doses should be increased to at least 48 hours.
Side effects
Classification of side effects: very often (? 1/10), often (? 1/100 to <1/10), infrequently (? 1/1000 to <1/100), rarely (? 1/10 000 to <1/1000), very rarely (<1/10 000, including isolated cases).
Possible adverse reactions:
- superinfection: often - candidiasis of the skin and mucous membranes;
- from the digestive system: very often - diarrhea in adults; often - nausea and vomiting in adults, diarrhea, nausea and vomiting in children (nausea usually occurs when the drug is taken in high doses);
- allergic reactions: infrequently - itching, false rash, urticaria; rarely, erythema multiforme; very rarely - allergic vasculitis, anaphylactic reactions, angioedema, bullous exfoliative dermatitis, serum-like syndrome (visceral skin allergy to drugs), acute generalized exanthematous pustulosis, toxic epidermal necrolysis, Stevens-Johnson syndrome;
- from the nervous system: infrequently - headache, dizziness; very rarely - changes in behavior, anxiety, agitation, reversible hyperactivity, insomnia (when using the drug in high doses or in patients with impaired renal function);
- from the urinary system: very rarely - hematuria, crystalluria, interstitial nephritis;
- from the hematopoietic and lymphatic system: rarely - reversible thrombocytopenia, reversible leukopenia (including neutropenia); very rarely - thrombocytosis, eosinophilia, anemia, reversible hemolytic anemia, reversible agranulocytosis, prolongation of bleeding time and prothrombin time;
- from the liver * and biliary tract: infrequently - a moderate increase in the activity of alanine aminotransferase and / or aspartate aminotransferase; very rarely - an increase in the concentration of bilirubin, an increase in the activity of alkaline phosphatase; as well as cholestatic jaundice and hepatitis (usually with the simultaneous use of other penicillins and cephalosporins).
* Side effects from the liver are observed mainly in men and elderly patients. May be associated with long-term treatment. Usually occur while taking the drug or shortly after its cancellation, but in some cases, they occur several weeks after stopping therapy. In children, such phenomena develop very rarely. Liver reactions are usually reversible. It is extremely rare in patients with a history of serious liver disease and patients receiving hepatotoxic drugs, reactions can be very severe, even fatal.
Overdose
Symptoms: disorders of the digestive system, imbalance in water and electrolyte balance. There are known cases of the development of amoxicillin crystalluria, including those leading to renal failure. In patients with impaired renal function and in patients who received the drug in high doses, convulsions are possible.
Overdose treatment is symptomatic. Particular attention is paid to the normalization of water and electrolyte balance. The drug can be removed from the plasma by hemodialysis.
special instructions
Before prescribing Rapiklav, the doctor must collect a complete history of the patient about previous hypersensitivity reactions to penicillins, cephalosporins and other allergens.
In general, the drug has low toxicity and is well tolerated. However, with prolonged therapy, it is worth monitoring the functions of the liver, kidneys and hematopoiesis.
Taking pills with meals can reduce the risk of developing adverse events from the gastrointestinal tract.
Rare serious and even fatal anaphylactic reactions to penicillins have been described (and amoxicillin belongs to their group). Patients with a history of hypersensitivity reactions to penicillins are at high risk. In the event of an allergic reaction (even skin), it is necessary to cancel Rapiklav and prescribe appropriate treatment. In case of serious anaphylactic reactions, urgent appropriate measures are required, including the administration of epinephrine. It may also be necessary to conduct oxygen therapy, intravenous administration of glucocorticosteroids, and ensure airway patency (including intubation).
With long-term treatment, an increase in the population of microorganisms insensitive to the drug is possible.
In patients with sepsis, Rapiklav can cause the development of bacteriolysis (Jarisch-Herxheimer reaction).
There are known cases of pseudomembranous colitis with the use of antimicrobial drugs. Its severity can range from mild to severe, life-threatening. This should be taken into account in patients who develop diarrhea during or after treatment. In case of prolonged and severe diarrhea while taking Rapiklav, therapy should be discontinued and the patient examined. Do not take medications that inhibit intestinal peristalsis.
In patients with reduced diuresis, crystalluria rarely occurs with the use of amoxicillin. And although this occurs mainly with parenteral therapy, it is still recommended while taking amoxicillin in high doses to consume enough fluids and maintain adequate diuresis. This will help reduce the risk of amoxicillin crystals forming.
If the patient is shown the simultaneous use of indirect anticoagulants, it is required to carefully monitor the prothrombin time or the international normalized ratio. It may be necessary to adjust the dose of indirect anticoagulants.
During treatment with Rapiklav, it is possible to obtain false positive results of the Coombs' test, as well as a test for determining glucose in urine when using Felling's solution or Benedict's reagent. To determine the level of glucose in urine, it is worth using the glucose oxidant method.
During the period of therapy, one should not forget about the likelihood of superinfection (usually caused by fungi of the genus Candida and bacteria of the genus Pseudomonas) - it requires discontinuation of the antibiotic and / or appropriate treatment.
Influence on the ability to drive vehicles and complex mechanisms
Given the risk of side effects from the central nervous system, it is recommended to be careful during treatment when driving and performing potentially hazardous work.
Application during pregnancy and lactation
Rapiklav is not recommended to be prescribed during pregnancy, except in cases of urgent need, when the benefits of therapy outweigh the potential risks.
During lactation, the drug can be used. No adverse effects have been observed in infants, with the exception of rare cases of oral mucosal candidiasis, diarrhea, and sensitization. If they develop, breastfeeding should be discontinued.
Pediatric use
Rapiklav is contraindicated in children under 12 years of age (or weighing <40 kg).
With impaired renal function
Rapiklav should be used with caution in patients with chronic renal failure.
Tablets 875 + 125 mg are contraindicated in patients with CC <30 ml / min.
For violations of liver function
Rapiklav should be used with caution in patients with severe hepatic impairment, regularly monitoring liver function. There are insufficient data to adjust the dose in these patients.
Use in the elderly
For elderly patients, dose adjustment of Rapiklav is not required. In the case of concomitant renal impairment, the dose is changed in the same way as for adult patients with impaired renal function.
Drug interactions
Ascorbic acid increases the absorption of Rapiklav's active ingredients, slows down and reduces their absorption with laxatives, antacids, aminoglycosides, glucosamine.
A synergistic effect is observed with the combined use of bactericidal antibiotics (including cycloserine, rifampicin, vancomycin, cephalosporins, aminoglycosides).
The antagonistic effect is observed with the combined use of bacteriostatic drugs (including tetracyclines, sulfonamides, lincosamides, macrolides, chloramphenicol).
Rapiklav enhances the effect of indirect anticoagulants (since, by suppressing the intestinal microflora, the drug reduces the synthesis of vitamin K and the prothrombin index). If it is necessary to use this combination, blood coagulation indicators should be monitored.
Rapiklav reduces the effect of ethinyl estradiol, oral contraceptives, as well as drugs, in the process of metabolism of which para-aminobenzoic acid is formed.
The following drugs increase the concentration of amoxicillin: nonsteroidal anti-inflammatory drugs, diuretics, phenylbutazone, allopurinol, and other drugs that block tubular secretion.
With the simultaneous use of allopurinol, the risk of skin allergic reactions increases.
Rapiclav is not recommended for use in combination with probenecid.
The drug may increase the toxicity of methotrexate.
Analogs
Rapiklav's analogs are Amoxiclav, Amoxivan, Amovikomb, Amoxicillin + Clavulanic acid, Amoxiclav Kviktab, Amoxicillin + Clavulanic acid-Vial, Augmentin, Augmentin SR, Augmentin EC, Arlet, Medklav, Betaklav, Ranlavokhlav, Clavoklav, Fibell, Foraclav, Ekoklav, Flemoklav Solutab.
Terms and conditions of storage
Store at temperatures up to 25 ° C in a dry, dark place out of reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Rapiklava
Reviews about Rapiklava are mostly positive. Patients note the high efficiency of the antibiotic, its fast action, good tolerance and relatively low cost.
Price for Rapiklav in pharmacies
Approximate prices for Rapiklav: tablets 250 + 125 mg (15 pieces in a package) - 303 rubles, tablets 500 + 125 mg (15 pieces in a package) - 283-335 rubles. The cost of the 875 + 125 mg tablets is currently unknown.
Rapiklav: prices in online pharmacies
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Drug name Price Pharmacy |
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Rapiklav 500 mg + 125 mg film-coated tablets 15 pcs. 287 r Buy |
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Rapiklav tablets p.p. 500mg + 125mg 15 pcs. RUB 300 Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
