Betaclav
Betaklav: 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. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Betaklav
ATX code: J01CR02
Active ingredient: amoxicillin (Amoxicillin) + clavulanic acid (Clavulanic acid)
Producer: Micro Labs Limited (India)
Description and photo update: 2019-11-07
Prices in pharmacies: from 267 rubles.
Buy
Betaclav is a combined bactericidal preparation containing a semi-synthetic antibiotic and an irreversible competitive inhibitor of beta-lactamases.
Release form and composition
The drug is available in the form of film-coated tablets: white, oval, with a dividing line on one side (tablets in aluminum strips: dosage 250 mg + 125 mg, 10 pcs., In a cardboard box 2 strips; dosage 500 mg + 125 mg 6, 7 or 10 pcs., in a cardboard box 1 or 2 strips; dosage 875 mg + 125 mg 4, 7 or 10 pcs., in a cardboard box 2 or 3 strips. Each pack also contains instructions for using Betaclav) …
1 tablet contains:
- active ingredients: amoxicillin trihydrate (equivalent to the content of amoxicillin) + potassium clavulanate (equivalent to the content of clavulanic acid + microcrystalline cellulose 1 ÷ 1) - 300, 600 or 1050 mg (250, 500 or 875 mg) + 125 mg (328,125 mg);
- auxiliary components: colloidal silicon dioxide, microcrystalline cellulose, sodium carboxymethyl starch, magnesium stearate;
- composition of the film casing: Tabcoat TS-1709 MV white (hypromellose, ethylene glycol, propylene glycol, titanium dioxide, talc), dimethicone.
Pharmacological properties
Pharmacodynamics
Betaclav is a combined preparation with bactericidal efficacy, the action of which is determined by its active components: semi-synthetic aminopenicillin amoxicillin and clavulanic acid, which is a competitive irreversible inhibitor of beta-lactamases.
Amoxicillin has a bactericidal effect as a result of inhibition of the synthesis of the bacterial wall. Possessing an affinity for beta-lactamases, clavulanic acid forms a stable complex with them, which protects amoxicillin from enzymatic degradation and ensures that it retains its bactericidal activity. The inhibitory activity of clavulanic acid is manifested to beta-lactamases II – V type according to the Richmond-Sykes classification. This group of bacterial enzymes can produce gram-positive, gram-negative and anaerobic microorganisms, including Staphylococcus speciales (spp.), Moraxella catarrhalis, Haemophilus influenzae, Escherichia coli, Klebsiella spp., Neisseria spp., Yersinia spp., Yersinia enter spp. Clavulanic acid does not inhibit type I beta-lactamases produced by Enterobacter spp., Pseudomonas aeruginosa,Acinetobacter spp., Serratia spp.
In vivo Betaclav has a bactericidal effect on the following microorganisms:
- gram-positive aerobes: Streptococcus pyogenes, Streptococcus pneumoniae, Staphylococcus aureus;
- gram-negative aerobes: Escherichia coli, Enterobacter spp., Haemophilus influenzae, Moraxella catarrhalis, Klebsiella spp.
In vitro, the following microorganisms are sensitive to the combination of amoxicillin and clavulanic acid:
- gram-positive aerobes: Streptococcus spp., Streptococcus agalactiae, Streptococcus spp. viridans groups, Bacillus anthracis, Enterococcus faecium, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes, Nocardia asteroides, coagulase-negative staphylococci (including Staphylococcus epidermidis);
- gram-positive anaerobes: Peptococcus spp., Clostridium spp., Peptostreptococcus spp.;
- Gram negative aerobes: Helicobacter pylori, Bordetella pertussis, Gardnerella vaginalis, Brucella spp., Legionella spp., Neisseria meningitidis, Neisseria gonorrhoeae, Pasteurella multocida, Proteus vulgaris, Proteus mirable.
- gram-negative anaerobes: Fusobacterium spp., Bacteroides spp. (including Bacteroides fragilis);
- others: Chlamydia spp., Borrelia burgdorferi, Treponema pallidum, Leptospira icterohaemorrhagiae.
Pharmacokinetics
Amoxicillin and clavulanic acid have similar pharmacokinetic parameters. With a combination of active components, the pharmacokinetics of each of them is not disturbed.
After oral administration, both components are rapidly absorbed from the gastrointestinal tract (GIT), their bioavailability is about 90%. Simultaneous food intake does not significantly affect the degree and rate of absorption. The maximum concentration (C max) in plasma is reached in approximately 1.1-1.5 hours. C max of amoxicillin can be ~ 3.7 mg / l after taking the Betaclav 250 mg + 125 mg tablet, ~ 6.5 mg / l after taking the 500 mg + 125 mg tablet and ~ 10.5 mg / l after taking the Betaclav 875 tablet mg + 125 mg. Clavulanic acid C max is ~ 2.2 mg / l; 2.8 mg / L and 2.2 mg / L, respectively.
High concentrations of active substances are found in plasma, bronchial secretions, pleural fluid, lung tissues, sputum, middle ear, uterus, ovaries, prostate gland, adipose tissue, peritoneal fluid. With meningitis, they overcome the blood-brain barrier; amoxicillin penetrates poorly through non-inflamed meninges. Both components penetrate the placental barrier, their low concentrations are found in breast milk.
Plasma protein binding: amoxicillin - 17-20%, clavulanic acid - 22-30%.
Amoxicillin is metabolized in part to form inactive metabolites. The main route of excretion of amoxicillin through the kidneys as a result of tubular secretion and glomerular filtration, including about 10–25% is excreted in the form of inactive penicilloic acid. The half-life (T 1/2) of amoxicillin is 1-1.3 hours.
Clavulanic acid is extensively metabolized in the liver to form 2,5-dihydro-4- (2-hydroxyethyl) -5-oxo-1H-pyrrole-3-carboxylic acid and 1-amino-4-hydroxy-butan-2-one. It is excreted through the kidneys by glomerular filtration (partly in the form of metabolites) and through the gastrointestinal tract. T 1/2 clavulanic acid - 1-1.2 hours.
During the first 6 hours after ingestion, about 60–70% of amoxicillin and 40–65% of clavulanic acid are excreted unchanged through the kidneys.
A clinically significant decrease in the clearance of active components in renal failure requires a dose adjustment of Betaclav.
Indications for use
The use of Betaclav is indicated for the treatment of infectious and inflammatory pathologies caused by microorganisms sensitive to amoxicillin of the following organs and systems:
- lower respiratory tract: bronchitis, pneumonia;
- organs of otorhinolaryngology (ENT): otitis media, sinusitis, tonsillitis;
- genitourinary system and pelvic organs: cystitis, urethritis, pyelonephritis, pyelitis, salpingitis, salpingo-oophoritis, cervicitis, endometritis, septic abortion, bacterial vaginitis, bacterial prostatitis, gonorrhea, chancre;
- skin and soft tissues: impetigo, abscess, secondarily infected dermatoses, phlegmon, erysipelas, wound infection;
- bones and joints: osteomyelitis.
Contraindications
Absolute:
- infectious mononucleosis, including if it is suspected;
- dysfunction of the liver or episodes of jaundice against the background of the use of amoxicillin and clavulanic acid in history;
- age under 12 years old or body weight less than 40 kg;
- hypersensitivity to beta-lactam antibiotics, including cephalosporins;
- individual intolerance to the components of the drug.
In addition, Betaclav 875 mg + 125 mg tablets are contraindicated for chronic renal failure with creatinine clearance (CC) less than 30 ml / min.
Betaclav should be taken with caution in chronic renal failure, severe liver failure, diseases of the gastrointestinal tract (including a history of colitis caused by the use of penicillins), during pregnancy and breastfeeding.
Betaklav, instructions for use: method and dosage
Betaclav tablets are taken orally at the beginning of a meal.
The doctor sets the dosage regimen individually, taking into account the age, body weight of the patient, the localization and severity of the infectious process, the sensitivity of the pathogen.
The recommended dosage regimen of Betaclav for adults and children over the age of 12 years or with a body weight of more than 40 kg:
- infections of mild to moderate severity: 1 pc. (250 mg + 125 mg) 3 times a day or 1 pc. (500 mg + 125 mg) 2 times a day;
- severe infections, lower respiratory tract infections: 1 pc. (500 mg + 125 mg) 3 times a day or 1 pc. (875 mg + 125 mg) 2 times a day.
The maximum daily dose for adults and children over 12 years old: amoxicillin - 6000 mg, clavulanic acid - 600 mg.
Due to the fact that tablets with different doses of amoxicillin contain the same amount of clavulanic acid (125 mg), it is important to take into account that its amount in 2 tablets (250 mg + 125 mg) is not equivalent to the content in 1 tablet (500 mg + 125 mg) …
The minimum duration of the course of treatment is 5 days. Without revising the clinical situation, you should not continue taking Betaclav for more than 14 days.
In chronic renal failure, correction of the Betaclav dosage regimen is required, which is carried out taking into account the QC:
- CC more than 30 ml / min: general dosage regimen;
- CC 10-30 ml / min: mild and moderate infections - 1 pc. (250 mg + 125 mg) 2 times a day; lower respiratory tract infections or severe infectious and inflammatory diseases - 1 pc. (500 mg + 125 mg) 2 times a day;
- CC less than 10 ml / min: mild and moderate infections - 1 pc. (250 mg + 125 mg) once a day; lower respiratory tract infections or severe infectious and inflammatory diseases - 1 pc. (500 mg + 125 mg) once a day.
Patients on hemodialysis are recommended to take Betaclav 2 pcs. (250 mg + 125 mg) or 1 pc. (500 mg + 125 mg) once every 24 hours in combination with taking 1 dose during and after the end of the hemodialysis session.
Side effects
- on the part of the hematopoietic system: reversible increase in bleeding time and prothrombin time, eosinophilia, leukopenia, thrombocytopenia, thrombocytosis, hemolytic anemia, agranulocytosis;
- from the digestive system: darkening of tooth enamel, nausea, vomiting, gastritis, stomatitis, diarrhea, black hairy tongue syndrome, glossitis, colitis (including pseudomembranous colitis), hepatitis, cholestatic jaundice, liver failure (more often with prolonged therapy, in the elderly patients and men), increased activity of alkaline phosphatase and hepatic transaminases, increased bilirubin content;
- from the central nervous system: anxiety, hyperactivity, behavior change, headache, dizziness, convulsions;
- from the urinary system: interstitial nephritis, hematuria, crystalluria;
- allergic reactions: exfoliative dermatitis, allergic vasculitis, erythematous rashes, urticaria, angioedema, exudative erythema multiforme, malignant exudative erythema (Stevens-Johnson syndrome), acute generalized exanthematous pustulosis, anaphylactic syndrome;
- others: the development of superinfection, candidiasis.
Overdose
Symptoms of Betaclav overdose: functional disorders of the gastrointestinal tract, changes in the water-electrolyte balance.
Treatment: hemodialysis and symptomatic therapy.
special instructions
In order to reduce the severity of gastrointestinal symptoms, Betaclav is recommended to be taken at the beginning of a meal.
Treatment with Betaclav must be accompanied by monitoring of the state of the kidneys, hematopoietic organs and liver.
The risk of developing superinfection caused by selection of resistant forms of the pathogen should be taken into account.
When determining the concentration of glucose in urine, it is required to use the glucose oxidase method due to the possible detection of false-positive results with other methods of research.
In patients with hypersensitivity to penicillins, cross-allergic reactions may develop when combined with cephalosporin antibiotics.
Influence on the ability to drive vehicles and complex mechanisms
During treatment, patients are advised to be careful when performing any potentially hazardous activities, including driving and working with complex mechanisms, due to the possible development of undesirable effects from the central nervous system.
Application during pregnancy and lactation
During gestation, Betaclav is recommended to be prescribed when, in the opinion of the doctor, the expected benefit from therapy for the mother outweighs the potential threat to the fetus.
It should be borne in mind that taking Betaclav during lactation is associated with the risk of sensitization due to the presence of trace amounts of amoxicillin and clavulanic acid in breast milk.
Pediatric use
The appointment of Betaclav is contraindicated for children under 12 years of age.
With impaired renal function
The use of Betaclav tablets at a dosage of 875 mg + 125 mg is contraindicated in chronic renal failure (CC less than 30 ml / min).
It is recommended to take the drug with caution in chronic renal failure; correction of the dosage regimen is required taking into account the patient's CC.
For violations of liver function
The use of Betaclav for the treatment of patients with a history of liver dysfunction or episodes of jaundice associated with the use of amoxicillin and clavulanic acid is contraindicated.
With caution, Betaclav should be prescribed in case of severe hepatic insufficiency.
Drug interactions
With simultaneous use with a combined preparation of amoxicillin and clavulanic acid:
- probenecid: causes a decrease in the tubular secretion of amoxicillin, contributing to an increase and persistence of amoxicillin serum levels, therefore, concomitant therapy with probenecid should be avoided. The combination with probenecid does not affect the serum concentration of clavulanic acid;
- laxatives, antacids, glucosamine: taking these drugs slows down and reduces the degree of absorption of amoxicillin;
- ascorbic acid: while taking ascorbic acid, the rate of absorption of amoxicillin increases;
- diuretics, allopurinol, nonsteroidal anti-inflammatory drugs, phenylbutazone, other drugs that block tubular secretion: these drugs increase the concentration of amoxicillin; when combined with allopurinol, the risk of skin rash increases;
- oral contraceptives: the effectiveness of contraceptives for oral administration decreases;
- acenocoumarol, warfarin: there is a risk of an increase in the international normalized ratio (INR) when combined with acenocoumarol or warfarin, therefore, if it is necessary to prescribe the drug to patients on therapy with indirect anticoagulants, it is recommended to carefully monitor the prothrombin time or INR, including after the cancellation of the combined antibiotic.
Analogs
Betaclav's analogs are Amoxicillin + Clavulanic acid, Amoxicillin + Clavulanic acid-Vial, Amovikomb, Amoxiclav, Arlet, Augmentin EC, Augmentin, Klamosar, Medoklav, Novaclav, Panklav, Rapiklav, Ranklav, Fibell, Foraklav Slav, Ferclav, Ferclav.
Terms and conditions of storage
Keep out of the reach of children.
Store in original packaging at temperatures up to 30 ° C.
Shelf life: film-coated tablets, 250 mg + 125 mg - 2 years; film-coated tablets, 500 mg + 125 mg and 875 mg + 125 mg - 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Betaclava
There are currently no reviews about Betaclava.
Price for Betaclav in pharmacies
The price of Betaklav for a package containing 14 tablets, at a dosage of 500 mg + 125 mg, can range from 285 rubles, at a dosage of 875 mg + 125 mg - from 324 rubles.
Betaklav: prices in online pharmacies
|
Drug name Price Pharmacy |
|
Betaclav tablets p.p. 500mg + 125mg 14 pcs. 267 r Buy |
|
Betaclav 500 mg + 125 mg film-coated tablets 14 pcs. 267 r Buy |
|
Betaclav 875 mg + 125 mg film-coated tablets 14 pcs. 328 RUB 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!