Description
Release form
Film-coated tablets 250 mg / 125 mg and 500 mg / 125 mg.
For 15 or 20 tablets in a jar of dark glass, corked with a plastic lid with silica gel and control of the first opening. 1 jar with instructions for use is placed in a cardboard box.
Packaging
20 pcs
Pharmacological action of
Pharmacodynamics of
Panclave is a combination of amoxicillin – semisynthetic penicillin with a wide spectrum of antibacterial activity and clavulanic acid – an irreversible inhibitor of beta-lactamases (type II, III, IV, type I) is inactive. Clavulanic acid forms a stable inactivated complex with these enzymes and protects amoxicillin from the loss of antibacterial activity caused by the production of -Lactamases, both the main pathogens and co-pathogens, and conditionally pathogenic microorganisms. This combination provides high bactericidal activity.
Panclave has a wide range of antibacterial effects. It is active against both strains sensitive to amoxicillin and strains producing β-lactamases: Gram-positive aerobes: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Staphylococcus aureus (except for methicillin-resistant resistance -resistant strains), Listeria spp., Enteroccocus spp.
Gram-negative aerobes: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus influenzae, Haemophilus ducreyi, Klebsiella spp., Moraxella catarrhalissella neissa neissaissa, Meraxella catarrhalissella neissa neissaissa, Meraxella catarrhalissella neissa neissa, Meraxella catarrhalissella neissa neissa, Nera Shigella spp., Vibrio cholerae, Yersenia enterocolitica.
Anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinomyces israelii.
Pharmacokinetics
The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Both components are well absorbed after oral administration, food intake does not affect the degree of absorption. Peak plasma concentrations are reached approximately 1 hour after ingestion.
Both components are characterized by a good distribution volume in body fluids and tissues (lungs, middle ear, pleural and peritoneal fluids, uterus, ovaries, etc.). Amoxicillin also penetrates the synovial fluid, liver, prostate gland, tonsils, muscle tissue, gall bladder, sinuses, saliva and bronchial secretions.
Amoxicillin and clavulanic acid do not cross the blood-brain barrier in uninflamed meninges.
Amoxicillin and clavulanic acid cross the placental barrier and are excreted in breast milk in trace concentrations.
Amoxicillin and clavulanic acid are characterized by low plasma protein binding.
Amoxicillin is partially metabolized, clavulanic acid is apparently subjected to intense metabolism.
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. 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 small amounts by peritoneal dialysis.
Indications
Infectious and inflammatory diseases caused by strains sensitive to the combination of amoxicillin / clavulanic acid:ita, pyelonephritis).
Infections in gynecology (including salpingitis, salpingoophoritis, endometritis, septic abortion).
Infections of bones and joints (including chronic osteomyelitis).
Infections of the skin and soft tissues (including phlegmon, wound infection).
Biliary tract infections (cholecystitis, cholangitis).
Sexually transmitted diseases (gonorrhea, chancroid).
Odontogenic infection.
Contraindications
Hypersensitivity to the drug, cephalosporins and other beta-lactam antibiotics, infectious mononucleosis (including with the appearance of a measles-like rash), children under 12 years of age (for this dosage form).
With caution – pregnancy, lactation, severe liver failure, diseases of the gastrointestinal tract (including a history of colitis associated with the use of penicillins), chronic renal failure.
Special instructions
Use with caution in patients with severe hepatic insufficiency, chronic renal failure, gastrointestinal diseases (including a history of penicillin-associated colitis).
When prescribed to patients with sepsis, the development of a bacteriolysis reaction (Jarisch-Herxheimer reaction) is possible.
During the course of treatment, it is necessary to monitor the state of the function of the blood, liver and kidneys.
In order to reduce the risk of dyspeptic side effects, the drug should be taken with meals.
Perhaps the development of superinfection due to the growth of microflora insensitive to it, which requires a corresponding change in antibiotic therapy.
In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.
Taking Panclav leads to the appearance of amoxicillin in the urine. High concentrations of amoxicillin give a false-positive reaction to urine glucose when using Benedict’s reagent or Felling’s solution. Enzymatic reactions with glucose oxidase are recommended.
Influence on the ability to drive vehicles and control mechanisms
The drug Panklav does not affect the ability to drive vehicles and control mechanisms.
Composition
One film-coated tablet 250 mg / 125 mg contains the active substances: amoxicillin (in the form of amoxicillin trihydrate) 250 mg, clavulanic acid (in the form of potassium clavulanate) 125 mg.
Excipients: colloidal silicon dioxide – 6.50 mg, sodium carboxymethyl starch – 13.00 mg, microcrystalline cellulose – 247.75 mg, magnesium stearate – 9.75 mg.
Shell: hypromellose – 13.589 mg, propylene glycol – 2.718 mg, titanium dioxide E171 – 9.693 mg.
One film-coated tablet 500 mg / 125 mg contains the active substances: amoxicillin (in the form of amoxicillin trihydrate) 500 mg, clavulanic acid (in the form of potassium clavulanate) 125 mg.
Excipients: colloidal silicon dioxide – 10.50 mg, sodium carboxymethyl starch – 21.05 mg, microcrystalline cellulose – 382.65 mg, magnesium stearate – 10.80 mg.
Shell: hypromellose – 21.951 mg, propylene glycol – 4.390 mg, titanium dioxide E171 – 15.659 mg.
Dosage and administration
Tablets should be taken orally with food, not chewing, with a little water.
For adults and children over 12 years of age (weighing more than 40 kg), the usual dose for mild and moderate infections is one tablet 250 mg / 125 mg 3 times a day.
In severe infections, 1 tablet 500/125 mg 3 times a day is prescribed.
The maximum daily dose of clavulanic acid (in the form of potassium salt) for adults is 600 mg and 10 mg / kg body weight for children.
The maximum daily dose of amoxicillin is 6 g for adults and 45 mg / kg 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 500 mg / 125 mg every 12 hours for 5 days.
The dosage for moderate renal failure (creatinine clearance 10-30 ml / min) is 1 tablet 500 mg / 125 mg every 12 hours or 1 tablet 250 mg / 125 mg (for mild to moderate) 2 times a day, with severe renal failure (creatinine clearance less than 10 ml / min) – 1 tablet 500/125 mg every 24 hours or 1 tablet 250 mg / 125 mg (for mild to moderate course) 1 time per day.
In anuria, the interval between dosing should be increased to 48 hours or more.
Two Panclave tablets of 250 mg / 125 mg are not equivalent to one Panclave tablet of 500 mg / 125 mg, because they contain different amounts of clavulanic acid.
Side effects of the
From the gastrointestinal tract: nausea, vomiting, diarrhea, impaired liver function, increased activity of “liver” transaminases, stomatitis, in rare cases – a moderate asymptomatic increase in the level of “liver” enzymes and alkaline phosphatase, cholestatic jaundice, hepatitis, pseudomembranous colitis.
Allergic reactions: urticaria, pruritus, erythematous rashes, rarely – erythema multiforme, anaphylactic shock, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, serum sickness, Quincke edema, extremely rarely – exfoliative dermatitis, Stevens-Johnson syndrome, and anaphylaxis.
From the central nervous system: dizziness, headache, cramps (cramps can occur with impaired renal function or in patients receiving high doses of Panclav).
Other: candidiasis of the skin and mucous membranes, development of superinfection, reversible increase in prothrombin time, vaginitis, interstitial nephritis.
Drug interactions
Antacids, glucosamine, laxatives, aminoglycosides slow down the absorption of Panclave, ascorbic acid – increases.
With the simultaneous use of Panclave and bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin), the latter have a synergistic effect of bacteriostatic drugs (macrolides, chloramphenicol, linkcosamides, tetracyclines, sulfonamides) – antagonistic.
When given concomitantly, Panklav increases the effectiveness of indirect anticoagulants (suppresses the intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). With the simultaneous administration of anticoagulants, it is necessary to monitor blood coagulation.
Combined use with Panclav reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism of which PABA is formed, ethinyl estradiol – the risk of acyclic bleeding.
Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).
Concomitant use of Panclave with allopurinol increases the risk of skin rash.
Overdose
Symptoms: impaired gastrointestinal function: nausea, vomiting are possible: agitation, insomnia, in rare cases, convulsive seizures, as well as a violation of water-electrolyte balance.
Treatment: symptomatic, with recent administration of the drug (less than 4 hours) – gastric lavage, intake of absorbent. Hemodialysis is effective.
Storage conditions
Store in a dry, dark place at 15 to 25oC.
Keep out of the reach and sight of children.
Term hodnosty
2 years
active substance
Amoxycillin, Clavulanic acid
Terms leave through pharmacies
In retseptu
Dosage form
tablet
Possible product names
Naftalan gel d / soul tube 200ml Ukraine
Panclav tablets 0.5 g + 125 mg, 20 pcs.
PANKLAV 0.5 / 0.125 N20 TABLE
PANKLAV 0.5 / 0, 125 N20 TABLE P / O
PANKLAV 500MG. + 125MG. No. 20 TAB. P / O / HEMOFARM /
