Active material: Amoksiцillin, Clavulanic acid
When ATH: J01CR02
CCF: Antibiotics penicillin with a broad-spectrum beta-lactamase inhibitor
ICD-10 codes (testimony): A46, A54, A57, H66, J00, J01, J02, J03, J04, J15, J20, J31, J32, J35.0, J37, J42, J47, J85, J86, J90, K05, K12, K81.0, K81.1, K83.0, L01, L02, L03, L08.0, L30.3, M00, M86, N10, N11, N30, N34, N41, N70, N71, N72, N73.0, O08.0, O85, T79.3, Z29.2
When CSF: 06.01.02.04.02
Manufacturer: HEMOFARM A.D. (Serbia)
Pills, Film-coated white, Oval, lenticular.
| 1 tab. | |
| amoksiцillin (in the form of trihydrate) | 250 mg |
| Clavulanic acid (in the form of potassium clavulanate) | 125 mg |
Excipients: colloidal silicon dioxide, sodium carboxymethyl, microcrystalline cellulose, magnesium stearate.
The composition of the shell: gipromelloza, propylene glycol, titanium dioxide E171.
15 PC. – банки темного стекла (1) – пачки картонные.
Pills, Film-coated white, Oval, lenticular, с буквами “А” и “К” и риской с одной стороны.
| 1 tab. | |
| amoksiцillin (in the form of trihydrate) | 500 mg |
| Clavulanic acid (in the form of potassium clavulanate) | 125 mg |
Excipients: colloidal silicon dioxide, sodium carboxymethyl, microcrystalline cellulose, magnesium stearate.
The composition of the shell: gipromelloza, propylene glycol, titanium dioxide E171.
20 PC. – банки темного стекла (1) – пачки картонные.
Broad-spectrum antibiotic; It contains a semisynthetic penicillin, amoxicillin and the β-lactamase inhibitor clavulanic acid. Clavulanic acid inhibits the most clinically important β-lactamases (Types II, III, IV и V – по классификации Ричмонда-Сайкса). Inactive against β-lactamase 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 β-lactamases, as the main agents and co-pathogens, and conditionally pathogenic microorganisms.
This combination provides high bactericidal activity Panklava.
Panklav has a broad spectrum of antibacterial action. It is active against both sensitive to amoxicillin strains, and against strains, продуцирующих b-лактамазы.
Panklav active against aerobic Gram-positive bacteria: Streptococcus pneumoniae, Streptococcus viridans, Streptococcus pyogenes, Streptococcus bovis, Staphylococcus aureus (except methicillin-resistant strains of), Staphylococcus epidermidis (except methicillin-resistant strains of), Listeria spp., Enterococcus spp.; Aerobic Gram-negative bacteria:
Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurela multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica; Anaerobic bacteria: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinomyces israelii.
Main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar.
Absorption
After oral administration, the two components of the drug rapidly absorbed from the gastrointestinal tract. Simultaneous food intake does not affect the extent of absorption. Cmax plasma levels are achieved after approximately 1 h after administration.
Distribution
The degree of binding to plasma proteins is low. Both components are characterized by a high volume of distribution in the body fluids and tissues (lung tissue, in the middle ear, pleural and peritoneal fluid, uterus, yaychnykah). Amoxicillin is also penetrating the synovial fluid, liver, prostate, tonsils, muscle, gallbladder, the secret of the paranasal sinuses, saliva and bronchial secretions.
The active substances do not penetrate the blood-brain barrier in the non-inflamed meninges, in trace concentrations excreted with breast milk, cross the placental barrier.
Metabolism
Amoxicillin partially metabolized, Clavulanic acid is exposed, apparently, intensive metabolism.
Deduction
T1/2 amoxicillin and clavulanic acid is 1-1.5 no. Amoxicillin appears kidneys virtually unchanged by tubular secretion and glomerular filtration rate. Clavulanic acid is mainly excreted by the kidneys by glomerular filtration, частично – в виде метаболитов. Smaller quantities can be displayed through the intestines or lungs.
Pharmacokinetics in special clinical situations
If the kidney function is reduced renal and extrarenal clearance of both components, which leads to their accumulation in the plasma.
In patients with severe renal insufficiency T1/2 amoxicillin increases to 7.5 no, клавулановой кислоты – до 4.5 no.
Both components are removed by hemodialysis, незначительные количества – перитонеальным диализом.
Infectious-inflammatory diseases, caused by susceptible to malaria infections:
- Infections of upper respiratory tract (acute and chronic sinusitis, acute and chronic otitis media, tonsillitis, pharyngitis);
- Respiratory tract infections (acute and chronic bronchitis, pneumonia, empyema);
- Urinary tract infections (incl. cistity, uretrity, pyelonephritis);
- Infections in gynecology (incl. salpingitis, salpingo-oophoritis, endometritis, septic abortion);
- Bone and joint infections (incl. chronic osteomyelitis);
- Infections of the skin and soft tissues (incl. flegmona, wound infection);
- Infection of the biliary tract (incl. cholecystitis, kholangit);
- Gonorrhea;
- Şankroid;
- Odontogenic infections.
Inside adults and children over 12 years (or with body weight more 40 kg) at light and moderate infections appoint 1 tab. 250 mg / 125 mg 3 times / day. At severe infections single dose of 2 tab. 250 mg / 125 mg or 1 tab. 500 mg / 125 mg 3 times / day.
The maximum daily dose of clavulanic acid (in the form of potassium salt) It is for Adult 600 mg, to children – 10 mg / kg body weight.
The maximum daily dose of amoxicillin for Adult 6 g, to children – 45 mg / kg body weight.
Course of treatment 5-14 days. Treatment should not continue more 14 days without re-medical examination.
At odontogenic infections рекомендуемая доза – 1 tab. by 500 mg / 125 mg every 12 h for 5 days.
Patients with renal failure secondary to (KK from 10 to 30 ml / min) The recommended dose is 1 tab. 500 mg / 125 mg 2 times / day for severe infections, and 1 tab. 250 mg / 125 mg 2 times / day in mild to moderate and. Patients with severe renal insufficiency (CC less than 10 ml / min) appoint 1 tab. 500 mg / 125 mg 1 time / day for severe infections, and 1 tab. 250 mg / 125 mg 1 time / day in mild to moderate and.
At anurii interval between doses should be increased to 48 h or more.
The tablets should be taken orally with meals, without chewing, with a little water.
It should be remembered, what 2 tab. Panklava 250 mg / 125 mg of an equivalent 1 tab. 500 mg / 125 mg, tk. they contain different amounts of clavulanic acid.
From the digestive system: nausea, vomiting, diarrhea, increase in liver transaminases and liver dysfunction, stomatitis; в единичных случаях – умеренное бессимптомное повышение активности печеночных трансаминаз и ЩФ, cholestatic jaundice, hepatitis, psevdomembranoznыy colitis.
Allergic reactions: hives, itching, erythematous rash; редко – многоформная эритема, toxic epidermal necrolysis, Acute generalized exanthematous pustulosis, serum sickness, angioedema; крайне редко – эксфолиативный дерматит, Stevens-Johnson syndrome, anaphylactic shock.
CNS: dizziness, headache, convulsions (convulsions may occur when the kidney function or patients, receiving high doses Panklava).
Other: candidiasis of the skin and mucous membranes, development of superinfection, reversible increase in prothrombin time, vaginitis, interstitial nephritis.
- Infectious mononucleosis (incl. the appearance of the rash morbilliform);
- Children up to age 12 years;
- Hypersensitivity to penicillins, cephalosporins, other beta-lactam antibiotics and other ingredients.
FROM caution the drug is used during pregnancy, lactation, in patients with severe liver failure, chronic renal failure, gastrointestinal diseases (incl. a history of colitis, associated with the use of penicillins).
Use of the drug Panklav during pregnancy and lactation is possible only in case, when the intended benefits to the mother outweighs the potential risk to the fetus.
If necessary, use during lactation should decide the issue of termination of breastfeeding.
In exchange treatment is necessary to control the state of hematopoiesis, the liver and kidneys.
To reduce the risk of diarrheal side effects should take the drug during meals.
Perhaps the development of superinfection due to growth insensitive to it microflora, which requires a corresponding change in antimicrobial therapy.
Patients, with hypersensitivity to penicillins, possible cross-allergic reaction cephalosporin antibiotic.
Receiving Panklava leads to amoxicillin in urine. High concentrations of amoxicillin give a false positive reaction to the detection of glucose in urine using Benedict's reagent or solution Felling. We recommend using enzymatic reaction with glucose oxidase.
Effects on ability to drive vehicles and management mechanisms
Panklav The drug does not affect the ability to drive vehicles and management mechanisms.
Symptoms: nausea, vomiting; возможно – возбуждение, insomnia; в редких случаях – судорожные припадки, disruption of water and electrolyte balance.
Treatment: while taking the drug less 4 ч назад – промывание желудка, Admission absorbent. Hemodialysis is effective.
Antacids, Glucosamine, laxatives, aminoglycosides slow down the absorption of Panklava, аскорбиновая кислота – повышает.
In an application with bactericidal antibiotics Panklava (incl. aminoglikozidy, cephalosporins, cycloserine, vancomycin, rifampicin) there is a synergistic effect; with bacteriostatic drugs (makrolidы, chloramphenicol, lincosamides, tetracikliny, sulfonamides) – антагонизм действия.
When concomitant administration Panklav increases the efficiency of indirect anticoagulants (suppressing the intestinal microflora, It reduces the synthesis of vitamin K and prothrombin index). At the same time taking anticoagulants need to monitor the performance of blood clotting.
The combined application with Panklavom decreased effectiveness of oral contraceptives; с этинилэстрадиолом – повышается риск развития кровотечений “прорыва”.
Panklav reduces the effectiveness of drugs, during metabolism which is formed PABA.
Diuretic, allopurinol, phenylbutazone, NSAIDs and other drugs, block tubular secretion, increase the concentration of amoxicillin (Clavulanic acid is derived mainly by glomerular filtration).
Concomitant use with allopurinol Panklava increases the risk of skin rashes.
The drug is released under the prescription.
List B. The drug should be stored out of reach of children, dry, dark place at a temperature of 15 ° to 25 ° C. Shelf life - 2 year.
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