PANKLAV

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)

Pharmaceutical form, composition and packaging

Pills, Film-coated white, Oval, lenticular.

Excipients: colloidal silicon dioxide, sodium carboxymethyl, microcrystalline cellulose, magnesium stearate.

The composition of the shell: gipromelloza, propylene glycol, titanium dioxide E171.

15 PC. – jars of dark glass (1) – packs cardboard.

Pills, Film-coated white, Oval, lenticular, Typewriter “A” and “K” and scored on one side.

Excipients: colloidal silicon dioxide, sodium carboxymethyl, microcrystalline cellulose, magnesium stearate.

The composition of the shell: gipromelloza, propylene glycol, titanium dioxide E171.

20 PC. – jars of dark glass (1) – packs cardboard.

Pharmacological action

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 and V – classification Richmond-Sykes). 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.

Pharmacokinetics

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. C_max 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

T_1/2 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, partially – as metabolites. 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 T_1/2 amoxicillin increases to 7.5 no, clavulanic acid – to 4.5 no.

Both components are removed by hemodialysis, minor amounts – peritoneal dialysis.

Testimony

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.

Dosage regimen

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 the recommended dose – 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.

Side effect

From the digestive system: nausea, vomiting, diarrhea, increase in liver transaminases and liver dysfunction, stomatitis; in a few cases – moderate asymptomatic elevated liver transaminases and alkaline phosphatase, cholestatic jaundice, hepatitis, psevdomembranoznыy colitis.

Allergic reactions: hives, itching, erythematous rash; rarely – erythema multiforme, toxic epidermal necrolysis, Acute generalized exanthematous pustulosis, serum sickness, angioedema; rarely – exfoliative dermatitis, 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.

Contraindications

- 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).

Pregnancy and lactation

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.

Cautions

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.

Overdose

Symptoms: nausea, vomiting; perhaps – excitation, insomnia; rarely – seizures, disruption of water and electrolyte balance.

Treatment: while taking the drug less 4 hours ago – gastric lavage, Admission absorbent. Hemodialysis is effective.

Drug Interactions

Antacids, Glucosamine, laxatives, aminoglycosides slow down the absorption of Panklava, vitamin C – increases.

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) – antagonistic action.

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; with ethinylestradiol – increased risk of bleeding “Breakthrough”.

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.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

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.