Panklav 2X - instructions for use, dose, side effects, contraindications

active ingredients: Amoxicillin (in the form of amoxicillin trihydrate) - 875.00 mg, clavulanic acid (in the form of a mixture of potassium clavulanate and microcrystalline cellulose (1: 1)) - 125.00 mg.

Excipients: cellulose microcrystalline 510.35 mg, sodium carboxymethyl starch (type A) 32.80 mg, magnesium stearate 32.00 mg, silicon dioxide colloidal anhydrous 24.00 mg, butyl hydroxy anisole 0.85 mg.

Sheath: hypromellose 34.84 mg, titanium dioxide E171 - 17.42 mg, propylene glycol 8.17 mg, talc 3.57 mg.

Description:Tablets are oval, biconcave, covered with a film membrane from white to almost white, with a risk on one side. At the break - yellowish color.

Pharmacotherapeutic group:antibiotic - penicillin semisynthetic + beta-lactamase inhibitor.

ATX: & nbsp

J.01.C.R.02 Amoxicillin in combination with enzyme inhibitors

Pharmacodynamics:

Panklava 2X is a combination of amoxicillin - semi-synthetic penicillin with a broad spectrum of antibacterial activity - and clavulanic acid - an irreversible inhibitor of β-lactamases.

Amoxicillin - semisynthetic aminopenicillin, a broad-spectrum antibacterial agent, belongs to the group of beta-lactam antibiotics. It inhibits transpeptidase, breaks the synthesis of peptidoglycan (the supporting protein of the cell wall) in the period of division and growth, causes bacterial lysis.

Clavulanic acid is an inhibitor of β-lactamase enzymes produced by certain bacteria and destroying penicillins and other β-lactam antibiotics. Adding clavulanic acid to amoxicillin, preventing the inactivation of the antibiotic, extends the spectrum of its action due to microorganisms whose resistance to amoxicillin is due to the production of β-lactamases. Clavulanic acid forms a stable inactive complex with β-lactamases and protects amoxicillin from the loss of antibacterial activity caused by the production of β-lactamases as the main pathogens and co-pathogens, and conditionally pathogenic microorganisms. In addition, clavulanic acid has a weak intrinsic antibacterial activity.

Panklava 2X possesses a wide spectrum of action, is active against amoxicillin-sensitive microorganisms, including strains producing β-lactamases: gram-positive aerobes: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus groups viridans, Streptococcus bovis, Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis (except methicillin-resistant strains), Staphylococcus saprophyticus, Listeria monocytogenes, Enteroccocus spp.;

gram-negative aerobes: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Escherichia coli, Gardnerella vaginalis, Haemophilus influenzae, Haemophilus ducreyi, Klebsiella spp., Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersenia enterocolitica, Helicobacter pylori, Eikenella corrodens;

Gram-positive anaerobes: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Actinomyces israelii, Fusobacterium spp., Prevotella spp.;

Gram-negative anaerobes: Bacteroides spp.

Pharmacokinetics:

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Both components are well absorbed after oral administration; the intake of food by the degree of absorption is not affected. Bioavailability is 90% for amoxicillin and 70% for clavulanic acid. The peak of plasma concentrations is achieved approximately 2 to 2.5 hours after administration. The maximum concentration of amoxicillin in the blood (C_m_Oh) is about 12 μg / ml, clavulanic acid is 3.3 μg / ml. The half-life period (T1 / 2) of amoxicillin and clavulanic acid is 1-1,5 hours.

Connection with plasma proteins: amoxicillin - about 18%, clavulanic acid - 25%. Apparent volume of distribution of amoxicillin is 0.3 - 0.4 l / kg, clavulanic acid - 0.2 l / kg.

Both components are found in many organs and tissues of the body, biological fluids and pathological detachable: amoxicillin - in the lung tissue, bronchial secretion and saliva; in the skin, subcutaneous, muscular and fatty tissues, in the palatine tonsils; in bone tissue and synovial fluid; mucous membrane of the intestine, liver, gall bladder, bile, female genital organs, fetal tissues; pleural and peritoneal fluid, the contents of skin blisters, sputum, bronchial secretion (to a lesser degree in purulent discharge), in exudate with inflammation of the middle ear and accessory sinuses of the nose; clavulanic acid - in the palatine tonsils, organs of the abdominal cavity, bone, muscle and fatty tissues, synovial and peritoneal fluids, bile and purulent discharge. Neither the active components of Panklava 2X nor their metabolites are cumulated in any organs and tissues.

Amoxicillin and clavulanic acid do not penetrate the unchanged blood-brain barrier.

Amoxicillin and clavulanic acid penetrate the placental barrier and into breast milk.

Amoxicillin partially (10 - 25% of the absorbed dose) is metabolized to inactive penicillinacids; Clavulanic acid is metabolized intensively, its metabolites are excreted through the kidneys, intestines and lungs.

Amoxicillin is excreted mainly by the kidneys through tubular secretion and glomerular filtration. The total clearance of the combination amoxicillin / clavulanic acid is 25 l / h. During the first 6 hours after a single dose of the drug, 60% and 40% of the administered dose of amoxicillin and clavulanic acid are excreted unchanged from the body, respectively.

Both components are removed during hemodialysis, to a lesser extent - with peritoneal dialysis.

Elderly patients: Because of the possible age-related decline in the excretory function of the kidneys, use with caution is recommended.

Patients with severe renal insufficiency the elimination half-life increases to 7.5 hours for amoxicillin and up to 4.5 hours for clavulanic acid.

Indications:

Infectious-inflammatory diseases caused by microorganisms sensitive to amoxicillin / clavulanic acid:

- infections of the upper respiratory tract and ENT organs (including acute and chronic sinusitis, acute and chronic otitis media, peritonsillar abscess, tonsillitis, pharyngitis);

- infection of the lower respiratory tract (acute bronchitis with bacterial superinfection, exacerbation of chronic bronchitis, pneumonia);

- urinary tract infections;

- infections of the pelvic organs;

- infection of the skin and soft tissues (including after bites of animals and humans);

- infection of bones and joints (including osteomyelitis);

- infection of the biliary tract (cholecystitis, cholangitis);

- infection in dentistry.

Contraindications:

Hypersensitivity to the active and / or accessory components of Panclav 2X, increased sensitivity to beta-lactam antibiotics (penicillins, cephalosporins, carbapenems, etc.), history of cholestatic jaundice and / or liver dysfunction caused by taking a penicillin antibiotic or combination amoxicillin / clavulanic acid; impaired renal function (creatinine clearance less than 30 ml / min); infectious mononucleosis, breastfeeding (lactation period), children under 12 and / or body weight less than 40 kg (for tablets 875 mg / 125 mg).

Carefully:

Hepatic insufficiency, chronic renal failure (creatinine clearance more than 30 ml / min), pseudomembranous colitis in history, elderly age (over 65 years, see Pharmacokinetics section), hyperkalemia (see.section Special instructions "), pregnancy.

Pregnancy and lactation:

In pregnancy, it can be used when the benefits of using it for the mother greatly exceed the risk to the fetus. If you need to use the drug during lactation, breastfeeding is suspended.

Dosing and Administration:

Inside, washing down with water; at the beginning of food intake (to reduce the risk of side effects from the gastrointestinal tract), 2 times a day, strictly observing the interval between meals at 12 hours.

Adults and children over 12 years.

Adults and children over 12 years of age (body weight 40 kg and more) - take 1 tablet 2 times a day, every 12 hours.

The maximum daily dose of amoxicillin for adults is 6 g, for children - 45 mg / kg / day.

The maximum daily dose of clavulanic acid for adults (in the form of potassium clavulanate) is 600 mg, for children -10 mg / kg / day.

A course of treatment 5-14 days; is established individually, taking into account the features of the pathogen, the localization and severity of the infection.

Dosing in renal failure

Tablets 875 mg / 125 mg should be used only in patients with creatinine clearance greater than 30 ml / min, with no dose adjustment required.

Patients on peritoneal dialysis do not need dose adjustment.Patients on hemodialysis may need a dose adjustment.

Important! If the drug is missed, you should take the pill as soon as possible without waiting for the next time. Further, to observe equal intervals of time between doses - for 12 hours. Never take a double dose to compensate for missed medication!

Side effects:

Very often - more than 10%; often - more than 1 and less than 10%; infrequently - more than 0.1 and less than 1%>; rarely - more than 0.01 and less than 0.1%>; very rarely - less than 0.01%.

From the central nervous system: infrequently - dizziness, headache; very rarely - excitement, anxiety, reversible hyperactivity, insomnia, behavior change, convulsions.

From the gastrointestinal tract: often - loss of appetite, nausea, vomiting, diarrhea; infrequent - dyspepsia, mild asymptomatic increase in activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and / or increased bilirubin concentration; rarely - pseudomembranous colitis, change color of teeth (reversible, removed by hygienic means); very rarely - "black hairy tongue", hepatitis, cholestatic jaundice, liver failure (usually in the elderly, in men, with prolonged therapy), stomatitis, glossitis.

On the part of the organs of hematopoiesis: rarely - neutropenia, thrombocytopenia / thrombocytosis, hemolytic anemia; very rarely - leukopenia, agranulocytosis, increased prothrombin time and bleeding time, eosinophilia.

From the urinary system: very rarely - interstitial nephritis, crystalluria, hematuria.

Allergic reactions: infrequently - urticaria, rash, itchy skin; rarely erythema multiforme; frequency is not known - angioedema, anaphylaxis, allergic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), bullous exfoliative dermatitis, acute generalized exanthematous pustulosis, a syndrome similar to serum sickness.

Other: often candidiasis of the skin and mucous membranes; very rarely - the development of superinfection.

Overdose:

Symptoms: nausea, vomiting, abdominal pain, diarrhea, disturbance of water-electrolyte balance; there may be excitement, insomnia; There are isolated cases of seizures and crystalluria in patients with initially impaired renal function. No reports of death or development of life-threatening adverse events in an overdose of the drug.

Treatment: symptomatic; Gastric lavage and intake of absorbent are effective if the drug was taken less than 4 hours ago. Hemodialysis is effective.

Interaction:

Antacids, glucosamine, laxatives, aminoglycosides - slow down and reduce absorption; ascorbic acid increases absorption.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin) have a synergistic effect; bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - antagonistic.

Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). With the simultaneous administration of anticoagulants, it is necessary to monitor blood coagulability. Reduces the effectiveness of oral contraceptives, drugs, in the process of metabolism which forms para-aminobenzoic acid, ethinyl estradiol - the risk of bleeding "breakthrough".

Diuretics, allopurinol, phenylbutazone, nonsteroidal anti-inflammatory drugs, etc.drugs that block tubular secretion, increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).

Allopurinol increases the risk of skin rash.

Special instructions:

With a long course of treatment, it is necessary to provide control over the status of the function of the organs of hematopoiesis, liver and kidneys.

Patients with severe renal dysfunction require adequate dose adjustment or an increase in intervals between doses of the drug.

To reduce the risk of side effects from the gastrointestinal tract, the drug should be taken at the beginning of food intake.

To prevent the development of crystalluria, the drug should be washed down with a relatively large amount of water (0.5-1 cup).

Unchanged amoxicillin is excreted in the urine. High concentrations of amoxicillin give a false positive reaction to urine glucose when using a Benedict reagent or Felling solution. It is recommended to use enzymatic reactions with glucose oxidase.

Possible development of bacterial or fungal superinfection (Pseudomonas spp., Candida albicans) due to the growth of insensitive to the drug microflora, which requires a corresponding change in antibacterial therapy.

During therapy with the drug as a result of toxin exposure FROM. Difficile possibly the development of pseudomembranous colitis In the case of severe diarrhea, as in the case of diarrhea lasting 2-3 days, it is necessary to see a doctor as soon as possible.

With the development of mild diarrhea against the background of Panklava 2X, antidiarrheal drugs should be avoided that inhibit intestinal peristalsis; it is possible to use kaolin or attapulgite-containing antidiarrhoeic agents.

Since Panklav 2X contains potassium, caution should be exercised when prescribing it to patients with initial hyperkalemia.

It is advisable to use caution when administering Panklava 2X to patients with hepatic insufficiency and to provide regular laboratory monitoring of liver function.

When jaundice coloring of the skin, eye whites, darkening of the color of urine and / or clarification of the stool, it is necessary to consult a doctor immediately.

In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.

It is not recommended to use Panklav2X for infectious mononucleosis and for suspected it, as the drug can cause an erythematous skin rash, which aggravates the symptoms of the disease / complicates the diagnosis.

In neonates born to mothers who received preventive therapy with amoxicillin / clavulanic acid for premature rupture of the membranes (premature bladder) with premature pregnancy, there is an increased risk of developing necrotizing enterocolitis.

Effect on the ability to drive transp. cf. and fur:

During the period of treatment it is recommended to use caution when driving vehicles and engaging in other potentially dangerous activities, as vertigo is possible.

Form release / dosage:

Tablets, film-coated, 875 mg + 125 mg.

Packaging:For 14 tablets in a jar of brown glass (type III), capped with a plastic lid with silica gel and controlled by the first autopsy. 1 bank with instructions for use in a pack of cardboard.

Storage conditions:

Store at a temperature of no higher than 30 ° C in the original packaging.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001474

Date of registration:03.02.2012

The owner of the registration certificate:Hemofarm ADHemofarm AD Serbia

Manufacturer: & nbsp

HEMOFARM, A.D. Serbia

Representation: & nbspHEMOFARM A.D. HEMOFARM A.D. Serbia

Information update date: & nbsp03.02.2012

Illustrated instructions

Instructions

Panklaw 2X (Panklav 2X)