Panklav, 2x pills 875mg+125mg 14pcs

Composition

Active ingredients:  

Amoxicillin (in the form of amoxicillin trihydrate) – 875 mg.,

Clavulanic acid (in the form of a mixture of potassium clavulanate and microcrystalline cellulose (1: 1)) – 125 mg.,

Auxiliary substances:  

Microcrystalline cellulose – 510.35 mg,

Sodium Carboxymethyl starch (type A) – 32.8 mg,

Magnesium stearate – 32 mg,

Colloidal anhydrous silicon dioxide-24 mg,

Butylhydroxyanisole – 0.85 mg.

Film shell:  

Hypromellose – 34.84 mg,

Titanium dioxide (E 171) – 17.42 mg,

Propylene Glycol – 8.17 mg,

Talcum powder – 3.57 mg

Pharmacological action

Panclav 2X is a combination of amoxicillin, a semisynthetic penicillin with a broad spectrum of antibacterial activity, and clavulanic acid, an irreversible beta-lactamase inhibitor.

Active ingredients

Amoxicillin + Clavulanic Acid

Indications

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

— urinary tract infections;

infections of the pelvic organs;

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

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

— infections of bones and joints (including osteomyelitis);

infections of skin and soft tissue (including after bites animals and humans);

infection of the biliary tract;

dental infection.

Use during pregnancy and lactation

Use during pregnancy is possible only if the benefit of its use for the mother significantly exceeds the risk to the fetus. If it is necessary to use the drug during lactation, breastfeeding should be suspended.

Contraindications

— hypersensitivity to Panklav 2X;

— hypersensitivity to beta-lactam antibiotics (penicillins, cephalosporins, carbapenems, etc. );

the impairment of renal function (creatinine clearance less than 30 ml/min);

infectious mononucleosis;

— a history of cholestatic jaundice and/or liver dysfunction caused by antibiotic penicillin or a combination of amoxicillin/clavulanic acid;

— breastfeeding (lactation);

— children’s age up to 12 years of age and/or body weight less than 40 kg (for tablets 875 mg/125 mg).

With caution:

Hepatic insufficiency, chronic renal insufficiency (creatinine clearance greater than 30 ml / min), a history of pseudomembranous colitis, elderly age (over 65 years), hyperkalemia, pregnancy.

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-agitation, anxiety, reversible hyperactivity, insomnia, behavior changes, convulsions. From the gastrointestinal tract: often-loss of appetite, nausea, vomiting, diarrhea; infrequently — dyspepsia, moderate asymptomatic increase in the activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and/or increased bilirubin concentration;rarely — pseudomembranous colitis, discoloration of teeth (reversible, removed by hygienic means); very rarely — “black hairy tongue”, hepatitis, cholestatic jaundice, liver failure (more often in the elderly, in men, with long — term therapy), stomatitis, glossitis. Hematopoietic disorders: 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, pruritus; rarely-erythema multiforme; frequency unknown-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.

Interaction

Diuretics, phenylbutazone, allopurinol, nonsteroidal anti-inflammatory drugs, and other drugs that block tubular secretion increase the concentration of amoxicillin.

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

Bactericidal antibiotics have a synergistic effect; bacteriostatic drugs have an antagonistic effect.

Reduces the effectiveness of oral contraceptives, drugs that produce paraaminobenzoic acid and ethinyl estradiol in the process of metabolism – the risk of developing “breakthrough” bleeding.

Increases the effectiveness of indirect anticoagulants (suppressing intestinal microflora, reduces the synthesis of vitamin K and prothrombin index). When taking anticoagulants at the same time, it is necessary to monitor blood clotting indicators.

Allopurinol increases the risk of developing a skin rash.

How to take, course of use and dosage

Inside, washed down with water; at the beginning of a meal (in order to reduce the risk of side effects from the gastrointestinal tract),2 times a day, strictly observing the interval between meals of 12 hours. Adults and children over 12 years of age. Adults and children over 12 years of age (body weight 40 kg or 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. The course of treatment is 5-14 days; it is determined individually, taking into account the characteristics of the pathogen, localization and severity of the infection. Dosage in renal insufficiency 875 mg/125 mg tablets should only be used in patients with creatinine clearance greater than 30 ml / min, and no dose adjustment is required. No dose adjustment is required for patients undergoing peritoneal dialysis. Patients undergoing hemodialysis may need to adjust the dose of the drug. Important! If you miss taking the drug, you should take the pill as soon as possible, without waiting for the time of the next intake. Then observe equal intervals of time between receptions-12 hours each. Never take a double dose to make up for a missed medication intake!

Overdose

Symptoms:  nausea, vomiting, abdominal pain, diarrhea, impaired water and electrolyte balance; possible agitation, insomnia.

There are no reports of fatal or life-threatening adverse events with overdose of the drug.

Treatment:  symptomatic; gastric lavage and intake of an absorbent are effective if the drug was taken no more than 4 hours ago. Hemodialysis is effective.

Description

Antibiotic-penicillin semi-synthetic + beta-lactamase inhibitor

Description

Tablets are oval, biconvex, film-coated from white to almost white in color, with a risk on one side. On the break — yellowish color.

Functional features

The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Both components are well absorbed after ingestion; food intake does not affect the degree of absorption. Bioavailability is 90% for amoxicillin and 70% for clavulanic acid. Peak plasma concentrations are reached approximately 2 to 2.5 hours after use. The maximum concentration of amoxicillin in the blood (Cmax) is about 12 mcg / ml, clavulanic acid-3.3 mcg/ml. The half-life (half-life) of amoxicillin and clavulanic acid is 1-1.5 hours. Plasma protein binding: amoxicillin — about 18%, clavulanic acid-25%. The 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 secretions: amoxicillin — in lung tissue, bronchial secretions and saliva; in skin, subcutaneous, muscle and fat tissues, in palatine tonsils; in bone tissue and synovial fluid;intestinal mucosa, liver, gallbladder, bile, female genitalia, fetal tissues; pleural and peritoneal fluid, the contents of skin blisters, phlegm, bronchial secretions(to a lesser extent in purulent discharge), exudate in inflammation of the middle ear and paranasal sinuses; clavulanic acid — in the palatine tonsils, abdominal organs, bone, muscle and adipose tissues, synovial and peritoneal fluids, bile and purulent discharge. Neither the active components of Panclav 2 X nor their metabolites accumulate in any organs and tissues. Amoxicillin and clavulanic acid do not cross the unchanged blood-brain barrier. Amoxicillin and clavulanic acid pass through the placental barrier and into breast milk. Amoxicillin is partially (10-25% of the absorbed dose) metabolized to inactive penicillic acid; clavulanic acid is extensively metabolized, its metabolites are eliminated from the body through the kidneys, intestines and lungs. Amoxicillin is mainly excreted by the kidneys through tubular secretion and glomerular filtration. The total clearance of the amoxicillin/clavulanic acid combination is 25 l/h.Within 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 by hemodialysis, to a lesser extent by peritoneal dialysis. Elderly patients: due to the possible age-related decrease in excretory function of the kidneys, it is recommended to use with caution. In patients with severe renal insufficiency, the elimination half-life is extended to 7.5 hours for amoxicillin and 4.5 hours for clavulanic acid.

Result

Panclav 2X is a combination of amoxicillin, a semisynthetic penicillin with a broad spectrum of antibacterial activity, and clavulanic acid, an irreversible beta-lactamase inhibitor. Amoxicillin-semi-synthetic aminopenicillin, a broad-spectrum bactericidal agent, belongs to the group of beta-lactam antibiotics. It inhibits transpeptidase, disrupts the synthesis of peptidoglycan (a cell wall support protein) during division and growth, and causes bacterial lysis. Clavulanic acid is an inhibitor of beta-lactamases, enzymes produced by certain bacteria that destroy penicillins and other beta-lactam antibiotics. The addition of clavulanic acid to amoxicillin, preventing inactivation of the antibiotic, expands the spectrum of its action due to microorganisms whose resistance to amoxicillin is due to the production of beta-lactamases. Clavulanic acid forms a stable inactive complex with beta-lactamases and protects amoxicillin from loss of antibacterial activity caused by the production of beta-lactamases by both major pathogens and co-pathogens, as well as conditionally pathogenic microorganisms. In addition, clavulanic acid has a weak intrinsic antibacterial activity. Panclav 2 X has a broad spectrum of action, is active against microorganisms sensitive to amoxicillin, including strains that produce beta-lactamases: gram-positive aerobes:Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus viridans group, Streptococcus bovis, Staphylococcus aureus (except methicillinresistant strains), Staphylococcus epidermidis(except methicillinresistant 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.

Complete set

Film-coated tablets,875 mg+125 mg. 14 tablets in a brown glass jar (type III), sealed with a plastic lid with silica gel and first opening control. 1 jar with instructions for use in a cardboard pack.

Special instructions

With a long course of treatment, it is necessary to monitor the state of function of the hematopoietic organs, liver and kidneys.

In patients with severe renal impairment, an adequate dose adjustment or an increase in the intervals between doses of the drug is required.

Bacterial or fungal superinfection (Pseudomonas spp., Candida albicans) may develop due to the growth of microflora that is insensitive to the drug, which requires changes in antibacterial therapy.

In order to prevent the development of crystalluria, the drug should be washed down with a relatively large amount of water (0.5-1 glass).

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

Pseudomembranous colitis may develop during drug therapy as a result of exposure to the C. Difficile toxin.

If you develop severe diarrhea, as well as if diarrhea lasts 2-3 days, you should consult a doctor as soon as possible.

With the development of mild diarrhea on the background of Panclav 2 X, antidiarrheal drugs that inhibit intestinal motility should be avoided; kaolin or attapulgite-containing antidiarrheal agents can be used.

In patients with hypersensitivity to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible.

It is not recommended to use Panclav 2 X for infectious mononucleosis and if it is suspected, since the drug can cause an erythematous skin rash, which aggravates the symptoms of the disease, and also complicates diagnosis.

Caution should be exercised when prescribing Panclav 2 to patients with hepatic insufficiency and regular laboratory monitoring of liver function should be ensured.

If you experience jaundice of the skin, whites of the eyes, darkening of the color of urine and / or lightening of the stool, you should immediately consult a doctor.

During the treatment period, it is recommended to use caution when driving vehicles and engaging in other potentially dangerous activities, due to the possibility of developing dizziness.

On a doctor’s prescription.

Form of production

Film-coated tablets.

Storage conditions

Store at a temperature not exceeding 30 ° C in the original packaging. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Amoxicillin, Clavulanic Acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

Pregnant women as prescribed by a doctor, Children over 12 years of age, Children as prescribed by a doctor, Adults as prescribed by a doctor, Nursing mothers as prescribed by a doctor

Indications

Osteomyelitis, Otitis Media, Periodontitis, Sinusitis, Urinary Tract Infections, Pharyngitis, Cholecystitis, Tonsillitis, Skin Infections, Bronchitis, Pneumonia, Sore Throat