Panclave 2X tablets 875 mg + 125 mg 14 pcs. in Novosibirsk

Pharmacological properties of the drug Panklav

Pharmacodynamics. Panclave is a combination drug of amoxicillin and clavulanic acid. Amoxicillin is a semi-synthetic penicillin with a wide spectrum of antibacterial activity. It has a bactericidal effect on gram-positive and gram-negative microorganisms. Resistant to the action of gastric juice, unstable to the action of bacterial beta-lactamases. Clavulanic acid is a beta-lactamase inhibitor; it forms a stable inactivated complex with it, protecting amoxicillin from a decrease in antibacterial activity caused by the action of this enzyme. This combination provides high bactericidal activity of Panklav against both amoxicillin-sensitive strains and strains that produce beta-lactamases. Panclave is active regarding:

• aerobic gram-positive bacteria: Streptococcus pneumonie, Streptococcus pyogenes, Streptococcus viridans, Streptococcus bovis, Staphylococcus epidermidis (except methicillin-resistant strains), Staphylococcus aureus (except methicillin-resistant strains), Corynobacterium spp., Enterococcus spp., Listeria monocytogenes;
• aerobic gram-negative bacteria: Bordetella pertussis, Brucella spp., Campylobacter jejuni, Campylobacter coli, Escherichia coli, Gardnerela vaginalis, Haemophilus influenzae, Haemophilus ducreyi, Helicobacter pylori, Klebsiella spp., Moraxella catarrhalis, Naisseria gonorrhoeae, Naisseria meningitides, Pasteurela multocida, Proteus spp. ., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica;
• anaerobic bacteria: Actinomyces israelii, Bacteroides spp., Clostridium spp., Peptostreptococcus spp., Peptococcus spp. The combination of amoxicillin and clavulanic acid should not be prescribed for infections for which amoxicillin alone is effective.

Pharmacokinetics. After oral administration, both components of the drug are rapidly absorbed, the maximum concentration in the blood plasma is reached 1 hour after administration. The presence of food does not affect the absorption of active substances. Both components penetrate well into most tissues and body fluids, through the placental barrier, in meningitis - through the BBB, and are detected in trace amounts in breast milk. The half-life of amoxicillin is about 1.3 hours, clavulanic acid - 1 hour. With a decrease in kidney function, this period lengthens. About 60% of amoxicillin and approximately 30% of clavulanic acid are excreted in the urine within 6 hours.

Panclave 2X 875 mg/125 mg amoxicillin + clavulanic acid, 14 film-coated tablets

Registration Certificate Holder

HEMOFARM (Serbia)

Dosage form

Medicine – Panklav 2X (Panklav 2X)

Description

Film-coated tablets

from white to almost white, oval, biconvex, with a notch on one side; On a cross section, the kernel is almost white to white with a yellowish tint.

1 tab.

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

Excipients

: microcrystalline cellulose, sodium carboxymethyl starch (type A), magnesium stearate, colloidal anhydrous silicon dioxide, butylated hydroxyanisole.

Excipients (shell):

hypromellose, titanium dioxide, propylene glycol, talc.

14 pcs. — dark glass jars with first opening control (1) — cardboard packs.

Indications

Infectious and 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);
• lower respiratory tract infections (acute bronchitis with bacterial superinfection, exacerbation of chronic bronchitis, pneumonia);
• urinary tract infections;
• pelvic organ infections;
• infections of the skin and soft tissues (including after animal and human bites);
• infections of bones and joints (including osteomyelitis);
• biliary tract infections (cholecystitis, cholangitis);
• infections in dentistry.

Contraindications for use

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

With caution
: Liver failure, chronic renal failure (creatinine clearance more than 30 ml/min), history of pseudomembranous colitis, old age (over 65 years, hyperkalemia, pregnancy.

pharmachologic effect

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

Amoxicillin is a semisynthetic aminopenicillin, a broad-spectrum bactericidal agent, belongs to the group of beta-lactam antibiotics. Inhibits transpeptidase, disrupts the synthesis of peptidoglycan (supporting protein of the cell wall) during division and growth, and causes lysis of bacteria.

Clavulanic acid is an inhibitor of β-lactamases - enzymes produced by some bacteria and destroying penicillins and other (3-lactam antibiotics. The addition of clavulanic acid to amoxicillin, preventing inactivation of the antibiotic, expands its spectrum of action due to microorganisms whose resistance to amoxicillin is due to the production of β- lactamase 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 by both the main pathogens and co-pathogens and opportunistic microorganisms. In addition, clavulanic acid has weak intrinsic antibacterial activity.

Panclave 2X has a wide spectrum of action, is active against amoxicillin-sensitive microorganisms, including strains that produce β-lactamases: gram-positive aerobes: Streptococcus pneumoniae, Streptococcus pyogenes, viridans group Streptococcus, Streptococcus bovis, Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis ( except for methicillin-resistant strains), Staphylococcus saprophytics, Listeria monocytogenes, Enteroccocus spp.;

gram -negative aerobes: bordetella perussis, Brucella spp., Campylobacter Jejuni, Escherichia Coli, Gardnerella vaginalis, Haemophilus Influenzae, Haemophilus Ducreyi, KlebsIella SPP. Oraxella 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.

Drug interactions

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 intestinal microflora, reduces the synthesis of vitamin K and the prothrombin index). When taking anticoagulants simultaneously, it is necessary to monitor blood clotting indicators.

Reduces the effectiveness of oral contraceptives, drugs, during the metabolism of which para-aminobenzoic acid is formed, ethinyl estradiol - the risk of developing “breakthrough” bleeding.

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

Allopurinol increases the risk of developing skin rashes.

Dosage regimen

Inside, 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 doses of 12 hours.

Adults and children over 12 years old.

Adults and children over 12 years old (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; is established individually, taking into account the characteristics of the pathogen, localization and severity of the infection.

Dosing for renal failure

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

Patients on peritoneal dialysis do not require dose adjustment. Patients on hemodialysis may require dose adjustment of the drug.

Important! If a dose is missed, you should take the tablet as soon as possible without waiting for the next dose. Next, observe equal intervals of time between doses - 12 hours each. Never take a double dose to make up for a missed dose of medication!

Overdose

Symptoms:

nausea, vomiting, abdominal pain, diarrhea, water and electrolyte imbalance; possible agitation, insomnia; There are isolated cases of the development of seizures and crystalluria in patients with initially impaired renal function. There are no reports of death or life-threatening adverse events following an overdose of the drug.

Treatment:

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

Side effect

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; uncommon - dyspepsia, moderate asymptomatic increase in the activity of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase and/or increase in bilirubin concentration; rarely - pseudomembranous colitis, discoloration of teeth (reversible, removed with 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.

From the hematopoietic organs:

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, itching; rarely - erythema multiforme; frequency not known - angioedema, anaphylaxis, allergic vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), bullous exfoliative dermatitis, acute generalized exanthematous pustules, a syndrome similar to serum sickness.

Other:

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

special instructions

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

In patients with severe renal impairment, adequate dose adjustment or increased intervals between doses of the drug are required.

In order to reduce the risk of side effects from the gastrointestinal tract, the drug should be taken at the beginning of a meal.

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

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

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

During drug therapy, pseudomembranous colitis may develop as a result of exposure to C. Difficile toxin. If severe diarrhea develops, or if the diarrhea lasts for 2-3 days, you should consult a doctor as soon as possible. If mild diarrhea develops against the background of Panclava 2X, antidiarrheal drugs that inhibit intestinal motility should be avoided; You can use kaolin or attapulgite-containing antidiarrheals.

Since Panclave 2X contains potassium, caution is recommended when prescribing it to patients with baseline hyperkalemia.

It is recommended to exercise caution when prescribing Panclava 2X to patients with liver failure and ensure regular laboratory monitoring of liver function.

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

In patients who are hypersensitive to penicillins, cross-allergic reactions with cephalosporin antibiotics are possible. It is not recommended to use Panclave 2X for infectious mononucleosis or if it is suspected, since the drug can cause an erythematous skin rash, which aggravates the symptoms of the disease / complicates diagnosis.

Newborns born to mothers receiving prophylactic therapy with amoxicillin/clavulanic acid for premature rupture of membranes (membrane sac) during preterm pregnancy have an increased risk of developing necrotizing enterocolitis.
Impact on the ability to drive vehicles and operate machinery
During the treatment period, it is recommended to be careful when driving vehicles and engaging in other potentially hazardous activities, since dizziness may develop.

Storage conditions

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

Best before date

Shelf life: 2 years.

Use during pregnancy and breastfeeding

Restrictions during pregnancy - With caution. Restrictions during breastfeeding - Contraindicated. Can be used during pregnancy when the benefit of its use for the mother significantly outweighs the risk to the fetus. If it is necessary to use the drug during lactation, breastfeeding is suspended.

Use for renal impairment

Restrictions for impaired renal function - With caution.

Contraindicated in case of impaired renal function (creatinine clearance less than 30 ml/min); use with caution in chronic renal failure (creatinine clearance more than 30 ml/min),

Use for liver dysfunction

Restrictions for liver dysfunction - With caution.

Contraindicated in case of liver dysfunction. Use the drug with caution in case of liver failure.

Use in elderly patients

Restrictions for elderly patients - With caution. Due to the possible age-related (over 65 years) decrease in renal excretory function, use with caution is recommended.

Use in children

Restrictions for children - Contraindicated.

Contraindicated for children under 12 years of age and children weighing less than 40 kg.

Terms of sale

On prescription.

Contacts for inquiries

STADA (Russia)

603950 Nizhny Novgorod st. Salganskaya, 7 Tel. Fax E-mail

Indications for use of the drug Panklav

Infectious and inflammatory diseases caused by microorganisms sensitive to the drug:

• infections of the ENT organs and upper respiratory tract (acute and chronic sinusitis, otitis media, tonsillitis, pharyngitis);
• lower respiratory tract infections (acute and chronic bronchitis, pneumonia);
• infections of the genitourinary system (cystitis, urethritis, pyelonephritis, salpingitis, salpingoophoritis, endometritis, bacterial vaginitis, postpartum sepsis, septic abortion, pelvioperitonitis, gonorrhea, chancroid);
• infections of bones and joints (including chronic osteomyelitis);
• infections of the skin and soft tissues (including cellulitis, wound infection);
• biliary tract infections (including cholecystitis, cholangitis);
• surgical infections;
• dental infections (during preparation for surgery);
• prevention of infectious and inflammatory complications during operations on the abdominal organs, pelvis, heart, kidneys, and maxillofacial surgery).

Nosological classification (ICD-10)

• H66.9 Otitis media, unspecified
• J01 Acute sinusitis
• J02 Acute pharyngitis
• J03 Acute tonsillitis [tonsillitis]
• J06 Acute upper respiratory tract infections of multiple and unspecified localization
• J18 Pneumonia without specifying the pathogen
• J20 Acute bronchitis
• J22 Acute respiratory infection of the lower respiratory tract, unspecified
• J31.2 Chronic pharyngitis
• J32 Chronic sinusitis
• J35.0 Chronic tonsillitis
• J36 Peritonsillar abscess
• J42 Chronic bronchitis, unspecified
• K81 Cholecystitis
• K83.0 Cholangitis
• L08.9 Local infection of skin and subcutaneous tissue, unspecified
• M00.9 Pyogenic arthritis, unspecified (infectious)
• M79.9 Soft tissue disease, unspecified
• M86 Osteomyelitis
• M89.9 Bone disease, unspecified
• N39.0 Urinary tract infection without established location
• N73.9 Inflammatory diseases of the female pelvic organs, unspecified
• Z01.2 Dental examination

Use of the drug Panklav

Adults and children over 12 years of age (or weighing more than 40 kg) are prescribed 1 tablet of Panclava 500 mg/125 mg 2–3 times a day, depending on the severity of the infectious disease, or 1 tablet of Panclava 875 mg/125 mg 2 once a day (every 12 hours). The maximum daily dose of amoxicillin is 6 g for adults and 45 mg/kg body weight for children. The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults and 10 mg/kg body weight for children. The tablets should be taken with meals, without chewing, with a small amount of water. The course of treatment is 5–14 days. Treatment should not be continued for more than 14 days without repeated medical examination. Dosing for renal failure The dose of the drug depends on creatinine clearance. If creatinine clearance is 10–30 ml/min, prescribe 1 tablet of Panclava 500 mg/125 mg every 12 hours; if creatinine clearance is less than 10 ml/min, prescribe 1 tablet of Panclava 500 mg/125 mg every 24 hours. For anuria, the interval between dosing should be increased to 48 hours or more.

Compound

Side effects of the drug Panklav

The drug is usually well tolerated. Side effects are rare and transient. From the gastrointestinal tract: diarrhea, nausea, vomiting, colitis (especially in children), candidiasis of the mucous membranes. Hypersensitivity reactions: skin rash, itching, urticaria, rarely - angioedema, anaphylactic reactions, interstitial nephritis. From the kidneys: rarely - crystalluria. From the liver: moderate increase in liver enzymes, rarely - hepatitis, cholestatic jaundice. From the blood system: very rarely - reversible leukopenia, thrombocytopenia, hemolytic anemia, reversible increase in prothrombin time. From the central nervous system: dizziness, headache, convulsions, fear, insomnia.

Special instructions for the use of the drug Panklav

Panclave is prescribed with extreme caution to patients with a history of allergies, including to cephalosporins (due to the possibility of a cross-reaction). The drug is used with extreme caution in patients with renal or hepatic insufficiency, and regular laboratory monitoring is recommended. Panclave 875 mg/125 mg is not prescribed to patients with creatinine clearance ≤30 ml/min. In patients with infectious mononucleosis or lymphocytic leukemia, it is not recommended to use the drug due to the possible appearance of a skin rash. During treatment, there is a possibility of developing superinfection with bacteria or fungi (for example Pseudomonas spp., Candida albicans ). In this case, you must stop using the drug. Due to the possibility of crystalluria, it is recommended to drink large amounts of fluid while taking the drug. If the amount of urine decreases, you should consult a doctor. The drug contains potassium, so it is recommended to prescribe it with caution to patients on a diet with a reduced potassium content (for example, with hyperkalemia). In order to reduce the risk of developing dyspeptic side effects, the drug should be taken with meals. During pregnancy and breastfeeding. Use in case of emergency. Since Panclave is excreted in breast milk and can cause allergic reactions in an infant, the drug is recommended to be used with caution during breastfeeding. Effect on laboratory tests. When determining glucosuria by chemical methods, due to the high concentration of the drug in the urine, a false positive result can be obtained (therefore, during drug therapy, enzymatic methods should be used to determine the amount of glucose in the urine). A false positive result from the Coombs test may occur. Use of amoxicillin or a combination of amoxicillin and clavulanic acid during pregnancy may reduce the concentration of total conjugated estriol, estriol glucuronoid, conjugated estrone and estradiol in the blood plasma.

Release form

Film-coated tablets, 875 mg + 125 mg. 14 tablets each. in a brown glass jar (type III), sealed with a plastic lid with silica gel and tamper evident. 1 jar is placed in a cardboard pack.

Powder for the preparation of suspension for oral administration, (400 mg + 57 mg)/5 ml. 15 g or 30 g of powder in a glass bottle of III hydrolytic class, sealed with a screw-on plastic cap with first opening control. On the top side of the cap there is a diagram for opening the bottle. 1 fl. complete with a measuring spoon, volume 5 ml, with a line for volume 2.5 ml, placed in a cardboard pack.

Interactions of the drug Panklav

The simultaneous use of Panclave with magnesium hydroxide or aluminum hydroxide causes a decrease in the resorption of amoxicillin; with cimetidine - increases the concentration and increases the half-life of amoxicillin and clavulanic acid. Probenecid slows down the elimination of amoxicillin from the body and increases its concentration in the blood without affecting the level of clavulanic acid. In patients taking anticoagulants, the use of the drug may cause prolongation of the bleeding period and prothrombin time. Concomitant use with allopurinol increases the incidence of skin rash; with oral contraceptives - reduces the effectiveness of the latter. In combination with aminoglycosides, amoxicillin exhibits a synergistic antibacterial effect against a larger number of bacteria, including enterococci and group B streptococci. Simultaneous use with bacteriostatic antibiotics (for example, chloramphenicol, macrolides, tetracyclines) can reduce the bactericidal effect of amoxicillin. Rifampicin reduces the effectiveness of the drug.

Overdose of the drug Panklav, symptoms and treatment

Unlikely. Taking the drug in a high dose can cause gastrointestinal complications (abdominal pain, nausea, vomiting, diarrhea). Rarely, skin rash, hyperactivity or drowsiness, and convulsions appear. When prescribed in high doses, amoxicillin can concentrate in the urine, which is why crystalluria is likely to occur. To prevent this, you should drink a large amount of fluid, which will ensure the necessary removal of the drug. Treatment: drug withdrawal and symptomatic therapy. Particular attention should be paid to maintaining water and electrolyte balance. If no more than 4 hours have passed since the poisoning and there are no complications, you can induce vomiting, rinse the stomach and use activated charcoal. Amoxicillin and clavulanic acid are removed from the bloodstream during hemodialysis.