Composition, form of production and packaging
The tablets covered with a film shell of white color, oval, biconcave.
1 tab.
amoxicillin (in the form of amoxicillin trihydrate) 250 mg
clavulanic acid (in the form of potassium clavulanate) 125 mg
Excipients: silicon colloidal dioxide - 6.5 mg, sodium carboxymethyl starch - 13 mg, microcrystalline cellulose - 247.75 mg, magnesium stearate - 9.75 mg.
The composition of the shell: hypromellose - 13.589 mg, propylene glycol - 2.718 mg, titanium dioxide (E171) - 9.693 mg.
15 pcs. - banks of dark glass (1) - packs of cardboard.
20 pcs. - banks of dark glass (1) - packs of cardboard.
The tablets covered with a film shell of white color, oval, biconcave, with embossed letters "A" and "K" and risk on one side.
1 tab.
amoxicillin (in the form of amoxicillin trihydrate) 500 mg
clavulanic acid (in the form of potassium clavulanate) 125 mg
Excipients: silicon colloidal dioxide - 10.5 mg, sodium carboxymethyl starch - 21.05 mg, microcrystalline cellulose - 382.65 mg, magnesium stearate - 10.8 mg.
Sheath composition: hypromellose - 21.951 mg, propylene glycol - 4.39 mg, titanium dioxide (E171) - 15.659 mg.
15 pcs. - banks of dark glass (1) - packs of cardboard.
20 pcs. - banks of dark glass (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Broad-spectrum antibiotic; contains semi-synthetic penicillin amoxicillin and an inhibitor of О±-lactamase clavulanic acid. Clavulanic acid inhibits the majority of clinically significant ОІ-lactamases (types II, III, IV and V - according to the Richmond-Sykes classification). It is inactive with respect to ОІ-lactamases of 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 ОІ-lactamases, both the main pathogens and co-pathogens, and conditionally pathogenic microorganisms.
This combination provides high bactericidal activity of Panklava.
Panklava has a broad spectrum of antibacterial action. It is active in relation to both strains sensitive to amoxicillin and against strains producing ОІ-lactamase.
Panklave is active against aerobic Gram-positive bacteria: Streptococcus pneumoniae, Streptococcus viridans, Streptococcus pyogenes, Streptococcus bovis, Staphylococcus aureus (except methicillin-resistant strains), Staphylococcus epidermidis (except methicillin-resistant strains), 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
The main pharmacokinetic parameters of amoxicillin and clavulanic acid are similar.
Suction
After oral administration, both components of the drug are rapidly absorbed from the digestive tract. Simultaneous food intake does not affect the degree of absorption. C max in blood plasma are achieved approximately 1 hour after administration.
Distribution
The degree of binding to plasma proteins is low. Both components are characterized by a high volume of distribution in body fluids and tissues (in lung tissue, in the middle ear, in the pleural and peritoneal fluid, in the uterus, in the ovaries). Amoxicillin also penetrates into the synovial fluid, the liver, the prostate, palatine tonsils, muscle tissue, gall bladder, the secret of the paranasal sinuses, saliva and bronchial secretions.
Active substances do not penetrate through the BBB in uninflated meninges, in trace concentrations are excreted in breast milk, penetrate the placental barrier.
Metabolism
Amoxicillin is partially metabolized, clavulanic acid undergoes, apparently, intensive metabolism.
Excretion
T 1/2 amoxicillin and clavulanic acid is 1-1.5 hours. Amoxicillin is excreted by the kidneys practically unchanged through tubular secretion and glomerular filtration.Clavulanic acid is mainly excreted by the kidneys through glomerular filtration, in part - in the form of metabolites. Small amounts can be excreted through the intestine or lungs.
Pharmacokinetics in special clinical cases
If the renal function is impaired, the renal and extrarenal clearance of both components decreases, which leads to their cumulation in the plasma.
In patients with severe renal insufficiency, severe T 1/2 amoxicillin is increased to 7.5 h, clavulanic acid - up to 4.5 h.
Both components are removed by hemodialysis, insignificant amounts by peritoneal dialysis.
INDICATIONS
Infectious-inflammatory diseases caused by microorganisms sensitive to the preparation:
- infections of the upper respiratory tract and ENT organs (acute and chronic sinusitis, acute and chronic otitis media, tonsillitis, pharyngitis);
- infections of the lower respiratory tract (acute and chronic bronchitis and pneumonia, empyema of the pleura);
- urinary tract infections (including cystitis, urethritis, pyelonephritis);
- infections in gynecology (including salpingitis, salpingoophoritis, endometritis, septic abortion);
- infections of bones and joints (including chronic osteomyelitis);
- infections of the skin and soft tissues (including phlegmon, wound infection);
- biliary tract infections (including cholecystitis, cholangitis);
- Gonorrhea;
- chancroid;
odontogenic infections.
DOSING MODE
Inside adults and children over 12 years of age (or with a body weight of more than 40 kg) with a mild and moderate infection are prescribed 1 tab. 250 mg / 125 mg 3 times / day. In severe infections , 1 tablet is prescribed. 500 mg / 125 mg 3 times / day.
The maximum daily dose of clavulanic acid (in the form of potassium salt) is 600 mg for adults , 10 mg / kg for children .
The maximum daily dose of amoxicillin is 6 g for adults , 45 mg / kg for children .
The course of treatment is 5-14 days. Treatment should not be continued for more than 14 days without a second medical examination.
For odontogenic infections, the recommended dose is 1 tablet. 500 mg / 125 mg every 12 hours for 5 days.
Patients with renal insufficiency of moderate severity (CK from 10 to 30 ml / min) the recommended dose is 1 tab. 500 mg / 125 mg 2 times / day for severe infection and 1 tab. 250 mg / 125 mg 2 times / day for mild and moderate flow. Patients with severe renal insufficiency (CC less than 10 ml / min) are prescribed 1 tab. 500 mg / 125 mg 1 time / day for severe infection and 1 tab. 250 mg / 125 mg 1 time / day for mild and moderate flow.
In anuria, the interval between doses should be increased to 48 hours or more.
Tablets should be taken orally while eating, without chewing, with a small amount of water.
It should be remembered that 2 tab. Panclava 250 mg / 125 mg is not equivalent to 1 tablet. 500 mg / 125 mg; they contain different amounts of clavulanic acid.
SIDE EFFECT
On the part of the digestive system: nausea, vomiting, diarrhea, increased activity of hepatic transaminases and impaired liver function, stomatitis; in isolated cases - a moderate asymptomatic increase in the activity of hepatic transaminases and alkaline phosphatase, cholestatic jaundice, hepatitis, pseudomembranous colitis.
Allergic reactions: urticaria, skin itch, erythematous rashes; rarely - erythema multiforme, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, serum sickness, Quincke's edema; extremely rare - exfoliative dermatitis, Stevens-Johnson syndrome, anaphylactic shock.
From the side of the central nervous system: dizziness, headache, convulsions (convulsions can occur if the kidney function is impaired or in patients receiving high doses of Panklava).
Other: candidiasis of skin and mucous membranes, development of superinfection, reversible increase in prothrombin time, vaginitis, interstitial nephritis.
CONTRAINDICATIONS
- infectious mononucleosis (including when there is a measles-like rash);
- Children under 12 years of age (for this dosage form);
- Hypersensitivity to penicillins, cephalosporins, other beta-lactam antibiotics and other components of the drug.
With caution apply the drug during pregnancy, during lactation, in patients with severe hepatic insufficiency, chronic renal failure, gastrointestinal diseases (including colitis in history, associated with the use of penicillins).
PREGNANCY AND LACTATION
The use of Panklave during pregnancy and lactation is possible only if the intended benefit to the mother exceeds the potential risk to the fetus.
If you need to use the drug during lactation, you should decide whether to stop breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Patients with renal insufficiency (KC from 10 to 30 ml / min) the recommended dose is 1 tab. 500 mg every 12 hours, patients with renal insufficiency (CC less than 10 ml / min) - 1 tab. 500 mg every 24 hours.
In anuria, the interval between doses should be increased to 48 hours or more.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Be wary appoint patients with severe hepatic insufficiency.
APPLICATION FOR CHILDREN
Contraindication: children under 12 years.
SPECIAL INSTRUCTIONS
In course treatment it is necessary to monitor the condition of hematopoiesis, liver and kidney functions.
In order to reduce the risk of developing dyspeptic side effects, you should take the drug while eating.
It is possible to develop superinfection due to the growth of insensitive microflora, which requires a corresponding change in antibacterial therapy.
In patients who are hypersensitive to penicillins, there may be cross-allergic reactions with cephalosporin antibiotics.
Reception Panklava leads to the appearance of amoxicillin in the urine. High concentrations of amoxicillin give a false positive response to the detection of glucose in the urine using a Benedict reagent or Felling solution. It is recommended to use enzymatic reactions with glucose oxidase.
Impact on the ability to drive vehicles and manage mechanisms
The Panklave drug does not affect the ability to drive vehicles and control mechanisms.
OVERDOSE
Symptoms: nausea, vomiting; possibly - arousal, insomnia; in rare cases - convulsive seizures, a violation of the water-electrolyte balance.
Treatment: when taking the drug less than 4 hours ago - washing the stomach, absorbent. Hemodialysis is effective.
DRUG INTERACTION
Antacids, glucosamine, laxatives, aminoglycosides slow the absorption of Panclav, ascorbic acid - increases.
With the simultaneous use of Panklava with bactericidal antibiotics (including aminoglycosides, cephalosporins, cycloserine, vancomycin, rifampicin), synergy is observed; with bacteriostatic drugs (macrolides, chloramphenicol, lincosamides, tetracyclines, sulfonamides) - the antagonism of the action.
With a simultaneous appointment, Panclav improves 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.
When combined with Panklava, the effectiveness of oral contraceptives decreases; with ethinyl estradiol - increases the risk of bleeding "breakthrough".
Panklava reduces the effectiveness of drugs, in the process of metabolism which forms PABC.
Diuretics, allopurinol, phenylbutazone, NSAIDs and other drugs that block tubular secretion, increase the concentration of amoxicillin (clavulanic acid is excreted mainly by glomerular filtration).
The simultaneous use of Panklava with allopurinol increases the risk of skin rash.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children, dry, protected from light at a temperature of 15 В° to 25 В° C. Shelf life - 2 years.
