Trade name
Klavam 1000
International unlicensed name
Are not present
the Dosage form
of the Tablet, film coated, 1000 mg
Structure
One tablet contains
active agents: amoxicillin 875.000
(in the form of trihydrate amoxicillin ** 1029.413)
clavulanic acid
125.000 (in the form of clavulanate potassium in mix
in avitsely (1: 1) ***) 305.025 mg)
excipients: sodium of a kroskarmeloz, silicon dioxide colloidal anhydrous, the talc purified magnesium stearate.
structure of a cover: hydroksipropilmetiltsellyuloza of E-5, ethyl cellulose,
diethyl phthalate, talc, titan dioxide (E171), hydroksipropilmetiltsellyuloza of E-15, polyethyleneglycol 6000.
Description
of the Tablet, oblong shape, biconvex surface, film coated white color.
Pharmacotherapeutic group
Beta laktamnye antibacterial drugs – Penicillin.
Penicillin in a combination with inhibitors beta laktamaz.
The ATX J01CR02 code
the Pharmacological
Pharmacokinetics Key Pharmacokinetic Parameters properties of amoxicillin and clavulanic acid are similar. Amoxicillin and clavulanic acid in a combination do not influence at each other.
Absorption: after intake both components of drug are quickly absorbed from digestive tract. The concomitant use of food does not influence absorption.
Distribution: the maximum concentration in blood plasma is reached approximately in 1 h and makes for amoxicillin (depending on a dose) 3-12 mkg/ml, for clavulanic acid – 2 mkg/ml. Both components are characterized by the good volume of distribution in liquids and body tissues (lungs, a middle ear, pleural and peritoneal liquids, a uterus, ovaries). Amoxicillin also gets into synovial fluid, a liver, a prostate, palatine tonsils, muscle tissue, a gall bladder, secretion of adnexal bosoms of a nose, saliva, bronchial secretion. Get through a blood-brain barrier at the inflamed meninx. The maximum concentration in liquids of an organism is observed in 1 h after achievement of the maximum concentration in blood plasma.
Active agents in low concentration are emitted with breast milk, get through a placental barrier. Linking with proteins of blood plasma for amoxicillin makes 17-20%, for clavulanic acid - 22-30%.
Removal: amoxicillin is removed generally by kidneys by canalicular secretion and glomerular filtration. Clavulanic acid is actively metabolized in a liver and removed by glomerular filtration, partially in the form of metabolites. Small amounts can be removed through intestines and lungs. Elimination half-life of amoxicillin makes 1-1.3 h, clavulanic acid – 1.2 h.
In a renal failure the removal of drug is slowed down therefore correction of the mode of dosing (dose decline and increase in intervals between administrations of drug) is necessary.
The pharmacodynamics
Klavam 1000 an antibiotic of a broad spectrum of activity, contains semi-synthetic penicillin amoxicillin and inhibitor beta laktamaz clavulanic acid. Clavulanic acid inhibits the majority clinically significant beta laktamaz, the produced Staphylococcus spp., Escherichia coli, Proteus mirabilis, Haemophilus influenzae, Moraxella catarrhalis, Bacteroides spp. It is inactive concerning a beta laktamaz of 1 type produced by Enterobacter spp., Morganella morganii, Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.
This combination provides high bactericidal activity of Klavam (including concerning strains of the microorganisms resistant to amoxicillin). Clavulanic acid, having higher affinity to a beta laktamaze, than amoxicillin, forms the stable deactivated complex with enzyme, interfering with enzymatic degradation of amoxicillin under the influence of a beta laktamaz.
Thus, Klavam affects bakteritsidno a wide range of gram-positive and gram-negative bacteria (including strains which gained resistance to a beta laktamnym to antibiotics owing to products beta laktamaz).
Klavam is active concerning aerobic gram-positive bacteria: Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus viridans, Streptococcus milleri, Streptococcus pyogenes, Streptococcus bovis), Enterococcus faecium, Staphylococcus aureus (except Methicillinum - resistant strains), Staphylococcus epidermidis (except Methicillinum - resistant strains), Corynebacterium spp., Listeria monocytogenes, Nocardia asteroides, aerobic gram-negative bacteria: Aeromonas spp., Bordetella pertussis, Brucella spp., Campylobacter jejuni, Campylobacter coli, Citrobacter spp. (are moderately sensitive), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Klebsiella spp., Legionella pneumophila, Moraxella catarrhalis, Morganella spp. (are moderately sensitive), Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Providencia spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica (is moderately sensitive), anaerobic bacteria: Actinomyces israelii, Bacteroides spp. (including Bacteroides fragilis), Prevotella melaninogenica, Clostridium spp. (except Clostridium difficile), Peptostreptococcus spp., Eikenella corrodens, Fusobacterium spp., Propionibacterium spp., Treponema pallidum.
Mycobacterium chelonae is resistant to drug.
Indications
the Infectious and inflammatory diseases caused by microorganisms, sensitive to drug:
- an infection of upper parts of airways (including acute and chronic sinusitis, retropharyngeal abscess, tonsillitis, pharyngitis)
- infections of lower parts of airways (including acute and chronic bronchitis with bacterial superinfection, pneumonia)
- acute and chronic otitis
- infections of urinary tract
- gynecologic infections
- infections of skin and soft tissues
- infections of bones and joints
- infections of bilious ways (cholecystitis, a cholangitis)
- shankroid
- gonorrhea
- dontogenous infections.
The route of administration and doses
the Mode of dosing is set individually depending on age, body weight, function of kidneys and also from severity of an infection. Klavam is recommended to accept at the beginning of food. It is not necessary to continue treatment more than 14 days without repeated assessment of a condition of the patient. Klavam is recommended to apply to decrease in possible gastrointestinal disorders just before food.
Adults and teenagers (12 years and with body weight not less than 40 kg are more senior). A standard dose one tablet of 1000 mg each 12 hours or one tablet of 625 mg makes two or three times a day (depending on weight of an infection): In slight and medium-weight infections one tablet of 625 mg each 12 hours, and in heavier infections one tablet of 625 mg each 8 hours.
The maximum daily dose of amoxicillin makes 6 g for the adult and 45 mg/kg of body weight for children.
The maximum daily dose of clavulanic acid (in the form of potassium salt) makes 600 mg for the adult and 10 mg/kg of body weight for children.
A renal failure
- insignificant dysfunction (clearance of creatinine & gt, 30 ml/min.): the dose does not change.
- moderate dysfunction (clearance of creatinine of 10-30 ml/min.): one tablet of 625 mg each 12 hours.
- heavy dysfunction (clearance of creatinine & lt, 10 ml/min.): use is not recommended.
An abnormal liver function
Drug should be used with care. It is necessary to check function of a liver regularly. Experience on use of drug at patients with a liver failure is insufficient to make certain recommendations about dosing.
In the infections caused by β-hemolytic streptococci for the purpose of prevention of development of late complications (e.g., rheumatic fever, a glomerulonephritis), the therapy lasting not less than 10 days is shown.
Side effects
Very often (≥1/10)
- diarrhea
Often (≥1/100, & lt, 1/10)
- candidiasis
- nausea, vomiting
Infrequently (≥1/1000, & lt, 1/100)
- dizziness, a headache
- dyspepsia
- moderate increase in level of liver enzymes
- skin rash, an itching, a small tortoiseshell
Seldom (≥1/10000, & lt, 1/1000)
- a reversible leukopenia (including a neutropenia), thrombocytopenia
- a multiformny erythema
Does not know
- a reversible agranulocytosis and hemolytic anemia, increase in a bleeding time and the index of a prothrombin time
- a Quincke's disease, an anaphylaxis, the syndrome similar to a serum disease, an allergic vasculitis
- reversible superactivity and spasms
- pseudomembranous or hemorrhagic colitis
- change of coloring of a blanket of adamantine substance of tooth
- hepatitis, cholestatic jaundice
- Stephens-Johnson's syndrome, a toxic epidermal necrolysis, bullous exfoliative dermatitis, sharp generalized exanthematous pustulyoz
- interstitial nephrite,
the Contraindication crystalluria
- hypersensitivity to penicillin or to any component of drug
- the known hypersensitivity to others beta laktamnym to antibiotics (cephalosporins, karbapenema, monobaktama)
- an infectious mononucleosis
- a lymphoid leukosis
- a liver failure
- the cholestatic jaundice or hepatitis caused by reception of antibiotics of group of penicillin in the anamnesis
- bronchial asthma, a senny pollinosis
- the children's age up to 12 years
Medicinal interactions
At simultaneous use of Klavam and indirect anticoagulants is noted increase in a prothrombin time. Therefore this combination is appointed with care.
At simultaneous use of Klavam with Allopyrinolum the risk of development of such side effects as a dieback increases.
At simultaneous use Klavam enhances toxicity of a methotrexate.
The amoxicillin combination with rifampicin is antagonistic (mutual weakening of antibacterial action is noted).
Klavam it is not necessary to apply along with bacteriostatic antibiotics (macroleads, tetracyclines), streptocides because of possible decrease in efficiency of Klavam.
At simultaneous use Klavam reduces efficiency of oral contraceptives.
Probenetsid reduces renal canalicular secretion of amoxicillin. Simultaneous use with Klavam can lead it to the increased amoxicillin level in blood, however, it is not observed concerning clavulanic acid. As well as the efficiency of oral contraceptives can reduce other antibiotics of a broad spectrum of activity of Klavam. In certain cases drug can extend a prothrombin time, for this reason it is necessary to be careful at simultaneous use of oral anticoagulants and Klavama.
Special instructions
With care appoint drug to the patients inclined to allergic reactions and also patients with the known hypersensitivity to antibiotics of a tsefalosporinovy row since there is a risk of development of cross sensitivity.
Periodic control of function of a liver is required from patients with abnormal liver functions.
Adequate correction of the mode of dosing or increase in intervals between dosing is required from patients with heavy renal failures.
For the purpose of reduction of risk of development of side reactions from digestive tract it is necessary to take the drug at meal time.
Because at a large number of the patients with an infectious mononucleosis and a lymphoid leukosis receiving ampicillin observed appearance of erythematic rash, use of antibiotics of group of ampicillin for such patients is not recommended.
At use Klavama is possible false positive reaction when determining level of glucose in urine when using a reactant of Benedict or Fellinga solution (recommend to apply enzymatic reactions with glucose oxydas).
It is necessary to avoid co-administration with Disulfiramum.
Use in pediatrics
Drug in the form of tablets, coated, is not appointed to children 12 years are younger (with body weight less than 40 kg).
Klavam is not recommended to apply pregnancy and the period of a lactation during pregnancy.
Klavam gets into breast milk that can cause diarrhea and fungal infections of mucous membranes in the children who are on breastfeeding. The decision on use of drug during pregnancy and breastfeeding is accepted after careful assessment of a ratio of advantage and risk. When assigning in the period of a lactation it is recommended to stop breastfeeding.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
In extremely exceptional cases amoxicillin/clavulanic acid can cause such undesirable reactions as confusion of consciousness, dizziness and spasms which can break ability to run the vehicle and difficult mechanisms and/or it is safe to work.
The overdose
is not available messages about a lethal outcome or emergence of life-threatening side effects owing to drug overdose.
Symptoms: an abdominal pain, diarrhea, vomiting, it is possible also uneasiness, excitement, insomnia, dizziness, in some cases - spasms.
Treatment: in case of recent administration of drug (less than 4 h) it is necessary to carry out gastric lavage and to appoint activated carbon for drug absorption reduction, if necessary carry out symptomatic therapy. The hemodialysis is effective.
Form of release and packing
of the Tablet, film coated, 1000 mg.
On 10 tablets place in blister strip packaging from aluminum foil.
On 1 konturno to strip packaging together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place at a temperature not above 25 °C.
To store drug out of children's reach!
2 years
not to use a period of storage after the expiration date specified on packing.
Prescription status
According to the prescription
the Develop Producer Alkem Laboratories Ltd
Klavam 1000
International unlicensed name
Are not present
the Dosage form
of the Tablet, film coated, 1000 mg
Structure
One tablet contains
active agents: amoxicillin 875.000
(in the form of trihydrate amoxicillin ** 1029.413)
clavulanic acid
125.000 (in the form of clavulanate potassium in mix
in avitsely (1: 1) ***) 305.025 mg)
excipients: sodium of a kroskarmeloz, silicon dioxide colloidal anhydrous, the talc purified magnesium stearate.
structure of a cover: hydroksipropilmetiltsellyuloza of E-5, ethyl cellulose,
diethyl phthalate, talc, titan dioxide (E171), hydroksipropilmetiltsellyuloza of E-15, polyethyleneglycol 6000.
Description
of the Tablet, oblong shape, biconvex surface, film coated white color.
Pharmacotherapeutic group
Beta laktamnye antibacterial drugs – Penicillin.
Penicillin in a combination with inhibitors beta laktamaz.
The ATX J01CR02 code
the Pharmacological
Pharmacokinetics Key Pharmacokinetic Parameters properties of amoxicillin and clavulanic acid are similar. Amoxicillin and clavulanic acid in a combination do not influence at each other.
Absorption: after intake both components of drug are quickly absorbed from digestive tract. The concomitant use of food does not influence absorption.
Distribution: the maximum concentration in blood plasma is reached approximately in 1 h and makes for amoxicillin (depending on a dose) 3-12 mkg/ml, for clavulanic acid – 2 mkg/ml. Both components are characterized by the good volume of distribution in liquids and body tissues (lungs, a middle ear, pleural and peritoneal liquids, a uterus, ovaries). Amoxicillin also gets into synovial fluid, a liver, a prostate, palatine tonsils, muscle tissue, a gall bladder, secretion of adnexal bosoms of a nose, saliva, bronchial secretion. Get through a blood-brain barrier at the inflamed meninx. The maximum concentration in liquids of an organism is observed in 1 h after achievement of the maximum concentration in blood plasma.
Active agents in low concentration are emitted with breast milk, get through a placental barrier. Linking with proteins of blood plasma for amoxicillin makes 17-20%, for clavulanic acid - 22-30%.
Removal: amoxicillin is removed generally by kidneys by canalicular secretion and glomerular filtration. Clavulanic acid is actively metabolized in a liver and removed by glomerular filtration, partially in the form of metabolites. Small amounts can be removed through intestines and lungs. Elimination half-life of amoxicillin makes 1-1.3 h, clavulanic acid – 1.2 h.
In a renal failure the removal of drug is slowed down therefore correction of the mode of dosing (dose decline and increase in intervals between administrations of drug) is necessary.
The pharmacodynamics
Klavam 1000 an antibiotic of a broad spectrum of activity, contains semi-synthetic penicillin amoxicillin and inhibitor beta laktamaz clavulanic acid. Clavulanic acid inhibits the majority clinically significant beta laktamaz, the produced Staphylococcus spp., Escherichia coli, Proteus mirabilis, Haemophilus influenzae, Moraxella catarrhalis, Bacteroides spp. It is inactive concerning a beta laktamaz of 1 type produced by Enterobacter spp., Morganella morganii, Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp.
This combination provides high bactericidal activity of Klavam (including concerning strains of the microorganisms resistant to amoxicillin). Clavulanic acid, having higher affinity to a beta laktamaze, than amoxicillin, forms the stable deactivated complex with enzyme, interfering with enzymatic degradation of amoxicillin under the influence of a beta laktamaz.
Thus, Klavam affects bakteritsidno a wide range of gram-positive and gram-negative bacteria (including strains which gained resistance to a beta laktamnym to antibiotics owing to products beta laktamaz).
Klavam is active concerning aerobic gram-positive bacteria: Streptococcus spp. (including Streptococcus pneumoniae, Streptococcus viridans, Streptococcus milleri, Streptococcus pyogenes, Streptococcus bovis), Enterococcus faecium, Staphylococcus aureus (except Methicillinum - resistant strains), Staphylococcus epidermidis (except Methicillinum - resistant strains), Corynebacterium spp., Listeria monocytogenes, Nocardia asteroides, aerobic gram-negative bacteria: Aeromonas spp., Bordetella pertussis, Brucella spp., Campylobacter jejuni, Campylobacter coli, Citrobacter spp. (are moderately sensitive), Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Klebsiella spp., Legionella pneumophila, Moraxella catarrhalis, Morganella spp. (are moderately sensitive), Neisseria gonorrhoeae, Neisseria meningitidis, Pasteurella multocida, Proteus mirabilis, Proteus vulgaris, Providencia spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica (is moderately sensitive), anaerobic bacteria: Actinomyces israelii, Bacteroides spp. (including Bacteroides fragilis), Prevotella melaninogenica, Clostridium spp. (except Clostridium difficile), Peptostreptococcus spp., Eikenella corrodens, Fusobacterium spp., Propionibacterium spp., Treponema pallidum.
Mycobacterium chelonae is resistant to drug.
Indications
the Infectious and inflammatory diseases caused by microorganisms, sensitive to drug:
- an infection of upper parts of airways (including acute and chronic sinusitis, retropharyngeal abscess, tonsillitis, pharyngitis)
- infections of lower parts of airways (including acute and chronic bronchitis with bacterial superinfection, pneumonia)
- acute and chronic otitis
- infections of urinary tract
- gynecologic infections
- infections of skin and soft tissues
- infections of bones and joints
- infections of bilious ways (cholecystitis, a cholangitis)
- shankroid
- gonorrhea
- dontogenous infections.
The route of administration and doses
the Mode of dosing is set individually depending on age, body weight, function of kidneys and also from severity of an infection. Klavam is recommended to accept at the beginning of food. It is not necessary to continue treatment more than 14 days without repeated assessment of a condition of the patient. Klavam is recommended to apply to decrease in possible gastrointestinal disorders just before food.
Adults and teenagers (12 years and with body weight not less than 40 kg are more senior). A standard dose one tablet of 1000 mg each 12 hours or one tablet of 625 mg makes two or three times a day (depending on weight of an infection): In slight and medium-weight infections one tablet of 625 mg each 12 hours, and in heavier infections one tablet of 625 mg each 8 hours.
The maximum daily dose of amoxicillin makes 6 g for the adult and 45 mg/kg of body weight for children.
The maximum daily dose of clavulanic acid (in the form of potassium salt) makes 600 mg for the adult and 10 mg/kg of body weight for children.
A renal failure
- insignificant dysfunction (clearance of creatinine & gt, 30 ml/min.): the dose does not change.
- moderate dysfunction (clearance of creatinine of 10-30 ml/min.): one tablet of 625 mg each 12 hours.
- heavy dysfunction (clearance of creatinine & lt, 10 ml/min.): use is not recommended.
An abnormal liver function
Drug should be used with care. It is necessary to check function of a liver regularly. Experience on use of drug at patients with a liver failure is insufficient to make certain recommendations about dosing.
In the infections caused by β-hemolytic streptococci for the purpose of prevention of development of late complications (e.g., rheumatic fever, a glomerulonephritis), the therapy lasting not less than 10 days is shown.
Side effects
Very often (≥1/10)
- diarrhea
Often (≥1/100, & lt, 1/10)
- candidiasis
- nausea, vomiting
Infrequently (≥1/1000, & lt, 1/100)
- dizziness, a headache
- dyspepsia
- moderate increase in level of liver enzymes
- skin rash, an itching, a small tortoiseshell
Seldom (≥1/10000, & lt, 1/1000)
- a reversible leukopenia (including a neutropenia), thrombocytopenia
- a multiformny erythema
Does not know
- a reversible agranulocytosis and hemolytic anemia, increase in a bleeding time and the index of a prothrombin time
- a Quincke's disease, an anaphylaxis, the syndrome similar to a serum disease, an allergic vasculitis
- reversible superactivity and spasms
- pseudomembranous or hemorrhagic colitis
- change of coloring of a blanket of adamantine substance of tooth
- hepatitis, cholestatic jaundice
- Stephens-Johnson's syndrome, a toxic epidermal necrolysis, bullous exfoliative dermatitis, sharp generalized exanthematous pustulyoz
- interstitial nephrite,
the Contraindication crystalluria
- hypersensitivity to penicillin or to any component of drug
- the known hypersensitivity to others beta laktamnym to antibiotics (cephalosporins, karbapenema, monobaktama)
- an infectious mononucleosis
- a lymphoid leukosis
- a liver failure
- the cholestatic jaundice or hepatitis caused by reception of antibiotics of group of penicillin in the anamnesis
- bronchial asthma, a senny pollinosis
- the children's age up to 12 years
Medicinal interactions
At simultaneous use of Klavam and indirect anticoagulants is noted increase in a prothrombin time. Therefore this combination is appointed with care.
At simultaneous use of Klavam with Allopyrinolum the risk of development of such side effects as a dieback increases.
At simultaneous use Klavam enhances toxicity of a methotrexate.
The amoxicillin combination with rifampicin is antagonistic (mutual weakening of antibacterial action is noted).
Klavam it is not necessary to apply along with bacteriostatic antibiotics (macroleads, tetracyclines), streptocides because of possible decrease in efficiency of Klavam.
At simultaneous use Klavam reduces efficiency of oral contraceptives.
Probenetsid reduces renal canalicular secretion of amoxicillin. Simultaneous use with Klavam can lead it to the increased amoxicillin level in blood, however, it is not observed concerning clavulanic acid. As well as the efficiency of oral contraceptives can reduce other antibiotics of a broad spectrum of activity of Klavam. In certain cases drug can extend a prothrombin time, for this reason it is necessary to be careful at simultaneous use of oral anticoagulants and Klavama.
Special instructions
With care appoint drug to the patients inclined to allergic reactions and also patients with the known hypersensitivity to antibiotics of a tsefalosporinovy row since there is a risk of development of cross sensitivity.
Periodic control of function of a liver is required from patients with abnormal liver functions.
Adequate correction of the mode of dosing or increase in intervals between dosing is required from patients with heavy renal failures.
For the purpose of reduction of risk of development of side reactions from digestive tract it is necessary to take the drug at meal time.
Because at a large number of the patients with an infectious mononucleosis and a lymphoid leukosis receiving ampicillin observed appearance of erythematic rash, use of antibiotics of group of ampicillin for such patients is not recommended.
At use Klavama is possible false positive reaction when determining level of glucose in urine when using a reactant of Benedict or Fellinga solution (recommend to apply enzymatic reactions with glucose oxydas).
It is necessary to avoid co-administration with Disulfiramum.
Use in pediatrics
Drug in the form of tablets, coated, is not appointed to children 12 years are younger (with body weight less than 40 kg).
Klavam is not recommended to apply pregnancy and the period of a lactation during pregnancy.
Klavam gets into breast milk that can cause diarrhea and fungal infections of mucous membranes in the children who are on breastfeeding. The decision on use of drug during pregnancy and breastfeeding is accepted after careful assessment of a ratio of advantage and risk. When assigning in the period of a lactation it is recommended to stop breastfeeding.
Features of influence of medicine on ability to run the vehicle or potentially dangerous mechanisms
In extremely exceptional cases amoxicillin/clavulanic acid can cause such undesirable reactions as confusion of consciousness, dizziness and spasms which can break ability to run the vehicle and difficult mechanisms and/or it is safe to work.
The overdose
is not available messages about a lethal outcome or emergence of life-threatening side effects owing to drug overdose.
Symptoms: an abdominal pain, diarrhea, vomiting, it is possible also uneasiness, excitement, insomnia, dizziness, in some cases - spasms.
Treatment: in case of recent administration of drug (less than 4 h) it is necessary to carry out gastric lavage and to appoint activated carbon for drug absorption reduction, if necessary carry out symptomatic therapy. The hemodialysis is effective.
Form of release and packing
of the Tablet, film coated, 1000 mg.
On 10 tablets place in blister strip packaging from aluminum foil.
On 1 konturno to strip packaging together with the instruction for medical use in the state and Russian languages place in a pack from cardboard.
To Store storage conditions in the dry, protected from light place at a temperature not above 25 °C.
To store drug out of children's reach!
2 years
not to use a period of storage after the expiration date specified on packing.
Prescription status
According to the prescription
the Develop Producer Alkem Laboratories Ltd
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