РАНКЛАВ®

General characteristics. Structure:

Active agents: 
Amoxicillin the trihydrate equivalent to amoxicillin - 250 mg, 500 mg
The potassium clavulanate equivalent to clavulanic acid - 125 mg

Description. Ранклав® 250/125 mg, 500/125 mg. Tablets, coated white or almost white color, oval, biconvex, with a text of "R-625" on one party.

Pharmacological properties:

Ранклав – an amoxicillin combination – semi-synthetic penicillin with a wide range of antibacterial action and clavulanic acid – irreversible inhibitor beta лактамаз. Clavulanic acid forms the resistant inactivated complex with the specified enzymes and protects amoxicillin from loss of the antibacterial activity caused by products beta лактамаз, both the main activators, and uslovnopatogenny microorganisms.

Ранклав it is active concerning gram-positive aerobes: Streptococcus pneumoniae, S.pyogenes, S.viridans, S.bovis, Staphylococcus aureus (except metitsillinorezistentny strains), S.epidermidis (except metitsillinorezistentny strains), Listeria spp., Enterococcus spp. Gram-negative aerobes: Bordetella pertussis, Brucella spp., Campylobacter jejuni, E.coli, Gardnerella vaginalis, H.influenzae, H.ducreyi, Klebsiella spp., Moraxella catarrhalis, N.gonorrhoeae, N.meningitidis, Pasteurella multocida, Proteus spp., Salmonella spp., Shigella spp., Vibrio cholerae, Yersinia enterocolitica. Anaerobe bacterias: Peptococcus spp., Peptostreptococcus spp., Clostridium spp., Bacteroides spp., Actinomyces israelii.

Pharmacokinetics. The key pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. It is quickly soaked up after intake (meal does not exert impact on absorption). Cmax is reached in 1 h after reception. Has the large volume of distribution — high concentration are found in liquids and body tissues (lungs, pleural, peritoneal, synovial fluid, palatine tonsils, a bronchial secret, a prostate, muscular tissue, fatty tissue, a secret of adnexal bosoms of a nose, a middle ear, etc.). The peak of concentration in liquids of an organism is observed in 1 h after achievement of peak of plasma concentration. Does not pass through GEB at an uninflammed meninx, passes through a placental barrier and in trace concentration gets into breast milk. Poorly contacts proteins of plasma. Amoxicillin is partially metabolized, clavulanic acid is exposed to intensive metabolism. Amoxicillin is removed by kidneys practically in not changed look tubular secretion and glomerular filtering; clavulanic acid — by glomerular filtering, partially in the form of metabolites. Small amounts are removed by intestines and lungs. T1/2 makes 1–1,5 h, at a heavy renal failure increases to 7,5 (for amoxicillin) and 4,5 h (for clavulanic acid). Is removed at a hemodialysis, it is insignificant — at peritoneal dialysis.

Indications to use:

Treatment of the infections caused by sensitive aerobic and anaerobic microorganisms:

- Infections of ENT organs (acute and chronic sinusitis, acute and chronic otitis, tonsillitis, pharyngitis);
- Respiratory infections (acute and chronic bronchitis and pneumonia, pleura empyema);
- Infections of urinary tract (including cystitis, uretrita, pyelonephritises);
- Infections in gynecology (including a salpingitis, a salpingo-oophoritis, an endometritis, septic abortion, a pelviperitonitis);
- Infections of bones and joints (including chronic osteomyelitis);
- Infections of skin and soft tissues (including phlegmon and wound fever);
- Infections of bilious ways (cholecystitis, cholangitis);  
- Diseases, sexually transmitted (gonorrhea, шанкроид);
- Dontogenous infections.

Route of administration and doses:

Inside. Drug should be accepted during food, without chewing, washing down with a small amount of water. To adults and children 12 years (or more than 40 kg of body weight) in case of the easy or medium-weight course of infections on 1 tablet 250mg/125mg 3 of time a day are more senior. At the heavy course of an infection appoint on 1 tablet 500mg/125mg 3 of time a day.

Features of use:

At course treatment it is necessary to carry out control of a condition of function of bodies of a hemopoiesis, a liver and kidneys.

For the purpose of decrease in risk of development of side effects from a GIT it is necessary to accept drug during food.

Development of superinfection due to growth of microflora, insensitive to it, is possible that demands corresponding change of antibacterial therapy.

Can yield false positive results when determining glucose in urine. In this case it is recommended to apply a glyukozoksidantny method of definition of concentration of glucose in urine.

After cultivation it is necessary to store suspension no more than 7 days in the refrigerator, but not to freeze.

At the patients having hypersensitivity to penicillin cross allergic reactions with tsefalosporinovy antibiotics are possible.

Cases of development of a necrotizing coloenteritis in newborns, at pregnant women with a premature rupture of fetal membranes were revealed.

As tablets contain identical amount of clavulanic acid (125 mg), it is necessary to consider that 2 tablets on 250 mg (on amoxicillin) are not equivalent to 1 tablet on 500 mg (on amoxicillin).

Side effects:

Loss of appetite, dryness of a mucous oral cavity, nausea, vomiting, diarrhea, headache, dizziness, tremor, sleeplessness, granulocytopenia, anemia, thrombocytosis, candidiasis, pseudomembranous colitis, allergic reactions. Use at pregnancy and feeding by a breast: It is possible if the expected effect of therapy exceeds potential risk for a fruit. For the period of treatment it is necessary to stop breastfeeding.

Interaction with other medicines:

Antacids, glycosamine, laxative medicines, aminoglycosides slow down and reduce absorption; ascorbic acid increases absorption.
 
Bacteriostatic medicines (macroleads, chloramphenicol, linkozamida, tetracyclines, streptocides) have antagonistic effect.

Increases efficiency of indirect anticoagulants (suppressing intestinal microflora, reduces synthesis of vitamin K and a prothrombin ratio). At a concomitant use of anticoagulants it is necessary to watch indicators of coagulability of blood.
 
Reduces efficiency of oral contraceptives, medicines in the course of which metabolism PABK, ethinylestradiol - risk of development of bleedings of "break" is formed.

Diuretics, Allopyrinolum, phenylbutazone, NPVP, etc. the medicines blocking canalicular secretion increase concentration of amoxicillin (clavulanic acid is removed generally by glomerular filtering).
 
Allopyrinolum increases risk of development of skin rash.

Contraindications:

— hypersensitivity (including to cephalosporins, etc. beta лактамным to antibiotics);
— an infectious mononucleosis (including at emergence of korepodobny rash);
— fenilketonuriya;
— episodes of jaundice or an abnormal liver function as a result of use of amoxicillin/clavulanic acid in the anamnesis;

— KK less than 30 ml/min. (for tablets of 875 mg / 125 mg).

With care: pregnancy, the lactation period, a heavy liver failure, gastrointestinal diseases (including the colitis in the anamnesis connected using penicillin), a chronic renal failure.

Use at pregnancy and feeding by a breast.

With care: pregnancy, lactation period.
 
Cases of development of a necrotizing coloenteritis in newborns, at pregnant women with a premature rupture of fetal membranes were revealed.

Use at abnormal liver functions

Contraindicated at episodes of jaundice or abnormal liver functions as a result of use of amoxicillin/clavulanic acid in the anamnesis.
 
With care: heavy liver failure

Use at renal failures.
At a chronic renal failure carry out dose adjustment and frequency rates of introduction depending on KK: at KK more than 30 ml/min. of dose adjustment are not required; at KK of 10-30 ml/min.: inside - 250-500 mg / each 12 h; in/in - 1 g, then on 500 mg in/in; at KK it is less than 10 ml/min. - 1 g, then on 500 mg / in/in or 250-500 mg / inside in one step. For children of a dose it is necessary to reduce in the same way. At KK less than 30 ml/min. use of tablets of 875 mg / 125 is contraindicated to mg.

The patients who are on a hemodialysis - 250 mg or 500 mg inside in one step or 500 mg in/in, in addition 1 dose during dialysis and 1 more dose at the end of dialysis session.

Use for children.
To children up to 12 years - in the form of suspension, syrup or drops for intake. The single dose is established depending on age: children up to 3 months - 30 mg/kg / in 2 receptions; 3 months are also more senior - at infections of easy severity - 25 mg/kg / in 2 receptions or 20 mg/kg / in 3 receptions, at heavy infections - 45 mg/kg / in 2 receptions or 40 mg/kg / in 3 receptions.
The maximum daily dose of amoxicillin for children up to 12 years - 45 mg/kg of body weight.

The maximum daily dose of clavulanic acid for children up to 12 years - 10 mg/kg of body weight.

Overdose:

Symptoms: dysfunction of a GIT and water and electrolytic balance. Treatment: symptomatic. The hemodialysis is effective.

Issue conditions:

According to the recipe