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medicalmeds.eu Medicines Antibiotic. Pank lavas

Pank lavas

Препарат Панклав. Hemofarm, A.D. (Хемофарм А.Д.) Сербия



General characteristics. Structure:

Tablets, film coated 1 table.
active agents:  
amoxicillin (in the form of trihydrate amoxicillin) 250 mg
clavulanic acid (in the form of potassium of a klavunat) 125 mg
excipients: silicon dioxide colloid; karboksimetilkrakhmal sodium; MKTs; magnesium stearate  
cover: gipromelloza; propylene glycol; titanium dioxide (E171)  
Tablets, film coated 1 table.
active agents:  
amoxicillin (in the form of trihydrate amoxicillin) 500 mg
clavulanic acid (in the form of potassium of a klavunat) 125 mg
excipients: silicon dioxide colloid; karboksimetilkrakhmal sodium; MKTs; magnesium stearate  
cover: gipromelloza; propylene glycol; titanium dioxide (E171)  



Pharmacological properties:

The combined drug of amoxicillin and clavulanic acid - inhibitor beta лактамаз. Works bakteritsidno, synthesis of a bacterial wall oppresses.
It is active concerning aerobic gram-positive bacteria (including the strains producing beta lactamelements): Staphylococcus aureus; aerobic gram-negative bacteria: Enterobacter spp., Escherichia coli, Haemophilus influenzae, Klebsiella spp., Moraxella catarrhalis. The following activators are sensitive only in vitro: Staphylococcus epidermidis, Streptococcus pyogenes, Streptococcus anthracis, Streptococcus pneumoniae, Streptococcus viridans, Enterococcus faecalis, Corynebacterium spp., Listeria monocytogenes; anaerobic Clostridium spp., Peptococcus spp., Peptostreptococcus spp.; and also aerobic gram-negative bacteria (including the strains producing beta lactamelements): Proteus mirabilis, Proteus vulgaris, Salmonella spp., Shigella spp., Bordetella pertussis, Yersinia enterocolitica, Gardnerella vaginalis, Neisseria meningitidis, Neisseria gonorrhoeae, Haemophilus ducreyi, Yersinia multocida (before Pasteurella), Campylobacter jejuni; anaerobic gram-negative bacteria (including the strains producing beta lactamelements): Bacteroides spp., including Bacteroides fragilis.
Clavulanic acid suppresses II, III, IV and V types beta лактамаз, is not active concerning the beta laktamaz of the I type produced by Pseudomonas aeruginosa, Serratia spp., Acinetobacter spp. Clavulanic acid possesses a high tropnost to penicillinases thanks to what forms a stable complex with enzyme that prevents enzymatic degradation of amoxicillin under the influence of a beta laktamaz.

Pharmacokinetics. After intake both components are quickly absorbed in a GIT. The concomitant use of food does not influence absorption. TCmax - 45 min. After intake in a dose of 250/125 mg each 8 h Cmax of amoxicillin - 2.18-4.5 mkg/ml, clavulanic acid - 0.8-2.2 mkg/ml, in a dose of 500/125 mg each 12 h Cmax of amoxicillin - 5.09-7.91 mkg/ml, clavulanic acid - 1.19-2.41 mkg/ml, in a dose of 500/125 mg each 8 h Cmax of amoxicillin - 4.94-9.46 mkg/ml, clavulanic acid - 1.57-3.23 mkg/ml, in a dose of 875/125 mg of Cmax of amoxicillin - 8.82-14.38 mkg/ml, clavulanic acid - 1.21-3.19 mkg/ml.
Later in/in introductions in doses of 1000/200 and 500/100 mg of Cmax of amoxicillin - 105.4 and 32.2 mkg/ml respectively, and clavulanic acid - 28.5 and 10.5 mkg/ml.
Time of achievement of the maximum inhibiting concentration of 1 mkg/ml for amoxicillin is similar at use in 12 h and 8 h both at adults, and at children.
Communication with proteins of plasma: amoxicillin - 17-20%, clavulanic acid - 22-30%.
Both components in a liver are metabolized: amoxicillin - for 10% of the entered dose dose, clavulanic acid - for 50%.
T1/2 after reception in a dose of 375 and 625 mg - 1 and 1.3 h for amoxicillin, 1.2 and 0.8 h - for clavulanic acid respectively. T1/2 later in/in introductions in a dose of 1200 and 600 mg - 0.9 and 1.07 h - for amoxicillin, 0.9 and 1.12 h - for clavulanic acid respectively. It is removed generally by kidneys (glomerular filtering and canalicular secretion): 50-78 and 25-40% of the entered dose of amoxicillin and clavulanic acid are removed respectively in not changed look during the first 6 h after reception.


Indications to use:

— the bacterial infections caused by sensitive activators: lower respiratory tract infections (bronchitis, pneumonia, pleura empyema, lung abscess);
— infections of ENT organs (sinusitis, tonsillitis, average otitis);
infections of urinogenital system and bodies of a small pelvis (pyelonephritis, pyelitis, cystitis, urethritis, prostatitis, cervicitis, salpingitis, salpingo-oophoritis, tubo-ovarian abscess, endometritis, bacterial vaginitis, septic abortion, postnatal sepsis, pelviperitonitis, venereal ulcer, gonorrhea);
— infections of skin and soft tissues (the ugly face, impetigo for the second time infected a dermatosis, abscess, phlegmon, a wound fever);
osteomyelitis;
— postoperative infections;
— prevention of infections in surgery.


Route of administration and doses:

Inside, in / century.
Doses are given in terms of amoxicillin. The mode of dosing is set individually depending on weight of a current and localization of an infection, sensitivity of the activator.
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/days in 2 receptions; 3 months are also more senior - at infections of easy severity - 25 mg/kg/days in 2 inclusion or 20 mg/kg/days in 3 receptions, at heavy infections - 45 mg/kg/days in 2 inclusion or 40 mg/kg/days in 3 receptions.
To adults and children 12 years or with the body weight of 40 kg and more are more senior: 500 mg of 2 times/days or 250 mg of 3 times/days. At infections of heavy severity and respiratory infections - 875 mg of 2 times/days or 500 mg of 3 times/days.
The maximum daily dose of amoxicillin for adults and children is more senior than 12 years - 6 g, for children up to 12 years - 45 mg/kg of body weight.
The maximum daily dose of clavulanic acid for adults and children is more senior than 12 years - 600 mg, for children up to 12 years - 10 mg/kg of body weight.
At difficulty of swallowing at adults suspension use is recommended.
At preparation of suspension, syrup and a thaw as solvent it is necessary to use water.
At in introduction by the adult and to teenagers 12 years are more senior enter 1 g (on amoxicillin) 3 times a day, if necessary - 4 times a day. The maximum daily dose - 6 g. For children of 3 months-12 of years - 25 mg/kg 3 times a day; in hard cases - 4 times a day; for children up to 3 months: premature and in the perinatal period - 25 mg/kg 2 times a day, in the post-perinatal period - 25 mg/kg 3 times a day.
Treatment duration - up to 14 days, acute average otitis - up to 10 days.
For prevention of postoperative infections at operations, lasting less than 1 h, during introduction anesthesia enter in a dose 1 g in / century. At longer operations - on 1 g each 6 h within a day. At high risk of infection introduction can be continued within several days.
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/days 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/days in/in or 250-500 mg/days inside in one step. For children of a dose it is necessary to reduce in the same way.
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.


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:

From the alimentary system: nausea, vomiting, diarrhea, gastritis, stomatitis, a glossitis, increase in activity of hepatic transaminases, in isolated cases - cholestatic jaundice, hepatitis, a liver failure (is more often at elderly, men, at long therapy), pseudomembranous and hemorrhagic colitis (can also develop after therapy), a coloenteritis, black "hairy" language, darkening of an adamantine substance of tooth.

From bodies of a hemopoiesis: reversible increase in a prothrombin time and bleeding time, thrombocytopenia, thrombocytosis, eosinophilia, leukopenia, agranulocytosis, hemolitic anemia.

From a nervous system: dizziness, headache, hyperactivity, alarm, change of behavior, spasm.

Local reactions: in some cases - phlebitis in the place in/in introductions.

Allergic reactions: urticaria, erythematic rashes, it is rare - a multiformny exudative erythema, an acute anaphylaxis, a Quincke's disease, is extremely rare - exfoliative dermatitis, a malignant exudative erythema (Stephens-Johnson's syndrome), the allergic vasculitis, a syndrome similar to a serum disease, acute generalized exanthematous пустуллез.

Others: candidiasis, development of superinfection, intersticial nephrite, crystalluria, hamaturia.


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 of the drug AMOKSITSILLIN+KLAVULANOVAYA KISLOTA 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/days 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/days in/in or 250-500 mg/days 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.


Overdose:

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


Storage conditions:

In the place protected from light and moisture, at a temperature of 15-25 °C.
To store in the place, unavailable to children.


Issue conditions:

According to the recipe


Packaging:

Tablets, покр. film obol., 250 mg +125 mg: 15 or 20 pieces.

Tablets, покр. film obol., 500 mg +125 mg: 15 or 20 pieces.



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