Амиклав
Producer: JSC Himfarm Republic of Kazakhstan
Code of automatic telephone exchange: J01CR02
Release form: Liquid dosage forms. Powder for a solution prigotovlgeniye for injections.
General characteristics. Structure:
Active agents: amoxicillin sodium in terms of amoxicillin of 500 mg
clavulanate potassium in terms of clavulanic acid of 100 mg.
Description: powder of white or almost white color.
Pharmacological properties:
Pharmacokinetics. The key pharmacokinetic parameters of amoxicillin and clavulanic acid are similar. Amoxicillin and clavulanic acid in a combination do not influence at each other. Both components are characterized by the good volume of distribution in bodies and fabrics. Get through a blood-brain barrier at the inflamed meninx. Active agents in low concentration are emitted with breast milk, get through a placental barrier. Linkng with proteins of a blood plasma for amoxicillin makes 17-20%, for clavulanic acid - 22-30%. Amoxicillin is removed, generally by kidneys by canalicular secretion and glomerular filtering. Clavulanic acid is actively metabolized in a liver and removed by glomerular filtering, partially in the form of metabolites. Small amounts can be removed through intestines and lungs. The elimination half-life of amoxicillin makes 1-1,3 h, clavulanic acid - 0-1,2 h.
In special clinical cases, at a renal failure removal of drug is slowed down therefore correction of the mode of dosing (a dose decline and increase in intervals between administrations of drug) is necessary.
Pharmacodynamics. The antibiotic of a broad spectrum of activity, contains semi-synthetic penicillin amoxicillin and inhibitor beta лактамаз clavulanic acid. Clavulanic acid inhibits the majority clinically significant beta лактамаз (types 2, 3, 4 and 5 – on classification of Richmond of Sykes), the produced Staphylococcus spp., Escherichia coli, Proteus mirabilis, Haemophilus influenzae, Moraxella catarrhalis, Bacteroides spp.
This combination provides high bactericidal activity Amiklava, including concerning strains of 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 action a beta – лактамаз.
Амиклав 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 лактамаз).
Амиклав it is active concerning aerobic gram-positive bacteria: Streptococcus spp. groups A, B, C, G, 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., Escherichia coli, Gardnerella vaginalis, Haemophilus ducreyi, Haemophilus influenzae, Helicobacter pylori, Klebsiella spp., Legionella pneumophila, Moraxella catarrhalis, Morganella spp., Neisseria gonorrhoeae, Neisseria meningitidis, Proteus mirabilis, Salmonella spp., Shigella spp., Vibrio cholerae, anaerobic bacteria: Actinomyces israelii, Bacteroides spp., Clostridium spp., Peptostreptococcus spp., Treponema pallidum.
Indications to use:
- acute and chronic sinusitis, tonsillitis, pharyngitis;
- chronic bronchitis, pneumonia, pleura empyema;
- cystitis, urethritis, pyelonephritis;
- salpingitis, salpingo-oophoritis, endometritis, septic abortion, pelviperitonitis;
- infections of skin and soft tissues (including phlegmon, wound fever);
- infections of bones and joints (including chronic osteomyelitis);
- gonorrhea.
Route of administration and doses:
To adults and children 12 years - on 1,2 g in 8 h are more senior (in hard cases in 6 h).
To children from 3 months to 12 years - on 0,03 g/kg in 8 h (in hard cases in 6 h).
To children aged up to 3 months: premature and during the perinatal period – on 0,03 g/kg each 12 h; in the post-perinatal period – in the same dose each 8 h.
Course of treatment of 5 - 10 days.
Patients with a heavy renal or liver failure should correct the mode of dosing reduction of a single dose or increase in an interval between purposes of drug.
Rules of preparation and administration of solution for intravenous injections. Bottles of 600 mg: to dissolve bottle contents in 10 ml of water for injections. The resuspended solutions are painted in light yellow color. To enter slowly within 3-4 min.
Rules of preparation and administration of solution for intravenous infusions. Bottles of 600 mg: to add the solution resuspended in 10 ml of water for injections to 50 ml of infusional liquid. Infusion is carried out within 30-40 min.
Features of use:
With care appoint to the patients inclined to allergic reactions to cephalosporins and others beta лактамные antibiotics (risk of development of cross sensitivity).
Care is necessary at appointment for patients with heavy abnormal liver functions and kidneys.
It is not recommended to the patients suffering from an infectious mononucleosis and a lymphoid leukosis in connection with a possibility of emergence of erythematic rash.
Purpose of drug at pregnancy is possible when the estimated advantage for mother exceeds potential risk for a fruit. For the period of treatment it is necessary to stop breastfeeding.
Drug does not exert impact on speed of psychomotor reactions and ability to concentration of attention.
Side effects:
- itch, skin rashes, Quincke's disease, bronchospasm.
Seldom:
- development of superinfection (stomatitis, mycotic vulvovaginitis).
Extremely seldom:
- tranzitorny increase in activity of hepatic transaminases;
- cholestatic jaundice, hepatitis, abnormal liver functions.
Interaction with other medicines:
At simultaneous use of Amoxiclav and indirect anticoagulants increase in a prothrombin time is noted. Therefore this combination is appointed with care.
At simultaneous use of Amoxiclav with Allopyrinolum the risk of development of such side effects as a dieback increases.
At simultaneous use Amoxiclav increases toxicity of a methotrexate.
Amoxiclav and aminoglikozidny antibiotics physically and chemically are not compatible.
It is necessary to avoid mixing of Amoxiclav with solutions of glucose, a dextran, bicarbonate (since in them drug is less stable), and also with the solutions containing blood, proteins and lipids.
Amoxiclav is not mixed in one syringe or an infusional bottle with other medicines.
Contraindications:
- hypersensitivity to drug components;
- the cholestatic jaundice or hepatitis caused by reception of antibiotics of group of penicillin in the anamnesis;
- infectious mononucleosis, lymphoid leukosis.
Overdose:
Symptoms - nausea, diarrhea, vomiting, are possible – excitement, sleeplessness, dizziness, in certain cases – convulsive attacks.
Treatment - symptomatic, in case of recent reception (less than 4 h) to remove drug from digestive tract (a gastric lavage, reception of absorbent carbon for absorption reduction). The hemodialysis is effective.
Storage conditions:
To store in the dry, protected from light place, at a temperature not above 25 °C. To store in the place, unavailable to children!
Issue conditions:
According to the recipe
Packaging:
Powder of 600 mg for injections in the bottles hermetically corked by a stopper in a cardboard pack 1 bottle with the application instruction.
