Амклав (громенат)

General characteristics. Structure:

Active ingredient: 250 mg of amoxicillin in the form of trihydrate amoxicillin? 125 mg of clavulanic acid in the form of potassium salt.

Semi-synthetic antibiotic with a wide range of antibacterial activity.

Pharmacological properties:

Pharmacodynamics. Amoxicillin – a semi-synthetic antibiotic with a wide range of antibacterial activity concerning many gram-positive and gram-negative microorganisms. Amoxicillin pldvergatsya to destruction by beta lactases and therefore it is not active concerning the microorganisms producing these enzymes. Clavulanic acid – beta лактамное connection, has ability to inactivate a wide range beta лактамаз, enzymes which usually produce microorganisms, resistant to penicillin and cephalosporins. It has special activity against plasmid beta лактамаз with which medicinal resistance is often connected. It is not active concerning chromosomal beta лактамаз 1 type. Presence of clavulanic acid as a part of the tablets "Gromenat" protects amoxicillin from destruction by beta lactamelements and expands a range of its antibacterial activity with inclusion in it of microorganisms, usually resistant to other penicillin and cephalosporins.

Gram-positive. Aerobes: Bacillus anthracis, Corynebacterium species, Enterococcus faecalis, Listeria monocytogenes, Staphylococcus aureas, Staphylococcus epidermidis, Streptococcus agalactiae, Streptococcus pneumonia, Streptococcus pyogenes, Streptococcus viridians, Streptococcus species.

Anaerobe bacterias: Clostridium species, Peptococcus species, Peptostreptococcus species.

Gram-negative. Aerobes: Bordetella pertussis, Escherichia coli, Gardnerela vaginalis, Haemophilus influenzae, Helicobacter pylori, Klebsiella species, Legionella species, Moraxella catarrhalis, Neisseria gonorrhoeae, Neisseria meningitides, Pasteurela multocida, Proteus mirabilis, Proteus vulgaris, Salmonella species, Shigella species, Vibrio cholerae, Yersinia enterocolitica.

Anaerobe bacterias: Bacteroides species (including Bacteroides fragilis), Fusobacterium species.

Others: Borrelia burgdorferi, Chlamydiae, Leptospira icterohaemorrhagiae, Treponema pallidum.

Indications to use:

Amklav (Gromenat) is applied to treatment of the slight and medium-weight bacterial infections caused by sensitive microorganisms including:

Upper respiratory tract infections (including infections of an ear, throat, nose), for example, recurrent tonsillitis, sinusitis, average otitis.

Lower respiratory tract infections, for example, acute bronchitis and exacerbation of chronic bronchitis, community-acquired pneumonia and bronchial pneumonia.

Infections of urinogenital system and bodies of a small pelvis, for example, cystitis, urethritis, pyelitis, pyelonephritis, gynecologic infections.

Route of administration and doses:

Doses. The mode of dosing is set individually depending on age, body weight, function of kidneys of the patient, and also from severity of a current and localization of an infection, sensitivity of the activator.

For the maximum absorption and reduction of side effects from digestive tract Gromenat is recommended to accept at the beginning of food.

The course of treatment makes 5-14 days. Duration of a course of treatment is defined individually and should not exceed more than 14 days without repeated medical examination.

Adults and children are more senior than 12 years or with body weight Slight and medium-weight infections - 1 tablet 250/125 of mg 3 times a day to Children aged from 6 up to 12 years appoint more than 40 kg on 1 tablet 250/125 of mg 3 times a day.

Renal failure. The technique of selection of a dose is based on the greatest possible level of amoxicillin at a certain extent of decrease in clearance of creatinine.

The recommended doses for adults. The clearance of creatinine> 30 ml/min. - Correction of a dose is not required Clearance of creatinine of 10-30 ml/min. - 1-2 tablets on 250/125 mg depending on weight of an infection 2 times a day Clearance of creatinine <10 ml/min. - 1-2 tablets on 250/125 mg depending on weight of an infection once a day the Recommended doses for children Clearance of creatinine> 30 ml/min. - Correction of a dose is not required Clearance of creatinine of 10-30 ml/min. and less <10 ml/min. - Drug do not appoint the Hemodialysis and an abnormal liver function

There are no sufficient data for the recommendation of doses at such patients.

Features of use:

Before purpose of therapy by Gromenat it is necessary to collect carefully the anamnesis at patients for clarification of hypersensitivity cases in it on penicillin, cephalosporins or other allergens.

Care is necessary at appointment for patients with heavy abnormal liver functions.

Adequate dose adjustment or increase in intervals between dosing is required from patients with heavy renal failures.

It is necessary to abstain from use of Gromenat in case of suspicion on an infectious mononucleosis as with this disease amoxicillin can cause skin rash in patients that complicates diagnosis of a disease.

It is necessary to consider a possibility of reversible increase in a prothrombin time (at reception with anticoagulants it is necessary to control indicators of coagulability of blood).

Side effects:

Side effects at administration of drugs in an amoxicillin combination with clavulanic acid arise seldom and happen preferential easy and tranzitorny.

Gastrointestinal symptoms: development of diarrhea, digestion disturbance, nausea, vomiting is possible.

The colitis associated with reception of antibiotics (including pseudomembranous and hemorrhagic colitis), meets seldom. Nausea, though is not typical, but arises at intake of high doses of drug. Expressiveness of gastrointestinal symptoms decreases at administration of drug at the beginning of food.

Liver: moderate asymptomatic increase in level of nuclear heating plant and/or ALT and alkaline phosphotazy is sometimes observed. Hepatitis and cholestatic jaundice meet seldom.

Side effects from a liver are reversible, arise in time or soon after the end of treatment, very seldom lead to a lethal outcome.

Blood: seldom a tranzitorny leukopenia (including neurosinging), thrombocytopenia and very seldom reversible agranulocytosis and hemolitic anemia, increase in a bleeding time and a prothrombin time meet.

Hypersensitivity reactions: very seldom: Quincke's disease, anaphylaxis, syndrome similar to a serum disease, allergic vasculitis.

From skin and hypodermic fabrics: skin rash, a small tortoiseshell, seldom poliformny erythema, very seldom Stephens-Johnson's syndrome, a toxic epidermal necrolysis, violent exfoliative dermatitis, acute generalized exanthematous пустулез are possible.

Treatment should be stopped at emergence of one of the listed symptoms.

From kidneys and urinary tract: very seldom: intersticial nephrite, crystalluria. For reduction of formation of crystals of amoxicillin it is recommended to accept enough liquid and to support an adequate diuresis.

TsNS: symptoms from TsNS develop very seldom. The reversible hyperactivity, dizziness, a headache, spasms concern to them. Spasms can arise at a renal failure or at the patients receiving high doses of drug.

Interaction with other medicines:

At the patients receiving Gromenat lengthening of a bleeding time and prothrombin time is possible. It is necessary to be careful at co-administration of anticoagulants and Gromenat.

Drug can increase efficiency of indirect anticoagulants as, suppressing intestinal microflora, it reduces synthesis of vitamin K and a prothrombin.

Gromenat can lower efficiency of oral contraceptives, ethinylestradiol with risk of development of bleedings of "break". Simultaneous use with Allopyrinolum can cause allergic skin reactions.

Diuretics, Allopyrinolum, phenylbutazone, NPVP and other drugs blocking canalicular secretion increase concentration of amoxicillin.

Antacids, glycosamine, purgatives, aminoglycosides slow down and reduce absorption of Gromenat, ascorbic acid increases it.

Bactericidal antibiotics (including aminoglycosides, cephalosporins, Cycloserinum, Vancomycinum, rifampicin) have sinergidny effect, bacteriostatic drugs (macroleads, chloramphenicol, linkozamida, tetracyclines, streptocides) - antagonistic.

Contraindications:

Hypersensitivity to a beta laktamnym to antibiotics in the anamnesis (to penicillin and cephalosporins).

Jaundice/abnormal liver function, connected using drugs in an amoxicillin combination with clavulanic acid, in the anamnesis of patients.

Infectious mononucleosis.

Overdose:

In case of overdose the patient has to be under observation, a symptomatic treatment.

In most cases symptoms of overdose include frustration from a GIT (an abdominal pain, diarrhea, vomiting) and disturbance of water and electrolytic balance.

Clinical symptoms of overdose can also include alarming excitement, sleeplessness, dizziness, in certain cases convulsive attacks.

During reception of high doses of amoxicillin it is necessary to support adequate consumption of liquid and release of urine at patients to reduce probability of development of an amoksitsillinovy krastalluriya.

In case of recent reception (less than 4 hours) to remove drug from a GIT with a gastric lavage, further reception of absorbent carbon for absorption reduction.

Amoxicillin / clavulanate of potassium is removed a hemodialysis.

Storage conditions:

To store drug in protected from moisture, light and the place, unavailable to children, at a temperature not above 25 °C. Period of validity 3 years. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets, coated, 250mg/125mg, in bottles: 15 tablets in packaging.