Amoksitsillin-pharma

General characteristics. Structure:

Active ingredient: 0,125 g (125 mg) or 0,250 g (250 mg) of trihydrate amoxicillin in terms of amoxicillin in 5 ml of suspension.

Excipients: xanthane gum, silicon dioxide colloid anhydrous, calcium stearate, Natrium benzoicum, sodium citrate, aspartame, dye carmoisin, additive vkusoaromatichesky Aromatik AP220 Vanillin, vkusoaromatichesky Aromatik additive AP1943 Wild strawberry, granulated sugar.

Antibiotic of group of semi-synthetic penicillin of a broad spectrum of activity.

Pharmacological properties:

Pharmacodynamics. The antibiotic of a broad spectrum of activity from group of semi-synthetic penicillin, oppresses synthesis of a cellular cover of bacteria. Possesses a broad spectrum of activity.

It is active concerning a large number of both gram-negative, and gram-positive microorganisms. Escherichia coli, Proteus mirabilis, Salmonella, Shigella, Campilobacter, Haemophilus influenzae, Bordetella pertussis, Leptospira, Chlamydia are sensitive to medicine. It is active concerning streptococci of the group A, B, C, G, H, I, M, Streptococcus pneumoniae, stafilokokk which are not producing a penicillinase, neysseriya; Erysipelothrix rhusiopathiae, Corynebacterium, Bacillus anthracis, Actinomycetes, Streptobaccili, Spirillium minus, Pastereulla multocida, Listeria, Spirochaeta (Leptospira, Treponema, Borrelia, etc.), and also various anaerobic microorganisms (including peptokokk, peptostreptokokk, clostridiums, fuzobakteriya). 

Pharmacokinetics. Absorption. At intake amoxicillin is almost completely absorbed from a GIT. Meal does not influence absorption. The maximum concentration in plasma is reached in 1-2 h after intake.

Distribution. Amoxicillin well gets into fabrics and liquids of an organism, including a phlegm. At normal function of a liver in bile high concentration of amoxicillin is observed.

Removal. Amoxicillin is removed preferential by kidneys, about 50% - in an invariable look. The elimination half-life makes 1-2 h.

Indications to use:

Treatment of the infectious and inflammatory diseases caused by microorganisms, sensitive to drug, including:
- infectious diseases of upper parts of respiratory tracts and ENT organs;
- infectious diseases of lower parts of respiratory tracts (acute and chronic bronchitis, pneumonia, lung abscesses, initial stages or incubation interval of whooping cough);
- infectious diseases of bodies of urinogenital system (acute and chronic pyelonephritises, pyelites, prostatitis, an epididymite, cystitis, an urethritis, an asymptomatic bacteriuria during pregnancy);
- gonorrhea;
- gynecologic infections (septic abortion, adnexitis, endometritis);
- a typhoid and a paratyphoid, including complicated by a septicaemia (in a combination with aminoglycosides);
- salmonellonositelstvo;
- shigellosis;
- infectious diseases of bilious ways (a cholangitis, cholecystitis) in case of lack of a cholestasia;
- infectious diseases of skin and soft tissues;
- hay fever;
- acute and latent listeriosis.

Medicine is also applied for short-term (24-48 h) prevention of infectious complications during small surgical interventions.

Medicine is used also at treatment of an infectious endocarditis (in combination with aminoglycosides), meningitis, a septicaemia in case parenteral antimicrobic therapy is not required.

Route of administration and doses:

From Amoksitsillin-Pharma who has the powder form before use of medicine it is necessary to prepare suspension, ready to the use. For this purpose in the beginning to stir up powder in a bottle, further to add the prokipyachenny drinking water cooled to room temperature to a tag of "60 ml" (when using 20,0 g of powder), to a tag of "100 ml" (when using 33,3 g of powder) and to shake up intensively. After the formed foam will accumulate, to bring in addition suspension volume water to 60 ml, to 100 ml, to shake up carefully. Suspension is ready to the use.

Before each use the bottle is intensively shaken up and left to stand until the formed foam accumulates.

The mode of dosing is set individually, depending on sensitivity of microorganisms and localization of infectious process.

Adult on average appoint 1,5-2 g/days. If necessary it is possible to increase a drug dose to 6 g/days. Frequency rate of reception makes 2 times/days.

At  GIT acute infectious diseases (paratyphus, a typhoid) and bilious ways, and also at gynecologic infectious diseases взрослымпрепарат appoint 1,5-2 g 3 times/days or on 1-1,5 g 4 times/days.

At a hay fever the adult appoint on 500-750 mg of 4 times/days within 6-12 days.

At a salmonellonositelstvo the adult – on 1,5-2 g 3 times/days within 2-4 weeks.

For prevention of an endocarditis at small surgical interventions by the adult enter 3-4 g for 1 h before holding a procedure. If necessary the repeated dose is appointed in 8-9 h. At children the drug dose should be reduced twice.

Treatment of Amoksitsillinom-Pharma should be continued within 2-5 days after disappearance of symptoms. For the prevention of complications streptococcal infections it is necessary to treat, at least, 10 days.

At patients with renal failures at KK lower than 30 ml/min. reduce a drug dose and/or increase an interval between receptions. At KK of 15-40 ml/min. the interval between receptions of medicine has to make not less than 12 h. At patients with an anury the drug dose should not exceed 2 g/days.

At infectious diseases of urinogenital ways of dose adjustment it is not required.
To children medicine is appointed in doses at the rate of 30-60 mg/kg/days. Frequency rate of reception – 2 times/days.

Age	Daily dose
till 1 year 1-6 years 6-10 years 10-14 years 14-18 years	250 mg 500 mg 750 mg 1 g 1,5 g

At the heavy course of an infectious disease it is possible to increase a dose for children to 100 mg/kg/days. At premature and newborn the drug dose is reduced and/or increase an interval between receptions.

Features of use:

At patients with hypersensitivity to cephalosporins it is necessary to consider possibility of a cross allergy.

At heavy infections of a GIT with constant diarrhea and vomiting it is not necessary to appoint medicine because of possible deterioration in absorption.

With care appoint medicine to patients with allergic diathesis, bronchial asthma and hay fever.

At patients with cholecystitis and a cholangitis Amoksitsillin-Pharma appoint only at the easy course of a disease and in the absence of a cholestasia.

At patients with a typhoid, leptospirosis or syphilis against the background of therapy by medicine Yarisha-Gerkskheymer's reaction caused by a lysis of bacteria can develop.

At prolonged use of high drug doses at patients it is necessary to control indicators of function of a liver and kidneys, to carry out the general analyses of urine. It is reasonable to control a pattern of peripheral blood.

At prolonged treatment it is necessary to consider a possibility of development of superinfection by insensitive microorganisms, including mushrooms.

When performing therapy it is necessary to provide adequate consumption of liquid and maintenance of a sufficient diuresis.

At emergence watery a calla with impurity of slime and blood, abdominal pains, fevers, tenezm it is necessary to suspect development of pseudomembranous colitis. In this case medicine it is necessary to cancel and appoint the corresponding treatment. At the same time the drugs which are slowing down a GIT peristaltics are contraindicated.

Before a gonorrhea initiation of treatment at patients with estimated primary syphilis it is necessary to conduct a bakterioskopichesky research in a dark field. All patients with the estimated accompanying syphilis should conduct a serological research in dynamics within, at least, 4 months.

Obtaining false positive results when determining glucose in blood is possible.

Amoksitsillin-Pharma can distort results of definition of urobilinigen.

At prescription of medicine by the patient with a diabetes mellitus it is necessary to consider that Amoksitsillin-Pharma for preparation of suspension is a part of powder refined sugar.

Side effects:

From a GIT and a liver: nausea, diarrhea, it is rare – increase  in activity of hepatic transaminases in a blood plasma, a glossitis, stomatitis. Development of pseudomembranous colitis is possible.

From system of a hemopoiesis: thrombocytopenia, leukopenia, eosinophilia, agranulocytosis.

From a nervous system and mentality: headache, increased fatigue. At patients with epilepsy and/or meningitis, and/or depression of function of kidneys the risk of emergence of neurotoxic complications (spasm) is increased.

Allergic reactions: seldom – urticaria, fever, joint pains, a multiformny erythema, exfoliative dermatitis, a Quincke's edema, in exclusively exceptional cases – an acute anaphylaxis.

Others: seldom – intersticial nephrite.

Interaction with other medicines:

At simultaneous use with Allopyrinolum the risk of developing of skin rash increases.

Medicine affects only the breeding microorganisms therefore it is not necessary to appoint it along with the antimicrobic drugs operating bacteriostatically.

In the presence of positive tests for sensitivity of the activator Amoksitsillin-Pharma it is possible to apply in a combination with other bactericidal antibiotics (cephalosporins, aminoglycosides).

Simultaneous use of medicine with probenetsidy leads to increase in concentration of amoxicillin in blood due to reduction of its removal by kidneys. At the same time penetration of medicine into fabrics can decrease.

The concomitant use of antacids reduces Amoksitsillin-Pharma's absorption.
Medicine can reduce efficiency of oral contraceptives.

Contraindications:

- infectious mononucleosis;
- hypersensitivity to penicillin.

Use of medicine in a combination with metronidazole is contraindicated at diseases of a nervous system, hemopoiesis disturbances, a lymphoid leukosis, infectious mononucleosis, hypersensitivity to nitroimidazole derivatives, at the diseases of a digestive tract proceeding with long diarrhea or vomiting at heavy pathology of a liver, do not appoint to patients younger 18 years, and also during pregnancy and feeding a breast.

Overdose:

Symptoms: nausea, vomiting, diarrhea, disturbance of water and electrolytic balance (as a result of vomiting and diarrhea).

Treatment: a gastric lavage, absorbent carbon, salt laxatives, medicines for maintenance of water and electrolytic balance; hemodialysis.

Storage conditions:

To store in the place protected from light and moisture at a temperature not above +25 °C. Period of validity 2 years. A period of validity of the prepared suspension of 10 days at storage at a temperature of +2 °C - +8 °C.

Issue conditions:

According to the recipe

Packaging:

On 20,0 g, on 33,3 g in the plastic bottles with the glass dosing packed together with a leaf insert into packs from a cardboard.