Gramoks-A

General characteristics. Structure:

Active ingredient: amoxicillin; 1 capsule contains amoxicillin in terms of anhydrous amoxicillin 500 mg; excipient: magnesium stearate. Ponso 4R (E124) is a part of the capsule. Main physical and chemical properties: solid opaque gelatin capsules with powder of white or almost white color with a yellowish shade with a specific smell.

Pharmacological properties:

Pharmacodynamics. Gramoks-A — a β-laktamny antibiotic of a broad spectrum of activity from group of semi-synthetic penicillin of subgroup of aminopenicillin. It is active concerning gram-positive and gram-negative microorganisms. Bactericidal effect of drug is connected with blocking of biosynthesis of mukopeptid of cellular membranes of bacteria. Are sensitive to drug: Streptococcus pneumoniae, Streptococcus pyogenes, Streptococcus faecalis, Streptococcus viridans, Staphylococcus spp. (excepting the strains producing β-lactamelements), Clostridium spp, Listeria monocytogenes, Moraxella cataralis, Helicobacter pylori, Enterococcus spp., Haemophilus influenzae, Neisseria gonorrhoae, Neisseria meningitidis, Escherichia coli, Proteus mirabilis, Klebsiella spp., Shigella spp., Salmonella spp., Bordetella pertussis, Brucella spp. Are less sensitive to Gramoksu-A: E.Rhusopathiae, Eikenella spp., P.acnes, Peptostreptococcus, Actinomyces, Leptospires, Borrelia, Treponema, Eubacterium, Vibrio cholere.

Pharmacokinetics. After intake drug is quickly and almost completely soaked up in digestive tract irrespective of meal, кислотоустойчив — keeps activity both in a stomach, and in intestines. The maximum concentration of drug in a blood plasma is observed in 1-2 hours after its reception. After absorption amoxicillin in not changed look well gets into the majority of fabrics and fluid mediums of an organism (a bronchial secret, paranasal sinuses, amniotic liquid, saliva, the lacrimal liquid, serous covers, a middle ear, bile) in therapeutic effective concentration. Amoxicillin gets into cerebrospinal fluid of healthy people in insignificant quantity. 15-20% of amoxicillin contact proteins of a blood plasma. At normal function of kidneys the elimination half-life of drug makes 1-1,5 hours, at a considerable renal failure the amoxicillin elimination half-life considerably increases (till 8 o'clock). The most part of drug (60-80%) is allocated in not changed view with urine, smaller — with bile. Amoxicillin is partially metabolized in a liver, the majority of its metabolites are inactive.

Indications to use:

• Upper respiratory tract infections;
• average otitis;
• acute and chronic bronchitis;
• pneumonia;
• cystitis, urethritis, pyelonephritis;
• gynecologic infections, including septic abortion;
• gonorrhea;
• peritonitis;
• septicaemia;
• bacterial endocarditis;
• infections of skin and soft tissues;
• N.'s eradikation of Pylori in complex treatment of a peptic ulcer of a stomach and duodenum;
• abscess of an oral cavity (in combination with surgical treatment);
• prevention of an endocarditis (Gramoks-A can be applied to the prevention of the bacteremia connected with dental intervention at persons with risk of development of a bacterial endocarditis).

Route of administration and doses:

The dose of drug is established individually taking into account weight of infectious process and sensitivity of a contagium to amoxicillin. The Gramoksa-A capsules accept inside irrespective of meal, washing down with a small amount of liquid. The standard dose for adults and children is more senior than 10 years makes 500 mg 3 times a day. Treatment needs to be continued on an extent of 2-3 days after disappearance of symptoms of a disease. At treatment of the infections caused by a β-hemolitic streptococcus for achievement of an eradikation of the activator duration of treatment has to make not less than 10 days. High-dose therapy at adults and children is more senior than 10 years. The maximum recommended daily dose for this age category makes 6 g divided into several receptions. Treatment by a short course at adults and children is more senior than 10 years. At uncomplicated infections of urinary tract of Gramoks-A it is possible to appoint in a dose 3 g to one reception with an interval of 10-12 hours (only 2 receptions). At abscess of an oral cavity of Gramoks-A appoint in a dose 3 g to one reception with an interval of 8 hours (only 2 receptions). For treatment of gonorrhea drug appoint in a dose 3 g once. At a peptic ulcer of a stomach and duodenum of Gramoks-A apply to N.'s eradikation of Pylori in complex schemes (together with blockers of a proton pomp and other antibacterial agent) 1000 mg 2 times a day for 7 days. Before dental intervention to persons with high risk of its emergence without artificial valves of heart which did not accept a penicillinic antibiotic for a month Gramoks-A apply to prevention of a bacterial endocarditis according to the following scheme.

	Adults and children are more senior than 10 years	Children up to 10 years
The patient does not need the general anesthesia	3 g in 1 hour prior to the procedure and if necessary repeatedly 3 g in 6 hours after holding a procedure	A half of a dose for adults
The patient needs the general anesthesia	3 g in 4 hours prior to intervention, then 3 more g after anesthesia	A half of a dose for adults

 

Clearance of creatinine	Drug dose
> 30 ml/min.	Correction is not required
10-30 ml/min.	15 mg/kg two times a day (at most 500 mg two times a day)
<10 ml/min.	15 mg/kg once a day (at most 500 mg a day)

Clearance of creatinine	Drug dose
> 30 ml/min.	Correction is not required
10-30 ml/min.	At most 500 mg two times a day
<10 ml/min.	At most 500 mg a day

Features of use:

Before use of Gramoksa-A it is necessary to specify carefully at the patient existence of the previous allergic reactions to penitsshshina and cephalosporins. Serious and sometimes lethal allergic (anaphylactic) reactions were recorded during treatment by penicillin at persons with the known hypersensitivity to β-laktamny antibiotics. At use of amoxicillin for patients with an infectious mononucleosis emergence of erythematic or papular rash is possible. Prolonged use of amoxicillin can lead to the overgrowth of insensitive microorganisms. At patients with reduced urination the crystalluria therefore at use of high doses of drug it is necessary to support the adequate use of liquid and normal urination was very seldom observed. At patients with a renal failure it is necessary to adjust drug doses according to clearance of creatinine (see the section "Route of Administration and Doses").

Ability to influence speed of response at control of motor transport or the robot with other mechanisms. Some patients after use of drug can have a dizziness, a headache, spasms that should be meant at control of motor transport.

Use during pregnancy or feeding by a breast. It is possible to use drug during pregnancy in case the expected advantage for mother exceeds potential risk for a fruit. Amoxicillin gets into breast milk therefore feeding by a breast during use of drug needs to be stopped temporarily.

Children. Gramoks-A appoint to children aged from 10 years. Children aged up to 10 years for the accuracy of dosing are recommended to use drug in the form of Gramoks-@ suspension.

Side effects:

Side reactions classify as very frequent (> 1 on 10 patients), frequent (from 1 on 100 patients to 1 on 10 patients), infrequent (from 1 on 1000 patients to 1 on 100 patients), rare (from 1 on 10000 patients to 1 on 1000 patients), very rare (<1 on 10000 patients). Infectious complications: very seldom — candidiasis of skin and mucous membranes. Blood and lymphatic system: very seldom — a reversible leukopenia (including a heavy neutropenia or an agranulocytosis), reversible thrombocytopenia, an eosinophilia and hemolitic anemia. Increase in a bleeding time and prothrombin time is possible. Imunny system: very seldom — as well as at use of other antibiotics, development of serious allergic reactions (a Quincke's disease, an acute anaphylaxis, a serum disease, an allergic vasculitis) is possible. In case of allergic reactions drug needs to be cancelled. Nervous system: very seldom — a hyperkinesia, dizziness, spasms. Spasms can develop at persons with a renal failure or at the patients accepting high doses of drug. Digestive tract: often — nausea and diarrhea; infrequently — vomiting; very seldom — antibiotikoassotsiirovanny colitis (including pseudomembranous colitis and hemorrhagic colitis), black "hairy" language, superficial decolouration of teeth at children, the correct hygiene of an oral cavity warns this complication, and color of teeth is recovered after cleaning. Liver and biliary tract: very seldom — hepatitis and cholestatic jaundice, moderate increase in level of transaminases which value is unknown. Skin and hypodermic cellulose: often — skin rash; infrequently — urticaria, an itch; very seldom — a multiformny erythema, Stephens-Johnson's syndrome, a toxic epidermal necrolysis, violent and exfoliative dermatitis, acute generalized exanthematous пустулез. Urinary system: very seldom — intersticial nephrite, a crystalluria. Overdose. Symptoms: nausea, vomiting, diarrhea and, as a result, disturbance of water and electrolytic balance; a dieback, fever, an abnormal liver function, kidneys, an eosinophilia, an agranulocytosis, disturbances from the central nervous system (excitement, sleeplessness, dizziness, spasms). Treatment: gastric lavage, reception of enterosorbents and symptomatic therapy. If necessary — a hemodialysis. There is no specific antidote.

Interaction with other medicines:

Probenetsid reduces a canalicular reabsorption of amoxicillin. Combined use of a probenetsid with amoxicillin leads to increase in concentration of amoxicillin in a blood plasma. As well as other antibiotics, amoxicillin can influence intestinal microflora that leads to reduction of a reabsorption of estrogen and decrease in effect of the combined oral contraceptives. Combined use with Allopyrinolum can lead to increase in frequency of skin reactions. It is necessary to kotrolirovat a prothrombin time at patients who at the same time accept anticoagulants and amoxicillin as lengthening of a prothrombin time was in rare instances noted. It is recommended to apply enzymatic glyukozooksidazny methods of a research of availability of sugar in urine during treatment by amoxicillin. Due to the high concentration of amoxicillin in urine other methods of a research can yield false positive results.

Contraindications:

Hypersensitivity to β-laktamny antibiotics (penicillin, cephalosporins), an infectious mononucleosis, a lymphoid leukosis.

Storage conditions:

To store at a temperature not above +25 °C. To store in the place, unavailable to children. Not to use drug after the termination of the term of its validity specified on packaging.

Period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

Capsules on 12, 16 or 20 pieces in a polypropylene container, and in a cardboard pack.