Gramoks-D

General characteristics. Structure:

Active ingredient: amoxicillin; 5 ml (1 measured spoon) of suspension contain 125 mg or 250 mg of amoxicillin of trihydrate in terms of anhydrous amoxicillin; excipients: sodium saccharin, methylparahydroxybenzoate (нипагин) (E218), fragrance fruit, sodium carboxymethylcellulose (sodium of a karmelloz), sorbite (E420). Main physical and chemical properties: powder of color, white or white with a pink shade, with a specific smell. Also existence of a yellowish shade is admissible.

Pharmacological properties:

Pharmacodynamics. Gramoks-D — 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 spp., Moraxella cataralis, Helicobacter pylori, Enterococcus spp., Haemophilus influenzae, Neisseria gonorrhea, Neisseria meningitidis, Escherichia coli, Proteus mirabilis, Klebsiella spp., Shigella spp., Salmonella spp., Bordetella pertussis, Brucella spp. Are less sensitive to amoxicillin: E.Rhusopathiae, Eikenella spp., P.acnes, Peptostreptococcus, Actinomyces, Leptospires, Borrelia, Treponema, Eubacterium, Vibrio cholerae.

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, saliva, the lacrimal liquid, bile, serous covers, paranasal sinuses, a middle ear) 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:

Route of administration and doses:

The dose of drug is established individually depending on weight of infectious process and sensitivity of a contagium to amoxicillin. For suspension preparation the bottle with powder should be turned that powder separated from a bottom, then to fill with boiled water of room temperature to the green measured line on the label, to shake up carefully, again to add water to the red measured line and once again to shake up bottle contents before formation of homogeneous suspension. After that in a special frame of the label it is recommended to date suspension preparation. Before each use the bottle with suspension should be shaken up well.

Drug dosing

Age	Course of a disease	Concentration	Dosing
0-10 years	LUNG	125 mg / 5 ml	1 measured spoon three times a day
	AVERAGE	125 mg / 5 ml	2 measured spoons three times a day
		250 mg / 5 ml	1 measured spoon three times a day
10 years are more senior	LUNG	250 mg / 5 ml	1 measured spoon three times a day
	SEREDNY	250 mg / 5 ml	2 measured spoons three times a day

Treatment has to continue for 2-3 more days after disappearance of symptoms of a disease. For treatment of the infections caused by a β-hemolitic streptococcus for achievement of an eradikation of the activator a course of treatment has to make not less than 10 days.

High-dose therapy at children is more senior than 10 years. The maximum recommended daily dose for this age category makes 6 g.

Treatment by a short course at children is more senior than 10 years. At uncomplicated infections of urinary tract Gramoks-D it is possible to appoint in a dose 3 g to reception with an interval of 10-12 hours (only 2 times). At abscess of an oral cavity Gramoks-D appoint in a dose 3 g to reception with an interval of 8 hours (only 2 doses). For treatment of gonorrhea drug appoint in a dose 3 g once.

Before dental intervention at persons with high risk of its emergence without artificial valves of heart which did not accept a penicillinic antibiotic for a month Gramoks-D apply to prevention of a bacterial endocarditis according to the following schemes.

	Children are more senior than 10 years and adults	Children up to 10 years	Children up to 5 years
The patient does not need the general anesthesia	3 g in 1 hour prior to the procedure. If there is a need, in 6 hours use in a dose of 3 g can be repeated	Half of a dose of adults	Fourth part of a dose of adults
The patient needs the general anesthesia	3 g in 4 hours prior to intervention, then 3 more g after anesthesia	Half of a dose of adults	Fourth part of a dose of adults

 

Doses at a renal failure at children with body weight to 40 kg

Clearance of creatinine	Drug dose
> 30 ml/min.	It is not necessary for correction
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)

 

Is more than 40 have some of dose at a renal failure children with body weight

Clearance of creatinine	Drug dose
> 30 ml/min.	It is not necessary for correction
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 Gramoksa-D it is necessary to specify carefully at the patient existence of the previous allergic reactions to penicillin and cephalosporins. Serious and sometimes fatal allergic (anaphylactic) reactions were recorded during treatment by penicillin most of which often arose 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.

Ability to influence speed of response at control of motor transport or in work 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. During pregnancy use of drug is possible in case the expected advantage for mother exceeds potential risk for a fruit. Drug gets into breast milk therefore in need of use in the period of a lactation breastfeeding needs to be stopped temporarily for drug use.

Children. Drug is appointed from the first days of life of the child.

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 or hemolitic anemia, an eosinophilia. Increase in a bleeding time and prothrombin time is possible. Immune 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 treatment needs to be stopped. 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. GIT: 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 ekzentematozny пустулез. Urinary system: very seldom — intersticial nephrite, a crystalluria.

Interaction with other medicines:

Gramoks-D shows a synergism of antimicrobic action at combined use with aminoglycosides. Drugs of bacteriostatic action (antibiotics of a tetracycline row, macroleads, chloramphenicol) can neutralize bactericidal effect of amoxicillin. Simultaneous use of amoxicillin with digoxin can lead to increase in absorption of the last that can cause the necessity of dose adjustment of digoxin. The combined purpose of amoxicillin with probenetsidy, phenylbutazone, oksifenbutazony, at least with acetylsalicylic acid, indometacin and Sulfinpyrazonum leads to increase in concentration of amoxicillin in a blood plasma. The concomitant use of antacids reduces drug absorption. Gramoksa-D with Allopyrinolum can lead use to increase in frequency of emergence of skin reactions. As well as other antibiotics, amoxicillin, in isolated cases activity of oral contraceptives can reduce.

Contraindications:

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

Overdose:

Symptoms: nausea, vomiting, diarrhea and, as a result, disturbance of water and electrolytic balance. There is no specific antidote. Treatment: gastric lavage, reception of enterosorbents and symptomatic therapy. If necessary — a hemodialysis.

Storage conditions:

To store at a temperature not above +25 °C. To store in the place, unavailable to children. Period of validity of ready suspension of 8 days. Ready suspension store at a temperature from + 5 °C to + 8 °C.

Period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

Powder for preparation of suspension of 125 mg / 5 ml or 250 mg / 5 ml in the plastic container of brown color corked by a plastic cover in a cardboard pack together with a measured spoon.