Active substancePhenoxymethylpenicillinPhenoxymethylpenicillin
Dosage form: & nbspPowder for suspension for oral administration
Composition:

Composition per package:

Active substance:

phenoxymethylpenicillin

37.5 mg

75 mg

Excipients:

citric acid monohydrate

0.00525 g

0.0105 g

sodium benzoate

0.003125 g

0.00625 g

aroma of raspberry

0.0003125 g

0.000625 g

sucrose (sugar)

up to the contents of the package:

2.5 grams

5 grams

Description:

The powder is white or almost white with a specific odor.

Pharmacotherapeutic group:antibiotic-penicillin biosynthetic
ATX: & nbsp

J.01.C.E.   Penicillins sensitive to beta-lactamases

J.01.C.E.02   Phenoxymethylpenicillin

Pharmacodynamics:

Antibacterial agent from the group of penicillins, acts bactericidal, inhibits the synthesis of the cell wall. Active with gram-positive (Staphylococcus spp., Streptococcus spp. (groups A, C, G, H, L and M), in t.ch. Streptococcus pneumoniae) and Gram-negative cocci (Neisseria meningitidis, Neisseria gonorrhoeae); Gram-negative and Gram-positive rods: Actinomyces bovis, Corynebacterium spp., Clostridium spp., Listeria monocytogenes, Bacillus anthracis, Streptobacillus moniliformis and Leptospira spp., Haemophilus influenzae, Treponema spp.

He acts on strains Staphylococcus spp., producing penicillinase, Mycobacterium tuberculosis, most gram-negative bacteria, viruses, Rickettsia spp., Entamoeba histolytica.

Acid-resistant; is destroyed by the action of penicillinase.

Pharmacokinetics:

It is stable in an acidic medium. Absorption in the small intestine - 30-60%. Food intake slightly reduces absorption. Connectivity from plasma proteins - 60-80%, long circulates in the blood, slowly penetrates into the tissues. High concentrations are determined in the kidneys, smaller - in the liver, the wall of the small intestine, the skin. Therapeutic concentrations in the blood after ingestion are reached after 30 minutes and remain for 3-6 hours.

Metabolised in the liver (30-35%). The half-life is 30-45 minutes and is prolonged in newborns, elderly patients, with renal insufficiency. It is excreted by the kidneys in unchanged form (25%) and in the form of metabolites (35%), about 30% - by the intestine.

Indications:

The mild and moderate severity of infection caused by microorganisms sensitive to penicillin.

Infections of the upper respiratory tract scarlet fever, erysipelas (mild), caused by Streptococcus spp. groups A, C, G, H, L them.

Respiratory infections, otitis media caused by Streptococcus pneumoniae.

Infections of the skin and subcutaneous tissue of mild Staphylococcus spp.

Fusospirochetosis (gingivitis and pharyngitis Vincent) of mild and moderate severity.

Prevention of recurrence of rheumatic fever and small chorea.

Prevention of bacterial endocarditis in patients with congenital heart disease, rheumatic or other acquired heart disease undergoing tooth extraction or tonsillectomy.

Contraindications:

Hypersensitivity (including to other beta-lactam antibiotics - penicillins, cephalosporins, carbapenems), severe course of the disease, aphthous stomatitis, pharyngitis and deficit sucrase / isomaltase intolerance to fructose and glucose-galactose malabsorption, gastrointestinal tract, accompanied by vomiting and diarrhea, children's age less than 3 months.

Carefully:

Allergic reactions (in the anamnesis), bronchial asthma, diabetes mellitus.

Pregnancy and lactation:

In pregnancy, phenoxymethylpenicillin can be used when the expected benefit to the mother exceeds the potential risk to the fetus.

During lactation, breastfeeding should be abolished.

Dosing and Administration:

Inside, for 0.5-1 h before meals, squeezed an abundant amount of liquid.

Adults and children over 5 years of age:

With infections of the upper respiratory tract, scarlet fever, erysipelas (mild), caused by Streptococcus spp. - 150-300 mg every 6-8 hours for 10 days.

For respiratory infections, otitis media caused by Streptococcus pneumoniae - 300-600 mg every 6 hours until normal body temperature is restored and for at least 2 more days.

In infections of skin and subcutaneous retina of mild degree caused by Staphylococcus spp. - 300-600 mg every 6-8 hours for 7 days.

When fusospirochetoze (gingivitis and pharyngitis Vincent) light and moderate severity - 300-600 mg every 6-8 hours.

For the prevention of relapses of rheumatic fever and small chorea - 150 to 300 mg twice a day for a long time.

Children 3-12 months - 75 mg every 6 hours; 1-5 years - 150 mg every 6 hours.

The duration of treatment depends on the etiology of the infection.

For the prevention of bacterial endocarditis in patients with congenital, rheumatic or other acquired heart defects, undergoing surgical (including dental) interventions on the upper respiratory tractx - 2 g for 1 h before the intervention and 1 g at 6 h after.

Children with a body weight of less than 27 kg - 1 g 14 hours before the operation and 500 mg 6 hours after.

In severe chronic renal failure, the interval between doses is increased to 12 hours.

Preparation of the suspension

Pour boiled and cooled water into a clean cup (see table), then pour the contents of one packet and mix until a homogeneous suspension is obtained.

The dose in the package, mg

The amount of water,

poured into cup, ml

37,5

2,5

75

5

After taking the glass, rinse with water, dry and store in a dry and clean place.
Side effects:

Allergic reactions: urticaria, skin hyperemia, angioedema, rhinitis, conjunctivitis, rarely - fever, serum sickness, arthralgia, eosinophilia, extremely rare - anaphylactic shock.

On the part of the organs of hematopoiesis: hemolytic anemia, leukopenia, agranulocytosis, thrombocytopenia, pancytopenia.

From the digestive system: dyspeptic disorders (nausea, vomiting, diarrhea), glossitis, stomatitis, vesiculitis cheilitis (associated with irritant effect of the drug on mucous membranes), decreased appetite, dry mouth, impaired taste, rarely - pseudomembranous enterocolitis.

Other: interstitial nephritis, pharyngitis, vasculitis.

Overdose:

Symptoms: nausea, vomiting, diarrhea; with a significant overdose - a cramp.

Treatment: cancellation of the drug, gastric lavage, symptomatic therapy. Phenoxymethylpenicillin is excreted by hemodialysis. There are no specific antidotes.

Interaction:

Increases the effectiveness of indirect anticoagulants (suppressing the intestinal microflora, reduces the formation of vitamin K); reduces the effectiveness of oral contraceptives and drugs, in the process of metabolism of which forms para-aminobenzoic acid.

Increases the risk of bleeding "breakthrough" against the background of taking ethinyl estradiol.

Antacids, glucosamine, laxatives, aminoglycosides and food slow down and reduce absorption; ascorbic acid - Increases.

Bactericidal antibiotics (including cephalosporins, cycloserine, vancomycin, rifampicin), aminoglycosides - synergy of action; bacteriostatic antibiotics (including macrolides, chloramphenicol, lincosamides, tetracyclines) - antagonism.

Diuretics, allopurinol, phenylbutazone, non-steroidal anti-inflammatory drugs and other drugs that reduce tubular secretion, increase the concentration of phenoxymethylpenicillin.

Allopurinol increases the risk of allergic reactions (skin rashes).

Special instructions:

Prolonged or repeated administration may cause the development of superinfections, the causative agents of which are resistant bacteria or fungi.

If severe persistent diarrhea is observed during treatment or in the first weeks after discontinuation, pseudomembranous colitis should be ruled out. Phenoxymethylpenicillin should not be used for severe pneumonia, empyema, bacteremia, pericarditis, meningitis and arthritis.

In infections caused by Streptococcus spp., with the purpose of complete elimination of the pathogen, treatment should continue for at least 10 days.

Patients with diabetes should take into account that the maximum daily dose of the drug contains 13.1 units of bread.

Effect on the ability to drive transp. cf. and fur:

Care should be taken when driving vehicles and working with mechanisms that require special attention and speed of the psychomotor reaction.

Form release / dosage:

Powder for the preparation of the suspension for ingestion, 37.5 mg, 75 mg.

Packaging:

2.5 g or 5 g (37.5 mg or 75 mg of active ingredient, respectively) of the powder in heat-seal single-dose bags of buflen; material of combined multilayer on the basis of foil; or paper packaging with polyethylene coating.

30 bags of 37.5 mg or 15 packages of 75 mg with instructions for use and a plastic cup are placed in a pack of cardboard.

30 packages of 37.5 mg or 15 packets of 75 mg with instructions for use are placed in a pack of cardboard.

Storage conditions:

AT dry, protected from light at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription
Registration number:LS-000491
Date of registration:11.05.2010
The owner of the registration certificate:SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products Russia
Manufacturer: & nbsp
Representation: & nbspSYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products SYNTHESIS JSC Joint-Stock Kurgan Society of Medical Preparations and Products Russia
Information update date: & nbsp20.09.2015
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