Sulfadimetoksin-Darnitsa

General characteristics. Structure:

Active ingredient: sulfadimethoxine;

1 tablet contains sulfadimethoxine in terms of 100% dry matter of 500 mg;

excipients: potato starch, povidone (polyvinylpirrolidone low-molecular medical), silicon dioxide colloid anhydrous, calcium stearate.

Pharmacological properties:

Pharmacodynamics. Antimicrobic bacteriostatic means, streptocide of long action. The mechanism of action is connected with competitive antagonism with paraaminobenzoic acid, oppression of a digidropteroatsintetaza, disturbance of synthesis of the tetrahydrofolic acid necessary for synthesis of purines and pyrimidines. It is active concerning gram-positive and gram-negative microorganisms: Staphylococcus spp., Streptococcus spp., including Streptococcus pneumoniae, Friedlander's, Escherichia coli, Shigella spp sticks., Chlamydia trachomatis.

Pharmacokinetics. After intake in 30 min. it is found in blood, time of achievement of the maximum concentration in blood (Tmax) – 8-12 h Badly get through a blood-brain barrier. Therapeutic concentration at adults is noted at reception 1-2 g in 1 day and 0.5-1 g in the next days. Unlike other streptocides in most cases metabolism is carried out on the way of the microsomal glyukuronirovaniye connected with P450 cytochrome and NADFN-zavisimogo. It is removed preferential with urine. An elimination half-life (T1/2) – 16 hours.

Pharmaceutical characteristics.

Main physical and chemical properties. Tablets of color, white or white with a creamy shade, a ploskotsilindrichesky form, with a facet and risky.

Indications to use:

The infectious and inflammatory diseases caused by microflora, sensitive to effect of drug: tonsillitis, bronchitis, pneumonia, antritis, otitis, dysentery, inflammatory diseases of bilious and urinary tract, gonorrhea, an ugly face, a pyoderma, meningitis, an infection of wounds, trachoma, toxoplasmosis, a shigellosis, resistant forms of malaria (in combination with antimalarial drugs).

Route of administration and doses:

Sulfadimetoksin-Darnitsa the adult appoint inside once a day in a daily dose of 0,5-1 bucketed between receptions of 24 h. At lungs and averages on weight disease forms in the first day appoint respectively 1-2 g, in the subsequent – 0,5-1 g.

Doses for children, since 3 years: in the 1st day – 25 mg/kg of weight, in the subsequent – 12,5 mg/kg. For children over 12 years the initial and supporting doses are equal respectively 1 g and 0,5 g. After normalization of temperature in maintenance doses apply 2-3 more days. The course of treatment averages 7-14 days.

Features of use:

Use during pregnancy or feeding by a breast.

Drug is contraindicated during pregnancy and feeding by a breast.

Children.

Drug is appointed to children from 3 years.

At Sulfadimetoksin-Darnits's use it is regularly necessary to carry out blood tests and urine. At treatment of Sulfadimetoksinom-Darnitsa it is necessary to be careful at appointment as the patient with chronic heart failure, diseases of a liver and at a renal failure. During therapy it is recommended to use a large amount of alkaline liquid.

Ability to influence speed of response at control of motor transport or work with other mechanisms.

There are no data on influence of drug on ability to manage vehicles and performance of potentially dangerous types of activity.

Side effects:

From a nervous system: headache.

From a digestive tract: thirst, dryness in a mouth, the dispepsichesky phenomena, nausea, vomiting.

From a liver and biliary tract: increase in activity of liver ALT, nuclear Heating Plant enzymes, acid phosphatase, cholestatic hepatitis.

From an urinary system: urine discoloration (saturated yellowy-brown color), crystalluria.

From system of blood: leukopenia, agranulocytosis.

Allergic reactions: skin rashes, urticaria, allergic dermatitis.

From an organism in general: medicinal fever, pain in right hypochondrium and a waist.

Interaction with other medicines:

The non-steroidal anti-inflammatory drugs derivative of sulphonylurea, antitrombotichesky means, antagonists of vitamin K – at simultaneous use effect of these drugs amplifies.

Folic acid, bactericidal antibiotics (including penicillin, cephalosporins) – decreases efficiency of sulfadimethoxine.

Bactericidal antibiotics, oral contraceptives – at simultaneous use effect of these drugs decreases.

PASK and barbiturates – at use of sulfadimethoxine together with these drugs amplifies activity of sulfadimethoxine.

Pyrazyl ketone derivatives, indometacin and salicylates – increase activity and toxicity of drug.

The methotrexate and dipheninum – increase toxicity of sulfadimethoxine.

Erythromycin, lincomycin, tetracycline – at simultaneous use of drugs mutually amplifies antibacterial activity, the action spectrum extends.

Rifampicin, streptomycin, Monomycinum, Kanamycinum, gentamycin, oxyquinoline derivatives (nitroxoline) – at simultaneous use antibacterial effect of drugs does not change.

Acidum nalidixicum (Nevigramonum) – is sometimes observed antagonism.

Chloramphenicol, nitrofuran – decrease in a cooperative effect.

Drug is not appointed along with hexamethylenetetramine (urotropin), with anti-diabetic drugs (sulfonilmochevina derivatives), with dipheninum, neodicoumarin and other indirect anticoagulants.

Contraindications:

Existence in the anamnesis of the expressed toksiko-allergic reactions to streptocides, hypersensitivity to drug components, oppression of a marrowy hemopoiesis, a renal and/or liver failure, dekompensirovanny chronic heart failure, deficit glyukozo-6-fosfatdegidrogenazy, a porphyria, an azotemia, pregnancy, feeding by a breast, age up to 3 years.

Overdose:

Symptoms: thirst, dryness in a mouth, pain in right hypochondrium and a waist, an oliguria, urine discoloration (saturated yellowy-brown color). At biochemical analysis – increase in activity of liver ALT, nuclear Heating Plant enzymes, acid phosphatase, a leukopenia.

Treatment. Termination of administration of drug. If necessary initiation of vomiting, gastric lavage. Salt laxative. Absorbent carbon. High cleansing enema. Alkaline drink. In hard cases – an artificial diuresis.

Storage conditions:

Period of validity. 5 years. To store in the place, unavailable to children, in original packaging at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in a blister strip packaging, on 1 blister strip packaging in a pack. On 10 tablets in blister strip packagings.