Sulfadimezin (sulfadimidine) tablets 0.5 g. №10

Description

Sulfadimezin (sulfadimidine) tablets 0.5 g. №10

Composition

active substance: sulfadimidine;

1 tablet contains sulfadimidine 500 mg;

Excipients: potato starch, gelatin, colloidal anhydrous silica, calcium stearate.

Dosage form

Tablets.

Main physical and chemical properties: round tablets with a flat surface, beveled edges and a dash, white or slightly yellowish.

Pharmacotherapeutic group

Antimicrobial agents for systemic use. Short-acting sulfonamides. Sulfadimidine.
ATX code J01E B03.

Pharmacological properties

Sulfadimezin is a short-acting sulfanilamide drug. Active against gram-positive and gram-negative cocci, Escherichia coli, Shigella, Klebsiella, Vibrio cholerae, pathogens of gas gangrene, anthrax, diphtheria, catarrhal pneumonia, plague, as well as chlamydia, actinomycetes, toxoplasmosis pathogens. Acts bacteriostatically. The mechanism of action is associated with para-aminobenzoic acid (PABA) and competitive inhibition of dihydropteroate synthetase, which leads to disruption of the synthesis of tetrahydrofolic acid, which is necessary for the synthesis of purines and pyrimidines.

Indications

Infections caused by microorganisms sensitive to the drug:

• infections of the respiratory tract and ENT organs (bronchitis, pneumonia, tonsillitis, sinusitis, otitis media);
• inflammatory diseases of the bile and urinary tract;
• infections of the skin and soft tissues (wound infection, pyoderma, erysipelas);
• gonorrhea, trachoma;
• shigellosis;
• toxoplasmosis.

Contraindications:

• hypersensitivity to sulfadimidine or to other components of the drug;
• a history of toxic and allergic reactions to other sulfonamides or their derivatives;
• systemic blood diseases, suppression of bone marrow hematopoiesis, including anemia, leukopenia;
• severe liver and / or kidney dysfunction, renal and / or hepatic failure;
• acute porphyria;
• hyperthyroidism;
• azotemia;
• deficiency of glucose-6-phosphate dehydrogenase (hemolysis is possible).

Method of administration and dosage

Take sulfadimezin orally.
Average doses for adults – 2 g (4 tablets) for the first dose, then 1 g (2 tablets) 4-6 times a day. Higher doses for adults: single – 2 g, daily – 7 g.
For children from 3 years of age, appoint 0.1 g / kg of body weight for the first dose, then 0.025 g / kg of body weight every 4-6-8 hours.
In the treatment of shigellosis, the drug is prescribed for adults according to the following scheme:

• 1-2 day – 1 g 6 times a day (every 4 hours);
• 3-4th day – 1 g 4 times a day (every 6 hours);
• 5-6th day – 1 g 3 times a day (every 8 hours).

Total for the course of treatment – 25-30 g of the drug.
After a 5-6-day break, a second course of therapy should be prescribed:

• Day 1-2 – 1 g 5 times a day (every 4 hours, and at night – after 8 hours);
• 3-4th day – 1 g 4 times a day (do not take at night);
• 5th day – 1 g 3 times a day.

During the second course, 21 g of Sulfadimezin are taken. In mild cases of shigellosis, the dose can be reduced to 18 g.
Doses for the treatment of shigellosis in children from 3 years of age: a single dose – from 0.4 g to 0.75 g, which should be taken 4 times a day. The drug must be taken within 5-7 days. In most infectious diseases, treatment continues for at least another 48-72 hours after the disappearance of the symptoms of the disease and confirmation of recovery by the results of bacteriological analysis.

Children

The drug should be used in children from 3 years of age.

Overdose

Symptoms: anorexia, abdominal cramping, nausea, vomiting, dizziness, headache, drowsiness, loss of consciousness. Hyperthermia, hematuria, crystalluria are possible. Pathological changes in the blood (leukopenia, agranulocytosis, hemolytic anemia) and jaundice are later manifestations of overdose. Development of methemoglobinemia is possible.
Treatment: immediate discontinuation of the drug, gastric lavage, an enhanced drinking regimen of solutions that alkalize urine is shown; with a decrease in urine output and normal renal function – intravenous administration of solutions. Further – symptomatic treatment.
When methemoglobinemia is confirmed, intravenous administration of 1% methylene blue is indicated.
Peritoneal dialysis is not effective, hemodialysis is only moderately effective in treating sulfonamide overdose.

Side effects:

• The same side reactions are possible as with the use of other sulfonamides.
• Digestive system: pain in the abdomen, dyspeptic symptoms, including nausea, vomiting, diarrhea, anorexia; stomatitis, sialoadenitis, pancreatitis, pseudomembranous colitis.
• Hepatobiliary system: increased serum levels of hepatic transaminases, hepatomegaly, occasionally jaundice, hepatitis, possible hepatonecrosis.
• Nervous system: headache, neurological reactions including aseptic meningitis, ataxia, benign intracranial hypertension, convulsions, dizziness, vertigo, drowsiness / insomnia, fatigue, peripheral or optic neuropathies, tinnitus.
• Mental disorders: depression, psychosis, hallucinations.
• Immune system: hypersensitivity reactions, incl. pruritus, skin rashes (including urticaria), drug fever, chills, photosensitivity reactions, exfoliative dermatitis, toxic epidermal necrolysis (Lyell’s syndrome), erythema nodosum, erythema multiforme, erythroderma, fixed drug erythema, periodemoid syndrome, Stevens-Syndrome Syndrome , anaphylactic reactions, incl. angioedema, very rarely – anaphylactic shock. In addition, cases of allergic myocarditis, periarteritis nodosa, systemic lupus erythematosus / lupus-like syndrome have been reported.
• Blood and lymphatic system: very rarely – agranulocytosis, aplastic anemia, thrombocytopenia, leukopenia, neutropenia, eosinophilia, acute hemolytic anemia with deficiency of glucose-6-phosphate dehydrogenase, purpura, hypoprothrombinemia, methemoglobinemia.
• Urinary system: crystalluria (possibly with low back pain, hematuria, oliguria, anuria), the risk of which can be reduced if the drug is used with a sufficient amount of fluid, is treated by alkalinizing urine; nephrotoxic reactions: interstitial nephritis, tubular necrosis, renal failure. Increased levels of urea, serum creatinine.
• Endocrine system: hypothyroidism, hypoglycemia.
• Respiratory system: cough, sore throat, shortness of breath, pulmonary eosinophilic infiltrates, fibrosing alveolitis.
• Others: tachycardia, arteritis, vasculitis, joint pain, muscle pain.

If adverse reactions occur, you should immediately stop taking the drug.