Streptocide

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STREPTOCID

Composition:

Active substance: sulfanilamide;

1 tablet contains 300 mg of streptocid (sulfanilamide);

Excipients: potato starch, talc.

Pharmaceutical form. Tablets.

Main physicochemical properties: intact, regular, round cylindrical tablets with flat upper and lower surfaces, beveled edges, a dividing score line, white or almost white in color.

Pharmacotherapeutic group.

Antibacterial agents for systemic use. Short-acting sulfonamides.

ATC code J01E B06.

Pharmacological properties.

Pharmacodynamics.

Streptocide disrupts the formation in microorganisms of the so-called "growth factors" – folic acid, dihydrofolic acid, and other compounds containing para-aminobenzoic acid (PABA) in their molecule. Due to structural similarity between PABA and sulfanilamide, the latter acts as a competitive antagonist of the acid, integrates into the metabolic chain of microorganisms, and interferes with metabolic processes, resulting in a bacteriostatic effect. Streptocide is a short-acting sulfanilamide, exhibiting bacteriostatic activity against streptococci, meningococci, pneumococci, gonococci, Escherichia coli, Toxoplasma gondii, and malaria parasites. It has no effect on anaerobic microorganisms.

Pharmacokinetics.

When administered orally, it is rapidly absorbed – maximum blood concentration of streptocide is reached within 1–2 hours (detectable in cerebrospinal fluid within 4 hours); a 50% reduction in maximum blood concentration occurs in less than 8 hours. Approximately 95% of the drug is excreted by the kidneys.

Clinical characteristics.

Indications.

Infectious-inflammatory diseases caused by microorganisms sensitive to the drug: infections of the skin and mucous membranes (wounds, ulcers, pressure sores), enterocolitis, pyelitis, cystitis.

Contraindications.

Individual hypersensitivity to sulfonamides, sulfa drugs, or other components of the drug; history of severe toxic-allergic reactions to sulfonamides; bone marrow suppression; uncompensated heart failure; blood disorders; anemia; leukopenia; Basedow's disease; kidney and liver diseases (nephrosis, nephritis, hepatic insufficiency, severe renal insufficiency, acute hepatitis); hyperthyroidism; congenital glucose-6-phosphate dehydrogenase deficiency; azotemia; porphyria.

Interaction with other medicinal products and other types of interactions.

When used concomitantly:

• with nonsteroidal anti-inflammatory drugs, sulfonylurea derivatives, antithrombotic agents, vitamin K antagonists – the effect of these drugs is enhanced;
• with folic acid, bactericidal antibiotics (including penicillins, cephalosporins) – the efficacy of sulfonamides is reduced;
• with bactericidal antibiotics, oral contraceptives – the effect of these drugs is reduced;
• with para-aminosalicylic acid (PAS) and barbiturates – the activity of sulfonamides is enhanced;
• with erythromycin, lincomycin, tetracycline – mutual enhancement of antibacterial activity and broadening of the spectrum of action;
• with rifampicin, streptomycin, monomycin, kanamycin, gentamicin, oxquinoline derivatives (nitroxoline) – antibacterial activity of the drugs remains unchanged;
• with nalidixic acid (negramon) – antagonism is sometimes observed;
• with chloramphenicol, nitrofurans – the total effect is reduced;
• with agents containing esters of PABA (procaine, anestezin, dicaine) – antibacterial activity of sulfonamides is inactivated.

Sulfonamides should not be prescribed simultaneously with hexamethylenetetramine (urotropin), antidiabetic agents (sulfonylurea derivatives), defenin, neodicoumarin, and other indirect anticoagulants.

Streptocide may enhance the effect and/or toxicity of methotrexate due to its displacement from protein binding and/or reduced metabolism.

Concomitant use with other drugs causing bone marrow suppression, hemolysis, or hepatotoxic effects may lead to the development of toxic effects.

Simultaneous use with methenamine (urotropin) is not recommended due to increased risk of crystalluria in acidic urine.

Phenylbutazone (butadione), salicylates, and indomethacin may displace sulfonamides from plasma protein binding, thereby increasing their blood concentration. When used together with para-aminosalicylic acid and barbiturates, the activity of sulfonamides is enhanced; with chloramphenicol – the risk of agranulocytosis increases; with agents containing esters of para-aminobenzoic acid (procaine, anestezin, dicaine), the antibacterial activity of sulfonamides is inactivated.

Special precautions for use.

During treatment with the drug, it is necessary to systematically monitor kidney function, peripheral blood parameters, and blood glucose levels.

With prolonged treatment, periodic blood tests (biochemical and complete blood counts) should be performed. Insufficient dosing or premature discontinuation of the drug may promote increased microbial resistance to sulfonamides.

Sulfonamides should not be used for the treatment of infections caused by group A beta-hemolytic streptococci, as they do not eradicate this pathogen and therefore cannot prevent complications such as rheumatic fever and glomerulonephritis.

The drug should be prescribed with caution in patients with chronic heart failure, liver disease, or impaired kidney function. Streptocide should be used cautiously in patients with severe forms of allergic disorders or bronchial asthma, as well as in those with blood system disorders. If signs of hypersensitivity reactions occur, the drug should be discontinued. In renal insufficiency, accumulation of sulfonamide and its metabolites in the body is possible, which may lead to the development of toxic effects.

Sulfonamides, including streptocide, should be used cautiously in patients with diabetes mellitus, as sulfonamides may affect blood glucose levels. High doses of sulfonamides have a hypoglycemic effect.

Since sulfonamides are bacteriostatic rather than bactericidal agents, a full course of therapy is required to prevent infection relapse and the development of resistant microbial strains.

Due to structural similarity, sulfonamides should not be administered to individuals with hypersensitivity to furosemide, thiazide diuretics, carbonic anhydrase inhibitors, or sulfonylurea derivatives.

Patients should consume sufficient fluids to prevent crystalluria and the development of urolithiasis.

In elderly patients, there is an increased risk of severe adverse skin reactions, bone marrow suppression, and thrombocytopenic purpura (the latter especially when combined with thiazide diuretics). Administration of the drug should be avoided in patients aged 65 years and older due to the increased risk of severe adverse reactions.

Exposure to direct sunlight and artificial ultraviolet radiation should be avoided due to the potential for photosensitization during sulfonamide therapy.

During treatment, the prescribed dosing regimen must be strictly followed, with the recommended dose administered at 24-hour intervals, and doses should not be skipped. If a dose is missed, the next dose should not be doubled.

If symptoms of the disease do not begin to resolve, or if the patient's condition worsens or adverse effects occur, drug administration should be discontinued and medical advice should be sought regarding further treatment.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding.

If treatment with the drug is necessary, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

Until individual response to the drug is established, patients should refrain from driving vehicles or operating machinery, as sulfonamide therapy may cause nervous system side effects such as dizziness, seizures, ataxia, drowsiness, depression, and psychosis.

Dosage and Administration.

Take orally during or after meals with 150–200 ml of water. The single dose for adults and children aged 12 years and older is 600 mg–1.2 g; the daily dose is 3–6 g. Divide the daily dose into 5 doses. Maximum doses for adults: single dose – 2 g, daily dose – 7 g.

The single dose for children aged 3 to 6 years is 300 mg; for children aged 6 to 12 years – 300–600 mg. Children should take the medication 4–6 times daily.

Maximum daily dose for children – 0.9–2.4 g.

The duration of treatment is determined individually by a physician, depending on the severity and course of the disease, localization of the process, and therapeutic efficacy.

Children.

The drug is indicated for children aged 3 years and older.

Overdose.

Exaggerated manifestations of adverse effects may occur.

In case of overdose, anorexia (loss of appetite), nausea, vomiting, colicky abdominal pain, headache, drowsiness, dizziness, and syncope may develop. With prolonged use, fever, hematuria, crystalluria, cyanosis, tachycardia, paresthesia, diarrhea, cholestasis, renal failure with anuria, toxic hepatitis, leukopenia, and agranulocytosis are possible.

Treatment. In case of overdose, seek medical advice immediately. Treatment is symptomatic. Before medical help arrives, gastric lavage with a 2% solution of sodium bicarbonate is recommended, followed by administration of activated charcoal suspension or other enterosorbents. Intake of large amounts of fluids, forced diuresis, and hemodialysis are indicated.

Adverse Reactions

Blood system disorders: leukopenia, agranulocytosis, aplastic anemia, thrombocytopenia, hypoprothrombinemia, eosinophilia, hemolytic anemia in glucose-6-phosphate dehydrogenase deficiency.

Cardiovascular system disorders: tachycardia, myocarditis.

Nervous system disorders: headache; neurological reactions including aseptic meningitis; ataxia; mild intracranial hypotension; seizures; dizziness; somnolence/insomnia; fatigue; depression; peripheral or optic neuropathies; visual disturbances; psychosis; lethargy; paresthesia.

Respiratory system disorders: pulmonary infiltrates, fibrosing alveolitis.

Gastrointestinal disorders: thirst, dry mouth, dyspeptic symptoms, nausea, vomiting, diarrhea, anorexia, pancreatitis, pseudomembranous colitis.

Hepatobiliary system disorders: increased liver enzyme activity (alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase), cholestatic hepatitis, hepatonecrosis, hepatomegaly, jaundice, cholestasis.

Urinary system disorders: change in urine color (intense yellow-brown), crystalluria in acidic urine; possible nephrotoxic reactions: interstitial nephritis, tubular necrosis, renal failure, hematuria, shock kidney with anuria.

Skin and subcutaneous tissue disorders: skin hyperemia, skin rashes (including erythematous-squamous, papular), pruritus, urticaria, allergic dermatitis, photosensitization, exfoliative dermatitis, nodular erythema, cyanosis.

Allergic reactions: toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, systemic lupus erythematosus, serum sickness, anaphylactic reactions, Quincke's edema, rhinitis.

General disorders: drug fever, pain in the right hypochondrium and lumbar region.

Other: dyspnea, polyarteritis nodosa, hypothyroidism, hypoglycemia. Hypothyroidism may develop in isolated cases.

Shelf life. 5 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach of children.

Packaging.

10 tablets in blisters.

10 tablets in a blister, 1, 5, or 10 blisters per carton.

Prescription status.

Prescription only.

Manufacturer.

JSC "Lubnifarm".

Manufacturer's address and location of business activity.

16, Barvinkova St., Lubny, Poltava region, 37500, Ukraine.