Streptocide

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT STREPTOCID (STREPTOCID)

Composition:

Active substance: sulfanilamide;

1 tablet contains 0.3 g or 0.5 g of sulfanilamide;

Excipients: potato starch, talc, stearic acid.

Pharmaceutical form. Tablets.

Main physico-chemical properties: white tablets with flat surface, scored line, and beveled edges.

Pharmacotherapeutic group.

Antibacterial agents for systemic use. Short-acting sulfonamides.

ATC code J01EB06.

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 Streptocide, the sulfonamide acts as a competitive antagonist of the acid, incorporates into the metabolic chain of microorganisms, and disrupts metabolic processes, resulting in a bacteriostatic effect. Streptocide is a short-acting sulfonamide, 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 concentration of streptocide in blood is reached within 1–2 hours (within 4 hours it can be detected in cerebrospinal fluid); 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: skin and mucous membrane infections (wounds, ulcers, pressure sores), enterocolitis, pyelitis, cystitis.

Contraindications.

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

Interaction with other medicinal products and other types of interactions.

When used simultaneously:

• 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, oxchinoline 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 drugs containing esters of PABA (procaine, anesthesin, dicaine) – antibacterial activity of sulfonamides is inactivated.

Sulfonamides must not be administered concurrently with hexamethylenetetramine (urotropin), antidiabetic agents (sulfonylurea derivatives), defimin, neodicumarin, and other indirect anticoagulants.

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

When used simultaneously with other drugs causing bone marrow suppression, hemolysis, or hepatotoxic effects, development of toxic effects is possible.

Concurrent 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 drugs containing esters of para-aminobenzoic acid (procaine, anesthesin, dicaine) – 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 count) should be performed. Prescribing the drug in insufficient doses or discontinuing treatment prematurely may promote increased microbial resistance to sulfonamides.

Sulfonamides should not be used to treat infections caused by group A beta-hemolytic streptococci, as they do not eradicate the 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 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 may occur, potentially leading to 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 may produce 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 developing severe adverse reactions, including skin reactions, bone marrow suppression, and thrombocytopenic purpura (the latter especially when combined with thiazide diuretics). The use 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, without missing doses. If a dose is missed, the next dose should not be doubled.

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

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy or breastfeeding. If use of the drug is necessary, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

Until the individual patient's response to the drug is known, patients should refrain from driving or operating machinery, considering that during treatment with Streptocide, adverse reactions of the nervous system such as dizziness, seizures, ataxia, drowsiness, depression, and psychosis may occur.

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 0.6–1.2 g; the daily dose is 3–6 g. The daily dose should be divided 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 0.3 g; for children aged 6 to 12 years – 0.3–0.6 g. 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 not administered to children under 3 years of age.

Overdose.

Exacerbation of adverse effects may occur.

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

Treatment. In case of overdose, seek medical attention immediately. Treatment is symptomatic. Prior to medical assistance, 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 fluid, forced diuresis, and hemodialysis are indicated.

Adverse Reactions.

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

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

Renal and urinary system disorders: change in urine color (intense yellow-brown), crystalluria in acidic urine; 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: allergic reactions, including 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.

Do not use the medicinal product after the expiry date stated on the packaging.

Storage conditions.

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

Packaging.

0.3 g and 0.5 g in blisters of 10.

Prescription category. Prescription only.

Manufacturer/Marketing Authorization Holder.

TOV "Ternopharm".

Manufacturer's address and location of its business activity / Marketing Authorization Holder's address.

46010, Ternopil, Fabrychna St., 4, Ukraine.

Tel./fax: (0352) 521-444, www.ternopharm.com.ua.