Streptocide

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

Composition:

active substance: streptocid;

1 tablet contains streptocid (sulfanilamide) 500 mg (0.5 g);

excipients: potato starch, calcium stearate.

Pharmaceutical form. Tablets.

Basic physico-chemical properties: white tablets with flat surface, bevelled edges and a score line.

Pharmacotherapeutic group. Antimicrobial agents for systemic use. Sulfonamides. ATC code J01EB06.

Pharmacological properties.

Pharmacodynamics.

Sulfanilamide, like other sulfonamides, disrupts the formation in microorganisms of growth factors—folic acid, dihydrofolic acid, and other compounds containing para-aminobenzoic acid in their molecular structure. Due to its structural similarity to para-aminobenzoic acid, sulfanilamide acts as a competitive antagonist of this acid, incorporates into the metabolic chain of microorganisms, and interferes with metabolic processes, resulting in a bacteriostatic effect. The drug belongs to short-acting sulfonamides.

Sulfanilamide exerts a bacteriostatic effect against streptococci, meningococci, and gonococci, as well as Escherichia coli, causative agents of toxoplasmosis, and malaria. However, in terms of efficacy, it is significantly inferior to modern antibiotics. Currently, a large number of microbial strains, especially hospital strains, are resistant to sulfanilamide.

The activity of sulfanilamide increases in an alkaline environment.

Enterococci, Pseudomonas aeruginosa, and anaerobes are insensitive to sulfanilamide.

Pharmacokinetics.

When administered orally, the drug is rapidly absorbed. The maximum concentration of sulfanilamide in the blood is observed within 1–2 hours; within 4 hours, the drug appears in the cerebrospinal fluid. A 50% reduction in the 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: infectious diseases of the skin and mucous membranes (wounds, ulcers, pressure sores), enterocolitis, pyelitis, cystitis.

Contraindications.

• Individual intolerance to sulfonamides, sulfones, and other components of the medicinal product; history of severe toxic-allergic reactions to sulfonamides;
• nephroses, nephritis;
• Basedow's disease;
• acute hepatitis;
• bone marrow hematopoiesis suppression;
• renal and/or hepatic insufficiency;
• decompensated chronic heart failure;
• congenital deficiency of glucose-6-phosphate dehydrogenase, porphyria;
• hematopoietic system disorders: anemia, leukopenia;
• hyperthyroidism;
• azotemia.

Interaction with other medicinal products and other types of interactions.

When used simultaneously:

• with nonsteroidal anti-inflammatory agents, 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), barbiturates – the activity of sulfonamides is enhanced;
• with pyrazolone derivatives, indomethacin, and salicylates – the activity and toxicity of sulfonamides are increased;
• with methotrexate and phenytoin – the toxicity 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, oxichinoline 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 para-aminobenzoic acid (novocaine, anestezin, dicaine) – the antibacterial activity of sulfonamides is inactivated.

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

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

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

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; when used with chloramphenicol, the risk of agranulocytosis increases.

Special precautions.

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 prematurely discontinuing its use 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 this pathogen and therefore cannot prevent complications such as rheumatic fever and glomerulonephritis.

The drug should be prescribed with caution to patients with chronic heart failure, liver disease, or impaired kidney function. In renal insufficiency, accumulation of sulfonamide and its metabolites in the body may occur, potentially leading to toxic effects.

Streptocide should be administered cautiously to patients with severe forms of allergic disorders or bronchial asthma, as well as those with blood system disorders. If signs of hypersensitivity reactions appear, the drug should be discontinued.

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 hypoglycemic effects.

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 maintain adequate fluid intake to prevent crystalluria and the development of urolithiasis.

In elderly patients, there is an increased risk of developing severe adverse reactions affecting the skin, blood dyscrasias, and thrombocytopenic purpura (the latter being particularly associated with concomitant use of thiazide diuretics).

Administration of the drug to patients aged 65 years and older should be avoided 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 improve, 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 and breastfeeding.

Ability to influence reaction speed when driving or operating machinery.

Until the individual patient's response to the drug is known, driving vehicles or operating machinery should be avoided, considering that treatment with Streptocide may cause the following nervous system-related adverse reactions: dizziness, seizures, ataxia, somnolence, depression, and psychosis.

Dosage and Administration.

Take orally during or after meals with 150–200 ml of water. Adults and children aged 12 years and older should take 500–1000 mg five times daily, for a total daily dose of 3–6 g. Maximum dose for adults: single dose – 2 g, daily dose – 7 g.

For children aged 3 to 6 years: 250 mg 4–6 times daily; for children aged 6 to 12 years: 250–500 mg 4–6 times daily. Maximum dose for children: 1–2.5 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.

An overdose may intensify adverse effects.

Symptoms of overdose may include anorexia (loss of appetite), nausea, vomiting, colicky abdominal pain, headache, drowsiness, dizziness, and fainting.

With prolonged use, fever, hematuria, crystalluria, cyanosis, tachycardia, paresthesia, diarrhea, cholestasis, renal failure with anuria, toxic hepatitis, leukopenia, and agranulocytosis may occur.

Treatment. In case of overdose, seek medical advice immediately. Prior to medical assistance, perform gastric lavage with a 2% solution of sodium bicarbonate and administer activated charcoal suspension or other enterosorbents. Increased fluid intake, forced diuresis, and hemodialysis are indicated. Symptomatic treatment should be provided.

Adverse reactions

Blood and lymphatic system disorders: leucopenia, agranulocytosis, aplastic anaemia, thrombocytopenia, hypoprothrombinemia, eosinophilia, haemolytic anaemia in glucose-6-phosphate dehydrogenase deficiency.

Cardiovascular system disorders: tachycardia, myocarditis.

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

Respiratory system disorders: pulmonary infiltrates, fibrosing alveolitis.

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

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

Renal and urinary disorders: change in urine colour (intense yellow-brown colour), crystalluria in acidic urine; possible nephrotoxic reactions: interstitial nephritis, tubular necrosis, renal failure, haematuria, 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.

Immune system disorders: hypersensitivity reactions, including toxic epidermal necrolysis (Lyell’s syndrome), Stevens-Johnson syndrome, systemic lupus erythematosus, serum sickness-like syndrome, anaphylactic reactions, Quincke’s oedema, rhinitis.

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

Other: dyspnoea, nodular periarteritis, hypothyroidism, hypoglycaemia.

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 strips or blisters.

10 tablets per strip; 2 or 10 strips per cardboard pack.

10 tablets per blister; 2, 3, or 10 blisters per cardboard pack.

Supply category

Prescription only.

Manufacturer: JSC "Monfarm".

Manufacturer's address and place of business:

8, Zavodska St., Avramivka, Uman district, Cherkasy region, 19161, Ukraine.