Streptocide-darnitsa

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT STREPTOCID-DARNITSA (STREPTOCID-DARNITSA)

Composition:

Active substance: sulfanilamide;

1 tablet contains sulfanilamide 300 mg;

Excipients: potato starch, povidone, colloidal anhydrous silicon dioxide, stearic acid.

Pharmaceutical form. Tablets.

Main physicochemical properties: white-colored, flat cylindrical tablets with a score line and beveled edges.

Pharmacotherapeutic group. Antibacterial agents for systemic use. Short-acting sulfonamides. ATC code J01E B06.

Pharmacological Properties.

Pharmacodynamics.

Sulfanilamide (Streptocide), like other sulfonamides, disrupts the formation in microorganisms of growth factors – folic acid, dihydrofolic acid, and other compounds containing para-aminobenzoic acid in their molecule. 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 disrupts metabolic processes, resulting in a bacteriostatic effect. The drug belongs to short-acting sulfonamides. Streptocide exerts a bacteriostatic effect against streptococci, meningococci, pneumococci, gonococci, Escherichia coli, causative agents of toxoplasmosis and malaria. In terms of efficacy, it is considerably inferior to modern antibiotics. Currently, a large number of microbial strains, particularly hospital strains, are resistant to streptocide.

The activity of streptocide increases in an alkaline environment.

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

Pharmacokinetics.

When administered orally, the drug is rapidly absorbed: maximum concentration of streptocide in blood is observed within 1–2 hours; within 4 hours, the drug appears 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: infections of the skin and mucous membranes (wounds, ulcers, pressure sores), enterocolitis, pyelitis, cystitis.

Contraindications.

• Individual hypersensitivity to sulfonamides, sulfones, and other components of the drug; history of severe toxic-allergic reactions to sulfonamides;
• nephroses, nephritis;
• Graves' disease;
• acute hepatitis;
• bone marrow 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 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 PAS (para-aminosalicylic acid) and 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) – the antibacterial effect 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 para-aminobenzoic acid (procaine, anestezin, dicaine) – the antibacterial activity of sulfonamides is inactivated.

Sulfonamides must not be prescribed simultaneously with hexamethylenetetramine (urotropine), antidiabetic drugs (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 inhibition of its metabolism.

When used concurrently with other drugs that cause bone marrow suppression, hemolysis, or hepatotoxic effects, there is a risk of developing toxic effects.

Concurrent use with methenamine (urotropine) 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.

Special precautions for use.

During streptocide therapy, 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. Prescribing the medicinal product in insufficient doses or premature discontinuation of the drug 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 medicinal product 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 is possible, which may lead to the development of toxic effects.

Streptocid-Darnytsia 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.

Sulfonamides, including streptocide, should be used cautiously in patients with diabetes mellitus, as sulfonamides may affect blood sugar 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 recurrence and the development of resistant microbial strains.

Due to similarities in chemical structure, 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 individuals, there is an increased risk of developing severe adverse skin reactions, bone marrow suppression, and thrombocytopenic purpura (the latter being especially pronounced 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 missed doses. 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, the use of the medicinal product should be discontinued and medical advice should be sought regarding further treatment.

Use during pregnancy or breastfeeding.

The medicinal product is contraindicated during pregnancy or breastfeeding.

If use of the medicinal product is necessary, breastfeeding should be discontinued.

Ability to affect reaction speed when driving or operating machinery.

There is no available information on the effect of the medicinal product on the ability to drive or operate machinery.

Until individual response to the drug is established, patients should refrain from driving or operating machinery, as adverse reactions of the nervous system such as dizziness, seizures, ataxia, drowsiness, depression, and psychosis may occur during sulfonamide therapy.

Method of Administration and Dosage.

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. The daily dose should be divided into 5 doses.

For children aged 3 to 6 years: 300 mg per dose; for children aged 6 to 12 years: 300–600 mg per dose. The frequency of administration in children is 4–6 times daily.

The duration of treatment is determined individually and depends on the severity and course of the disease, localization of the process, and therapeutic efficacy.

Higher doses for adults: single dose – 2 g, daily dose – 7 g.

Maximum daily dose for children: 900 mg – 2.4 g.

Children.

The medicinal product is indicated for children aged 3 years and older.

Overdose.

Exaggeration of adverse effects may occur.

In case of overdose, anorexia (loss of appetite), nausea, vomiting, colicky 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. Prior to medical assistance, the stomach should be washed out with a 2% solution of sodium bicarbonate, and activated charcoal or other enterosorbents should be administered as a suspension. Intake of large amounts of fluid, forced diuresis, and hemodialysis are indicated. Symptomatic treatment.

Side effects.

Blood and lymphatic 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 hypertension, seizures, dizziness, somnolence/insomnia, fatigue, depression, peripheral or optic neuropathies, visual disturbances, psychosis, depressed state, 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 (ALT, AST, alkaline phosphatase), cholestatic hepatitis, hepatonecrosis, hepatomegaly, jaundice, cholestasis.

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

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 edema, rhinitis.

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

Other: dyspnea, nodular polyarteritis, hypothyroidism, hypoglycemia.

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. Keep out of reach of children.

Packaging.

10 tablets in a blister pack, 1 blister pack in a carton; 10 tablets in blister packs.

Prescription status. Prescription only.

Manufacturer. JSC "Pharmaceutical Company "Darnytsia".

Manufacturer's address.

13, Borispilska Street, Kyiv, 02093, Ukraine.