Streptocide

INSTRUCTIONS for medical use of the medicinal product STREPTOCID (STREPTOCID)

Composition:

active substance: sulfanilamide;

1 tablet contains sulfanilamide calculated as 100% substance 300 mg;

excipients: potato starch, talc, sodium croscarmellose, methylcellulose.

Pharmaceutical form. Tablets.

Main physicochemical properties: white or yellowish-white tablets with a flat surface, a score line and bevelled edges. Marbling on the tablet surface is permissible.

Pharmacotherapeutic group. Antimicrobial agents for systemic use. Antibacterial agents for systemic use. Short-acting sulfonamides. Sulfanilamide. 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, acting as a competitive antagonist of the acid, incorporates into the metabolic chain of microorganisms and interferes with metabolic processes, resulting in a bacteriostatic effect. Sulfanilamides are synthetic bacteriostatic antibiotics with a broad spectrum of activity against most Gram-positive and Gram-negative microorganisms; however, many strains of certain species may be resistant.

Pharmacokinetics.

When administered orally, it is rapidly absorbed. Maximum concentration of streptocide in blood is reached within 1–2 hours (within 4 hours it is detectable 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 or allergic reactions to sulfonamides;
• nephroses, nephritis;
• Graves' disease;
• acute hepatitis;
• bone marrow hematopoiesis suppression;
• renal and/or hepatic insufficiency;
• decompensated chronic heart failure;
• glucose-6-phosphate dehydrogenase deficiency, porphyria;
• pregnancy or breastfeeding period.

Interaction with other medicinal products and other types of interactions.

When used concurrently:

• 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 erythromycin, lincomycin, tetracycline – mutual enhancement of antibacterial activity occurs, broadening 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 may occasionally occur;

• with chloramphenicol, nitrofurans – the overall 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 (urotropine), antidiabetic agents (sulfonylurea derivatives), definin, neodicumarin, and other indirect anticoagulants.

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. Inadequate dosing 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 lead to eradication of 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 administered cautiously to patients with severe forms of allergic diseases or bronchial asthma, as well as those with blood system disorders.

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 essential to prevent infection relapse and the development of resistant microbial strains.

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

The use of the drug should be avoided in patients aged 65 years and older due to an 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 missed. If a dose is missed, the next dose should not be doubled.

Use during pregnancy or breastfeeding.

The use of streptocide during pregnancy is contraindicated.

Sulfonamides are excreted in breast milk in small amounts; therefore, breastfeeding during treatment with the drug is contraindicated.

Ability to affect reaction speed when driving or operating machinery.

There is no information regarding the effect of the drug on the ability to drive vehicles or operate complex machinery.

Until individual response to the drug is established, patients should refrain from driving vehicles 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. Divide the daily dose into 5 doses. Maximum doses for adults: single dose – 2 g, daily dose – 7 g.

Single dose for children aged 3 to 6 years – 300 mg; for children aged 6 to 12 years – 300 – 600 mg. Frequency of administration in children is 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 treatment efficacy.

Children.

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

Overdose.

May enhance manifestations of adverse reactions.

In case of overdose, anorexia (loss of appetite), nausea, vomiting, colicky pain, headache, drowsiness, dizziness, and fainting may occur. With prolonged use, fever, hematuria, crystalluria, cyanosis, tachycardia, paresthesias, 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. Prior to medical assistance, wash out the stomach with a 2% solution of sodium bicarbonate and take 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: 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, benign intracranial hypertension, seizures, dizziness, somnolence/insomnia, fatigue, depression, peripheral or optic neuropathies, 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 system disorders: increased liver enzyme activity (ALT, AST, alkaline phosphatase), cholestatic hepatitis, hepatonecrosis, hepatomegaly, jaundice, cholestasis.

Renal and urinary system 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 hyperaemia, skin rash (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 oedema, rhinitis.

General disorders: drug-induced fever, pain in the right hypochondrium and lumbar region. Others: 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 a strip; 10 tablets in a blister, 1 blister in a carton.

Prescription status. Prescription only.

Manufacturer.

JSC "Kyivmedpreparat", Ukraine.

JSC "Halychpharm", Ukraine.

Manufacturer's address and location of its business activities.

Ukraine, 01032, Kyiv, Saksahanskoho St., 139.

Ukraine, 79024, Lviv, Opryshkovska St., 6/8.

Marketing Authorization Holder.

JSC "Halychpharm", Ukraine.

Address of the Marketing Authorization Holder.

Ukraine, 79024, Lviv, Opryshkovska St., 6/8.

Date of latest review.

APPROVED

Order of the Ministry of

Healthcare of Ukraine

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Registration Certificate

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