INSTRUCTION
for medical use of the drug
STREPTOCIDE
(STREPTOCID)
Storage:
active substance: sulfonamide;
1 tablet contains sulfanilamide 0.3 g or 0.5 g;
excipients: potato starch, talc, stearic acid.
Dosage form. Tablets.
Main physical and chemical properties: white tablets with a flat surface, dash and bevel.
Pharmacotherapeutic group.
Antibacterial agents for systemic use. Short-acting sulfonamides.
ATX code J01E B06.
Pharmacological properties.
Pharmacodynamics.
Streptocide disrupts the formation in microorganisms of so-called "germ factors" - folic, dehydrofolic acids, other compounds that have in their molecule paraaminobenzoic acid (PABA). Due to the similarity of the structures of PABX and Streptocide, sulfonamide as a competitive antagonist of the acid is included in the metabolic chain of microorganisms and disrupts metabolic processes, which leads to a bacteriostatic effect. Streptocide is a short-acting sulfanilamide that has a bacteriostatic effect against streptococci, meningococci, pneumococci, gonococci, Escherichia coli, toxoplasmosis and malaria. Does not affect anaerobic microorganisms.
Pharmacokinetics.
When used internally, it is rapidly absorbed - the maximum concentration of streptocide in the blood is determined after 1-2 hours (within 4 hours it is detected in the cerebrospinal fluid); reduction of the maximum concentration in blood by 50% occurs in less than 8 hours. Approximately 95% of the drug is excreted by the kidneys.
Clinical characteristics.
Indication.
Infectious and inflammatory diseases caused by drug-sensitive microorganisms: infectious diseases of the skin and mucous membranes (wounds, ulcers, bedsores), enterocolitis, pyelitis, cystitis.
Contraindication.
Individual sensitivity to sulfonamides, sulfones or other components of the drug; the presence of a history of severe toxic-allergic reactions to sulfonamides; inhibition of hematopoiesis in the bone marrow; uncompensated heart failure; diseases of the hematopoietic system; anemia; leukopenia; base disease; kidney and liver diseases (nephrosis, nephritis, liver failure, severe renal failure, acute hepatitis); hyperthyroidism; congenital deficiency of glucose-6-phosphate dehydrogenase; azotemia; porphyria.
Interaction with other drugs and other types of interactions.
At simultaneous application:
with nonsteroidal anti-inflammatory drugs, sulfonylureas, antithrombotic agents, vitamin K antagonists - the effect of these drugs is enhanced;
with folic acid, bactericidal antibiotics (including penicillins, cephalosporins) - reduces the effectiveness of sulfonamides;
with bactericidal antibiotics, oral contraceptives - reduces the effect of these drugs;
with paraaminosalicylic acid (PAS) and barbiturates - the activity of sulfonamides increases;
with erythromycin, lincomycin, tetracycline - mutually enhances antibacterial activity, expands the spectrum of action;
with rifampicin, streptomycin, monomycin, kanamycin, gentamicin, oxyquinoline derivatives (nitroxoline) - the antibacterial effect of the drugs does not change;
with nalidixic acid (nevigramon) - sometimes there is antagonism;
with chloramphenicol, nitrofurans - the total effect is reduced;
with drugs containing PABX esters (novocaine, anesthesia, dicaine) - the antibacterial activity of sulfonamides is inactivated.
Sulfanilamides should not be prescribed concomitantly with hexamethylenetetramine (urotropin), with antidiabetic drugs (sulfonylurea derivatives), with definin, neodycoumarin and other indirect anticoagulants.
Streptocide may increase the effect and / or toxicity of methotrexate due to its displacement from protein binding and / or weakening of its metabolism.
When used concomitantly with other drugs that cause bone marrow suppression, hemolysis, hepatotoxic effects, the development of toxic effects is possible.
Concomitant use with methenamine (urotropin) is not recommended due to an increased risk of crystalluria in acidic urine reactions.
Phenylbutazone (butadione), salicylates and indomethacin may displace sulfonamides from binding to plasma proteins, thereby increasing their concentration in the blood. When used together with paraaminosalicylic acid and barbiturates, the activity of sulfonamides is enhanced; with chloramphenicol - increases the risk of agranulocytosis; with drugs containing esters of paraaminobenzoic acid (novocaine, anesthesia, dicaine), анти inactivated antibacterial activity of sulfonamide.
Features of application.
At treatment by drug it is necessary to carry out systematic control of function of kidneys and indicators of peripheral blood, level of glucose in blood.
During long-term treatment with the drug it is necessary to periodically perform blood tests (biochemical and general blood tests). Administration of the drug in insufficient doses or early discontinuation of the drug may increase the resistance of microorganisms to sulfonamides.
Sulfanilamides should not be used to treat infections caused by beta-hemolytic group A streptococcus, as they do not lead to eradication and, consequently, cannot prevent complications such as rheumatism and glomerulonephritis.
The drug should be used with caution in patients with chronic heart failure, liver disease and renal impairment. Streptocide should be used with caution in patients with severe allergic diseases or bronchial asthma, with diseases of the blood system. If there are signs of hypersensitivity reactions, the drug should be discontinued. With renal failure, the accumulation of sulfonamide and its metabolites in the body is possible, which can lead to the development of toxic effects.
Sulfanilamides, including streptocide, should be used with caution in diabetics, as sulphonamides may affect blood sugar levels. High doses of sulfonamides have a hypoglycemic effect.
Because sulfonamides are bacteriostatic, not bactericidal, a full course of therapy is needed to prevent recurrence of infection and the development of resistant forms of microorganisms.
Due to the similarity of the chemical structure, sulfonamides should not be used in people with hypersensitivity to furosemide, thiazide diuretics, carbonic anhydrase inhibitors and sulfonylureas.
Patients should drink enough fluids to prevent crystalluria and the development of urolithiasis.
Elderly people have an increased risk of severe skin side effects, hematopoiesis, thrombocytopenic purpura (the latter - especially in combination with thiazide diuretics). The drug should be avoided in patients over 65 years of age due to an increased risk of severe adverse reactions.
It is recommended to avoid exposure to direct sunlight and artificial ultraviolet radiation, given the possibility of photosensitization with sulfonamides.
During treatment it is necessary to adhere to the dosing regimen, apply the recommended dose with an interval of 24 hours, do not skip the drug. If a dose is missed, do not double the next dose.
If the symptoms do not begin to disappear or, conversely, the health deteriorates or side effects occur, it is necessary to suspend the use of the drug and consult a doctor about further use of the drug.
Use during pregnancy or breastfeeding.
During pregnancy or breastfeeding, the drug is contraindicated. If necessary, breast-feeding should be discontinued.
Ability to influence the speed of reaction when driving a car or other machinery.
Until the patient's individual response to the drug is clarified, one should refrain from driving or operating machinery, given that during treatment with Streptocide, side effects from the nervous system such as dizziness, convulsions, ataxia, drowsiness, depression may occur. , psychosis.
Method of application and dosage.
Take orally during or after a meal, drinking 150-200 ml of water. The single dose for adults and children over 12 years of age 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 - 2 g, daily - 7 g.
Single dose for children aged 3 to 6 years - 0.3 g, from 6 to 12 years - 0.3-0.6 g. The frequency of administration for children is 4-6 times a day.
The maximum daily dose for children is 0.9-2.4 g.
The duration of treatment is determined by the doctor individually, depending on the severity and course of the disease, the localization of the process, the effectiveness of therapy.
Children.
The drug is not used in children under 3 years.
Overdose.
Possible increase in the manifestations of side effects.
In case of overdose, anorexia (lack of appetite), nausea, vomiting, colic-like pain, headache, drowsiness, dizziness, fainting may occur. With prolonged use, fever, hematuria, crystalluria, cyanosis, tachycardia, paresthesia, diarrhea, cholestasis, renal failure with anuria, toxic hepatitis, leukopenia, agranulocytosis are possible.
Treatment. In case of overdose, it is recommended to consult a doctor. Treatment is symptomatic. Before providing medical care, gastric lavage with 2% sodium bicarbonate solution and take a suspension of activated charcoal or other enterosorbents. The use of a large amount of fluid, forced diuresis, hemodialysis are shown.
Adverse reactions.
From the blood and lymphatic system: leukopenia, agranulocytosis, aplastic anemia, thrombocytopenia, hypoprothrombinemia, eosinophilia, hemolytic anemia with glucose-6-phosphate dehydrogenase deficiency.
From the cardiovascular system: tachycardia, myocarditis.
From the nervous system: headache; neurological reactions, including aseptic meningitis; ataxia; slight intracranial hypotension; convulsions; dizziness; drowsiness / insomnia; feeling tired; depression; peripheral or optic neuropathy; visual impairment; psychosis; hypochondria; paresthesia.
From the respiratory system: pulmonary infiltrates, fibrosing alveolitis.
From the digestive tract: thirst, dry mouth, dyspepsia, nausea, vomiting, diarrhea, anorexia, pancreatitis, pseudomembranous colitis.
From the hepatobiliary system: increased activity of liver enzymes (alanine transaminase, aspartate transaminase, alkaline phosphatase), cholestatic hepatitis, hepatonecrosis, hepatomegaly, jaundice, cholestasis.
From the urinary system: change in urine color (saturated yellow-brown color), crystalluria with an acid reaction of urine; nephrotoxic reactions: interstitial nephritis, tubular necrosis, renal failure, hematuria, shock kidney with anuria.
From the skin and subcutaneous tissue: skin redness, skin rash (including erythematous-squamous, papular), itching, urticaria, allergic dermatitis, photosensitization, exfoliative dermatitis, erythema nodosum, cyanosis.
Allergic reactions: allergic reactions, including toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, systemic lupus erythematosus, serum syndrome, anaphylactic reactions, Quincke's edema, rhinitis.
Common disorders: drug fever, pain in the right hypochondrium and lower back.
Others: shortness of breath, nodular periarteritis, hypothyroidism, hypoglycemia. In isolated cases, the development of hypothyroidism is possible.
Expiration date. 5 years.
Do not use this medicine after the expiry date which is stated on the pack.
Storage conditions.
Store in the original package at a temperature not exceeding 25 ° C.
Packaging.
0.3 g and 0.5 g in a blister № 10.
Vacation category. According to the recipe.
Manufacturer / applicant.
LLC "Ternopharm".
Location of the manufacturer and address of the place of business / location of the applicant.
Ukraine, 46010, Ternopil, street Factory, 4.
