Instructions for Phthalazol 500 mg tablets No. 10
Composition
active ingredient: phthalylsulfathiazole;
1 tablet contains phthalylsulfathiazole 500 mg;
excipients: potato starch, calcium stearate.
Dosage form
Pills.
Main physicochemical properties: solid, regular, round cylinders, the upper and lower surfaces of which are flat, the edges of the surfaces are beveled, with a dividing line, white or white with a slightly yellowish tint.
Pharmacotherapeutic group
Antimicrobial agents used for intestinal infections. Sulfonamides.
ATX code A07A B02.
Pharmacological properties
Pharmacodynamics.
Phthalazole is a broad-spectrum antimicrobial sulfonamide drug containing the active ingredient phthalylsulfathiazole.
The drug is active against gram-positive and gram-negative microorganisms - pathogens of intestinal infections. It exhibits a bacteriostatic effect due to the disruption of the formation of growth factors of microorganisms - folic and dihydrofolic acids, necessary for the synthesis of purines and pyrimidines in microorganisms.
It also has an anti-inflammatory effect due to its ability to limit leukocyte migration, reduce the total number of migrating cellular elements, and partially stimulate the production of glucocorticoids.
Pharmacokinetics.
Phthalylsulfathiazole is practically not absorbed from the digestive tract, bioavailability is 5-10%. The main amount of it is retained in the intestine, where the active sulfonamide part of the molecule is cleaved - sulfathiazole. Part of the drug that was absorbed is acetylated in the liver and excreted in the urine. The high concentration of sulfathiazole in the intestine, taking into account the specific bacteriostatic activity of the drug against intestinal microflora, determines the high effectiveness of phthalylsulfathiazole in intestinal infections.
Indication
Acute dysentery (shigellosis), chronic dysentery in the acute phase, colitis, enterocolitis, gastroenteritis; prevention of infectious complications during intestinal surgeries.
Contraindication
Hypersensitivity to phthalylsulfathiazole, sulfonamide drugs and/or other components of the drug. Graves' disease, blood diseases, acute hepatitis, chronic renal failure, glomerulonephritis, intestinal obstruction.
Interaction with other medicinal products and other types of interactions
If the patient is taking any other medications, it is imperative to consult a doctor about the possibility of using Ftalazol.
Depending on the nature of the disease, Ftalazol can be used in combination with antibiotics (enhanced antimicrobial action is observed). Simultaneously with the drug, it is advisable to prescribe well-absorbed sulfonamides (sulfadimezin, etazol, etazol-sodium).
Incompatible with para-aminosalicylic acid, salicylates, diphenin (enhancement of the toxic effect of phthalylsulfathiazole), oxacillin (reduction of oxacillin activity), nitrofurans (increased risk of anemia and methemoglobinemia), male and female sex hormone preparations (suppression of gonadal function), calcium chloride and vitamin K (reduction of blood clotting).
Ftalazol should not be used simultaneously with enterosorbents and laxatives.
Myelotoxic drugs enhance the manifestations of the drug's hematotoxicity.
The use of phthalylsulfathiazole with acids and acid-reactive drugs, hexamethylenetetramine, and adrenaline solution is inappropriate, since they are chemically incompatible.
With the simultaneous use of phthalylsulfathiazole with drugs containing para-aminobenzoic acid esters (adrenaline, procaine, benzocaine, tetracaine), the antibacterial activity of sulfonamide is inactivated by a competitive mechanism.
Application features
You should consult a doctor before taking the medicine!
The drug should be taken with caution in patients with nephrosis and nephritis.
It is advisable to use B vitamins simultaneously with Ftalazol, since due to the inhibition of the growth of E. coli, the synthesis of vitamins of this group decreases.
If the signs of the disease do not disappear or, on the contrary, the state of health worsens or undesirable phenomena occur, it is necessary to stop taking Ftalazol and consult a doctor regarding further use of the drug.
Use during pregnancy or breastfeeding
Do not use during pregnancy.
Phthalylsulfathiazole passes into breast milk and can cause kernicterus in infants, as well as hemolytic anemia in infants with glucose-6-phosphate dehydrogenase deficiency, therefore Phthalazole is not prescribed during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
Since during therapy with the drug Ftalazol, such undesirable phenomena as headache and dizziness may develop, caution should be exercised when driving vehicles, operating machinery, and engaging in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
Method of administration and doses
Used internally by adults and children over 3 years of age.
Adults and children aged 12 and over.
In acute dysentery, it is used: in the first 2 days of treatment - 6 g per day (1 g every 4 hours), on the 3rd-4th day - 4 g per day (1 g every 6 hours), on the 5th-6th day - 3 g per day (1 g every 8 hours). The course dose is 25-30 g.
5-6 days after the first course of treatment, a second course is administered: the first 2 days - 1 g every 4 hours (at night - after 8 hours), a total of 5 g per day; 3-4 days - 1 g every 4 hours (do not use at night), a total of 4 g per day; 5 day - 1 g every 4 hours (do not use at night), a total of 3 g per day. The course dose is 21 g (with a mild course of the disease, the course dose can be reduced to 18 g).
Maximum doses: single dose – 2 g, daily dose – 7 g.
When treating other diseases, the drug is used in the first 2-3 days at 1-2 g every 4-6 hours, in the next 2-3 days - 500 mg -1 g.
For the prevention of purulent complications during intestinal surgery, adults are prescribed 1 g 4 times a day for the first 2–3 days; in the next 2–3 days - 500 mg 4 times a day. Treatment is combined with the appointment of antibiotics.
Children aged 3 to 12 years.
In acute dysentery, children aged 3 to 7 years are prescribed 500 mg per dose 4 times a day, children aged 7 to 12 years - 500-750 mg per dose 4 times a day. The course of treatment is up to 7 days.
In the treatment of other diseases, the drug is used on the 1st day at the rate of 100 mg/kg of body weight per day. It is taken in equal doses every 4 hours with a break for the night. In the following days, 250-500 mg is used every 6-8 hours. The course of treatment is up to 7 days.
If the child cannot swallow the tablet, it should be crushed and dissolved in a small amount of boiled, cooled water.
Children
The drug is not prescribed for children under 3 years of age.
Overdose
Symptoms: macrocytosis and pancytopenia may occur due to folic acid deficiency. This can be prevented by prescribing folic acid or calcium folinate. Typical adverse reactions may occur.
Treatment: drug withdrawal, symptomatic therapy.
Adverse reactions
Information on adverse reactions is presented according to the MedDRA system organ classification. The frequency of reactions is unknown (cannot be estimated from the available data).
Nervous system disorders: headache, dizziness, depressed mood.
Gastrointestinal disorders: nausea, vomiting, diarrhea, stomatitis, gingivitis, glossitis, gastritis, hypovitaminosis of B vitamins (thiamine, riboflavin, nicotinic acid) due to inhibition of intestinal microflora.
Liver and biliary tract disorders: cholangitis, hepatitis.
Renal and urinary disorders: urolithiasis.
Respiratory, thoracic and mediastinal disorders: eosinophilic pneumonia.
Cardiovascular system disorders: myocarditis, cyanosis.
Blood and lymphatic system disorders: leukopenia, thrombocytopenia, agranulocytosis, erythrocyte hemolysis, aplastic anemia. With prolonged use, anemia may occur due to a deficiency of pantothenic and pteroylglutaric acids, which are produced by microbial cells.
Skin and subcutaneous tissue disorders: skin manifestations of drug allergy in the form of various rashes, up to erythema nodosum and erythema multiforme, in some cases - toxic epidermal necrolysis (Lyell's syndrome). In some cases, allergic swelling of the lips and face, nodular periarteritis occur.
Expiration date
5 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
10 tablets in blisters;
10 tablets in a blister, 10 blisters in a pack.
Vacation category
Without a prescription - No. 10.
According to the recipe - No. 100.
Producer
JSC "Lubnypharm".
Location of the manufacturer and its business address.
Ukraine, 37500, Poltava region, Lubny, Barvinkova st., 16.
