Instructions for use Ftalazol-Darnitsa tablets 500 mg No. 10
Composition
active ingredient: phthalylsulfathiazole;
1 tablet contains phthalazole (phthalylsulfathiazole) 500 mg;
Excipients: potato starch, povidone, colloidal anhydrous silicon dioxide, talc, calcium stearate.
Dosage form
Pills.
Main physicochemical properties: tablets of white or white with a slightly yellowish tint, flat-cylindrical shape, with a score and a bevel.
Pharmacotherapeutic group
Antimicrobial agents used for intestinal infections. ATX code A07A B02.
Pharmacological properties
Pharmacodynamics
A broad-spectrum sulfonamide drug, active against gram-positive and gram-negative microorganisms - pathogens of intestinal infections. It has a bacteriostatic effect, the mechanism of which is due to the disruption of the synthesis in microorganisms of their growth factors - folic and dehydrofolic acids, necessary for the synthesis of purines and pyrimidines.
Pharmacokinetics
The drug is slowly absorbed from the gastrointestinal tract, the main amount of it is retained in the intestinal lumen. In the small intestine it disintegrates with the formation of sulfathiazole (norsulfazole), which has high antimicrobial activity.
The high concentration of sulfathiazole created in the intestine, taking into account the specific bacteriostatic activity against the intestinal flora, determines the 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 surgery.
Contraindication
Increased individual sensitivity to phthalylsulfathiazole, sulfonamide drugs and/or other components of the drug;
Graves' disease;
blood diseases;
acute hepatitis.
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 regarding the possibility of using the drug.
Depending on the nature of the disease, Ftalazol-Darnitsa can be used in combination with antibiotics (increased antimicrobial action is observed). Simultaneously with the drug Ftalazol-Darnitsa, it is advisable to prescribe well-absorbed sulfonamides (sulfadimezin, etazol, etazol-sodium, etc.). Incompatible with PASK, salicylates, diphenyl (increased toxic effect of phthalazole), oxacillin (decreased activity of oxacillin), nitrofurans (increased risk of anemia and methemoglobinemia), male and female sex hormone preparations (suppression of gonadal function), calcium chloride and vitamin K (decreased blood clotting).
Ftalazol-Darnitsa should not be used simultaneously with enterosorbents and laxatives.
Myelotoxic drugs enhance the manifestations of the drug's hematotoxicity.
Application features
Before taking the medicine, you should consult a doctor!
The drug should be taken with caution in patients with nephrosis and nephritis.
Simultaneously with Ftalazol-Darnitsa, it is advisable to use B vitamins (thiamine, riboflavin, nicotinic acid), 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, conversely, the state of health worsens, or undesirable effects occur, it is necessary to stop using the drug and consult a doctor regarding further use of the drug.
Use during pregnancy or breastfeeding
Phthalylsulfathiazole crosses the placenta, and animal studies have shown adverse effects on the fetus, so the drug should not be used 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, so the drug should not be used during breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect the speed of psychomotor reactions, it can be used in recommended doses for people driving vehicles or working with other mechanisms.
Method of administration and doses
Do not use the medicine for longer than the specified period without consulting a doctor!
For use internally by adults and children over 3 years of age.
Adults and children aged 12 and over.
5-6 days after the first course of treatment, conduct a second course: the first 2 days - 1 g every 4 hours (at night - after 8 hours), a total of 5 g per day; 3-4th day - 1 g every 4 hours (do not prescribe at night), a total of 4 g per day; 5th day - 1 g every 4 hours (do not prescribe 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 - 2 g, daily - 7 g.
When treating other diseases, the drug should be used in the first 2-3 days at 1-2 g every 4-6 hours, in the next 2-3 days - at 0.5-1 g.
Children aged 3 to 12 years.
In acute dysentery, children aged 3 to 7 years should take 500 mg per dose, 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. Take in equal doses every 4 hours with a break for the night. In the following days, use 250-500 mg 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
Phthalazole should not be prescribed to 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.
Side effects
If any undesirable effects occur, you should consult a doctor!
The drug is well tolerated in most cases. Systemic adverse reactions typical of sulfonamides occur rarely due to the low absorption of the active substance.
The following side effects are possible:
Blood and lymphatic system disorders: agranulocytosis, aplastic anemia;
from the immune system: hypersensitivity reactions including allergic reactions, fever, rash, itching;
others: hypovitaminosis of B vitamins (thiamine, riboflavin, nicotinic acid) due to suppression of intestinal microflora.
Expiration date
2 years.
It is not recommended to use the medicine after the expiration date indicated on the package.
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 pack; 10 tablets in blister packs.
Vacation category
Without a prescription.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Address
Ukraine, 02093, Kyiv, Boryspilska St., 13.
