FTHALAZOL-ZDOROVYA

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT PHTHALAZOL-ZDOROV'YA (PHTHALAZOL-ZDOROVYE)

Composition:

Active substance: phthalylsulfathiazole;

1 tablet contains phthalylsulfathiazole 500 mg;

Excipients: potato starch, calcium stearate, talc.

Pharmaceutical form. Tablets.

Main physico-chemical properties: white or almost white tablets, with flat surface, scored line and bevelled edge.

Pharmacotherapeutic group. Antimicrobial agents used in intestinal infections. Sulfonamides.

ATC code A07AB02.

Pharmacological properties.

Pharmacodynamics. Sulfonamide medicinal product. Exerts a bacteriostatic effect. The primary mechanism of action is due to inhibition of microbial synthesis of growth factors—folic acid and dihydrofolic acid.

Pharmacokinetics. The medicinal product is slowly absorbed from the gastrointestinal tract; the majority remains in the small intestine, where the active (sulfonamide) part of the molecule is gradually released. As a result, high concentrations of sulfonamide are achieved in the intestine. It is excreted mainly in feces. A small amount absorbed (5–10% of the dose) is uniformly distributed throughout the body, acetylated in the liver, and excreted in urine.

Clinical characteristics.

Indications.

Acute dysentery (shigellosis); chronic dysentery in the stage of exacerbation; colitis, enterocolitis, gastroenteritis; for prevention of infectious complications during intestinal surgery.

Contraindications.

• Hypersensitivity to phthalylsulfathiazole, sulfanilamide drugs, and/or other components of the medicinal product;
• Basedow's disease;
• Blood disorders;
• Acute hepatitis.

Interaction with other medicinal products and other types of interactions.

If the patient is taking any other medicinal products, it is necessary to consult a physician regarding the possibility of using Phthalazol.

Depending on the nature of the disease, the medicinal product can be used in combination with antibiotics (an enhanced antimicrobial effect is observed). It is advisable to prescribe simultaneously sulfanilamides that are well absorbed (sulfadimidine, etazole, etazole-sodium).

Incompatible with para-aminosalicylic acid (PAS), salicylates, and diphenin (increased toxic effect of phthalylsulfathiazole), oxacillin (reduced activity of oxacillin), nitrofurans (increased risk of anemia and methemoglobinemia), male and female sex hormones (suppression of gonadal function), calcium chloride and vitamin K (impaired blood coagulation).

The medicinal product must not be used simultaneously with enterosorbents and laxatives.

Myelotoxic medicinal products enhance the manifestations of hematotoxicity of the drug.

Special precautions for use.

Consult a physician before taking the medication!

Use with caution in patients with nephrosis or nephritis.

During the period of taking the medication, patients should take vitamin B complex (thiamine, riboflavin, nicotinic acid), as inhibition of Escherichia coli growth reduces the synthesis of these vitamins.

If symptoms of the disease do not begin to resolve, or if the patient's condition worsens or adverse effects occur, discontinue taking Phthalazolum and consult a physician for further guidance on the use of the medication.

Use during pregnancy or breastfeeding.

Phthalsulfathiazole crosses the placenta, and animal studies have shown its adverse effects on the fetus; therefore, the drug should not be used during pregnancy.

Phthalsulfathiazole passes into breast milk and may cause kernicterus in infants, as well as hemolytic anemia in infants with glucose-6-phosphate dehydrogenase deficiency; therefore, the drug should not be used during breastfeeding.

Ability to affect reaction speed when driving or operating machinery.

The drug does not affect psychomotor reaction speed; it may be used at recommended doses when driving or operating machinery.

Dosage and Administration

Administer orally to adults and children aged 3 years and older.

Adults and children aged 12 years and older.

For acute dysentery: during the first 2 days of treatment – 6 g per day (1 g every 4 hours); on days 3–4 – 4 g per day (1 g every 6 hours); on days 5–6 – 3 g per day (1 g every 8 hours). The total course dose is 25–30 g.

Five to six days after completion of the first course, administer a second course: first 2 days – 1 g every 4 hours (at night – every 8 hours), total 5 g per day; days 3–4 – 1 g every 4 hours (not administered at night), total 4 g per day; day 5 – 1 g every 4 hours (not administered at night), total 3 g per day. The total course dose is 21 g (in mild cases, the total course dose may be reduced to 18 g).

Maximum doses: single – 2 g, daily – 7 g.

For treatment of other diseases, administer the drug during the first 2–3 days at 1–2 g every 4–6 hours; during the following 2–3 days – 0.5–1 g.

Children aged 3 to 12 years.

For acute dysentery: children aged 3 to 7 years – 500 mg per dose, 4 times daily; children aged 7 to 12 years – 500–750 mg per dose, 4 times daily. Treatment course – up to 7 days.

For treatment of other diseases, administer on the first day at a dose of 100 mg/kg body weight per day, given in equal doses every 4 hours with a pause at night. In subsequent days, administer 250–500 mg every 6–8 hours. Treatment course – up to 7 days.

If a child cannot swallow the tablet, it should be crushed and dissolved in a small amount of cooled boiled water.

Children: To be used in children aged 3 years and older.

Overdose.

Symptoms: macrocytosis and pancytopenia due to folic acid deficiency may occur. This can be prevented by administration of folic acid or calcium folinate. Exacerbation of adverse reactions.

Treatment: discontinue the drug, symptomatic therapy.

Side effects.

The medicinal product is well tolerated in most cases. Systemic adverse effects typical of sulfonamides occur rarely due to the minimal absorption of the active substance.

Allergic reactions, including fever, rash, itching.

Hematopoietic system: agranulocytosis, aplastic anemia.

Other: vitamin B complex deficiency (thiamine, riboflavin, nicotinic acid) due to suppression of intestinal microflora.

If any adverse reactions occur, consult a physician.

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. Tablets No. 10, No. 10×10 in blisters in a box; No. 10 in a blister.

Dispensing category.

Over-the-counter: tablets No. 10.

By prescription only: tablets No. 10×10.

Manufacturer.

Limited Liability Company "Pharmaceutical Company "Zdorovye".

Manufacturer's address and place of business.

22, Shevchenka Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.