Flutamide pills coated 250mg N100
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Active ingredients
Flutamide
Release form
Pills
Composition
Flutamide 250 mg Auxiliary substances: microcrystalline cellulose, corn starch, lactose monohydrate, sodium lauryl sulfate, colloidal silicon dioxide, magnesium stearate.
Pharmacological effect
Antitumor drug, nonsteroidal antiandrogen. Competitively blocks the interaction of androgens with their cellular receptors. The mechanism of action is based on inhibition of androgen uptake and / or inhibition of androgen binding in the nuclei of target tissue cells. Its ability to inhibit the action of testosterone at the cellular level complements the drug "castration" caused by GnRH agonists. The target organs of the pharmacological action of flutamide are the prostate gland and seminal vesicles. Flutamide does not possess estrogenic, antiestrogenic, progestogenic and anti-progestogenic activity.
Indications
Treatment of metastatic prostate cancer when testosterone suppression is indicated: - at the beginning of treatment in combination with GnRH agonists. - as an additional treatment for patients already receiving treatment with GnRH agonists. - in patients with surgical castration. - treatment of patients in whom other types of hormone therapy were ineffective, or in case of intolerance to such treatment.
Contraindications
- severe liver failure. - children's age (safety and efficacy not established). - hypersensitivity to flutamide or to any other component of the drug. The drug should be used with caution in patients with reduced liver function, with a tendency to thrombosis and in cardiovascular diseases, as well as in conditions that predispose to aniline intoxication (one of the metabolites of flutamide is a methylaniline derivative), including deficiency of glucose-6-phosphate dehydrogenase, smoking, hemoglobinopathy (M-hemoglobin).
Use during pregnancy and lactation
The drug should be used with caution in patients with reduced liver function. Contraindication: severe liver failure.
Dosage and administration
Assign inside 250 mg 3 times / day every 8 hours. If a positive effect is achieved, the drug is applied until signs of progression of the tumor disease appear.In the case of combined therapy with GnRH agonists, both drugs can be prescribed simultaneously or Flutamide Pliva can be taken 3 days before the first dose of GnRH agonist.
Side effects
The frequency of side effects is described in accordance with the following gradation: often (& # 8805 .10%), infrequently (from 1% to 10%), rarely (<1%). When using the drug in monotherapy. From the endocrine system: often - gynecomastia and / or pain in the region of the mammary glands, sometimes accompanied by galactorrhea (these phenomena disappear after discontinuation of treatment or dose reduction). rarely, decreased libido, hot flashes (sensation of heat, excessive sweating). With prolonged treatment, suppression of spermatogenesis was noted. On the part of the digestive system: infrequently - diarrhea, nausea, vomiting, increased appetite, transient liver dysfunction, hepatitis. rarely, anorexia, heartburn, constipation, dyspepsia, hepatitis or jaundice (including cholestatic), hepatic necrosis, hepatic encephalopathy, increased transaminase activity (these side effects are usually reversible after cessation of therapy, but there have been reports of deaths due to severe hepatic failure with flutamide therapy). From the side of the central nervous system: infrequently - insomnia, fatigue. rarely - headache, dizziness, weakness, blurred vision, anxiety, depression. Dermatological reactions: rarely - subcutaneous hemorrhage, shingles, pruritus, lupus-like syndrome. in some cases, hypersensitivity reactions (including erythema, skin ulceration, bullous rash, epidermal necrolysis). From the hematopoietic system: rarely - thrombocytopenia. in some cases - hemolytic anemia, macrocytic anemia, methemoglobinemia. On the part of the body as a whole: thirst, chest pain, edema (toes, feet, legs), increased blood pressure. sometimes patients have a change in the color of urine from amber to yellow-green. When treated in combination with GnRH agonists On the part of the endocrine system: often - hot flashes (feeling hot, excessive sweating), decreased libido, impotence (the incidence of these side effects is the same as with monotherapy with GnRH agonists). infrequently - gynecomastia. On the part of the digestive system: often - diarrhea, nausea, vomiting (the incidence of these side effects,with the exception of diarrhea (more pronounced when used in combination with flutamide), the same as with monotherapy with GnRH agonists. infrequently - lack of appetite. rarely - liver failure, hepatitis, cholestatic jaundice, liver necrosis, hepatic encephalopathy. On the part of the blood system: infrequently - anemia, leukopenia, thrombocytopenia. From the side of the central nervous system: infrequently - drowsiness, depression, confusion, anxiety, neurosis. Other: infrequently - edema, symptoms of neuromuscular disorders, difficulty urinating, increased blood pressure. rarely - respiratory failure, increased photosensitivity, methemoglobinemia.
special instructions
The frequency of side effects is described in accordance with the following gradation: often (& # 8805 .10%), infrequently (from 1% to 10%), rarely (<1%). When using the drug in monotherapy. From the endocrine system: often - gynecomastia and / or pain in the region of the mammary glands, sometimes accompanied by galactorrhea (these phenomena disappear after discontinuation of treatment or dose reduction). rarely, decreased libido, hot flashes (sensation of heat, excessive sweating). With prolonged treatment, suppression of spermatogenesis was noted. On the part of the digestive system: infrequently - diarrhea, nausea, vomiting, increased appetite, transient liver dysfunction, hepatitis. rarely, anorexia, heartburn, constipation, dyspepsia, hepatitis or jaundice (including cholestatic), hepatic necrosis, hepatic encephalopathy, increased transaminase activity (these side effects are usually reversible after cessation of therapy, but there have been reports of deaths due to severe hepatic failure with flutamide therapy). From the side of the central nervous system: infrequently - insomnia, fatigue. rarely - headache, dizziness, weakness, blurred vision, anxiety, depression. Dermatological reactions: rarely - subcutaneous hemorrhage, shingles, pruritus, lupus-like syndrome. in some cases, hypersensitivity reactions (including erythema, skin ulceration, bullous rash, epidermal necrolysis). From the hematopoietic system: rarely - thrombocytopenia. in some cases - hemolytic anemia, macrocytic anemia, methemoglobinemia. On the part of the body as a whole: thirst, chest pain, edema (toes, feet, legs), increased blood pressure. sometimes patients have a change in the color of urine from amber to yellow-green.When treated in combination with GnRH agonists On the part of the endocrine system: often - hot flashes (feeling hot, excessive sweating), decreased libido, impotence (the incidence of these side effects is the same as with monotherapy with GnRH agonists). infrequently - gynecomastia. On the part of the digestive system: often - diarrhea, nausea, vomiting (the incidence of these side effects, with the exception of diarrhea (more pronounced when used in combination with flutamide), is the same as with monotherapy with GnRH agonists). infrequently - lack of appetite. rarely - liver failure, hepatitis, cholestatic jaundice, liver necrosis, hepatic encephalopathy. On the part of the blood system: infrequently - anemia, leukopenia, thrombocytopenia. From the side of the central nervous system: infrequently - drowsiness, depression, confusion, anxiety, neurosis. Other: infrequently - edema, symptoms of neuromuscular disorders, difficulty urinating, increased blood pressure. rarely - respiratory failure, increased photosensitivity, methemoglobinemia.