Anastrozole Ozone film-coated pills 1 mg N30
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Active ingredients
Anastrozole
Release form
Coated pills
Composition
Active ingredient: Anastrozole (anastrozole); Active ingredient concentration (mg): 1
Pharmacological effect
Antitumor agent. It is a selective non-steroidal aromatase inhibitor. In postmenopausal estradiol is mainly formed from estrone, which is produced in peripheral tissues by transformation from androstenedione (with the participation of the enzyme aromatase). Reducing circulating estradiol has a therapeutic effect in women with breast cancer. In postmenopausal anastrozole in a daily dose of 1 mg causes a decrease in estradiol levels by 80%. Anastrozole does not possess progestogenic, androgenic and estrogenic activity; in therapeutic doses does not affect the secretion of cortisol and aldosterone.
Pharmacokinetics
After oral administration, anastrozole is rapidly absorbed from the gastrointestinal tract. Cmax in plasma is reached within 2 hours (on an empty stomach). Food somewhat reduces the rate, but not the degree of absorption. Plasma protein binding is 40%. There is no information about cumulation. Anastrozole is metabolized by N-dealkylation, hydroxylation and glucuronization. Triazole, the major metabolite determined in plasma and urine, does not inhibit aromatase.; Anastrozole and its metabolites are excreted mainly with urine (less than 10% - unchanged) within 72 hours after a single dose. T1 / 2 from plasma - 40-50 hours; Anastrozole clearance after ingestion in volunteers with stabilized liver cirrhosis or renal dysfunction does not differ from clearance determined in healthy volunteers.; Anastrozole pharmacokinetics in postmenopausal women does not change.
Indications
Adjuvant therapy for early hormone-positive breast cancer in postmenopausal women; treatment of advanced breast cancer in postmenopausal women; adjuvant therapy for early hormone-positive breast cancer in postmenopausal women after tamoxifen therapy for 2–3 years.
Contraindications
Hypersensitivity to anastrozole or other components of the drug; pregnancy and lactation period; premenopausal period; severe renal failure (creatinine clearance less than 20 ml / min); average degree of liver failure; severe degree of liver failure (safety and efficacy not established); concomitant therapy with tamoxifen or drugscontaining estrogens; children's age up to 18 years (safety and efficacy in children have not been established).
Use during pregnancy and lactation
Contraindicated in pregnancy and lactation.
Dosage and administration
Inside The pill is swallowed whole with water. It is recommended to take the drug at the same time, regardless of the meal. Adults, including the elderly: 1 mg orally once a day for a long time. If there is evidence of disease progression, the drug should be discontinued. As adjuvant therapy, the recommended duration of treatment is 5 years. Mild and moderate renal failure: dose adjustment in patients with mild to moderate renal impairment is not required. Mild liver failure: dose adjustment in patients with mild hepatic insufficiency is not required .;
Side effects
On the part of the endocrine system: "hot flashes", vaginal dryness and thinning hair. On the part of the digestive system: anorexia, nausea, vomiting, diarrhea. In patients with advanced breast cancer, in most cases with metastases to the liver, there was an increase in GGT level, less often - alkaline membrane.; : skin rash.
Overdose
Currently, no cases of overdose have been reported.
Interaction with other drugs
Anastrozole reduces the effectiveness of estrogen.; Clinical studies have shown that with simultaneous use of anastrozole with antipyrine and cimetidine, drug interaction due to induction of liver microsomal enzymes is unlikely.
special instructions
If the patient’s hormonal status is uncertain, the condition of the menopause needs to be confirmed by additional biochemical studies. The safety of using anastrozole in patients with moderately impaired liver function has not been established. Anestrozole should not be used simultaneously with estrogens; treatment should not perform work that requires a high concentration of attention and quick psychomotor reactions.