Anastrozole-Teva
Anastrozole-Teva: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Anastrozole-Teva
ATX code: L02BG03
Active ingredient: anastrozole (Anastrozole)
Manufacturer: Teva Pharmaceutical Enterprises, Ltd. (Teva Pharmaceutical Industries, Ltd.) (Israel)
Description and photo update: 2019-10-07
Anastrozole-Teva is an antineoplastic drug that inhibits estrogen synthesis.
Release form and composition
The drug is produced in the form of film-coated tablets: round, biconvex, almost white or white, engraved on one side "93", on the other - "A10" (7 pcs. In blisters, in a cardboard box 4 or 8 blisters and instructions for use of Anastrozole-Teva).
1 tablet contains:
- active substance: anastrozole - 1 mg;
- auxiliary components: lactose monohydrate (spray dried), lactose monohydrate (200 mesh), K30 povidone, magnesium stearate, sodium carboxymethyl starch (type A);
- composition of the film shell: Opadrai white 02G28619 [macrogol 400, macrogol 6000, hypromellose (E464), titanium dioxide (E171)].
Pharmacological properties
Pharmacodynamics
Anastrozole-Teva is an antineoplastic drug, the action of which is due to the ability of the active component, anastrozole, to inhibit the synthesis of estrogens. Anastrozole is a highly selective non-steroidal aromatase inhibitor, an enzyme that, in postmenopausal women, is involved in the transformation of androstenedione in peripheral tissues into estrone and estradiol. The therapeutic effect of the drug in the treatment of breast cancer occurs as a result of a decrease in the concentration of circulating estradiol. In postmenopausal women, taking anastrozole at a dose of 1 mg per day reduces estradiol levels by 80%.
Does not show gestagenic, androgenic or estrogenic activity. In doses up to 10 mg per day, anastrozole has no effect on the secretion of cortisol and aldosterone, so there is no need for replacement corticosteroids.
Pharmacokinetics
After taking Anastrozole-Teva inside, the absorption of anastrozole from the gastrointestinal tract occurs quickly. It usually takes 2 hours to reach the maximum concentration (C max) in blood plasma when using the drug on an empty stomach. In the presence of food in the stomach, the rate of absorption of anastrozole decreases slightly, this does not affect the degree of absorption and does not lead to a clinically significant change in C ss (equilibrium concentration) in blood plasma. After 7 days of therapy, C ss of the active substance in the blood plasma is approximately 90–95%.
Plasma protein binding - 40%.
Anastrozole is metabolized in the postmenopausal period extensively by N-dealkylation, hydroxylation and glucuronidation. Its main metabolite, triazole, is determined in blood plasma, but has no pharmacological activity. Excretion of metabolites is carried out mainly through the kidneys.
The half-life (T 1/2) of the drug from blood plasma is from 40 to 50 hours. Within 72 hours, less than 10% of the dose taken is excreted unchanged through the kidneys.
The age of postmenopausal women does not affect the pharmacokinetics of anastrozole.
In case of impaired renal function or liver cirrhosis, the clearance of anastrozole does not change.
Indications for use
- early breast cancer with positive hormone receptors in postmenopausal women - as adjuvant therapy;
- locally advanced breast cancer with positive or unidentified hormone receptors in postmenopausal women - for first-line therapy;
- advanced breast cancer after tamoxifen treatment - for second-line therapy.
Contraindications
Absolute:
- premenopausal period;
- severe liver failure;
- the simultaneous use of tamoxifen or estrogen-containing drugs;
- period of pregnancy;
- breast-feeding;
- childhood;
- hypersensitivity to the components of the drug.
It is recommended with caution to prescribe Anastrozole-Teva tablets to patients with ischemic heart disease, osteoporosis, hypercholesterolemia, impaired liver function, severe renal failure [creatinine clearance (CC) less than 20 ml / min], with glucose-galactose malabsorption syndrome, lactase deficiency or intolerance lactose.
Anastrozole-Teva, instructions for use: method and dosage
Anastrozole-Teva tablets are taken orally, swallowed whole and washed down with water, always at the same time of day, before or after meals.
Recommended dosage: 1 pc. (With 1 mg) once a day.
The duration of treatment as adjuvant therapy is 5 years.
Long-term use of Anastrozole-Teva is assumed, which is stopped if signs of disease progression appear.
In case of impaired renal function and / or mild to moderate liver dysfunction, dose adjustment is not required.
Side effects
- on the part of the reproductive system: often - vaginal bleeding (mainly during the first weeks after the cancellation or replacement of previous hormonal therapy with anastrozole), dryness of the vaginal mucosa;
- on the part of the cardiovascular system: very often - flushing of the face;
- from the hepatobiliary system: an increase in the activity of alkaline phosphatase, alanine aminotransferase (ALT) and aspartate aminotransferase (AST); rarely - hepatitis, an increase in the activity of gamma-glutamyltransferase, an increase in the concentration of bilirubin;
- from the nervous system: very often - headache; often - increased drowsiness, carpal tunnel syndrome (more often in the presence of risk factors for this disease);
- from the musculoskeletal system: very often - arthralgia; rarely trigger finger;
- from the digestive system: very often - nausea; often - vomiting, diarrhea, anorexia;
- from the side of metabolism: often - hypercholesterolemia; frequency has not been established - decreased bone mineral density, osteoporosis, bone fractures;
- dermatological reactions: very often - skin rash; often - alopecia, thinning hair; very rarely - Stevens-Johnson syndrome (polymorphic erythema);
- from the immune system: often - allergic reactions; very rarely - urticaria, angioedema, anaphylactoid reactions, anaphylactic shock;
- others: very often - asthenia.
Overdose
A single dose of anastrozole, causing a threat to life, as well as overdose symptoms have not been established.
Treatment: there is no specific antidote, therefore, with an overdose of Anastrozole-Teva, symptomatic therapy is indicated. If the patient is awake, it is recommended to induce vomiting. Dialysis can be used to speed up the elimination of anastrozole from the body. It is necessary to carefully monitor the patient, conduct general supportive therapy, and monitor the vital functions of organs and systems.
special instructions
To confirm the hormonal status of the patient, it is necessary to determine the concentration of sex hormones in the blood serum. If uterine bleeding persists while taking the drug, observation and consultation of a gynecologist is required.
If osteoporosis or an increased risk of developing it occurs during the entire period of treatment, regular studies should be carried out to assess bone mineral density using densitometry, including DEXA (dual energy X-ray absorptiometry) scanning. Treatment of this category of patients should be accompanied by careful monitoring of their condition, which is associated with a high risk of a decrease in bone mineral density due to a decrease in the concentration of circulating estradiol while taking anastrozole. If necessary, patients are prescribed prophylaxis or treatment of osteoporosis. There is insufficient information about the positive effect of bisphosphonates on the restoration of bone mineral density, disturbed by anastrozole, or about their clinical effect when used for prophylaxis.
The safety and effectiveness of the simultaneous use of anastrozole with analogs of gonadotropin-releasing hormone has not been established.
The use of Anastrozole-Teva in patients with a receptor-negative tumor to estrogen did not demonstrate therapeutic efficacy, except in cases where there was a positive response to previous tamoxifen therapy.
It was found that regardless of the status of the patient's hormonal receptors, the efficacy and safety of the simultaneous use of anastrozole and tamoxifen are similar to those achieved with tamoxifen monotherapy.
The effectiveness of using anastrozole in conjunction with chemotherapy has not been established.
Influence on the ability to drive vehicles and complex mechanisms
While taking Anastrozole-Tev, such side reactions of anastrozole as asthenia and drowsiness may occur. Therefore, during the period of treatment, it is recommended to be careful when driving vehicles, mechanisms and performing other potentially hazardous activities that require increased concentration of attention and high speed of psychomotor reactions.
Application during pregnancy and lactation
The use of Anastrozole-Teva is contraindicated during pregnancy and lactation.
Pediatric use
The appointment of Anastrozole-Teva for the treatment of children is contraindicated; safety and efficacy have not been established.
With impaired renal function
Anastrozole-Teva should be used with caution in severe renal failure with CC less than 20 ml / min.
No dose adjustment is required for patients with impaired renal function.
For violations of liver function
The use of Anastrozole-Teva is contraindicated in severe hepatic failure due to the lack of information on safety and efficacy.
It is recommended to prescribe the drug with caution in case of mild to moderate liver dysfunction. No dose adjustment is required.
Drug interactions
The results of studies on the pharmacological interaction of anastrozole with phenazone and cimetidine allow us to conclude that there is a low probability of a clinically significant interaction mediated by cytochrome P 450 with other drugs.
In addition, clinically significant interaction is not expected with the simultaneous use of Anastrozole-Teva with other drugs, often prescribed simultaneously with it.
There is no information on the combination of anastrozole with other anticancer drugs.
Estrogen-containing drugs, tamoxifen help to reduce the pharmacological action of anastrozole.
Analogs
Anastrozole-Teva analogs are Anastrozole, Anastrozole Kabi, Vero-Anastrozole, Anastrozole-TL, Anastrozole San, AXASTROL, Anazales, Selana, Arimidex, Anastrex, Anamasten, Anastera, Estarizole, etc.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 25 ° C.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews of Anastrozole-Teva
Reviews about Anastrozole-Teva are positive. Pointing to the effectiveness of the drug, some patients report that severe joint pain appears on the background of prolonged therapy.
The price of Anastrozole-Teva in pharmacies
The price of Anastrozole-Teva for a package containing 28 tablets can be from 954 rubles, 56 tablets - from 1908 rubles.
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
