Anastrozole tablets p / o 1mg, No. 30

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SKU
BIDL3181327
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Expiration Date: 11/2025

Russian Pharmacy name:

Анастрозол таблетки п/о 1мг, №30

Anastrozole tablets p / o 1mg, No. 30

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.

Inside. The tablet 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 1 time per day for a long time. If signs of disease progression appear, the drug should be discontinued. As an adjuvant therapy, the recommended duration of treatment is 5 years.

Mild to moderate renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment.

Mild hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment.

1 film-coated tablet contains:

Active ingredient: anastrozole - 1.0 mg;

Excipients (core): lactose monohydrate (milk sugar) - 72.0 mg, microcrystalline cellulose - 15.6 mg, povidone (polyvinylpyrrolidone) - 3.0 mg, magnesium stearate - 0.9 mg, colloidal silicon dioxide - 0, 5 mg, sodium carboxymethyl starch - 2.0 mg.

Excipients (shell): hypromellose - 1.65 mg, macrogol-4000 - 0.45 mg, titanium dioxide - 0.90 mg.

Hypersensitivity to anastrozole or other components of the drug;

Pregnancy and lactation period;

Premenopausal period;

Severe renal failure (creatinine clearance <20 ml / min);

Moderate liver failure;

Severe hepatic impairment (safety and efficacy have not been established);

Concomitant therapy with tamoxifen or drugs containing estrogens;

Children under 18 years of age (safety and effectiveness in children have not been established).

Carefully:

osteoporosis hypercholesterolemia ischemic heart disease liver dysfunction lactase deficiency lactose intolerance glucose-galactose malabsorption (the drug formulation contains lactose).

Trade name of the drug

Anastrozole

International non-proprietary name

Anastrozole

Dosage form

film-coated tablets

Composition

1 film-coated tablet contains:

Active ingredient: anastrozole - 1.0 mg;

Excipients (core): lactose monohydrate (milk sugar) - 72.0 mg, microcrystalline cellulose - 15.6 mg, povidone (polyvinylpyrrolidone) - 3.0 mg, magnesium stearate - 0.9 mg, colloidal silicon dioxide - 0, 5 mg, sodium carboxymethyl starch - 2.0 mg.

Excipients (shell): hypromellose - 1.65 mg, macrogol-4000 - 0.45 mg, titanium dioxide - 0.90 mg.

Description

round biconvex tablets, film-coated white or almost white, two layers are visible on the break - a white or almost white core and a film shell.

Pharmacotherapeutic group

antineoplastic agent, estrogen synthesis inhibitor

ATX code

L02BG

Pharmacodynamics:

Anastrozole is a highly selective non-steroidal aromatase inhibitor, an enzyme by which in postmenopausal women androstenedione is converted in peripheral tissues into estrone and then into estradiol. Reducing circulating estradiol concentrations has been shown to have a beneficial effect in women with breast cancer. In postmenopausal women, anastrozole in a daily dose of 1 mg causes a decrease in the concentration of estradiol by 80%.

Anastrozole has no progestogenic androgenic or estrogenic activity. Regular intake of daily doses of anastrozole up to 10 mg does not affect the secretion of cortisol or aldosterone, therefore, when it is prescribed, substitutional administration of corticosteroids is not required.

Pharmacokinetics:

Absorption of anastrozole rapid maximum plasma concentration is achieved within two hours after ingestion (on an empty stomach). Food slightly reduces the rate of absorption, but not its degree, and does not lead to a clinically significant effect on the equilibrium concentration of anastrozole in plasma with a single daily dose of anastrozole. After a seven-day intake of the drug, approximately 90-95% of the equilibrium concentration of anastrozole in blood plasma is achieved. There is no information on the dependence of the pharmacokinetic parameters of anastrozole on time or dose. The pharmacokinetics of anastrozole does not depend on the age of postmenopausal women. Communication with blood plasma proteins - 40%.

Anastrozole is excreted slowly, the half-life from plasma is 40-50 hours. Extensively metabolized in postmenopausal women. Less than 10% of the dose taken is excreted by the kidneys unchanged within 72 hours after taking the drug. Anastrozole metabolism occurs through the stages of N-dealkylation, hydroxylation and glucuronidation. Triazole, the main plasma metabolite of anastrozole, does not inhibit aromatase. Metabolites are excreted mainly by the kidneys.

The clearance of anastrozole after oral administration in liver cirrhosis or renal impairment 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 <20 ml / min);

Moderate liver failure;

Severe hepatic impairment (safety and efficacy have not been established);

Concomitant therapy with tamoxifen or drugs containing estrogens;

Children under 18 years of age (safety and effectiveness in children have not been established).

Carefully:

osteoporosis hypercholesterolemia ischemic heart disease liver dysfunction lactase deficiency lactose intolerance glucose-galactose malabsorption (the drug formulation contains lactose).

Pregnancy and lactation:

Contraindicated in pregnancy. During treatment, breastfeeding should be discontinued.

Method of administration and dosage:

Inside. The tablet 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 1 time per day for a long time. If signs of disease progression appear, the drug should be discontinued. As an adjuvant therapy, the recommended duration of treatment is 5 years.

Mild to moderate renal impairment: No dose adjustment is required in patients with mild to moderate renal impairment.

Mild hepatic impairment: No dose adjustment is required in patients with mild hepatic impairment.

Side effects:

Vascular disorders: 'flushing' of blood to the face; increased blood pressure.

Musculoskeletal and connective tissue disorders: arthralgia / joint stiffness; arthritis; trigger finger bone and muscle pain.

Violations of the genitourinary system: urinary tract infections vulvovaginitis dryness of the vaginal mucosa vaginal bleeding (mainly during the first weeks after canceling or changing the previous hormone therapy to anastrozole).

Disorders from the skin and subcutaneous tissues: skin rash, thinning hair, sweating, alopecia; allergic reactions: urticaria erythema multiforme anaphylactoid reaction cutaneous vasculitis (including isolated cases of purpura (Shenlein-Henoch syndrome) Stevens-Johnson syndrome angioedema.

Disorders from the gastrointestinal tract: nausea diarrhea vomiting constipation dyspepsia gastrointestinal disorders.

Disorders of the blood and lymphatic system: anemia, lymphedema, venous thromboembolism.

Disturbances from the respiratory system of the chest and mediastinal organs: pharyngitis, shortness of breath, sinusitis, bronchitis.

Disturbances from the organ of vision: cataract.

On the part of the hepatobiliary system: an increase in the activity of alkaline phosphatase alanine aminotransferase aspartate aminotransferase, an increase in the activity of gamma-glutamyl transferase and the concentration of bilirubin hepatitis.

Disturbances from the nervous system: headache drowsiness depression insomnia dizziness anxiety paresthesia carpal tunnel syndrome (mainly observed in patients with risk factors for this disease).

Metabolic and nutritional disorders: anorexia, hypercholesterolemia, increased body weight, hypercalcemia (with / without an increase in parathyroid hormone concentration). Taking the drug can cause a decrease in bone mineral density due to a decrease in the concentration of circulating estradiol, thereby increasing the risk of osteoporosis and bone fractures.

Other: asthenia back pain abdominal pain chest pain occurrence of secondary infections flu-like neoplasm syndrome.

Overdose:

Isolated clinical cases of accidental drug overdose are described. A single dose of anastrozole that could lead to life-threatening symptoms has not been established. There is no specific antidote in case of overdose, treatment should be symptomatic.

Treatment: vomiting can be induced if the patient is conscious. Dialysis can be done. General supportive therapy is recommended, monitoring the patient and monitoring the function of vital organs and systems.

Interaction:

Studies on drug interactions with phenazone (Antipyrin) and cimetidine indicate that the combined use of anastrozole with other drugs is unlikely to lead to clinically significant drug interactions mediated by cytochrome P450.

There is no clinically significant drug interaction when taking Anastrozole at the same time as other commonly prescribed drugs.

At the moment, there is no information on the use of the drug Anastrozole in combination with other anticancer drugs.

Preparations containing estrogens reduce the pharmacological action of anastrozole, and therefore they should not be prescribed simultaneously with it.

Tamoxifen should not be administered concurrently with anastrozole as it can weaken the pharmacological effect of the latter.

Special instructions:

Safety and effectiveness in children have not been established.

In women with an estrogen receptor-negative tumor, the efficacy of anastrozole has not been demonstrated unless there has been a prior positive clinical response to tamoxifen. In case of doubt about the hormonal status of the patient, menopause should be confirmed by the determination of sex hormones in the blood serum.

Preparations containing estrogens should not be administered concurrently with anastrozole, since these drugs will neutralize its pharmacological effect.

There is no data on the use of anastrozole in patients with moderate and severe hepatic impairment.

In the case of persisting uterine bleeding while taking anastrozole, consultation and supervision of a gynecologist is necessary.

In patients with osteoporosis or at increased risk of osteoporosis, bone mineral density should be assessed using densitometry such as DEXA (dual energy X-ray absorptiometry) at the beginning of treatment and regularly throughout the course. If necessary, treatment or prevention of osteoporosis should be prescribed and the patient's condition should be carefully monitored. Since anastrozole reduces the concentration of circulating estradiol, it can lead to a decrease in bone mineral density. At the moment, there is insufficient data on the positive effect of bisphosphonates on the loss of bone mineral density caused by anastrozole or their benefits when used for prophylaxis.

There is no data on the simultaneous use of anastrozole and LHRH analogues (luteinizing hormone-releasing hormone).

It is not known whether anastrozole improves treatment outcomes when used with chemotherapy. Safety data for long-term treatment with anastrozole have not yet been obtained. With the use of anastrozole, ischemic diseases were observed more often than with tamoxifen therapy, however, no statistical significance was noted. The efficacy and safety of anastrozole and tamoxifen when used simultaneously, regardless of the status of hormonal receptors, are comparable to those when using tamoxifen alone. The exact mechanism of this phenomenon is not yet known.

Impact on the ability to drive vehicles. Wed and fur .:

Some side effects of anastrozole (asthenia, drowsiness, headache, dizziness) can adversely affect the ability to drive and use machinery. Therefore, during the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions. When the described undesirable phenomena appear, you should refrain from performing these activities.

Release form / dosage:

Film-coated tablets 1 mg.

Packaging:

On 10 30 tablets in a blister strip packaging from a film of polyvinyl chloride and printed aluminum foil varnished.

10 20 30 40 50 60 100 or 120 tablets in polymer jars for medicines. One can or 1 2 3 4 5 6 7 8 9 or 10 blisters together with instructions for use are placed in a cardboard package (pack).

Storage conditions:

In a dark place at a temperature not exceeding 25 ? C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use the drug after the expiration date.

Vacation conditions

On prescription

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