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Active Ingredient: Anastrozole.

Arimidex is used for treating breast cancer in women who have been through menopause, including women with disease progression after tamoxifen therapy. ⇜

Other names for this medication:
Anastrol, Anastrozolo, Anastrozolum, Armidex.

Clinico-pharmacological group
Antitumor drug. Aromatase Inhibitor.

Pharmachologic effect
Highly selective nonsteroidal aromatase inhibitor. Aromatase is an enzyme with which in postmenopausal women, androstenedione in peripheral tissues is converted into estrone and then into estradiol. Reducing circulating estradiol has a therapeutic effect in patients with breast cancer. In postmenopausal medication in a daily dose of 1 mg causes a decrease in estradiol levels by 80%.

Arimidex does not possess progestogenic, androgenic and estrogenic activity.

Arimidex in a daily dose of up to 10 mg has no effect on the secretion of cortisol and aldosterone (therefore, the use of the drug does not require the replacement of corticosteroids).

Pharmacokinetics

Suction
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. Small changes in the rate of absorption do not lead to a clinically significant effect on the Css of the drug in plasma with a daily intake of 1 tab. Arimidex.

Distribution
Anastrozole is associated with plasma proteins by 40%. Approximately 90-95% of Сss is achieved after 7 days of taking the drug. There is no information about the cumulation of the drug and the dependence of the pharmacokinetic parameters of anastrozole on time and dose.

Metabolism
Anastrozole is metabolized by N-dealkylation, hydroxylation and glucuronization. Triazole, the major metabolite detected in plasma, does not inhibit aromatase.

Removal
Anastrozole is displayed slowly, T1 / 2 – 40-50 h.

Anastrozole and its metabolites are excreted mainly with urine (less than 10% of the excreted dose – unchanged), within 72 hours after taking the drug.

Pharmacokinetics in special clinical situations

The determined clearance of anastrozole after oral administration in volunteers with stabilized liver cirrhosis or renal dysfunction does not differ from clearance determined in healthy volunteers.

Anastrozole pharmacokinetics does not depend on age in postmenopausal women.

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

☞renal failure severe (creatinine clearance less than 20 ml / min);

☞moderate and severe liver failure (safety and efficacy not established);

☞concomitant therapy with tamoxifen;

☞children’s age (safety and efficacy not established);

☞pregnancy;

☞lactation (breastfeeding);

☞Hypersensitivity to anastrozole and other components of the drug.

The drug is not prescribed to women in premenopausal women.

Dosage
Adults, including elderly patients, the drug is prescribed 1 mg orally 1 time / day, long-term. If there is evidence of disease progression, the drug should be discontinued. As adjuvant therapy, the recommended duration of treatment is 5 years.

Patients with mild and moderately severe renal impairment do not require dose adjustment.

Patients with mild hepatic impairment do not require dose adjustment.

The tablet should be swallowed whole and washed down with water. It is recommended to take the drug at the same time of day.

Side effects
👣 Determination of the frequency of adverse reactions: very often (> 10%); often (1-10%); rarely (0.1-1%); very rarely (<0.1%).

👣 Since the cardiovascular system: very often – tides.

👣 From the musculoskeletal system: often – arthralgia.

👣 Reproductive system: often – vaginal dryness; rarely, vaginal bleeding (mainly during the first weeks after the cancellation or change of previous hormonal therapy with Arimidex).

👣 On the part of the digestive system: often – nausea, diarrhea; rarely – anorexia, vomiting, increased activity of GGT and alkaline phosphatase.

👣 On the part of the nervous system: often – headache, carpal tunnel syndrome (mainly observed in patients with risk factors for this disease); rarely – drowsiness.

👣 Metabolism: rarely – hypercholesterolemia. The drug may cause a decrease in bone mineral density due to a decrease in circulating estradiol, thereby increasing the risk of osteoporosis and bone fractures.

👣 Dermatological reactions: often – thinning hair, skin rash; very rarely – erythema multiforme (Stevens-Johnson syndrome).

👣 Allergic reactions: very rarely – angioedema, urticaria, anaphylactic shock.

👣 Other: often – asthenia.

Overdose
Single clinical cases of drug overdose are described. A single dose of Arimidex, at which life-threatening symptoms develop, has not been established.

Treatment: there is no specific antidote. If necessary, carry out symptomatic therapy: induction of vomiting (if the patient is conscious), general supportive therapy, monitoring the patient and monitoring the function of vital organs and systems. Dialysis is possible.

Drug interaction
Clinical studies on drug interactions with antipyrine and cimetidine indicate that co-administration of Arimidex with other drugs is unlikely to lead to a clinically significant interaction due to cytochrome P450.

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

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

Estrogen containing preparations should not be administered concurrently with Arimidex, since they reduce the pharmacological effect of the latter.

Tamoxifen should not be given at the same time as Arimidex, since it may weaken the pharmacological action of the latter.

Special instructions
In women with a receptor-negative estrogen tumor, the efficacy of Arimidex has not been demonstrated, unless there was a prior positive clinical response to tamoxifen.

In case of doubts about the hormonal status of the patient, the menopause must be confirmed by determining the sex hormones in the blood serum.

There are no data on the safety of Arimidex in patients with severe liver dysfunction or in patients with severe renal insufficiency (CC less than 20 ml / min).

In case of persistent uterine bleeding while receiving Arimidex, consultation and supervision of a gynecologist is necessary.

Drugs containing estrogen should not be administered simultaneously with Arimidex.

By lowering the level of circulating estradiol, Arimidex can cause a decrease in bone mineral density.

In patients with osteoporosis or with the risk of osteoporosis, bone mineral density should be assessed by means of densimetry (for example, DEXA scan) at the beginning of treatment and over time. If necessary, treatment or prevention of osteoporosis should be initiated under the close supervision of a physician.

There is no data on the simultaneous use of anastrozole and preparations of GnRH analogues.

It is not known whether anastrozole improves the results of treatment when used in combination with chemotherapy.

Safety data for long-term treatment with anastrozole has not yet been obtained.

With the use of Arimidex, ischemic diseases were observed more frequently than with tamoxifen therapy, but no statistical significance was noted.

The efficacy and safety of Arimidex and tamoxifen, when applied simultaneously, regardless of the status of hormone receptors, are comparable to those of tamoxifen alone. The exact mechanism of this phenomenon is not yet known.

Use in Pediatrics

Safety and efficacy of the drug in children have not been established.

Influence on ability to drive motor transport and control mechanisms

Some side effects of Arimidex, such as asthenia and drowsiness, may adversely affect the ability to perform work that requires increased concentration of attention and quickness of psychomotor reactions. In this regard, it is recommended that when these symptoms appear, caution should be exercised when driving a car or moving machinery.

Pregnancy and lactation
The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in childhood
The drug is contraindicated for use in children (safety and efficacy not established).

In case of impaired renal function
Patients with mild and moderately severe renal impairment do not require dose adjustment.

Contraindicated in severe renal failure (creatinine clearance less than 20 ml / min).

With abnormal liver function
Patients with mild hepatic impairment do not require dose adjustment.

Contraindicated in moderate or severe liver failure (safety and efficacy not established).

Pharmacy sales terms
The drug is available without a prescription.

Terms and conditions of storage
The drug should be stored out of reach of children at a temperature not exceeding 30 ° C. Shelf life – 5 years.