Arimidex, 1 mg 28 pcs

Arimidex is a highly selective nonsteroidal aromatase inhibitor, the enzyme by which, in postmenopausal women, androstenedione is converted in peripheral tissues to estrone and then to estradiol. Reducing circulating estradiol levels in breast cancer patients has a therapeutic effect. In postmenopausal women the drug in a daily dose of 1 mg causes a decrease in estradiol levels by 80%.

Indications

Active ingredient

Composition

Active ingredients:

Anastrozole 1 mg.

Auxiliary Substances:

Lactose monohydrate,

povidone,

Sodium carboxymethylene starch,

Magnesium stearate,

Purified water.

Composition of the shell:

MacroGol 300, hypromellose, titanium dioxide, purified water.

How to take, the dosage

In adults, including elderly patients, the drug is prescribed 1 mg orally once daily, for a long time. If there are signs of disease progression, the drug should be discontinued. As adjuvant therapy, the recommended duration of treatment is 5 years.

Patients with mild to moderate renal dysfunction do not require dose adjustment.

Patients with mild hepatic impairment do not require dose adjustment.

The tablet should be swallowed whole and with water. It is recommended that the drug be taken at the same time of the day.

Interaction

Clinical studies on drug interactions with antipyrine and cimetidine indicate that coadministration of Arimidex with other drugs is unlikely to result in clinically significant cytochrome P450 interactions.

There are no clinically significant drug interactions when Arimidex is taken concomitantly with other commonly prescribed drugs.

There is currently no information about the use of Arimidex in combination with other anticancer drugs.

Oestrogen-containing medications should not be used concomitantly with Arimidex because they reduce the pharmacological effect of the latter.

Tamoxifen should not be used concomitantly with Arimidex because it may weaken the pharmacological action of the latter.

Special Instructions

In women with estrogen receptor-negative tumors, the efficacy of Arimidex has not been demonstrated unless there has been a previous positive clinical response to tamoxifen.

In cases of doubt about a patient’s hormonal status, menopause should be confirmed by determination of serum sex hormones.

There are no data on the safety of Arimidex in patients with significant hepatic impairment or in patients with severe renal impairment (CKR less than 20 ml/min).

In case of persistent uterine bleeding during treatment with Arimidex it is necessary to consult and monitor a gynecologist.

Oestrogen-containing drugs should not be administered concomitantly with Arimidex.

Arimidex may cause a decrease in bone mineral density by lowering circulating estradiol levels.

In patients with osteoporosis or who are at risk for osteoporosis, bone mineral density should be assessed by densiometry (e.g., DEXA scan) at the start of treatment and at follow-up. If necessary, treatment or prevention of osteoporosis should be initiated under close medical supervision.

There are no data on concomitant use of anastrozole and GnRH analogues.

It is not known whether anastrozole improves treatment outcomes when used together with chemotherapy.

Safety data are not yet available for long-term treatment with anastrozole.

Ischemic events have been observed more frequently with Arimidex than with tamoxifen therapy, but no statistical significance has been noted.

The efficacy and safety of Arimidex and tamoxifen when used concomitantly, regardless of hormone receptor status, are comparable to those with tamoxifen alone. The exact mechanism of this phenomenon is not yet known.

Pediatric use

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

Impact on ability to drive vehicles and other mechanisms requiring increased concentration

Some side effects of Arimidex, such as asthenia and somnolence, may adversely affect the ability to perform work requiring increased concentration and rapid psychomotor reactions. In this regard, caution is recommended when these symptoms occur when driving or operating moving machinery.

Contraindications

Side effects

Overdose

Pregnancy use

The drug is contraindicated in pregnancy and during lactation (breast-feeding).