Indications

Arimidex / Anastrozole is used to treat breast cancer in women after menopause. It is FDA- approved for the first-line treatment of postmenopausal women with hormone- receptor.

Therapeutic Class

Hormonal Chemotherapy

Pharmacology

The growth of many cancers of the breast is stimulated or maintained by estrogens. In postmenopausal women, estrogens are mainly derived from the action of the aromatase enzyme, which converts adrenal androgens (primarily androstenedione and testosterone) to estrone and estradiol.

The suppression of estrogen biosynthesis in peripheral tissues and in the cancer tissue itself can therefore be achieved by specifically inhibiting the aromatase enzyme.

Anastrozole / Arimidex is a selective non-steroidal aromatase inhibitor. It significantly lowers serum estradiol concentrations and has no detectable effect on formation of adrenal corticosteroids or aldosterone.

Dosage & Administration

Adults and elderly: 1 mg tablet to be taken orally once a day.

Interaction

Antipyrine and cemetidine clinical interaction studies indicate that the co administration of anastrozole / Arimidex with other drugs is unlikely to result in clinically significant drug interactions mediated by cytochrome P450.

Tamoxifen should not be co-administered with anastrozole / Arimidex as this may reduce its pharmacological action.

Contraindications

Patients with severe renal impairment (Creatinine clearance less than 20 mL/min), patients with moderate to severe hepatic disease and known hypersensitivity to anastrozole or to any of the excipients.

Oestrozen-containing therapies should not be co-administered with anastrazole / Arimidex as they would negate its pharmacological action.

Side Effects

More common side effects are: Blurred vision chest pain or discomfort, dizziness, headache nervousness, pounding in the ears, shortness of breath, slow or fast heartbeat, swelling of the feet or lower legs

Pregnancy & Lactation

Anastrozole / Arimidex is contraindicated in pregnant and lactating women.

Precautions & Warnings

Before taking anastrozole / Arimidex, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of heart disease (such as history of heart attack), bone loss (osteoporosis), liver disease, high blood pressure, blood clots.

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you dizzier. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

Anastrozole / Arimidex is used mainly in women after menopause. If you have not gone through menopause, this medication must not be used during pregnancy. It may harm an unborn baby.

Discuss the use of reliable forms of birth control (such as latex condoms) while taking this medication and for at least 3 weeks after stopping treatment with your doctor. Products containing estrogen (such as birth control pills) should not be used.

Use in Special Populations

Renal impairment: No dose change is recommended in patients with mild or moderate renal impairment.

Hepatic impairment: No dose change is recommended in patients with mild hepatic impairment. For early disease, the recommended duration of treatment should be 5 years.

Overdose Effects

Clinical trials have been conducted with Anastrozole / Arimidex tablets, up to 60 mg in a single dose given to healthy male volunteers and up to 10 mg daily given to postmenopausal women with advanced breast cancer; these dosages were tolerated.

A single dose of Anastrozole / Arimidex tablets that results in life-threatening symptoms has not been established. There is no specific antidote to overdosage, and treatment must be symptomatic.

In the management of an overdose, consider that multiple agents may have been taken. Vomiting may be induced if the patient is alert. Dialysis may be helpful because Anastrozole /Arimidex tablet is not highly protein bound.

General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.

Storage Conditions

Product should be stored within 30°C