Anastrozole

What is Anastrozole?

• Anastrozole (Arimidex) is an aromatase inhibitor used to treat certain types of breast cancer in postmenopausal women.

Anastrozole structure

What are the uses of this medicine?

Anastrozole (Arimidex) is a prescription medicine used in women after menopause (“the change of life”) for:

• treatment of early breast cancer
• after surgery
• in women whose breast cancer is hormone receptor-positive
• the first treatment of breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or has spread to other parts of the body (metastatic), in women whose breast cancer is hormone receptor-positive or the hormone receptors are not known
• treatment of advanced breast cancer, if the cancer has grown, or the disease has spread after tamoxifen therapy

Anastrozole-from-xtal-3D-balls

Limitations of use:

• Arimidexdoes not work in women with breast cancer who have not gone through menopause (premenopausal women).

How does this medicine work?

• Anastrozole (an as' troe zole) is a nonsteroidal inhibitor of aromatase, the enzyme responsible for the conversion of testosterone to estrone (E1) and of androstenedione to estradiol (E2).
• Highest levels of aromatase are found in the ovary and placenta, which are the major sources of estrogen in premenopausal women.
• However, aromatase is also found in other tissues, such as liver, kidney, adrenals, brain, muscle and subcutaneous fat where it is also active in producing estrogens, although at low levels.
• These tissues are the major source of estrogen in postmenopausal women.
• Inhibitors of aromatase were developed to block the synthesis of estrogen in the peripheral tissues and, thus, as antiestrogen therapy of estrogen receptor positive breast cancer in postmenopausal women.
• The aromatase inhibitors in current use include letrozole, exemestane and anastrozole.
• Anastrozole is a nonsteroidal, specific aromatase inhibitor which has little or no effect on adrenal glucocorticoid or mineralocorticoid synthesis.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• have had a severe allergic reaction to anastrozole or any of the ingredients in ARIMIDEX.

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Especially tell your healthcare provider if you take:

• tamoxifen. You should not take Arimidexif you take tamoxifen. Taking Arimidexwith tamoxifen may lower the amount of Arimidexin your blood and may cause Arimidexnot to work as well.
• Medicines that contain estrogen.

Arimidexmay not work if taken with any of these medicines:

• hormone replacement therapy
• birth control pills
• estrogen creams
• vaginal rings
• vaginal suppositories

Is this medicine FDA approved?

• Anastrozole was approved for use in postmenopausal women with breast cancer in the United States in 1995.

How should this medicine be used?

Recommended dosage:

• The dose of Arimidexis one 1 mg tablet taken once a day.
• No dosage adjustment is necessary for patients with renal impairment or for elderly patients.
• No changes in dose are recommended for patients with mild-to-moderate hepatic impairment.
• Arimidexhas not been studied in patients with severe hepatic impairment.

Administration:

• Arimidexcan be taken with or without food.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Take your next regularly scheduled dose. Do not take two doses at the same time.
• If you take too much ARIMIDEX, call your healthcare provider or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As 1 mg tablets

This medicine is available in fallowing brand namesː ARIMIDEX

What side effects can this medication cause?

The most common side effects of this medicine include:

• hot flashes
• weakness
• joint aches
• joint pain, stiffness or swelling (arthritis)
• pain
• sore throat
• high blood pressure
• depression
• nausea and vomiting
• rash
• back pain
• sleep problems
• bone pain
• headache
• swelling of your legs, ankles, or feet
• increased cough
• shortness of breath
• build up of lymph fluid in the tissues of your affected arm (lymphedema)
• tickling, tingling or numbness of your skin

Arimidexmay cause serious side effects including:

• heart disease
• osteoporosis
• fat in the blood
• skin reactions
• severe allergic reactions
• liver problems

What special precautions should I follow?

• In women with pre-existing ischemic heart disease, an increased incidence of ischemic cardiovascular events occurred with Arimidexuse compared to tamoxifen use. Consider risks and benefits.
• Decreases in bone mineral density may occur. Consider bone mineral density monitoring.
• Increases in total cholesterol may occur. Consider cholesterol monitoring.
• Based on findings from animal studies and its mechanism of action, Arimidexcan cause fetal harm when administered to a pregnant woman. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during therapy with Arimidexand for at least 3 weeks after the last dose.
• Anastrozole has been associated with a low rate of serum enzyme elevations during therapy and rare instances of clinically apparent liver injury.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• A single dose of Arimidexthat results in life-threatening symptoms has not been established.

Management of overdosage:

• 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 Arimidexis not highly protein bound.
• General supportive care, including frequent monitoring of vital signs and close observation of the patient, is indicated.

Can this medicine be used in pregnancy?

• Based on findings from animal studies and its mechanism of action, Arimidexmay cause fetal harm when administered to a pregnant woman.
• There are no studies of Arimidexuse in pregnant women.

Can this medicine be used in children?

• Efficacy has not been demonstrated for pubertal boys of adolescent age with gynecomastia or girls with McCune-Albright Syndrome and progressive precocious puberty.

What are the active and inactive ingredients in this medicine?

• Active ingredient: anastrozole
• Inactive ingredients: lactose, magnesium stearate, hypromellose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.

Who manufactures and distributes this medicine?

Distributed by:

• ANI Pharmaceuticals, Inc.
• Baudette, MN

• Arimidexis a registered trademark of the AstraZeneca group of companies and is licensed to ANI Pharmaceuticals, Inc.

What should I know about storage and disposal of this medication?

• Store Arimidexat room temperature between 68°F to 77°F (20°C to 25°C).

• Dailymed label info on Anastrozole
• FDA Anastrozole

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