Arimidex

DRUG DESCRIPTION

ARIMIDEX (anastrozole) tablets for oral administration contain 1 mg of anastrozole, a non-steroidal aromatase inhibitor. It is chemically described as 1,3-Benzenediacetonitrile, a, a, a', a'-tetramethyl-5-(1H-1,2,4-triazol-1-ylmethyl). Its molecular formula is C17H19N5 and its structural formula is:

ARIMIDEX
  (anastrozole) tablet  Structural Formula Illustration

Anastrozole is an off-white powder with a molecular weight of 293.4. Anastrozole has moderate aqueous solubility (0.5 mg/mL at 25C); solubility is independent of pH in the physiological range. Anastrozole is freely soluble in methanol, acetone, ethanol, and tetrahydrofuran, and very soluble in acetonitrile.

Each tablet contains as inactive ingredients: lactose, magnesium stearate, hydroxypropylmethylcellulose, polyethylene glycol, povidone, sodium starch glycolate, and titanium dioxide.

What are the possible side effects of anastrozole (Arimidex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • swollen glands;
  • a bone fracture; or
  • swelling in your hands or feet;

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Arimidex

What are the precautions when taking anastrozole (Arimidex)?

Before taking anastrozole, 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: liver disease, high blood pressure, heart disease (such as ischemic heart disease, history of chest pain), brittle bone disease (osteoporosis), blood clots.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Anastrozole is used mainly in women after menopause. If you have not...

Read All Potential Precautions of Arimidex


Arimidex Consumer (continued)

SIDE EFFECTS: Constipation, diarrhea, nausea, vomiting, upset stomach, loss of appetite, body aches and pains, breast swelling/tenderness/pain, headache, dry mouth, scratchy throat, increased cough, dizziness, trouble sleeping, tiredness/weakness, flushing and sweating (hot flashes/hot flushes), vaginal bleeding, hair thinning, and weight change can occur. Changes in diet such as eating several small meals may help lessen the chance of nausea and vomiting. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (e.g., depression), numbness/tingling/swelling of the hands or feet, persistent cough, unusual vaginal discharge/burning/itching/odor, unusually stiff muscles, pain/redness/swelling of the arms or legs, vision changes, bone pain, bone fracture, signs of infection (e.g., fever, chills, persistent sore throat).

Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, jaw/left arm pain, trouble breathing, confusion, fainting, slurred speech, weakness on one side of the body.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking anastrozole, 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: liver disease, high blood pressure, heart disease (such as ischemic heart disease, history of chest pain), brittle bone disease (osteoporosis), blood clots.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Anastrozole is used mainly in women after menopause. If you have not gone through menopause and your doctor has prescribed this for you, this medication must not be used during pregnancy. It may cause harm to an unborn baby or miscarriage. If you become pregnant or think you may be pregnant, tell your doctor immediately. Women of childbearing age should use reliable form(s) of contraception (such as latex condoms) during treatment. Products containing estrogen (such as birth control pills) should not be used. Consult your doctor for more details.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Arimidex Patient Information Including Side Effects

Brand Names: Arimidex

Generic Name: anastrozole (Pronunciation: an AS troe zole)

  • What is anastrozole (Arimidex)?
  • What are the possible side effects of anastrozole (Arimidex)?
  • What is the most important information I should know about anastrozole (Arimidex)?
  • What should I discuss with my healthcare provider before taking anastrozole (Arimidex)?
  • How should I take anastrozole (Arimidex)?
  • What happens if I miss a dose (Arimidex)?
  • What happens if I overdose (Arimidex)?
  • What should I avoid while taking anastrozole (Arimidex)?
  • What other drugs will affect anastrozole (Arimidex)?
  • Where can I get more information?

What is anastrozole (Arimidex)?

Anastrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.

Anastrozole is used to treat breast cancer in postmenopausal women. It is often given to women whose cancer has progressed even after taking tamoxifen (Nolvadex, Soltamox).

Anastrozole may also be used for other purposes not listed in this medication guide.

What are the possible side effects of anastrozole (Arimidex)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • sudden numbness or weakness, especially on one side of the body;
  • sudden headache, confusion, problems with vision, speech, or balance;
  • swollen glands;
  • a bone fracture; or
  • swelling in your hands or feet;

Less serious side effects may include:

  • hot flashes;
  • joint pain or stiffness;
  • weakness;
  • sore throat;
  • depression, mood changes;
  • nausea; or
  • back pain, bone pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about anastrozole (Arimidex)?

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use anastrozole without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You may need to take a pregnancy test before using anastrozole, to make sure you are not pregnant.

You also should not use this medication if you are breast-feeding a baby, or if you are allergic to anastrozole.

Before using anastrozole, tell your doctor if you have heart disease, circulation problems, a history of stroke of blood clot, severe liver disease, or if you have not yet completed menopause.

You may need to keep taking anastrozole for up to 5 years. Follow your doctor's instructions.

Anastrozole may not work as well if you take it together with tamoxifen or an estrogen medication. Before you start taking anastrozole, tell your doctor if you also take tamoxifen or estrogen.

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