Avodart

DRUG DESCRIPTION

AVODART is a synthetic 4-azasteroid compound that is a selective inhibitor of both the type 1 and type 2 isoforms of steroid 5 alpha-reductase, an intracellular enzyme that converts testosterone to DHT.

Dutasteride is chemically designated as (5?,17?)-N-{2,5 bis(trifluoromethyl)phenyl}-3 oxo-4-azaandrost-1-ene-17-carboxamide. The empirical formula of dutasteride is C27H30F6N2O2, representing a molecular weight of 528.5 with the following structural formula:

AVODART (dutasteride) Structural Formula Illustration

Dutasteride is a white to pale yellow powder with a melting point of 242 to 250C. It is soluble in ethanol (44 mg/mL), methanol (64 mg/mL), and polyethylene glycol 400 (3 mg/mL), but it is insoluble in water.

Each AVODART Soft Gelatin Capsule, administered orally, contains 0.5 mg of dutasteride dissolved in a mixture of mono-di-glycerides of caprylic/capric acid and butylated hydroxytoluene. The inactive excipients in the capsule shell are ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, and titanium dioxide. The soft gelatin capsules are printed with edible red ink.

What are the possible side effects of dutasteride (Avodart)?

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.

Less serious side effects may include:

  • decreased libido (sex drive);
  • decreased amount of semen released during sex;
  • impotence (trouble getting or keeping an erection); or
  • breast tenderness or enlargement.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side...

Read All Potential Side Effects and See Pictures of Avodart

What are the precautions when taking dutasteride (Avodart)?

Before taking dutasteride, tell your doctor or pharmacist if you are allergic to it; or to finasteride; 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.

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

Do not donate blood while you are taking this medication and for at least 6 months after you stop taking it. This will prevent the possibility of your blood being given to a pregnant woman.

This medication is not usually used in women....

Read All Potential Precautions of Avodart


Avodart Consumer (continued)

SIDE EFFECTS: Sexual problems (such as decreased sexual interest/ability, decrease in the amount of semen/sperm), increased breast size, or breast tenderness may occur. If any of these effects persist or worsen, tell 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.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: 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 dutasteride, tell your doctor or pharmacist if you are allergic to it; or to finasteride; 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.

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

Do not donate blood while you are taking this medication and for at least 6 months after you stop taking it. This will prevent the possibility of your blood being given to a pregnant woman.

This medication is not usually used in women. Therefore, it is unlikely to be used during pregnancy or breast-feeding. Consult your doctor if you have any questions about this medication.


Avodart Patient Information Including Side Effects

Brand Names: Avodart

Generic Name: dutasteride (Pronunciation: doo TAS ter ide)

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

What is dutasteride (Avodart)?

Dutasteride prevents the conversion of testosterone to dihydrotestosterone (DHT) in the body. DHT is involved in the development of benign prostatic hyperplasia (BPH).

Dutasteride is used to treat benign prostatic hyperplasia (BPH) in men with an enlarged prostate. Dutasteride helps improve urinary flow and may also reduce your need for prostate surgery later on.

Dutasteride is sometimes given with another medication called tamsulosin (Flomax). Be sure to read the medication guide or patient instructions provided with each of your medications.

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

What are the possible side effects of dutasteride (Avodart)?

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.

Less serious side effects may include:

  • decreased libido (sex drive);
  • decreased amount of semen released during sex;
  • impotence (trouble getting or keeping an erection); or
  • breast tenderness or enlargement.

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 dutasteride (Avodart)?

Before taking dutasteride, tell your doctor if you have ever had an allergic reaction to this medication, or to a similar medicine called finasteride (Propecia, Proscar).

Do not chew, crush, or open a dutasteride capsule. Swallow the capsule whole. Dutasteride can irritate your lips, mouth, or throat if the capsule has been broken or opened before you swallow it.

Dutasteride should never be taken by a woman or a child. Dutasteride can be absorbed through the skin, and women or children should not be permitted to handle dutasteride capsules.

Although dutasteride is not for use by women, this medication can cause birth defects if a woman is exposed to it during pregnancy. Dutasteride capsules should not be handled by a woman who is pregnant or who may become pregnant.

If a woman accidentally comes into contact with this medication from a leaking capsule, wash the area with soap and water right away.

Do not donate blood while taking dutasteride and for at least 6 months after your treatment ends. Dutasteride can be carried in the blood and could cause birth defects if a pregnant women receives a transfusion with blood that contains dutasteride.

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