Dutasteride (Page 7 of 7)

Intergel Pharmaceuticals Inc.
191 40th Street, Irvington, NJ 07111.

A division of IVC.




Dutasteride Capsules

Dutasteride Capsules are for use by men only.

Read this patient information before you start taking Dutasteride Capsules and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What are Dutasteride Capsules?

Dutasteride Capsules are a prescription medicine that contains dutasteride. Dutasteride Capsules are used to treat the symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate to:

  • improve symptoms,
  • reduce the risk of acute urinary retention (a complete blockage of urine flow),
  • reduce the risk of the need for BPH-related surgery.

Who should NOT take Dutasteride Capsules?

Do Not Take Dutasteride Capsules if you are:

  • pregnant or could become pregnant. Dutasteride Capsules may harm your unborn baby. Pregnant women should not touch Dutasteride Capsules. If a woman who is pregnant with a male baby gets enough dutasteride in her body by swallowing or touching Dutasteride Capsules, the male baby may be born with sex organs that are not normal. If a pregnant woman or woman of childbearing potential comes in contact with leaking Dutasteride Capsules, the contact area should be washed immediately with soap and water.
  • a child or a teenager.
  • allergic to dutasteride or any of the ingredients in Dutasteride Capsules. See the end of this leaflet for a complete list of ingredients in Dutasteride Capsules.
  • allergic to other 5 alpha-reductase inhibitors, for example, PROSCAR (finasteride) Tablets.

What should I tell my healthcare provider before taking Dutasteride Capsules?

Before you take Dutasteride Capsules, tell your healthcare provider if you:

  • have liver problems

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Dutasteride Capsules and other medicines may affect each other, causing side effects. Dutasteride Capsules may affect the way other medicines work, and other medicines may affect how Dutasteride Capsules work.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I take Dutasteride Capsules?

  • Take 1 Dutasteride Capsule once a day.
  • Swallow Dutasteride Capsules whole. Do not crush, chew, or open Dutasteride Capsules because the contents of the capsule may irritate your lips, mouth, or throat.
  • You can take Dutasteride Capsules with or without food.
  • If you miss a dose, you may take it later that day. Do not make up the missed dose by taking 2 doses the next day.

What should I avoid while taking Dutasteride Capsules?

  • You should not donate blood while taking Dutasteride Capsules or for 6 months after you have stopped taking Dutasteride Capsules. This is important to prevent pregnant women from receiving dutasteride through blood transfusions.

What are the possible side effects of Dutasteride Capsules?

dutasteride may cause serious side effects, including:

  • Rare and serious allergic reactions, including:
    • swelling of your face, tongue, or throat
    • serious skin reactions, such as skin peeling
    Get medical help right away if you have these serious allergic reactions.
  • Higher chance of a more serious form of prostate cancer.

The most common side effects of Dutasteride Capsules include:

  • trouble getting or keeping an erection (impotence)*
  • a decrease in sex drive (libido)*
  • ejaculation problems*
  • enlarged or painful breasts. If you notice breast lumps or nipple discharge, you should talk to your healthcare provider.

*Some of these events may continue after you stop taking Dutasteride Capsules.

Depressed mood has been reported in patients receiving Dutasteride Capsules.

Dutasteride Capsules have been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of Dutasteride Capsules on male fertility is not known.

Prostate-Specific Antigen (PSA) Test: Your healthcare provider may check you for other prostate problems, including prostate cancer before you start and while you take Dutasteride Capsules. A blood test called PSA (prostate-specific antigen) is sometimes used to see if you might have prostate cancer. Dutasteride Capsules will reduce the amount of PSA measured in your blood. Your healthcare provider is aware of this effect and can still use PSA to see if you might have prostate cancer. Increases in your PSA levels while on treatment with Dutasteride Capsules (even if the PSA levels are in the normal range) should be evaluated by your healthcare provider.

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects with Dutasteride Capsules. For more information, ask you healthcare provider or pharmacist.

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

How should I store Dutasteride Capsules?

  • Store Dutasteride Capsules at room temperature (59°F to 86°F or 15°C to 30°C).
  • Dutasteride Capsules may become deformed and/or discolored if kept at high temperatures.
  • Do not use Dutasteride Capsules if your capsules are deformed, discolored, or leaking.
  • Safely throw away medicine that is no longer needed.

Keep Dutasteride Capsules and all medicines out of the reach of children.

Medicines are sometimes prescribed for purposes other than those listed in a patient leaflet. Do not use Dutasteride Capsules for a condition for which it was not prescribed. Do not give Dutasteride Capsules to other people, even if they have the same symptoms that you have. It may harm them.

This patient information leaflet summarizes the most important information about Dutasteride Capsules. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about Dutasteride Capsules that is written for health professionals.

What are the ingredients in Dutasteride Capsules?

Active ingredient: dutasteride.

Inactive ingredients: butylated hydroxytoluene, ferric oxide (yellow), gelatin (from certified BSE-free bovine sources), glycerin, mono-di-glycerides of caprylic/capric acid, titanium dioxide, and edible black ink.

How do Dutasteride Capsules work?

Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). Dutasteride Capsules lower DHT production in the body, leading to shrinkage of the enlarged prostate in most men. While some men have fewer problems and symptoms after 3 months of treatment with Dutasteride Capsules, a treatment period of at least 6 months is usually necessary to see if Dutasteride Capsules will work for you.

Intergel Pharmaceuticals Inc.
191 40th Street, Irvington, NJ 07111.

A division of IVC.

Revision Date: March 29, 2016

Dutasteride Capsules 0.5 mg bottle label (30 count)
(click image for full-size original)

NDC 62112-8068-1

Dutasteride Capsules

0.5 mg

R X only

IPI 068

30 Capsules

WARNING: Dutasteride should not be used by women or children. Women who are or may potentially be pregnant should not use or handle Dutasteride Soft Gelatin Capsules (see prescribing information). If contact is made with leaking capsule, wash immediately with soap and water.

Each capsule contains 0.5 mg dutasteride.

Usual Dosage: 0.5 mg once a day. Capsules should be swallowed whole and not chewed or opened. See prescribing information for further dosing information.

Store at 25 o C (77 o F); excursions permitted to 15-30 o C (59-86 o F) [see USP Controlled Room Temperature].

Dispense in a well-closed container.

Do not use if printed safety seal under cap is broken or missing.

Intergel Pharmaceuticals Inc.
191 40th Street
Irvington, NJ
Made in the USA

A division of IVC


dutasteride capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62112-8068
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Inactive Ingredients
Ingredient Name Strength
Product Characteristics
Color yellow (light yellow) Score no score
Shape OVAL Size 18mm
Flavor Imprint Code IPI068
# Item Code Package Description Multilevel Packaging
1 NDC:62112-8068-2 90 CAPSULE, LIQUID FILLED in 1 BOTTLE None
2 NDC:62112-8068-1 30 CAPSULE, LIQUID FILLED in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA206373 12/10/2002
Labeler — Intergel Pharmaceuticals Inc (964464114)
Name Address ID/FEI Operations
Intergel Pharmaceuticals Inc 964464114 manufacture (62112-8068)

Revised: 03/2016 Intergel Pharmaceuticals Inc

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