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AVODART- dutasteride capsule, liquid filled


  1. Patient Information
  2. Avodart Is A Prescription Medicine That Contains Dutasteride. Avodart Is Used To Treat The Symptoms Of Benign Prostatic Hyperplasia (bph) In Men With An Enlarged Prostate To:
  3. Do Not Take Avodart If You Are:
  4. Before You Take Avodart, Tell Your Healthcare Provider If You:
  5. How Should I Take Avodart?
  6. What Should I Avoid While Taking Avodart?
  7. Rare And Serious Allergic Reactions, Including:
  8. The Most Common Side Effects Of Avodart Include:
  9. Prostate-specific Antigen (psa) Test:
  10. Active Ingredient:
  11. Inactive Ingredients:
  12. How Does Avodart Work?
  13. Manufactured For:
  14. Usual Dosage:
  15. Revised: 9/2014document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Patient Information).

PSA Monitoring

Inform patients that AVODART reduces serum PSA levels by approximately 50% within 3 to 6 months of therapy, although it may vary for each individual. For patients undergoing PSA screening, increases in PSA levels while on treatment with AVODART may signal the presence of prostate cancer and should be evaluated by a healthcare provider[

Avodart Is A Prescription Medicine That Contains Dutasteride. Avodart Is 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.

Do Not Take Avodart If You Are: 

pregnant or could become pregnant. AVODART may harm your unborn baby. Pregnant women should not touch AVODART capsules. If a woman who is pregnant with a male baby gets enough AVODART in her body by swallowing or touching AVODART, 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 AVODART 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 AVODART.

Before You Take Avodart, 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. AVODART and other medicines may affect each other, causing side effects. AVODART may affect the way other medicines work, and other medicines may affect how AVODART works.

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 Avodart? 

Take 1 AVODART capsule once a day.
Swallow AVODART capsules whole. Do not crush, chew, or open AVODART capsules because the contents of the capsule may irritate your lips, mouth, or throat.
You can take AVODART 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 Avodart? 

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

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 Avodart 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 AVODART.

Depressed mood has been reported in patients receiving AVODART.

AVODART has been shown to reduce sperm count, semen volume, and sperm movement. However, the effect of AVODART 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 AVODART. A blood test called PSA (prostate-specific antigen) is sometimes used to

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

Keep AVODART 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 AVODART for a condition for which it was not prescribed. Do not give AVODART 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 AVODART. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about AVODART that is written for health professionals.

For more information, go to www.AVODART.com or call 1-888-825-5249.

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 red ink.

How Does Avodart Work? 

Prostate growth is caused by a hormone in the blood called dihydrotestosterone (DHT). AVODART lowers 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 AVODART, a treatment period of at least 6 months is usually necessary to see if AVODART will work for you.

This Patient Information has been approved by the U.S. Food and Drug Administration.

AVODART is a registered trademark of the GSK group of companies.

The brands listed are trademarks of their respective owners and are not trademarks of the GSK group of companies. The makers of these brands are not affiliated with and do not endorse the GSK group of companies or its products.

Manufactured For: 

GlaxoSmithKline
Research Triangle Park, NC 27709

2014, the GSK group of companies. All rights reserved.

September 2014
AVT:9PIL

PRINCIPAL DISPLAY PANEL

NDC 0173-0712-04

AVODART

(dutasteride)

Soft Gelatin Capsules

0.5 mg

RXonly

GX CE2

90 Capsules

WARNING: AVODART should not be used by women or children. Women who are or may potentially be pregnant should not use or handle AVODART 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 25oC (77oF); excursions permitted to 15-30oC (59-86oF) [see USP Controlled Room Temperature].

Dispense in a well-closed container as defined in the USP.

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

Manufactured for: GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Ireland

10000000143749 Rev. 11/16
Avodart 0.5 mg 90 count label
AVODART
dutasteride capsule, liquid filled
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0712
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DUTASTERIDE(UNII: O0J6XJN02I) (DUTASTERIDE - UNII:O0J6XJN02I)DUTASTERIDE0.5 mg
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE(UNII: 1P9D0Z171K)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
GELATIN, UNSPECIFIED(UNII: 2G86QN327L)
GLYCERIN(UNII: PDC6A3C0OX)
CAPRYLIC/CAPRIC MONO/DIGLYCERIDES(UNII: U72Q2I8C85)
Product Characteristics
ColorYELLOW (dull yellow)Scoreno score
ShapeOVAL (soft gelatin capsule)Size19mm
FlavorImprint CodeGX;CE2
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0712-0490 in 1 BOTTLE; Type 0: Not a Combination Product12/10/2002
2NDC:0173-0712-1530 in 1 BOTTLE; Type 0: Not a Combination Product12/10/2002
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02131912/10/2002
Labeler -GlaxoSmithKline LLC (167380711)

Revised: 9/2014document Id: 

e15a8be0-4d79-466e-9c9a-4dfb0f3690d5Set id: dc330e70-a1d3-400b-3aaf-46067e3fd090Version: 25Effective Time: 20140929GlaxoSmithKline LLC



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