facebook
Subscribe50$/product give away!


Submit an Article to Pharmacy HQ     
Please include the author's name, title, and citations.     

BICALUTAMIDE tablet, film coated


  1. What Are Bicalutamide Tablets, Usp?
  2. Do Not Take Bicalutamide Tablets, Usp If:
  3. Before You Take Bicalutamide Tablets, Usp, Tell Your Healthcare Provider About All Your Medical Conditions Including If You:
  4. What Should I Avoid While Taking Bicalutamide Tablets, Usp?
  5. What Are The Possible Side Effects Of Bicalutamide Tablets, Usp?
  6. Get Medical Help Right Away, If You Have:
  7. The Most Common Side Effects Of Bicalutamide Tablets, Usp Include:
  8. How Should I Store Bicalutamide Tablets, Usp?
  9. What Are The Ingredients In Bicalutamide Tablets, Usp?
  10. What Are Bicalutamide Tablets?
  11. Do Not Take Bicalutamide Tablets If You Are:
  12. Bicalutamide Tablets May Cause Serious Side Effects, Including:
  13. Bicalutamide Tablets Include:
  14. Bicalutamide Tablets?
  15. Dose And Schedule:
  16. Hepatitis:
  17. Hemorrhage With Concomitant Use Of Coumarin Anticoagulant:
  18. Glucose Tolerance:
  19. Somnolence:
  20. Photosensitivity:
  21. Contraception And Fertility:
  22. Manufactured In Israel By:
  23. Manufactured For:
  24. Patient Information

What Are Bicalutamide Tablets, Usp? 

Bicalutamide Tablets, USP are a prescription medicine called an androgen receptor inhibitor, used in combination with lutenizing hormone-releasing hormone (LHRH) medicines to treat stage D2 metatastic prostate cancer. It is not known if Bicalutamide Tablets, USP are safe and effective in children.

Do Not Take Bicalutamide Tablets, Usp If: 

  • you are a woman.
  • you are allergic to any of the ingredients in Bicalutamide Tablets, USP.

Before You Take Bicalutamide Tablets, Usp, Tell Your Healthcare Provider About All Your Medical Conditions Including If You: 

  • are a woman (

    • Take Bicalutamide Tablets, USP exactly as prescribed.
    • Take Bicalutamide Tablets, USP at the same time everyday.
    • Your treatment with Bicalutamide Tablets, USP should start at the same time as your treatment with the LHRH medicine
    • If you miss a dose do not take an extra dose, take the next dose at your regular time. Do not take 2 doses at the same time.
    • Bicalutamide Tablets, USP can be taken with or without food.
    • If you take too much Bicalutamide Tablets, USP, call your healthcare provider or Poison Control Center or go to the nearest hospital emergency room right away.
    • Do not stop taking Bicalutamide Tablets, USP unless your healthcare provider tells you.
    • Your healthcare provider may do blood tests while you take Bicalutamide Tablets, USP
    • Your prostate cancer may get worse while taking Bicalutamide Tablets, USP in combination with LHRH medicines. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse.

What Should I Avoid While Taking Bicalutamide Tablets, Usp? 

Driving and operating machinery. Do not drive, operate machinery, or do other dangerous activities until you know how Bicalutamide Tablets, USP affects you.

What Are The Possible Side Effects Of Bicalutamide Tablets, Usp? 

Bicalutamide Tablets, USP can cause serious side effects.

Get Medical Help Right Away, If You Have: 

  • trouble breathing with or without a cough or fever. Some people who take Bicalutamide Tablets, USP get an inflammation in the lungs called interstitial lung disease.
  • An allergic reaction.Symptoms of an allergic reaction include:itching of the skin, hives (raised bumps), swelling of the face, lips, tongue, throat, or trouble swallowing.
  • Yellowing of the skin and eyes (jaundice), dark urine, right upper stomach pain, nausea, vomiting, tiredness, loss of appetite, chills, fever, whole body pain. These may be symptoms of liver damage.
  • Poor blood sugar control can happen in people who take Bicalutamide Tablets, USP in combination with LHRH medicines.
  • enlargement of breast (gynecomastia) and breast pain

The Most Common Side Effects Of Bicalutamide Tablets, Usp Include: 

  • hot flashes, or short periods of feeling warm and sweating
  • whole body pain in your back, pelvis, stomach
  • feeling weak
  • constipation
  • infection
  • nausea
  • swelling in your ankles, legs or feet
  • diarrhea
  • blood in your urine
  • waking from sleep to urinate at night
  • a decrease in red blood cells (anemia)
  • feeling dizzy

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 of Bicalutamide Tablets, USP. For more information, ask your 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 Bicalutamide Tablets, Usp? 

Store Bicalutamide Tablets, USP between 20 C to 25 C (68 F to 77 F).

Keep Bicalutamide Tablets, USP and all medicines out of the reach of children.

General information about the safe and effective use of Bicalutamide Tablets, USP.

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. Do not use Bicalutamide Tablets, USP for a condition for which it was not prescribed. Do not give Bicalutamide Tablets, USP 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 Bicalutamide Tablets, USP. If you would like more information about Bicalutamide Tablets, USP talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Bicalutamide Tablets, USP that is written for health professionals. For more information call 1-866-947-3282.

What Are The Ingredients In Bicalutamide Tablets, Usp? 

Active ingredients include: bicalutamide

Inactive ingredients include: lactose monohydrate, magnesium stearate, povidone, crospovidone, sodium lauryl sulfate, polyethylene glycol, hypromellose, titanium dioxide.

Manufactured for:
DAVA Pharmaceuticals, Inc.
Fort Lee, NJ 07024, USA

Manufactured by:
Synthon Hispania S.L.
Barcelona, Spain
Made in Spain

Revised: 06/2009

PPI-5003-1

What Are Bicalutamide Tablets? 

Bicalutamide tablets are a prescription medicine called an androgen receptor inhibitor, used in combination with luteinizing hormone-releasing hormone (LHRH) medicines to treat Stage D2metastatic prostate cancer

Bicalutamide 150 mg daily is not approved for use alone or with other treatments.

It is not known if bicalutamide is safe and effective in children.

Do Not Take Bicalutamide Tablets If You Are: 

  • allergic to bicalutamide or any of the ingredients in bicalutamide tablets.

    • Take bicalutamide tablets exactly as your healthcare provider tells you to take it.
    • Do not stop taking bicalutamide tablets unless your healthcare provider tells you to.
    • Bicalutamide tablets can be taken either in the morning or in the evening, but you should take it at the same time every day.
    • Your treatment with bicalutamide tablets should start at the same time as your treatment with the LHRH medicine.
    • If you miss a bicalutamide tablets dose do not take the missed dose, take the next dose at your next scheduled time. Do not take 2 doses at the same time.
    • Bicalutamide tablets can be taken with or without food.
    • If you take too many bicalutamide tablets, call your healthcare provider or go to the nearest hospital emergency room right away.

    What should I avoid during treatment with

Bicalutamide Tablets May Cause Serious Side Effects, Including: 

  • Liver problems.Severe liver problems, including liver failure that may need to be treated in a hospital or that may lead to death have happened in people who take bicalutamide tablets. Your healthcare provider should do blood tests to check your liver function before and during treatment with bicalutamide tablets. Tell your healthcare provider right away if you develop any of these symptoms of liver problems during treatment:
  • yellowing of the skin and eyes (jaundice)
  • dark urine
  • right upper stomach pain
  • nausea
  • vomiting
  • tiredness
  • loss of appetite
  • chills
  • fever
  • Bleeding problems.Serious bleeding problems have happened in people who take bicalutamide tablets in combination with a blood thinner medicine (coumarin anticoagulants). Bleeding problems have happened days to weeks after starting bicalutamide tablets treatment. If you take a blood thinner medicine during treatment with bicalutamide tablets, tell your healthcare provider if you develop any bleeding or unexplained bruising.
  • Breast enlargement (gynecomastia) and breast pain.
  • Blood sugar problems.Poor blood sugar control can happen in people who take bicalutamide tablets in combination with LHRH medicines.

Your healthcare provider may do blood tests during treatment with bicalutamide tablets to check for side effects.

Your prostate cancer may get worse during treatment with bicalutamide tablets in combination with LHRH medicines. Regular monitoring of your prostate cancer with your healthcare provider is important to determine if your disease is worse.

Tell your healthcare provider if you have trouble breathing with or without a cough or fever. Some people taking bicalutamide tablets get an inflammation in the lungs called interstitial lung disease.

The most common side effects of

Bicalutamide Tablets Include: 

  • hot flashes (short periods of feeling warm and sweating)
  • infection
  • diarrhea
  • body pain (including back, pelvis, stomach)
  • nausea
  • blood in your urine
  • feeling weak
  • swelling in your arms, ankles, legs or feet
  • frequent urination at night
  • constipation
  • shortness of breath (dyspnea)
  • a decrease in red blood cells (anemia)
  • dizziness

Bicalutamide may have an effect on male fertility which could be reversible. Talk to your healthcare provider if this is a concern for you.

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 of bicalutamide tablets. For more information, ask your 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

Bicalutamide Tablets? 

Store bicalutamide tablets at room temperature between 68 F to 77 F (20 C to 25 C).
Keepbicalutamide tablets and all medicines out of the reach of children.

General information about the safe and effective use ofbicalutamide tablets.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use bicalutamide tablets for a condition for which they were not prescribed. Do not give bicalutamide tablets 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 bicalutamide tablets. If you would like more information about bicalutamide tablets, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about bicalutamide tablets that is written for health professionals.

What are the ingredients in

Dose And Schedule: 

Inform patients that therapy with bicalutamide tablets and the LHRH analog should be started at the same time and that they should not interrupt or stop taking these medications without consulting their healthcare provider[see Dosage and Administration (2.1)].

Hepatitis: 

Inform patients that bicalutamide tablets can cause hepatitis, which may result in hepatic failure and death. Advise patients that liver function tests should be monitored regularly during treatment and to report signs and symptoms of hepatitis[see Warnings and Precautions (5.1)].

Hemorrhage With Concomitant Use Of Coumarin Anticoagulant: 

Inform patients that serious bleeding has occurred with reported increased anticoagulant effects while taking bicalutamide tablets. Advise patients to notify their healthcare provider of any bleeding or spontaneous bruising while on bicalutamide tablets and taking anticoagulants[see Warnings and Precautions (5.2) and Adverse Reactions (6.2)].

Glucose Tolerance: 

Inform patients that diabetes or loss of glycemic control in patients with preexisting diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving bicalutamide tablets in combination with LHRH agonists[see Warnings and Precautions (5.4)].

Somnolence: 

During treatment with bicalutamide tablets, somnolence has been reported. Advise patients who experience this symptom to observe caution when driving or operating machines[see Adverse Reactions (6.1)].

Photosensitivity: 

Inform patients that cases of photosensitivity have been reported during treatment with bicalutamide tablets and that they should avoid direct exposure to excessive sunlight or UV-light exposure. Consideration should be given to the use of sunscreen[see Adverse Reactions (6.2)].

Contraception And Fertility: 

Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 130 days after the last dose of bicalutamide tablets therapy. Advise male patients that bicalutamide tablets may impair fertility[see Use in Specific Populations (8.3)].

Manufactured In Israel By: 

Teva Pharmaceutical Ind. Ltd.

Jerusalem, 9777402, Israel

Manufactured For: 

Teva Pharmaceuticals USA, Inc.

North Wales, PA 19454

Rev. H 12/2017

Patient Information 

Patients should be informed that therapy with Bicalutamide Tablets, USP and the LHRH analog should be started at the same time and that they should not interrupt or stop taking these medications without consulting their physician.

During treatment with Bicalutamide Tablets, USP, somnolence has been reported, and those patients who experience this symptom should observe caution when driving or operating machines.

Patients should be informed that diabetes, or loss of glycemic control in patients with pre-existing diabetes has been reported during treatment with LHRH agonists. Consideration should therefore be given to monitoring blood glucose in patients receiving Bicalutamide Tablets, USP in combination with LHRH agonists.

Manufactured for:
DAVA Pharmaceuticals, Inc.
Fort Lee, NJ 07024, USA

Manufactured by:
Synthon Hispania S.L.
Barcelona, Spain
Made in Spain

Revised: 06/2009

PI-5002-1



Your use of this website constitutes your agreement to the terms and conditions linked below:
Terms and Conditions | Resources
2017 © Copyright PharmacyHQ.com. Questions?
Please contact: pharmacyhq.mail@gmail.com