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BICALUTAMIDE tablet


  1. Patient Information
  2. Dose And Schedule:
  3. Hepatitis:
  4. Hemorrhage With Concomitant Use Of Coumarin Anticoagulant:
  5. Glucose Tolerance:
  6. Somnolence:
  7. Photosensitivity:
  8. Contraception And Fertility:
  9. Manufactured For:
  10. Manufactured By:

Patient Information 

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

Dose And Schedule: 

Inform patients that therapy with bicalutamide 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[seeDosage and Administration (2.1)].

Hepatitis: 

Inform patients that bicalutamide 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[seeWarnings 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. Advise patients to notify their healthcare provider of any bleeding or spontaneous bruising while on bicalutamide and taking anticoagulants[seeWarnings and Precautions (5.2)andAdverse reaction (6.2)].

Glucose Tolerance: 

Inform patients 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 in combination with LHRH agonists[seeWarnings and Precautions (5.4)].

Somnolence: 

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

Photosensitivity: 

Inform patients that cases of photosensitivity have been reported during treatment with bicalutamide and that they should avoid direct exposure to excessive sunlight or UV-light exposure. Consideration should be given to the use of sunscreen[seeAdverse 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 therapy. Advise male patients that bicalutamide may impair fertility[seeUse in Specific Populations (8.3)].

Manufactured For: 

Accord Healthcare, Inc.,

1009, Slater Road,

Suite 210-B,

Durham, NC 27703,

USA.

Manufactured By: 

Intas Pharmaceuticals Limited,

Plot No. : 457, 458,

Village - Matoda,

Bavla Road, Ta.:Sanand,

Dist.: Ahmedabad : 382 210.

India.

10 0857 3 691691

Issued January 2019



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