Usual Adult Dose for Breast Cancer-Palliative

Tablets:
40 mg orally 4 times a day

Comments:

• At least 2 months of continuous treatment is considered an adequate period for determining the efficacy of this drug.

Use: For palliative treatment of advanced carcinoma of the breast (i.e., recurrent, inoperable, or metastatic disease); it should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy

Usual Adult Dose for Endometrial Carcinoma

Tablets:
40 to 320 mg orally daily in divided doses

Comments:

• At least 2 months of continuous treatment is considered an adequate period for determining the efficacy of this drug.

Use: For palliative treatment of advanced carcinoma of the endometrium (i.e., recurrent, inoperable, or metastatic disease); it should not be used in lieu of currently accepted procedures such as surgery, radiation, or chemotherapy

Usual Adult Dose for Weight Loss

Suspension (40 mg/mL):
800 mg orally once a day (20 mL/day)
OR
Suspension (125 mg/mL):
625 mg orally once a day (5 mL/day)
OR
Suspension ES (125 mg/mL):
625 mg orally once a day (1 mL/day)

Comments:

• NOTE: The 125 mg/mL strength is not interchangeable with any other strength.
• Shake container well before using.
• This 125 mg/mL strength is not substitutable with the 40 mg/mL strength on a mg per mg basis.
• Therapy with this drug for weight loss should only be instituted after treatable causes are addressed (e.g., malignancies, systemic infections, GI disorders affecting absorption, endocrine disease, renal disease, psychiatric diseases).
• This drug is not intended for prophylactic use to avoid weight loss.

Use: For the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS)

Usual Adult Dose for Anorexia

Suspension (40 mg/mL):
800 mg orally once a day (20 mL/day)
OR
Suspension (125 mg/mL):
625 mg orally once a day (5 mL/day)
OR
Suspension ES (125 mg/mL):
625 mg orally once a day (1 mL/day)

Comments:

• NOTE: The 125 mg/mL strength is not interchangeable with any other strength.
• Shake container well before using.
• This 125 mg/mL strength is not substitutable with the 40 mg/mL strength on a mg per mg basis.
• Therapy with this drug for weight loss should only be instituted after treatable causes are addressed (e.g., malignancies, systemic infections, GI disorders affecting absorption, endocrine disease, renal disease, psychiatric diseases).
• This drug is not intended for prophylactic use to avoid weight loss.

Use: For the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS)

Usual Adult Dose for Cachexia

Suspension (40 mg/mL):
800 mg orally once a day (20 mL/day)
OR
Suspension (125 mg/mL):
625 mg orally once a day (5 mL/day)
OR
Suspension ES (125 mg/mL):
625 mg orally once a day (1 mL/day)

Comments:

• NOTE: The 125 mg/mL strength is not interchangeable with any other strength.
• Shake container well before using.
• This 125 mg/mL strength is not substitutable with the 40 mg/mL strength on a mg per mg basis.
• Therapy with this drug for weight loss should only be instituted after treatable causes are addressed (e.g., malignancies, systemic infections, GI disorders affecting absorption, endocrine disease, renal disease, psychiatric diseases).
• This drug is not intended for prophylactic use to avoid weight loss.

Use: For the treatment of anorexia, cachexia, or an unexplained significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (AIDS)

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active component or any of the ingredients
• Pregnancy

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Obtain a negative pregnancy test in females of reproductive potential prior to initiating therapy with this drug.

Storage requirements:

• Store at 25C (77F); excursions permitted to 15C to 30°C (59F to 86°F).
• Protect from temperatures above 40C (104F).

Monitoring:

• Renal function (particularly in the elderly).