Amitiza (Lubiprostone) - Indications and Dosage

INDICATIONS AND USAGE

Chronic Idiopathic Constipation

Amitiza^® is indicated for the treatment of chronic idiopathic constipation in adults.

Irritable Bowel Syndrome with Constipation

Amitiza is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C) in women ≥ 18 years old.

DOSAGE AND ADMINISTRATION

Amitiza should be taken twice daily orally with food and water. Physicians and patients should periodically assess the need for continued therapy.

Chronic Idiopathic Constipation

24 mcg twice daily orally with food and water.

Irritable Bowel Syndrome with Constipation

8 mcg twice daily orally with food and water.

DOSAGE FORMS AND STRENGTHS

Amitiza is available as an oval, gelatin capsule containing 8 mcg or 24 mcg of lubiprostone.

• 8-mcg capsules are pink and are printed with “SPI” on one side
• 24-mcg capsules are orange and are printed with “SPI” on one side

HOW SUPPLIED/STORAGE AND HANDLING

Amitiza is available as an oval, soft gelatin capsule containing 8 mcg or 24 mcg of lubiprostone with “SPI” printed on one side. Amitiza is available as follows:

8-mcg pink capsule

• Bottles of 60 (NDC 64764-080-60)

24-mcg orange capsule

• Bottles of 60 (NDC 64764-240-60)
• Bottles of 100 (NDC 64764-240-10)

Store at 25°C (77°F); excursions permitted to 15°–30°C (59°–86°F).

PROTECT FROM EXTREME TEMPERATURES.