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Amitiza

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Amitiza

Indications
Dosage
How Supplied

INDICATIONS

Chronic Idiopathic Constipation

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

Opioid-induced Constipation

Amitiza is indicated for the treatment of opioid-induced constipation (OIC) in adults with chronic non-cancer pain.

Limitations of Use
  • Effectiveness of Amitiza in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established. [see Clinical Studies]

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

Take Amitiza orally with food and water. Swallow capsules whole and do not break apart or chew. Physicians and patients should periodically assess the need for continued therapy.

Chronic Idiopathic Constipation and Opioid-induced Constipation

The recommended dose is 24 mcg twice daily orally with food and water.

Dosage in patients with hepatic impairment

For patients with moderately impaired hepatic function (Child-Pugh Class B), the recommended starting dose is 16 mcg twice daily. For patients with severely impaired hepatic function (Child-Pugh Class C), the recommended starting dose is 8 mcg twice daily. If this dose is tolerated and an adequate response has not been obtained after an appropriate interval, doses can then be escalated to full dosing with appropriate monitoring of patient response [see Use In Specific Populations and CLINICAL PHARMACOLOGY].

Irritable Bowel Syndrome with Constipation

The recommended dose is 8 mcg twice daily orally with food and water.

Dosage in patients with h epatic impairment

For patients with severely impaired hepatic function (Child-Pugh Class C), the recommended starting dose is 8 mcg once daily. If this dose is tolerated and an adequate response has not been obtained after an appropriate interval, doses can then be escalated to full dosing with appropriate monitoring of patient response. Dosage adjustment is not required for patients with moderately impaired hepatic function (Child-Pugh Class B) [see Use in Specific Populations and CLINICAL PHARMACOLOGY].

HOW SUPPLIED

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

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° to 30°C (59° to 86°F).

Protect from light and extreme temperatures.

Marketed by: Sucampo Pharma Americas, LLC Bethesda, MD 20814 and Takeda Pharmaceuticals America, Inc. Deerfield, IL 60015. Revised: April 2013

Last reviewed on RxList: 5/20/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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Amitiza - User Reviews

Amitiza User Reviews

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