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AMITIZA
Colorectal disorders
Constipation and bowel cleansers
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Drug Name:

AMITIZA Rx

Generic Name and Formulations:
Lubiprostone 8mcg, 24mcg; caps.

Company:
Sucampo and Takeda

Therapeutic Use:

Indications for AMITIZA:

Irritable bowel syndrome with constipation (IBS–C) in women.

Adult:

Swallow whole. Take with food and water. ≥18yrs: 8mcg twice daily. Severe hepatic impairment (Child-Pugh Class C): initially 8mcg once daily; if tolerated and inadequate response, may escalate to full dose; monitor.

Children:

<18yrs: not established.

Contraindications:

Known or suspected mechanical GI obstruction.

Warnings/Precautions:

Confirm absence of GI obstruction before starting therapy. Severe diarrhea: not recommended. Hepatic impairment. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers; monitor infants for diarrhea.

Interactions:

Possibly antagonized by diphenylheptane opioids (eg, methadone). Increased risk of syncope/hypotension with antihypertensives.

Pharmacological Class:

GI motility enhancer (chloride channel activator).

Adverse Reactions:

Nausea, diarrhea (discontinue if severe), abdominal pain; syncope, hypotension, dyspnea.

Elimination:

Renal (primary), fecal.

Generic Availability:

NO

How Supplied:

8mcg—60; 24mcg—60, 100

Indications for AMITIZA:

Chronic idiopathic constipation. Opioid-induced constipation (OIC) in adults with chronic non-cancer pain, including chronic pain related to prior cancer or its treatment in patients who do not require frequent opioid dosage escalation.

Limitations Of use:

Effectiveness in the treatment of OIC in patients taking diphenylheptane opioids (eg, methadone) has not been established.

Adult:

Swallow whole. Take with food and water. 24mcg twice daily. Moderate hepatic impairment (Child-Pugh Class B): initially 16mcg twice daily. Severe hepatic impairment (Child-Pugh Class C): initially 8mcg twice daily. If tolerated and inadequate response, may escalate to full dose; monitor.

Children:

Not established.

Contraindications:

Known or suspected mechanical GI obstruction.

Warnings/Precautions:

Confirm absence of GI obstruction before starting therapy. Severe diarrhea: not recommended. Hepatic impairment. Reevaluate periodically. Pregnancy (Cat.C). Nursing mothers; monitor infants for diarrhea.

Interactions:

Possibly antagonized by diphenylheptane opioids (eg, methadone). Increased risk of syncope/hypotension with antihypertensives.

Pharmacological Class:

GI motility enhancer (chloride channel activator).

Adverse Reactions:

Nausea, diarrhea (discontinue if severe), headache, abdominal pain, abdominal distension, flatulence; syncope, hypotension, dyspnea.

Elimination:

Renal (primary), fecal.

Generic Availability:

NO

How Supplied:

8mcg—60; 24mcg—60, 100

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