Amitiza

— THERAPEUTIC CATEGORIES —
  • Colorectal disorders
  • Constipation and bowel cleansers

Amitiza Generic Name & Formulations

General Description

Lubiprostone 8mcg, 24mcg; caps.

Pharmacological Class

GI motility enhancer (chloride channel activator).

How Supplied

8mcg—60; 24mcg—60, 100

Manufacturer

Generic Availability

YES

Amitiza Indications

Indications

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

Amitiza Dosage and Administration

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.

Amitiza Contraindications

Contraindications

Known or suspected mechanical GI obstruction.

Amitiza Boxed Warnings

Not Applicable

Amitiza Warnings/Precautions

Warnings/Precautions

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

Amitiza Pharmacokinetics

See Literature

Amitiza Interactions

Interactions

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

Amitiza Adverse Reactions

Adverse Reactions

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

Amitiza Clinical Trials

See Literature

Amitiza Note

Not Applicable

Amitiza Patient Counseling

See Literature

Amitiza Generic Name & Formulations

General Description

Lubiprostone 8mcg, 24mcg; caps.

Pharmacological Class

GI motility enhancer (chloride channel activator).

How Supplied

8mcg—60; 24mcg—60, 100

Manufacturer

Generic Availability

YES

Amitiza Indications

Indications

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.

Amitiza Dosage and Administration

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.

Amitiza Contraindications

Contraindications

Known or suspected mechanical GI obstruction.

Amitiza Boxed Warnings

Not Applicable

Amitiza Warnings/Precautions

Warnings/Precautions

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

Amitiza Pharmacokinetics

See Literature

Amitiza Interactions

Interactions

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

Amitiza Adverse Reactions

Adverse Reactions

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

Amitiza Clinical Trials

See Literature

Amitiza Note

Not Applicable

Amitiza Patient Counseling

See Literature

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