Amitiza Generic Name & Formulations
Legal Class
Rx
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
Legal Class
Rx
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
Images
