lubiprostone

REMS

Chronic idiopathic constipation.
Irritable bowel syndrome with constipation in women ≥18 yr.
Opioid-induced constipation in adults with chronic, non-cancer pain, including those with chronic pain related to prior cancer or its treatment who do not need frequent (e.g. weekly) opioid dose escalation.

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity
Mechanical GI obstruction
Lactation: Lactation.

Use Cautiously in:

Severe diarrhea
Moderate or severe hepatic impairment (dose ↓ recommended)
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk
Pedi: Safety and effectiveness not established in children.

Adv. Reactions/Side Effects ⬆ ⬇

CV: hypotension, peripheral edema, syncope.

GI: diarrhea, nausea, abdominal distention, abdominal pain, dry mouth, dyspepsia, reflux, vomiting.

MS: arthralgia.

Neuro: dizziness, headache.

Resp: dyspnea.

Interactions ⬆ ⬇

Drug-Drug:

Concurrent use of antihypertensives may ↑ risk of hypotension and/or syncope.

Availability ⬆ ⬇

(Generic available)

Capsules: 8 mcg; 24 mcg;

Route/Dosage ⬆ ⬇

Chronic Idiopathic Constipation and Opioid-Induced Constipation

PO (Adults): 24 mcg twice daily.

Hepatic Impairment

PO (Adults): Moderate hepatic impairment (Child-Pugh Class B)-16 mcg twice daily; if patient tolerates, can titrate to 24 mcg twice daily, if needed; Severe hepatic impairment (Child-Pugh Class C)-8 mcg twice daily; if patient tolerates, can titrate to 24 mcg twice daily, if needed.

Irritable Bowel Syndrome with Constipation

PO (Adults): 8 mcg twice daily.

Hepatic Impairment

PO (Adults): Severe hepatic impairment (Child-Pugh Class C)-8 mcg once daily; if patient tolerates, can titrate to 8 mcg twice daily, if needed.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Increases intestinal fluid secretion by activating chloride channels in intestinal epithelium.

Therapeutic Effects:

Decreased symptoms of chronic constipation.

Classifications ⬆ ⬇

Therapeutic Classification: laxatives

Pharmacologic Classification: chloride channel activators

Pharmacokinetics ⬆ ⬇

Absorption: Minimal absorption, action is primarily in GI tract.

Distribution: Minimal systemic distribution.

Metabolism/Excretion: Metabolized by enzymes in the GI tract. Primary metabolite (M3) is excreted in urine (60%) and feces (30%).

Half-life: Unknown.

Time/Action Profile ⬆ ⬇

(reduction in symptoms)

ROUTE	ONSET	PEAK	DURATION
PO	within 1 wk	1 wk	unknown

Patient/Family Teaching ⬆ ⬇

Instruct patient to take lubiprostone as directed.
Inform patient that dyspnea or chest tightness may occur within 1 hr of first dose; usually resolves within 3 hrs, but may return with repeat doses.
Advise patients that lubiprostone may cause diarrhea. Advise patient to notify health care professional if diarrhea becomes severe.
Inform patient that syncope and hypotension may occur, usually with the 24 mcg twice daily dose. May recur with next dose. Usually resolves with discontinuation of therapy.
May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected and to avoid breastfeeding during therapy. If used during breastfeeding, monitor infant for diarrhea.

Pronunciation ⬆ ⬇

Code ⬆

NDC Code^*

35356- Lake Erie Medical DBA Quality Care Products LLC
35356-500- Amitiza 35356-500-60- 60 CAPSULE, GELATIN COATED in 1 BOTTLE (35356-500-60)

63629- Bryant Ranch Prepack
63629-6398- Amitiza 63629-6398-1- 90 CAPSULE, GELATIN COATED in 1 BOTTLE (63629-6398-1)

64764- Takeda Pharmaceuticals America, Inc.
64764-080- Amitiza 64764-080-60- 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-080-60)

64764- Takeda Pharmaceuticals America, Inc.
64764-240- Amitiza 64764-240-10- 100 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-240-10)

64764- Takeda Pharmaceuticals America, Inc.
64764-240- Amitiza 64764-240-60- 60 CAPSULE, GELATIN COATED in 1 BOTTLE (64764-240-60)

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Indications ⬇