Pharmacologic class: Chloride channel activator

Therapeutic class: GI motility enhancer

Pregnancy risk category C


Enhances chloride-rich intestinal fluid secretion without altering sodium and potassium serum concentrations; increases intestinal fluid secretion and intestinal motility, which promotes stool passage and relieves symptoms of chronic idiopathic constipation


Soft gelatin capsules: 8 mcg, 24 mcg

Indications and dosages

Chronic idiopathic constipation

Adults: 24 mcg P.O. twice daily

Treatment of irritable bowel syndrome with constipation in women

Adults ages 18 and older: 8 mcg P.O. b.i.d.

Dosage adjustment

• Moderate to severe hepatic impairment


• Hypersensitivity to drug or its components

• History of mechanical GI obstruction


Use cautiously in:

• severe diarrhea, hepatic or renal dysfunction

• pregnant or breastfeeding patients.


• Administer with food and water.

Adverse reactions

CNS: headache, dizziness, hypoesthesia, fatigue, depression, anxiety, insomnia

CV: chest discomfort or pain, hypertension

EENT: sinusitis, nasopharyngitis, pharyngolaryngeal pain

GI: nausea, vomiting, diarrhea, constipation, abdominal distention, abdominal pain or discomfort, flatulence, dyspepsia, gastroesophageal reflux disease, gastroenteritis, dry mouth

GU: urinary tract infection

Musculoskeletal: arthralgia, back pain, extremity pain, muscle cramp

Respiratory: upper respiratory tract infection, influenza, bronchitis, dyspnea, cough

Other: weight gain, peripheral edema, fever, viral infection



Patient monitoring

• Evaluate patient for signs and symptoms of mechanical obstruction before therapy begins.

• Assess patient periodically for continuing need for therapy.

Patient teaching

• Instruct patient not to break or chew capsule.

• Instruct patient not to take drug during episodes of severe diarrhea.

• Advise patient to report side effects, such as severe nausea, diarrhea, and dyspnea, to prescriber.

• Caution female patient with child-bearing potential that drug may pose hazard to fetus.

• Advise breastfeeding patient that she should decide whether to discontinue breastfeeding or stop taking drug.

• As appropriate, review all other significant adverse reactions.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved


(loo-bi-pross-tone) ,


(trade name)


Therapeutic: laxatives
Pharmacologic: chloride channel activators
Pregnancy Category: C


Chronic idiopathic constipation.Irritable bowel syndrome (IBS) with constipation in women ≥18 yr.Opioid-induced constipation in adults with chronic, non-cancer pain


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

Therapeutic effects

Decreased symptoms of chronic constipation.


Absorption: Minimal absorption, action is primarily in GI tract.
Distribution: Minimal systemic distribution.
Metabolism and 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)

POwithin 1 wk1 wkunknown


Contraindicated in: Hypersensitivity; Mechanical gastrointestinal obstruction; Lactation: Lactation.
Use Cautiously in: Severe diarrhea; Moderate or severe hepatic impairment (dose ↓ recommended); Obstetric: Use only if benefit outweighs risk; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • headache


  • peripheral edema


  • dyspnea


  • diarrhea (most frequent)
  • nausea (most frequent)
  • abdominal pain
  • abdominal distention
  • dyspepsia
  • dry mouth
  • reflux


  • arthralgia


Drug-Drug interaction

None noted.


Chronic Idiopathic Constipation and Opioid-Induced Constipation

Oral (Adults) 24 mcg twice daily.

Hepatic Impairment

Oral (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.

IBS with Constipation

Oral (Adults) 8 mcg twice daily.

Hepatic Impairment

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


Soft gelatin capsules: 8 mcg, 24 mcg

Nursing implications

Nursing assessment

  • Assess for abdominal distention, presence of bowel sounds, and usual bowel patterns prior to and periodically during therapy.
  • Assess color, consistency, and amount of stool produced.
  • Lab Test Considerations: Assess women of childbearing age for pregnancy. Begin therapy following a negative pregnancy test.

Potential Nursing Diagnoses

Constipation (Indications)
Diarrhea (Adverse Reactions)


  • Patients with symptoms suggestive of mechanical GI obstruction should be evaluated prior to initiating therapy.
  • Oral: Administer with food and water to decrease nausea. Swallow capsules whole; do not crush, break or chew.
    • Do not administer to patients severe diarrhea.

Patient/Family Teaching

  • Instruct patient to take lubiprostone as directed.
  • Inform patient that dyspnea 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.
  • May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Advise female patients that a negative pregnancy test should be determined prior to taking lubiprostone and to use effective contraception during therapy. Notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Decrease in symptoms of chronic constipation. Need for continued therapy should be assessed periodically.
Drug Guide, © 2015 Farlex and Partners
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References in periodicals archive ?
* Amitiza by Mallinckrodt PLC (NYSE:MNK through its Sucampo acquisition.
'We're pleased to have delivered a strong first half of the year, highlighted by the solid operational performance of all hospital products, AMITIZA, and the Specialty Generics segment, along with good progress on our Acthar Gel data generation efforts,' said Mark Trudeau, President and Chief Executive Officer of Mallinckrodt.
*IBS-C was the largest revenue generating segment by type in 2018 due to growing prevalence and increasing uptake of drugs such as Linzess/Constella and Amitiza
registration statement on Form 10 which, among other things, will reflect the removal of the Amitiza product from the assets to be held by the new specialty generics company at separation, is expected to be filed in June.
Mallinckrodt said the acquisition brings near-term net sales and earnings accretion through Amitiza and bolsters its pipeline in rare diseases with VTS-270 and CPP-1X/sulindac.
For United Kingdom-based Mallinckrodt, the deal would bring a pair of currently marketed pharmaceutical products: Amitiza (lubiprostone), a medication for constipation, and Rescula (unoprostone isopropyl ophthalmic solution 0.15%), a treatment for ocular hypertension and open-angle glaucoma.
Eleven pharmaceutical agents or classes of drugs are used to treat IBS: linaclotide (Linzess), lubipro-stone (Amitiza), eluxadoline (Viberzi), polyethylene glycol laxatives (Miralax, Glycolax), rifaximin (Xifaxan), alosetron (Lotronex), loperamide (Imodium), tricyclic antidepressants (Elavil), selective serotonin reuptake inhibitors (Prozac, Zoloft) and antispasmodics (Atropine, Bentyl), and plecanatide (Trulance), approved in January 2017.
Several newer medications, including Amitiza (lubiprostone) and Linzess (linaclotide), can help relieve chronic constipation.
These include the constipation-predominant IBS (IBS-C) therapies, Sucampo/Takeda/Abbott's Amitiza (lubiprostone) and Ironwood/Actavis/Almirall/Astellas' Linzess (linaclotide), and the diarrhea-predominant IBS (IBS-D) therapies, Prometheus' Lotronex (alosetron) and Astellas' Irribow (ramosetron).
Amitiza (lubiprostone) is indicated for the treatment of IBS-C in women 18 years of age and older, but only in the US.
* Lubiprostone (Amitiza) is a drug that increases intestinal fluid secretion.