Amitiza

lubiprostone

Amitiza

Pharmacologic class: Chloride channel activator

Therapeutic class: GI motility enhancer

Pregnancy risk category C

Action

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

Availability

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

Contraindications

• Hypersensitivity to drug or its components
• History of mechanical GI obstruction

Precautions

Use cautiously in:
• severe diarrhea, hepatic or renal dysfunction
• pregnant or breastfeeding patients.

Administration

• 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

Interactions

None

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.

lubiprostone

(loo-bi-pross-tone) ,

Amitiza

(trade name)

Classification

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

Indications

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

Action

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

Therapeutic effects

Decreased symptoms of chronic constipation.

Pharmacokinetics

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)

ROUTEONSETPEAKDURATION
POwithin 1 wk1 wkunknown

Contraindications/Precautions

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

Cardiovascular

  • peripheral edema

Respiratory

  • dyspnea

Gastrointestinal

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

Musculoskeletal

  • arthralgia

Interactions

Drug-Drug interaction

None noted.

Route/Dosage

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.

Availability

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)

Implementation

  • 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.

Amitiza

a trademark for lubiprostone.
Mentioned in ?
References in periodicals archive ?
In 2008, Amitiza gained a label expansion from the Food and Drug Administration (FDA) for the treatment of IBS-C in women of 18 years of age and older.
for the indications sanctioned for AMITIZA beginning January 1, 2021, or earlier under certain circumstances.
AMITIZA was approved by the FDA in January 2006 for the treatment of Chronic Idiopathic Constipation in adults.
Tokyo, Japan, Feb 1, 2006 - (JCN) - Pharmaceutical announced on February 1 that its US sales partner Sucampo Pharmaceuticals have obtained approval for AMITIZA capsules (lubiprostone), an oral treatment of chronic idiopathic constipation in adults, from the US Food and Drug Administration (FDA).
were cleared to sell their constipation drug Amitiza to women with irritable bowel syndrome.
AMITIZA (24 mcg, oral gel capsules, twice daily) is indicated for the treatment of Chronic Idiopathic Constipation in adults.
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).
The chronic idiopathic constipation drug Amitiza (lubiprostone) was approved by the Food and Drug Administration for irritable bowel syndrome with constipation in women 18 years and older, making it the only prescription drug available for irritable bowel syndrome with constipation.
AMITIZA is marketed in the United States by Sucampo Pharmaceuticals and Takeda Pharmaceuticals North America.
Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that, in the irritable bowel syndrome (IBS) drug market, linaclotide (Ironwood/Forest/Almirall/Astellas's Constella/Linzess), which launched on December 17th in the United States and received marketing authorization in Europe in November 2012, will capture significant market share from Sucampo/Takeda/Abbott's Amitiza, owing to linaclotide's superior efficacy in treating motility, as well as the drug's demonstrated efficacy in addressing other important symptoms of IBS with constipation (IBS-C), including abdominal pain and bloating.
AMITIZA (24 mcg, twice daily) is indicated for the treatment of Chronic Idiopathic Constipation in adults.