lubiprostone


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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.

lubiprostone

a miscellaneous GI agent.
indications This drug is used to treat chronic idiopathic constipation.
contraindications Known hypersensitivity to this drug and GI obstruction prohibit its use.
adverse effects Adverse effects of this drug include dizziness, depression, fatigue, insomnia, hypertension, chest pain, abdominal distension, constipation, diarrhea, dry mouth, dyspepsia, flatulence, gastroenteritis, viral gastroesophageal reflux disease, vomiting, fecal incontinence, fecal urgency, urinary tract infection, chest pain, peripheral edema, influenza, pyrexia, viral infection, back pain, arthralgia, muscle cramps, pain in extremities, bronchitis, cough, dyspnea, nasopharyngitis, sinusitis, and upper respiratory infection. Common side effects include headache, nausea, abdominal pain, and eructation.
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References in periodicals archive ?
IBS medications include anti-diarrheals, drugs like hyoscyamine (Levsin[R]) and dicyclomine (Bentyl[R]) to control colon spasms, and fiber supplements, laxatives, or drugs like linaclotide (Linzess[R]) or lubiprostone (Amitiza[R]) to ease constipation.
As for treatments to consider in patients who fail to respond to initial approaches, the AGA says that newer agents, such as lubiprostone and linaclotide, should be considered in those with normal or slow transit constipation who fail to respond to simple laxatives.
Washington, Mar 26 ( ANI ): Two prevalent drug therapies - rifaximin and lubiprostone - have been identified as having the fewest side effects for treating Irritable Bowel Syndrome, according to a study.
Hjelkrem and his colleagues assessed GoLytely and MiraLAX in a 1year study in which 425 patients undergoing screening colonoscopy were randomly assigned to bowel prep with GoLytely alone, MiraLAX alone, MiraLAX plus lubiprostone pretreatment, or MiraLAX plus bisacodyl pretreatment.
Numerous other agents are being made available or are in the process of being investigated, including lubiprostone (Amitiza), GnRH (gonadotropin-releasing hormone) analogues, and alosetron (Lotronex).
Treatment with lubiprostone significantly improved spontaneous bowel movement frequency and associated symptoms in a multicenter, open-label study of 109 children with functional constipation.
Numerous other agents arc being made available or investigated, including lubiprostone (Amitiza), GnRH (go-nadotropin-releasing hormone) analogues, and alosetron (Lotronex).
Lubiprostone is a selective chloride channel activator that works only in the gut and results in net fluid excretion and increased stool frequency.
Food and Drug Administration (FDA) approved the prescription drug lubiprostone (Amitiza), the first drug of its chemical type to treat chronic constipation in older adults in which the cause is unknown.
Lubiprostone increases fluid secretion into the intestinal tract.