lubiprostone (Rx)

Brand and Other Names:Amitiza
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 8mcg
  • 24mcg
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Chronic Idiopathic Constipation

24 mcg PO q12hr

Irritable Bowel Syndrome With Constipation

Treatment in women ≥18 years

8 mcg PO q12hr

Opioid-Induced Constipation

Treatment in patients with chronic noncancer pain

24 mcg PO q12hr

Effectiveness in patients taking diphenylheptane opioids (eg, methadone) has not been established

Dosing Modifications

Hepatic impairment

  • Mild: Dose adjustment not necessary
  • Moderate (Child-Pugh B): Chronic idiopathic or opioid-induced constipation, 16 mcg PO q12hr; irritable bowel syndrome with constipation (IBS-C), no dosage adjustment required
  • Severe (Child-Pugh C): Chronic idiopathic or opioid-induced constipation, 8 mcg PO q12hr; IBS-C, 8 mcg PO q24hr
  • If starting dose is tolerated and adequate response has not been obtained after appropriate interval, dose can be escalated to full standard dose with appropriate monitoring of patient response

Administration

Administer with food and water

Safety and efficacy not established

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Adverse Effects

>10%

Nausea (29%)

Headache (12%)

Diarrhea (11%)

1-10%

Edema (3%)

Chest discomfort (2%)

Peripheral edema (1-3%)

Fatigue (2%)

Dizziness (3%)

Flatulence (4-6%)

Abdominal distress (3%)

Dyspepsia (2%)

Xerostomia (1%)

Abdominal pain (4-8%)

Loose stools (3%)

Postmarketing Reports

Allergic reactions

Asthenia

Increased heart rate

Malaise

Muscle cramps or spasms

Rash

Syncope

Frequent bowel movement

Cough

Rectal hemorrhage

Fecal incontinence

Dysguesia

Gastritis

Loss of consciousness

Hypotension

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Warnings

Contraindications

Hypersensitivity

Mechanical GI obstruction

Cautions

Potential for mechanical GI obstruction

Potential for acute dyspnea; instruct patients to contact healthcare provider if dyspnea occurs

Avoid in severe diarrhea

May cause nausea and diarrhea (taking with food reduces chance of nausea); dose adjustment recommended

Patients with moderate-to-severe hepatic impairment (Child-Pugh class b or C) have higher systemic drug exposure

Syncope and hypotension reported, some of which required hospitalization; most cases occurred in patients taking 24 mcg twice daily and some occurred within hour after taking first dose or subsequent doses; patients should be aware of risk of syncope and hypotension during treatment and other adverse reactions, such as diarrhea or vomiting may increase this risk

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Pregnancy & Lactation

Pregnancy category: C

Lactation: Unknown whether drug is excreted in breast milk; because lubiprostone increases fluid secretion in the intestine and intestinal motility, monitor breastfeeding infants for diarrhea

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

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Pharmacology

Mechanism of Action

Locally acting chloride channel activator; increases intestinal fluid secretion and intestinal motility; acts locally at apical portion of intestine

Absorption

Low systemic absorption

Peak plasma time: 1 hr

Distribution

Protein binding: 94% in vitro (may be irrelevant because of low systemic absorption)

Metabolism

Probably metabolized in stomach and jejunum by carbonyl anhydrase

Elimination

Half-life: 0.9-1.4 hr

Excretion: Urine (60%), feces (trace amounts)

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Formulary

FormularyPatient Discounts

Adding plans allows you to compare formulary status to other drugs in the same class.

To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

Adding plans allows you to:

  • View the formulary and any restrictions for each plan.
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  • Compare formulary status to other drugs in the same class.
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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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