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Drug overview for AMITIZA (lubiprostone):
Generic name: LUBIPROSTONE (loo-bi-PROST-own)
Drug class: Irritable Bowel Syndrome Agents
Therapeutic class: Gastrointestinal Therapy Agents
Lubiprostone, a bicyclic fatty acid that selectively activates intestinal ClC-2 chloride channels, increases intestinal fluid secretion.
No enhanced Uses information available for this drug.
Generic name: LUBIPROSTONE (loo-bi-PROST-own)
Drug class: Irritable Bowel Syndrome Agents
Therapeutic class: Gastrointestinal Therapy Agents
Lubiprostone, a bicyclic fatty acid that selectively activates intestinal ClC-2 chloride channels, increases intestinal fluid secretion.
No enhanced Uses information available for this drug.
DRUG IMAGES
AMITIZA 8 MCG CAPSULE
The following indications for AMITIZA (lubiprostone) have been approved by the FDA:
Indications:
Chronic idiopathic constipation
Constipation predominant irritable bowel syndrome
Opioid-induced constipation
Professional Synonyms:
Constipation predominant IBS
Indications:
Chronic idiopathic constipation
Constipation predominant irritable bowel syndrome
Opioid-induced constipation
Professional Synonyms:
Constipation predominant IBS
The following dosing information is available for AMITIZA (lubiprostone):
Clinicians and patients (with chronic idiopathic constipation or irritable bowel syndrome with constipation) should periodically assess the need for continued therapy.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| AMITIZA 8 MCG CAPSULE | Maintenance | Adults take 1 capsule (8 mcg) by oral route 2 times per day with food and water |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| LUBIPROSTONE 8 MCG CAPSULE | Maintenance | Adults take 1 capsule (8 mcg) by oral route 2 times per day with food and water |
The following drug interaction information is available for AMITIZA (lubiprostone):
There are 0 contraindications.
There are 2 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Trofinetide/Laxatives SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Trofinetide commonly causes diarrhea of mild to moderate severity. Laxatives may increase the incidence or severity of diarrhea.(1) CLINICAL EFFECTS: Concurrent use of laxatives with trofinetide may increase the risk of severe diarrhea.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Patients should stop laxatives before starting trofinetide. If diarrhea occurs, consider anti-diarrheal treatment and monitor hydration status. If severe diarrhea or dehydration occurs, interrupt, reduce dose, or discontinue trofinetide.(1) DISCUSSION: In clinical trials, 85% of patients on trofinetide developed diarrhea. Concurrent use of laxatives may increase this risk.(1) |
DAYBUE |
| Tenapanor/Laxatives; Stool Softeners SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Tenapanor commonly causes diarrhea of mild to moderate severity. Laxatives and stool softeners may increase the incidence or severity of diarrhea.(1) CLINICAL EFFECTS: Concurrent use of laxatives or stool softeners with tenapanor may increase the risk of severe diarrhea.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The US manufacturer of tenapanor states that patients should be instructed to avoid stool softeners and laxatives with tenapanor. If severe diarrhea occurs, tenapanor should be discontinued.(1) DISCUSSION: In clinical trials, 43-53% of CKD patients on dialysis treated with tenapanor developed diarrhea. Diarrhea usually occurred soon after treatment initiation and was severe in 5% of patients.(1) |
XPHOZAH |
There are 0 moderate interactions.
The following contraindication information is available for AMITIZA (lubiprostone):
Drug contraindication overview.
Known hypersensitivity to lubiprostone or any ingredient in the formulation. Known or suspected mechanical GI obstruction.
Known hypersensitivity to lubiprostone or any ingredient in the formulation. Known or suspected mechanical GI obstruction.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Gastrointestinal obstruction |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Severe diarrhea |
There are 0 moderate contraindications.
The following adverse reaction information is available for AMITIZA (lubiprostone):
Adverse reaction overview.
Adverse effects reported in about 2% or more of patients receiving lubiprostone for the management of chronic idiopathic constipation include nausea, diarrhea, headache, abdominal distention, abdominal pain, flatulence, vomiting, dizziness, edema, loose stools, abdominal discomfort (abdominal tenderness, abdominal rigidity, GI discomfort), dyspepsia, chest discomfort/pain, dyspnea, and fatigue. Adverse effects reported in about 3% or more of women receiving lubiprostone for the treatment of IBS with constipation include nausea, diarrhea, abdominal pain, and abdominal distention.
Adverse effects reported in about 2% or more of patients receiving lubiprostone for the management of chronic idiopathic constipation include nausea, diarrhea, headache, abdominal distention, abdominal pain, flatulence, vomiting, dizziness, edema, loose stools, abdominal discomfort (abdominal tenderness, abdominal rigidity, GI discomfort), dyspepsia, chest discomfort/pain, dyspnea, and fatigue. Adverse effects reported in about 3% or more of women receiving lubiprostone for the treatment of IBS with constipation include nausea, diarrhea, abdominal pain, and abdominal distention.
There are 8 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. |
Dyspnea |
| Rare/Very Rare |
|---|
|
Chest tightness Hypokalemia Hypotension Ischemic colitis Rectal bleeding Throat constriction Unconsciousness |
There are 39 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Abdominal distension Acute abdominal pain Diarrhea Dizziness Flatulence Headache disorder Nausea |
Arthralgia Cough Depression Dyspepsia Fatigue Gastroesophageal reflux disease Influenza Loose stools Urinary tract infection Vomiting |
| Rare/Very Rare |
|---|
|
Anorexia Chest pain Constipation Cramps Dysgeusia Edema Eructation Fecal incontinence General weakness Hyperhidrosis Lethargy Malaise Muscle spasm Myalgia Palpitations Skin rash Symptoms of anxiety Syncope Tachycardia Tremor Weight gain Xerostomia |
The following precautions are available for AMITIZA (lubiprostone):
Safety and efficacy not established in patients younger than 18 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.) (Also see Fetal/Neonatal Morbidity and Mortality under Warnings/Precautions: Warnings, in Cautions.)
Not known whether lubiprostone is distributed into human milk; discontinue nursing or the drug, taking into account the importance of the drug to the woman.
Efficacy of lubiprostone in geriatric patients (65 years of age and older) with chronic idiopathic constipation was consistent with efficacy of the drug in the overall study population. Geriatric patients experienced a lower incidence (18 versus 29%) of associated nausea than the overall study population. Experience in those 65 years of age or older with irritable bowel syndrome (IBS) with constipation was insufficient to determine whether they respond differently from younger adults. Safety profile of lubiprostone in these patients was consistent with the safety profile in the overall study population.
The following prioritized warning is available for AMITIZA (lubiprostone):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for AMITIZA (lubiprostone)'s list of indications:
| Chronic idiopathic constipation | |
| K59.04 | Chronic idiopathic constipation |
| Constipation predominant irritable bowel syndrome | |
| K58.1 | Irritable bowel syndrome with constipation |
| Opioid-induced constipation | |
| K59.09 | Other constipation |
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