What is Amitiza Uses, warnings & interactions
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Amitiza (lubiprostone) is a prescription laxative that is manufactured by Takeda Pharmaceuticals. It increases the fluid in your intestines to help make your stools easier to pass. Amitiza was approved by the U.S. Food and Drug Administration (FDA) in 2006 for the treatment of chronic idiopathic constipation (CIC) in adults. It is also used to treat constipation from various other causes in adults.
What is Amitiza used for?
Amitiza (lubiprostone) is a chloride channel activator that is used to increase fluid secretion in your intestines to soften your stool, increase gastrointestinal motility, and encourage spontaneous bowel movements (SBM). Amitiza is approved by the U.S. Food and Drug Administration (FDA) to treat the following conditions in adults:
- Chronic idiopathic constipation (CIC).
- Opioid-induced constipation (OIC) in patients taking opioid drugs for chronic non-cancer pain. The effectiveness of Amitiza in the treatment of OIC in patients taking Dolophine (methadone) has not been established.
- Irritable bowel syndrome with constipation (IBS-C) in women ≥18 years old.
The safety and efficacy of Amitiza have not been established in pediatric patients under the age of 18.
How does Amitiza work?
Lubiprostone is a fatty acid derived from prostaglandin E1 that activates the CIC-2 chloride channels in your gastrointestinal epithelial cells. By activating the CIC-2 channels, lubiprostone increases the secretion of chloride-rich fluid in your intestines without affecting your serum electrolyte concentrations. Increasing fluid secretion helps improve GI motility and promote spontaneous bowel movements (SBM). In clinical studies, this reduced symptoms such as bloating, abdominal discomfort, and straining within 1 week.
What are the most commonly prescribed doses of Amitiza?
Amitiza is available as an oval, soft gelatin capsule containing 8 mcg or 24 mcg of lubiprostone with “SPI” printed on one side.
Before taking Amitiza
Before starting Amitiza, make your healthcare provider aware if you have any of the following medical conditions:
- Allergy to Amitiza or any of its inactive ingredients.
- Liver disease
- Abdominal obstruction or blockage
- Severe diarrhea
- Are pregnant, plan on becoming pregnant, or are breastfeeding
How to take Amitiza
- Read the Full Prescribing Drug Information including the Black Boxed Warning, Instructions for Use, and Medication Guide that comes with Amitiza.
- Take Amitiza exactly as your healthcare professional prescribes it to you. Do not change your dose or stop taking Amitiza without discussing it with them.
- Amitiza is typically taken twice daily. Taking Amitiza with food and water can help reduce the risk of nausea. You should swallow the Amitiza capsules whole. Do not break, crush, or chew Amitiza capsules.
- If you miss a dose of Amitiza, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and resume your regular dosing schedule. Do not take extra doses to make up for a missed dose.
- Store Amitiza capsules at room temperature between 15°C-30°C (59°F-86°F) away from light and extreme temperatures.
Amitiza is contraindicated in patients who have any of the following medical conditions:
- Allergic reaction to Amitiza or any of its inactive ingredients.
- Known bowel obstruction.
- Amitiza can cause severe nausea. Taking it with food and water can reduce the incidence of nausea.
- Discontinue treatment and contact your doctor immediately if you experience severe diarrhea.
- Low blood pressure and fainting have occurred after taking a dose of Amitiza. This typically resolves before your next dose but can happen again with repeat dosing. You should stop Amitiza and contact your doctor if these symptoms occur.
- Dyspnea (shortness of breath) can occur within an hour of your first Amitiza dose. It typically goes away within 3 hours but can happen again with repeat dosing. You should contact your doctor if this symptom occurs.
Common side effects of Amitiza
The most common adverse effects of Amitiza include:
- Abdominal pain
- Abdominal distension
- Flatulence (gas)
- Loose stools
- Lightheadedness and dizziness
- Dry mouth
Amitiza can cause serious adverse events, including:
- Hypersensitivity reactions including hives, angioedema, and trouble breathing
- Severe diarrhea
- Low blood pressure and fainting
- Shortness of breath
- Chest tightness or pain
This is not a complete list of the possible side effects of Amitiza. Contact your healthcare provider for medical advice about any serious side effects you experience while taking Amitiza. You can report your side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Amitiza drug interactions
When Amitiza is taken with other drugs, it may change the way they work or increase the frequency and severity of side effects. Make sure your doctor is aware of all prescription drugs, over-the-counter medications, vitamins, and herbal supplements you take. Some major drug interactions with Amitiza include:
- Possibility of a dose-dependent decrease in the effectiveness of Amitiza in patients using Dolophine (methadone).
There are other constipation medications that your doctor can prescribe if Amitiza is not the right medication for you. Some alternative FDA-approved treatment options include:
- Linzess (linaclotide)
- Trulance (plecanatide)
- Ibsrela (tenapanor)
- Motegrity (prucalopride)
- Symproic (naldemedine)
- Relistor (methylnaltrexone)
- Miralax (polyethylene glycol)
How does Amitiza compare with Linzess (linaclotide)?
Amitiza and Linzess work by different mechanisms of action to treat adults with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C). Amitiza is also approved to treat constipation caused by opioid pain reliever use in chronic, non-cancer pain. Amitiza is usually taken twice daily while Linzess is only taken once daily. They both cause many of the same side effects such as diarrhea and stomach pain. Amitiza can also cause nausea, dizziness, and chest pain.
There aren’t any head-to-head clinical trials that compare the 2 medications. A study looked at individual trials to indirectly compare several medications used to treat constipation. It showed that Amitiza and Linzess were similar in efficacy when compared to placebo. It also reported that Dulcolax (bisacodyl) worked better than both Amitiza and Linzess to increase the number of bowel movements per week.
There is currently no generic alternative available for Linzess, but there is one for Amitiza. Generic Amitiza, lubiprostone, has an average cost of approximately $350 for #60, 24mcg capsules while Linzess costs around $600 for #30, 145mcg capsules.
How long does Amitiza stay in your system?
Amitiza has a half-life of between 1 to 1.5 hours and will stay in your bloodstream for around 7.5 hours after the last dose.
How do I store Amitiza?
Store Amitiza capsules at room temperature between 15°C-30°C (59°F-86°F) away from light and extreme temperatures.
How long does it take for Amitiza to start working?
Amitiza usually works quickly. One clinical study showed that almost 57% of patients had a bowel movement within 24 hours of taking Amitiza and 80% had a bowel movement within 48 hours.
Will I develop a tolerance to Amitiza?
Tolerance to Amitiza has not been observed in clinical studies. After a month of treatment, no rebound constipation occurred after stopping Amitiza.
Can you take Amitiza while you are pregnant or breastfeeding?
There is limited data on the use of Amitiza in pregnant women. Animal studies did not show any structural deformations. There is also no data on whether Amitiza is found in breast milk or the effects it may have on the infant. It was found in rat milk during animal studies. If you are taking Amitiza during lactation, monitor your infant for diarrhea. You should always discuss the risks and benefits of any medication with your healthcare provider if you are pregnant, plan on becoming pregnant, or are breastfeeding.
Can males take Amitiza?
Yes, Amitiza can be used in males who have chronic idiopathic constipation (CIC) and constipation caused by opioid use in people with chronic non-cancer pain. It is not approved to treat irritable bowel syndrome with constipation (IBS-C) in men.
Is there a generic for Amitiza?
Currently, there is no generic for Amitiza available on the market. However, you can still save on brand-name drugs like Amitiza through NiceRx if eligible for assistance.