Description
Lubiprostone is used to treat long-lasting constipation in adults. It is also used to treat constipation caused by opioids (narcotic pain medicines) in adults with long-lasting pain that is not caused by cancer, or in patients with long-lasting pain caused by a previous cancer or its treatment who do not need weekly increases in opioid dosage. This medicine works by increasing the fluid secretion of the bowels, which helps ease the passage of stool and helps relieve the symptoms associated with constipation.
Lubiprostone is also used to treat irritable bowel syndrome (IBS) in women who have constipation as the main symptom.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Liquid Filled
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of lubiprostone in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of lubiprostone in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Bowel or stomach blockage, known or suspected or
- Diarrhea, severe—Should not be used in patients with these conditions.
- Liver disease, moderate to severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
Swallow the soft gelatin capsule whole. Do not crush, break, or chew it. It is best to take this medicine with food and water to lessen the chances of having nausea.
Drink at least 6 to 8 glasses (8 ounces each) of liquid each day. This will help make the stool softer.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For oral dosage form (soft gelatin capsules):
- For chronic constipation:
- Adults—24 micrograms (mcg) two times a day (once in the morning and once in the evening) with food and water.
- Children—Use and dose must be determined by your doctor.
- For constipation caused by opioid medicines:
- Adults—24 micrograms (mcg) two times a day (once in the morning and once in the evening) with food and water.
- Children—Use and dose must be determined by your doctor.
- For irritable bowel syndrome (IBS):
- Adults—8 micrograms (mcg) two times a day (once in the morning and once in the evening) with food and water.
- Children—Use and dose must be determined by your doctor.
- For chronic constipation:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. These symptoms are more likely to occur when you begin taking this medicine or if you become dehydrated. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness.
Lubiprostone may cause difficulty with breathing, nausea, or severe diarrhea. If your symptoms and condition do not improve within a few days, or if they become worse, check with your doctor.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Diarrhea
- full or bloated feeling or pressure in the stomach
- nausea
- stomach pain
- swelling of the abdominal or stomach area
Less common
- Black, tarry stools
- blood in the stools
- chest discomfort or pain
- chills
- colds
- cough
- difficult or labored breathing
- fever
- general feeling of discomfort or illness
- headache
- increased sweating
- joint pain
- loss of appetite
- loss of bowel control
- muscle aches and pains
- runny nose
- shivering
- sore throat
- stomach discomfort
- sweating
- tightness in the chest
- trouble sleeping
- unusual tiredness or weakness
- vomiting
Incidence not known
- Blurred vision
- confusion
- difficulty with swallowing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fainting
- fast, pounding, or irregular heartbeat or pulse
- hives or skin rash
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- stomach tenderness
- swelling
Get emergency help immediately if any of the following symptoms of overdose occur:
Symptoms of overdose
- Dry heaves
- dry mouth
- feeling of warmth
- lack or loss of strength
- paleness of the skin
- redness of the face, neck, arms, and occasionally, upper chest
- severe, unusual tiredness or weakness
- weight loss
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Excess air or gas in the stomach or intestines
- passing gas
Less common
- Belching
- bladder pain
- bloody or cloudy urine
- change in taste
- cold sweats
- difficult, burning, or painful urination
- difficulty with moving
- discouragement
- dizziness
- fear or nervousness
- feeling sad or empty
- frequent urge to urinate
- heartburn
- increased weight
- indigestion
- irritability
- loss of interest or pleasure
- loss of taste
- lower back or side pain
- muscle cramps
- muscle stiffness
- stomach upset
- swollen joints
- tingling of the hands or feet
- unusual drowsiness, dullness, tiredness, or feeling of sluggishness
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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