Amitiza

Generic Name: lubiprostone (Oral route)

loo-bi-PROST-one

Commonly used brand name(s):

In the U.S.

• Amitiza

Available Dosage Forms:

• Capsule, Liquid Filled
• Capsule

Therapeutic Class: Laxative

Uses For Amitiza

Lubiprostone is used to treat chronic constipation in adults. This medicine works by increasing intestinal fluid secretion, 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 .

Before Using Amitiza

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 geriatrics-specific problems that would limit the usefulness of lubiprostone in the elderly .

Pregnancy

Breast Feeding

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.

Interactions with Medicines

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.

Interactions with Food/Tobacco/Alcohol

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 blockage, or history of or
• Diarrhea, severe—This medicine should not be used in patients with these conditions .

Proper Use of Amitiza

Swallow the soft gelatin capsule whole. Do not crush, break, or chew it .

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 with food.
    • Children—Use and dose must be determined by your doctor .
  • For irritable bowel syndrome (IBS):
    • Adults—8 micrograms (mcg) two times a day with food.
    • Children—Use and dose must be determined by your doctor .

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 While Using Amitiza

If you will be taking this medicine for a long time, it is very important that your doctor check you at regular visits for any problems or unwanted effects that may be caused by this medicine. This will also allow your doctor to see if the medicine is working properly and to decide if you should continue to take it .

Lubiprostone may cause trouble with breathing, nausea, or diarrhea. If your symptoms and condition do not improve within a few days, or if they become worse, check with your doctor .

Make sure your doctor knows if you are pregnant before you use this medicine. If you are a woman of childbearing potential, you should use birth control to avoid getting pregnant while you are using this medicine. If you have become pregnant while using this medicine, tell your doctor right away .

Amitiza 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:

• Full or bloated feeling or pressure in the stomach
• stomach pain
• swelling of abdominal or stomach area

• Bladder pain
• bloody or cloudy urine
• blurred vision
• chest discomfort
• chest pain
• chills
• cold flu-like symptoms
• cough that produces mucus
• diarrhea
• difficult, burning, or painful urination
• difficult or labored breathing
• difficulty having a bowel movement (stool)
• dizziness
• fast heartbeat
• fever
• frequent urge to urinate
• general feeling of discomfort or illness
• headache
• hoarseness
• joint pain
• loss of appetite
• lower back or side pain
• muscle aches and pains
• nausea
• nervousness
• pounding in the ears
• runny nose
• shivering
• shortness of breath
• sore throat
• sweating
• swelling of hands, ankles, feet, or lower legs
• tightness in chest
• trouble sleeping
• unusual tiredness or weakness
• vomiting
• wheezing

• Cough
• difficulty swallowing
• fainting
• hives
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• skin rash

Get emergency help immediately if any of the following symptoms of overdose occur:

• Burning, itching, redness, or stinging of skin
• dry heaves
• feeling of warmth redness of the face, neck, arms and occasionally, upper chest
• increased sweating
• lack or loss of strength
• paleness of skin
• severe, unusual tiredness or weakness
• slow heartbeat
• sudden sweating
• 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:

• Excess air or gas in stomach or intestines
• passing gas

• Acid or sour stomach
• back pain
• belching
• body aches or pain
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficulty with moving
• discouragement
• dry mouth
• ear congestion
• fear
• feeling sad or empty
• heartburn
• increased weight
• indigestion
• irritability
• loss of interest or pleasure
• loss of voice
• muscle cramps
• muscle stiffness
• nasal congestion
• pain in arms or legs
• pain or tenderness around eyes and cheekbones
• sleeplessness
• sneezing
• stomach soreness, discomfort or upset
• stuffy nose
• tiredness
• trouble concentrating
• unable to sleep

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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