Description
Linaclotide is used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). It works by increasing intestinal fluid secretion, which helps ease the passage of stools and relieve the symptoms of constipation.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule
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
This medicine should not be used in children younger than 2 years of age because it may increase the risk of serious dehydration. Safety and efficacy have not been established in the pediatric population.
Geriatric
Although appropriate studies on the relationship of age to the effects of linaclotide have not been performed in the geriatric population, no geriatric-specific problems have been documented to date. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving this medicine.
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:
- Stomach or bowel blockage, or history of—Should not be used in patients with this condition.
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.
This medicine comes with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine on an empty stomach, at least 30 minutes before breakfast or the first meal of the day.
Swallow the capsule whole. Do not crush, break, or chew it.
If you have trouble swallowing the capsule, you may mix the contents with applesauce or water.
- To mix with applesauce: Open the capsule and sprinkle the beads on 1 teaspoonful of applesauce in a clean container. Swallow the mixture right away without chewing. Do not store the mixture for future use.
- To mix with water: Pour 30 mL (1 ounce) of water into a clean cup. Open the capsule and sprinkle the beads into the cup. Swirl the bead-water mixture for at least 20 seconds. Swallow the mixture right away. If there are beads remaining in the cup, you may repeat the same procedure. Do not store the mixture for future use.
- You may also take the bead-water mixture using a nasogastric or gastric feeding tube. After the mixture is given, flush the tube with an additional 10 mL (2 teaspoons) of water.
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 (capsules):
- For chronic idiopathic constipation:
- Adults—145 micrograms (mcg) once a day. Some patients may need 72 mcg once a day.
- Children 2 years of age and older—Use and dose must be determined by your doctor.
- Children younger than 2 years of age—Use is not recommended.
- For irritable bowel syndrome with constipation:
- Adults—290 micrograms (mcg) once a day.
- Children 2 years of age and older—Use and dose must be determined by your doctor.
- Children younger than 2 years of age—Use is not recommended.
- For chronic idiopathic constipation:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep the medicine in the original bottle until you are ready to use it. The bottle contains a desiccant packet that helps to protect the capsules from moisture. Do not remove the desiccant packet from the bottle.
Precautions
It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
Call your doctor right away if you have severe diarrhea with feeling of lightheadedness, dizziness, or fainting.
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
- Severe diarrhea
- stomach pain
Less common
- Heartburn
- loss of appetite
- nausea
- vomiting
- weakness
Incidence not known
- Bleeding from the rectum
- bloody, black, or tarry stools
- chest tightness
- confusion
- cough
- decreased urination
- difficulty swallowing
- dizziness
- dry mouth
- fainting
- fast heartbeat
- hives or welts, itching, skin rash or redness
- increase in heart rate
- large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lightheadedness
- loss of bowel control
- puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
- rapid breathing
- sunken eyes
- thirst
- trouble breathing
- unusual tiredness or weakness
- wrinkled skin
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
- Body aches or pain
- chills
- ear congestion
- excess air or gas in the stomach or intestines
- fever
- full or bloated feeling
- headache
- loss of voice
- passing gas
- sneezing
- sore throat
- stuffy or runny nose
Less common
- Acid or sour stomach
- belching
- indigestion
- pain or tenderness around the eyes and cheekbones
- pressure in the stomach
- stomach discomfort or upset
- swelling of the stomach area
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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