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Linaclotide (Oral route)

Pronunciation:

lin-AK-loe-tide

Brand Names:

  • Linzess

Dosage Forms:

  • Capsule

Warnings:

Oral route(Capsule)

Linaclotide is contraindicated in pediatric patients up to 6 years of age. Avoid use in pediatric patients 6 through 17 years of age. Linaclotide has caused deaths in young juvenile mice at clinically relevant adult doses .

Classifications:

Therapeutic—

Gastrointestinal Agent

Uses of This Medicine:

Linaclotide is used to treat irritable bowel syndrome with constipation (IBS-C). It is also used to treat chronic idiopathic constipation (CIC).

Linaclotide works by increasing intestinal fluid secretion, which helps ease the passage of stool and helps relieve the symptoms associated with constipation.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Linaclotide should not be given to children younger than 6 years of age. Use in children 6 to 17 years of age is not recommended. This medicine could be harmful to children.

Older adults—

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.

Pregnancy—

Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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.

Other 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.

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 these conditions.

Proper Use of This Medicine:

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.

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 (CIC):
      • Adults—145 micrograms (mcg) once a day.
      • Children—Use is not recommended.
    • For irritable bowel syndrome with constipation (IBS-C):
      • Adults—290 micrograms (mcg) once a day.
      • Children—Use is not recommended.

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 This Medicine:

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.

Stop using this medicine and call your doctor right away if you have 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 of This Medicine:

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
Abdominal or stomach pain
severe diarrhea
Less common
Heartburn
loss of appetite
nausea
vomiting
weakness
Rare
Bleeding from the rectum
bloody, black, or tarry stools
confusion
cough
decreased urination
difficulty swallowing
dizziness
dry mouth
fainting
fast heartbeat
hives or welts
increase in heart rate
itching
lightheadedness
loss of bowel control
puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
rapid breathing
redness of the skin
shortness of breath
skin rash
sunken eyes
thirst
tightness in chest
unusual tiredness or weakness
wheezing
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
difficulty in breathing
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 abdominal or 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.


Last Updated: 4/4/2014

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