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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 less than 6 years of age; in nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Avoid use of linaclotide in pediatric patients 6 to less than 18 years of age. The safety and efficacy of linaclotide has not been established in pediatric patients under 18 years of age .

Classifications:

Therapeutic—

Gastrointestinal Agent

Uses of This Medicine:

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.

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—

Use in children younger than 6 years of age is not recommended because of toxicity related to linaclotide.

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. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in patients receiving this medicine.

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 this condition.

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.

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. The mixture must be swallowed immediately without chewing. Do not store it for later 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. Gently swirl the bead-water mixture for at least 10 seconds. Swallow the entire mixture immediately. Add another 30 mL of water to the cup, swirl the water, and swallow it to make sure all of the beads are taken. Do not store it for later use.
  • The water mixture may also be used for 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 per day. Some patients may need 72 mcg once per day.
      • Children 6 years of age and older—Use and dose must be determined by your doctor.
      • Children younger than 6 years of age—Use is not recommended.
    • For irritable bowel syndrome with constipation:
      • Adults—290 micrograms (mcg) once per day.
      • Children 6 years of age and older—Use and dose must be determined by your doctor.
      • Children younger than 6 years of age—Use is not recommended.

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 While Using This Medicine:

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 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, itching, or skin rash or redness
increase in heart rate
lightheadedness
loss of bowel control
puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
rapid breathing
shortness of breath
sunken eyes
thirst
tightness in the chest
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 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: 8/4/2017
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