Safety
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Linaclotide Capsule: Uses, Dosage, Side Effects, Precautions and Alternates
| Generic name | Linaclotide |
|---|---|
| Drug class | Guanylate Cyclase-C Agonist |
| Forms | Capsules: 72 mcg, 145 mcg, and 290 mcg of linaclotide |
Quick overview
Linaclotide Capsule, known generically as Linaclotide, is a prescription medicine belonging to the Guanylate Cyclase-C Agonist class. It is used to treat certain types of constipation in adults, including some caused by irritable bowel syndrome, and works inside the gut to help you have more regular, softer bowel movements. It is taken once daily on an empty stomach and is available in several capsule strengths.
What is Linaclotide Capsule
Linaclotide is a prescription capsule medicine used to treat certain types of constipation in adults, including some caused by irritable bowel syndrome. It works inside the gut to help you have more regular, softer bowel movements.
Linaclotide Capsule uses
- Treatment of irritable bowel syndrome with constipation (IBS-C) in adults
- Treatment of chronic idiopathic constipation (CIC) in adults
- Treatment of functional constipation in children and adolescents 6 to 17 years of age (US labeling only)
Benefits of Linaclotide Capsule
- Relieves constipation
- Improves bowel movement frequency
- Helps soften stools
- Reduces abdominal discomfort associated with IBS-C
- Treats functional constipation in eligible pediatric patients
- Treats chronic idiopathic constipation in adults
How Linaclotide Capsule works
Linaclotide attaches to a receptor in the gut called guanylate cyclase C. This causes more fluid to move into the intestine, which makes bowel movements happen more often and makes stools softer. It can also ease abdominal pain, discomfort, and bloating.
Linaclotide Capsule dosage
Take once daily on an empty stomach, at least 30 minutes before the first meal of the day. Swallow the capsule whole with water; do not chew it. If you have difficulty swallowing, the capsule can be opened and the contents sprinkled on applesauce or mixed with water and swallowed right away. Sprinkling on other foods or mixing with other liquids has not been tested, so only use applesauce or water if needed. Do not store the applesauce or water mixture for later use; take it immediately.
If using a nasogastric or gastric feeding tube, the beads can be mixed with water and given through the tube as directed by your healthcare provider. If a dose is missed, skip it and take the next dose at the regular time; do not take two doses together to make up for a missed one. You can eat your first meal of the day 30 minutes after taking the dose.
| Age group | Dose |
|---|---|
| 2–6 years | 72 mcg once daily for functional constipation |
| 7–17 years | 72 mcg once daily for functional constipation; 145 mcg once daily for IBS-C |
| 18 years and older | 290 mcg once daily for IBS-C; 145 mcg once daily for chronic idiopathic constipation, with 72 mcg once daily an option based on tolerability |
Available forms and strengths
- Capsules: 72 mcg, 145 mcg, and 290 mcg of linaclotide
Side effects of Linaclotide Capsule
Common
- Diarrhea
- Passing gas (flatulence)
- Abdominal pain
- Bloating or swelling/fullness in the abdomen
- Nausea
- Vomiting
- Fatigue
- Stomach flu (viral gastroenteritis)
- Indigestion
Serious
- Severe diarrhea with persistent watery stools
- New or worsening abdominal pain not typical of your usual symptoms
- Allergic reactions such as skin rash, itching, hives, or swelling of the face, lips, tongue, or throat
- Bloody or black, tarry stools accompanying severe stomach pain
Warnings and precautions
- This medicine must not be given to children under 6 years old (and in the US, under 2 years old), because it can cause severe diarrhea that can seriously harm young children, including serious dehydration.
- This medicine is not recommended for children and teens between 6 and 18 years of age because its safety hasn't been fully studied in this group and it could cause harm (though a related US product allows use from age 6 for functional constipation).
- Do not use this medicine if you have a bowel blockage (intestinal obstruction).
- Diarrhea often starts within the first two weeks of treatment and can sometimes be severe.
- Do not start taking any new medicine while on this drug without checking with your healthcare provider first.
- There isn't enough research on whether this medicine is safe for pregnant women. It should only be used during pregnancy if your doctor decides the benefit is worth the possible risk to the baby.
- This medicine is only minimally absorbed by the body, and it was not found in breast milk in studies, so breastfeeding is not expected to expose your baby to the drug. Talk to your doctor before breastfeeding while taking it.
- No dose changes are needed for people with kidney problems, since the medicine isn't expected to build up in the body in a way that affects the kidneys.
- No dose changes are needed for people with liver problems, since the medicine isn't expected to be affected by liver function.
Storage
- Store at room temperature between 15°C and 25°C (59°F to 86°F, or per US labeling 68°F to 77°F)
- Keep the medicine in its original container; do not subdivide or repackage
- Protect from moisture
- Do not remove the desiccant packet from the container
- Keep the container tightly closed and in a dry place
- Keep out of reach and sight of children
When to see a doctor
- Stop taking the medicine and call your doctor right away if you develop severe diarrhea with persistent watery stools.
- Get medical help right away if you have new or worsening abdominal pain that is unusual for your condition.
- If you think you or someone you're caring for has taken too much of this medicine, contact a healthcare professional, hospital emergency department, or your local poison control center right away, even without symptoms.
- Go to the nearest hospital emergency room right away if you have unusual or severe stomach-area pain along with bright red, bloody stools or black, tar-like stools.
Alternatives
- Lubiprostone
- Plecanatide
- Polyethylene glycol
Watch the video
FAQs
What is Linaclotide Capsule used for?
It treats irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation in adults, and functional constipation in children 6 to 17 years old under US labeling.
How should I take Linaclotide Capsule?
Take it once daily on an empty stomach, at least 30 minutes before your first meal. Swallow the capsule whole with water, or if needed, open it and sprinkle the contents on applesauce or mix with water and take immediately.
What are the common side effects of Linaclotide Capsule?
Common side effects include diarrhea, gas, abdominal pain, bloating, nausea, vomiting, fatigue, indigestion, and stomach flu-like symptoms.
Can children take Linaclotide Capsule?
It must not be given to children under 6 years old (under 2 in the US) due to risk of severe diarrhea and dehydration. It is not generally recommended for ages 6 to 18, though a related US product allows use from age 6 for functional constipation.
Is Linaclotide Capsule safe during pregnancy or breastfeeding?
There isn't enough research on safety during pregnancy, so it should only be used if a doctor decides the benefit outweighs potential risk. It is only minimally absorbed and wasn't found in breast milk in studies, so talk to your doctor before breastfeeding.
General information, not medical advice
Your prescriber and the leaflet in your pack know your situation. This page does not.
- Follow your prescriber and the leaflet
- Don't start, stop, or change a dose on your own
- Doses and warnings differ by country and product
Sources
- Health Canada Product Monograph: CONSTELLA (linaclotide) capsules, AbbVie Corporation, Revised OCT 13, 2022
- FDA Prescribing Information: LINZESS (linaclotide) capsules, Revised 6/2023
- Corsetti M, Tack J. Linaclotide: A new drug for the treatment of chronic constipation and irritable bowel syndrome with constipation. United European Gastroenterol J. 2013;1(1):7-20.
- Patient medication information sheet (ASHP/consumer medication information): Linaclotide Capsules
Video
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