- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Oral formulation of linaclotide.
Moderate to severe Irritable Bowel Syndrome with constipation: treatment
Efficacy of linaclotide has been established for up to 6 months.
If patients have not experienced improvement in their symptoms after 4 weeks of treatment, the patient should be re-examined and the benefit and risks of continuing treatment reconsidered.
290 micrograms once daily, taken at least 30 minutes before a meal.
Children under 18 years
Inflammatory bowel disease
Mechanical gastrointestinal obstruction
Precautions and Warnings
Predisposition towards electrolyte imbalance
Contains propylene glycol
Advise patient to take at least 30 minutes before a meal
Advise patient to stop and contact Dr if severe/persistent abdominal pain
Advise patient to inform physician if severe diarrhoea occurs
Advise patients to report lower gastrointestinal bleeding
Discontinue if severe and persistent abdominal pain occurs
Discontinue if severe and persistent diarrhoea develops
Female:Additional contraception method advised in cases of severe diarrhoea
Advise patient to consult doctor if no improvement after 4 weeks
The treatment should be carefully monitored and periodically re-assessed in the elderly.
Intestinal perforation has been reported after use of linaclotide in patients with conditions that may be associated with localised or diffuse weakness of the intestinal wall.
Pregnancy and Lactation
Linaclotide is contraindicated during pregnancy.
The manufacturer notes that as a precautionary measure, it is preferable to avoid the use of linaclotide during pregnancy due to the limited amount of data available. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Linaclotide is considered safe for use during breastfeeding.
The manufacturer states that linaclotide may be used during breastfeeding. Linaclotide absorption is considered minimal following oral administration. Neither linaclotide or its metabolite were detected in a study conducted on 7 breastfeeding women taking linaclotide, hence exposure to infants is not expected.
Decrease in blood bicarbonate
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Last Full Review Date: June 2021
Summary of Product Characteristics: Constella 290 micrograms hard capsules. Allergan Pharmaceuticals International Ltd. Revised December 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 18 June 2021
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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