Drugs List

Therapeutic Indications

Uses

Moderate to severe Irritable Bowel Syndrome with constipation: treatment

Contraindications

Children under 18 years
Inflammatory bowel disease
Mechanical gastrointestinal obstruction
Pregnancy

Precautions and Warnings

Elderly
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

Pregnancy

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.

Lactation

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.

Side Effects

Abdominal distension
Abdominal pain
Decrease in blood bicarbonate
Decreased appetite
Dehydration
Diarrhoea
Dizziness
Faecal incontinence
Faecal urgency
Flatulence
Gastro-enteritis
Gastro-intestinal perforation
Gastrointestinal bleeding
Haemorrhoidal bleeding
Hypokalaemia
Nausea
Orthostatic hypotension
Rash
Rectal bleeding
Urticaria
Vomiting

Presentation

Oral formulation of linaclotide.

Drugs List

Therapeutic Indications

Uses

Moderate to severe Irritable Bowel Syndrome with constipation: treatment

Dosage

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.

Adults

Contraindications

Children under 18 years
Inflammatory bowel disease
Mechanical gastrointestinal obstruction
Pregnancy

Precautions and Warnings

Elderly
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

Pregnancy

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.

Lactation

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.

Side Effects

Abdominal distension
Abdominal pain
Decrease in blood bicarbonate
Decreased appetite
Dehydration
Diarrhoea
Dizziness
Faecal incontinence
Faecal urgency
Flatulence
Gastro-enteritis
Gastro-intestinal perforation
Gastrointestinal bleeding
Haemorrhoidal bleeding
Hypokalaemia
Nausea
Orthostatic hypotension
Rash
Rectal bleeding
Urticaria
Vomiting

Overdosage

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 ).

Further Information

Last Full Review Date: June 2021

Reference Sources

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