Drugs List

Therapeutic Indications

Uses

Constipation
Bowel clearance before surgery or radiological investigation

Administration

For rectal administration.

Suppositories are usually effective in about 20 minutes but in some cases it may take up to 45 minutes.

Suppositories should be unwrapped and inserted into the rectum pointed end first.

Contraindications

Intestinal obstruction

Acute inflammatory bowel disease

Ileus

Acute surgical abdominal conditions such as acute appendicitis

Severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned conditions

Severe dehydration

Anal fissures

Ulcerative proctitis with mucosal damage

Children under 2 years

Precautions and Warnings

Breast feeding - see Lactation section.

Pregnancy - see Pregnancy section.

Avoid long term chronic use. Bisacodyl suppositories should not be used on a continuous daily basis for more than five days. If laxatives are needed every day, the cause of constipation should be investigated.

Prolonged use may lead to fluid and electrolyte imbalance and hypokalaemia, and may precipitate rebound constipation.

Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. Bisacodyl must be discontinued in patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients). Prolonged use may also lead to atonic non-functioning colon.

Children under 10 years should not receive bisacodyl without medical advice.

Dizziness and or syncope have been reported in patients during the use of bisacodyl consistent with defecation syncope (or syncope attributable to straining at stool) or with vasovagal response to abdominal pain, which may be related to the constipation that prompted the use of laxatives.

Patients may experience blood in stool that is generally mild and self-limiting.

There have been isolated reports of abdominal pain and bloody diarrhoea after taking bisacodyl. Some cases were associated with colonic mucosal ischaemia.

The use of suppositories may lead to painful sensations and local irritation, especially in anal fissures and ulcerative proctitis.

Pregnancy and Lactation

Pregnancy

Bisacodyl should be used with caution during pregnancy.

If laxative treatment is considered necessary, and neither bulk or osmotic laxatives are effective, then bisacodyl may be considered the drug of choice.

At the time of writing, there is no published experience concerning exposed pregnancies and their outcomes. No reports describing the use of bisacodyl in animal or human data have been located. It is not known if bisacodyl crosses the placenta, however its molecular weight is low enough for passive diffusion to occur. The minimal amounts in systemic circulation (5%) suggest that neither the embryo nor foetus will have clinically significant exposure to the drug.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ). Licensed in pregnancy? - No

Recommended for use in pregnancy? - No. However bisacodyl is the drug of choice when treating constipation throughout the entire pregnancy.

Known human teratogen? - Unknown, but no teratogenic effects have been observed.

Animal data - None located at time of writing.

Crosses placenta? - Unknown, although molecular weight is low enough for passive diffusion. Minimal amounts in systemic circulation (5%) suggest that neither the embryo nor foetus will have clinically significant exposure to the drug.

Lactation

Bisacodyl should be used with caution during breast feeding.

At the time of writing, there is no published experience concerning the use of bisacodyl during breastfeeding. Its molecular weight is low enough for excretion into breast milk but minimal amounts (5%) are absorbed into maternal circulation. The effects on the nursing infant are unknown but appear to be negligible. Schaefer concludes that if a change in dietary habits is not successful bisacodyl may be taken during breast feeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Drug excreted in breast milk? - Unknown. A low molecular weight suggests excretion into breast milk but minimal amounts are absorbed into maternal circulation (5%).

Considered suitable or recommended by manufacturer? - Yes.

Side Effects

Abdominal cramps
Abdominal pain
Griping
Diarrhoea
Anal irritation
Hypokalaemia
Vomiting
Abdominal discomfort
Nausea
Fluid and electrolyte disturbances
Allergic reactions
Angioedema
Anaphylaxis
Dehydration
Dizziness
Syncope
Blood in stool
Anorectal discomfort
Colitis

Presentation

Suppository containing 5mg bisacodyl
Suppository containing 10mg bisacodyl

Drugs List

Therapeutic Indications

Uses

Constipation
Bowel clearance before surgery or radiological investigation

Dosage

Adults

Children

Patients with Renal Impairment

Administration

For rectal administration.

Suppositories are usually effective in about 20 minutes but in some cases it may take up to 45 minutes.

Suppositories should be unwrapped and inserted into the rectum pointed end first.

Contraindications

Intestinal obstruction

Acute inflammatory bowel disease

Ileus

Acute surgical abdominal conditions such as acute appendicitis

Severe abdominal pain associated with nausea and vomiting which may be indicative of the aforementioned conditions

Severe dehydration

Anal fissures

Ulcerative proctitis with mucosal damage

Children under 2 years

Precautions and Warnings

Breast feeding - see Lactation section.

Pregnancy - see Pregnancy section.

Avoid long term chronic use. Bisacodyl suppositories should not be used on a continuous daily basis for more than five days. If laxatives are needed every day, the cause of constipation should be investigated.

Prolonged use may lead to fluid and electrolyte imbalance and hypokalaemia, and may precipitate rebound constipation.

Intestinal loss of fluids can promote dehydration. Symptoms may include thirst and oliguria. Bisacodyl must be discontinued in patients suffering from fluid loss where dehydration may be harmful (e.g. renal insufficiency, elderly patients). Prolonged use may also lead to atonic non-functioning colon.

Children under 10 years should not receive bisacodyl without medical advice.

Dizziness and or syncope have been reported in patients during the use of bisacodyl consistent with defecation syncope (or syncope attributable to straining at stool) or with vasovagal response to abdominal pain, which may be related to the constipation that prompted the use of laxatives.

Patients may experience blood in stool that is generally mild and self-limiting.

There have been isolated reports of abdominal pain and bloody diarrhoea after taking bisacodyl. Some cases were associated with colonic mucosal ischaemia.

The use of suppositories may lead to painful sensations and local irritation, especially in anal fissures and ulcerative proctitis.

Pregnancy and Lactation

Pregnancy

Bisacodyl should be used with caution during pregnancy.

If laxative treatment is considered necessary, and neither bulk or osmotic laxatives are effective, then bisacodyl may be considered the drug of choice.

At the time of writing, there is no published experience concerning exposed pregnancies and their outcomes. No reports describing the use of bisacodyl in animal or human data have been located. It is not known if bisacodyl crosses the placenta, however its molecular weight is low enough for passive diffusion to occur. The minimal amounts in systemic circulation (5%) suggest that neither the embryo nor foetus will have clinically significant exposure to the drug.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ). Licensed in pregnancy? - No

Recommended for use in pregnancy? - No. However bisacodyl is the drug of choice when treating constipation throughout the entire pregnancy.

Known human teratogen? - Unknown, but no teratogenic effects have been observed.

Animal data - None located at time of writing.

Crosses placenta? - Unknown, although molecular weight is low enough for passive diffusion. Minimal amounts in systemic circulation (5%) suggest that neither the embryo nor foetus will have clinically significant exposure to the drug.

Lactation

Bisacodyl should be used with caution during breast feeding.

At the time of writing, there is no published experience concerning the use of bisacodyl during breastfeeding. Its molecular weight is low enough for excretion into breast milk but minimal amounts (5%) are absorbed into maternal circulation. The effects on the nursing infant are unknown but appear to be negligible. Schaefer concludes that if a change in dietary habits is not successful bisacodyl may be taken during breast feeding.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Drug excreted in breast milk? - Unknown. A low molecular weight suggests excretion into breast milk but minimal amounts are absorbed into maternal circulation (5%).

Considered suitable or recommended by manufacturer? - Yes.

Effects on Ability to Drive and Operate Machinery

Side effects such as dizziness, abdominal spasm and syncope may have effects on the ability to drive and/or operate machinery.

Counselling

Advise patient to avoid long term chronic use. Bisacodyl suppositories should not be used on a continuous daily basis for more than five days and if laxatives are needed every day, the cause of constipation should be investigated.

Side Effects

Abdominal cramps
Abdominal pain
Griping
Diarrhoea
Anal irritation
Hypokalaemia
Vomiting
Abdominal discomfort
Nausea
Fluid and electrolyte disturbances
Allergic reactions
Angioedema
Anaphylaxis
Dehydration
Dizziness
Syncope
Blood in stool
Anorectal discomfort
Colitis

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 ).

Shelf Life and Storage

Store below 25 degrees C
Store in the original container

Further Information

Last Full Review Date: August 2011

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 8th edition (2008) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Dulco-Lax Suppositories for Children, 5mg. Boehringer Ingelheim. Revised March 2011.

Summary of Product Characteristics: Dulco-Lax Suppositories, 10mg. Boehringer Ingelheim. Revised March 2011.

Summary of Product Characteristics: Dulco-Lax Tablets, 5mg. Boehringer Ingelheim. Revised March 2011.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Bisacodyl. Last revised: May 7, 2011
Last accessed: August, 2011