Drugs List

Administration

To be administered rectally.

The protective cap should be removed and the applicator inserted gently into the rectum and the tube squeezed until empty. A small quantity of the gel may be used as a lubricant if required.

Contraindications

Nausea
Vomiting
Haemorrhoids
Anal fissures
Rectocolitis
Recent rectal or anal bleeding
Abdominal pain of unknown cause
Intestinal obstruction
Inflammatory bowel disease
Paralytic ileus
Children under 12 years

Precautions and Warnings

Docusate sodium enema is for short term use only, prolonged use can cause atonic non-functioning colon and hypokalaemia.

Pregnancy (see 'Pregnancy' section)

Pregnancy and Lactation

Pregnancy

Briggs concludes that there are no reports located linking the use of docusate sodium with congenital defects.

The manufacturer, however, states that there are no adequate data from the use of docusate enema in pregnant women and recommend that as minimal systemic absorption cannot be ruled out following rectal application, docusate sodium enema should be used with caution.

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 ).

Lactation

It is not known whether docusate is excreted in human breast milk. Animals studies have shown excretion of docusate and its metabolites in breast milk when administered systemically. Docusate administered rectally is not known to be harmful.

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

Side Effects

Rectal burning and pain
Rash
Short lasting diarrhoea
Rectal bleeding
Hepatotoxicity has been reported with oral formulations- especially when used with concurrent laxatives
Urticaria

Drugs List

Dosage

Adults

Elderly

Children

Additional Dosage Information

Administration

To be administered rectally.

The protective cap should be removed and the applicator inserted gently into the rectum and the tube squeezed until empty. A small quantity of the gel may be used as a lubricant if required.

Contraindications

Nausea
Vomiting
Haemorrhoids
Anal fissures
Rectocolitis
Recent rectal or anal bleeding
Abdominal pain of unknown cause
Intestinal obstruction
Inflammatory bowel disease
Paralytic ileus
Children under 12 years

Precautions and Warnings

Docusate sodium enema is for short term use only, prolonged use can cause atonic non-functioning colon and hypokalaemia.

Pregnancy (see 'Pregnancy' section)

Pregnancy and Lactation

Pregnancy

Briggs concludes that there are no reports located linking the use of docusate sodium with congenital defects.

The manufacturer, however, states that there are no adequate data from the use of docusate enema in pregnant women and recommend that as minimal systemic absorption cannot be ruled out following rectal application, docusate sodium enema should be used with caution.

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 ).

Lactation

It is not known whether docusate is excreted in human breast milk. Animals studies have shown excretion of docusate and its metabolites in breast milk when administered systemically. Docusate administered rectally is not known to be harmful.

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

Counselling

Advise patients on the correct manner of use.

Side Effects

Rectal burning and pain
Rash
Short lasting diarrhoea
Rectal bleeding
Hepatotoxicity has been reported with oral formulations- especially when used with concurrent laxatives
Urticaria

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: February 2012

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

Summary of Product Characteristics: Norgalax. Norgine Limited. Revised July 2010