Drugs List

Therapeutic Indications

Uses

Constipation in terminally ill patients

Contraindications

Abdominal pain of unknown cause
Breastfeeding
Gastrointestinal obstruction
Pregnancy

Precautions and Warnings

Children under 6 years
Faecal incontinence
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Lactose intolerance
Urinary incontinence

Restricted use - terminally ill patients only
Should not be used in infants wearing nappies
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Capsules not licensed in children under 6 years
Risk of adenocarcinoma of the bowel and liver
Not for long term use
May discolour urine orange

Pregnancy and Lactation

Pregnancy

Co-danthrusate is contraindicated in pregnancy.

In animal studies, dantron has been associated with adenocarcinomas in the bowel and tumours in the liver. A theoretical risk of similar effects in humans is therefore possible.

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 to 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

Co-danthrusate is contraindicated in breastfeeding.

LactMed states that docusate is minimally absorbed from the gastrointestinal tract and therefore the drug is unlikely to be found in the maternal serum or breast milk. Laxatives that are completely unabsorbed may be preferred.

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

Discolouration of mucosa of the large intestine
Discolouration of urine
Perianal discolouration
Perianal excoriation
Perianal irritation
Perineal erythema
Rash

Presentation

Oral formulations of dantron and docusate sodium.

Drugs List

Therapeutic Indications

Uses

Constipation in terminally ill patients

Dosage

Adults

Children

Contraindications

Abdominal pain of unknown cause
Breastfeeding
Gastrointestinal obstruction
Pregnancy

Precautions and Warnings

Children under 6 years
Faecal incontinence
Galactosaemia
Glucose-galactose malabsorption syndrome
Hereditary fructose intolerance
Lactose intolerance
Urinary incontinence

Restricted use - terminally ill patients only
Should not be used in infants wearing nappies
Presentations with sorbitol unsuitable in hereditary fructose intolerance
Some formulations contain lactose
Capsules not licensed in children under 6 years
Risk of adenocarcinoma of the bowel and liver
Not for long term use
May discolour urine orange

Pregnancy and Lactation

Pregnancy

Co-danthrusate is contraindicated in pregnancy.

In animal studies, dantron has been associated with adenocarcinomas in the bowel and tumours in the liver. A theoretical risk of similar effects in humans is therefore possible.

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 to 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

Co-danthrusate is contraindicated in breastfeeding.

LactMed states that docusate is minimally absorbed from the gastrointestinal tract and therefore the drug is unlikely to be found in the maternal serum or breast milk. Laxatives that are completely unabsorbed may be preferred.

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

Discolouration of mucosa of the large intestine
Discolouration of urine
Perianal discolouration
Perianal excoriation
Perianal irritation
Perineal erythema
Rash

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 2015

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, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Normax 50mg/60mg Capsules / Co-danthrusate 50mg/60mg Capsules. Galen Limited. Revised November 2014.

Summary of Product Characteristics: Co-danthrusate suspension. Pinewood Healthcare. Revised August 2015.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 23 June 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
Docusate. Last revised: 07 September 2013
Last accessed: 18 June 2015