Drugs List

Therapeutic Indications

Uses

Dermatitis herpetiformis
Dermatoses
Leprosy
Malaria - prophylaxis
Prophylaxis of pneumocystis jirovecii pneumonia in immunodeficiency

Dapsone is indicated for the following indications:

Treatment of all forms of leprosy as part of a multi-drug regimen
Treatment of dermatitis herpetiformis and other dermatoses
Prophylaxis of malaria in combination with pyrimethamine
Prophylaxis of pneumocystis jirovecii pneumonia in immunodeficient subjects, especially AIDS patients

For up to date advice on geographical resistance patterns and appropriate prophylaxis, current guidelines should be consulted.
Guidelines for Malaria Prevention from the Health Protection Agency specifically developed for travellers from the United Kingdom may be obtained on the HPA website: https://www.hpa.org.uk/webw

Advice from a member of the Panel of Leprosy Opinion is essential for the treatment of leprosy. The Memorandum on Leprosy 2012 on behalf of the Panel of Leprosy Opinion (https://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1317137370320) should be consulted.

Contraindications

Neonates under 1 month
Galactosaemia
Porphyria
Severe anaemia
Severe G6PD deficiency

Precautions and Warnings

Children under 6 years
Anaemia
Breastfeeding
Cardiac disorder
G6PD deficiency
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Methaemoglobin reductase deficiency
Methaemoglobinaemia
Pregnancy
Pulmonary disease
Renal impairment - glomerular filtration rate below 20ml/minute

Reduce dose in patients with hepatic impairment
Advice available from specialist unit for the use of this drug
Correct severe anaemia before starting treatment
Drugs for malaria prophylaxis are not prescribable on the NHS
Contains lactose
Monitor blood counts regularly
Advise patient/carer to see Dr immed'ly if signs of blood disorder develop
Consult Dr.at once if rash, sore throat, mouth ulcers, bruising,fever occur
Dapsone syndrome: steroid therapy may be required for several weeks
Discontinue immediately if dapsone syndrome (btw 3-6 wks of therapy) occurs
Discontinue or reduce dosage if eye or nerve trunk lepra reactions
Pregnancy: Advise taking folate supplement as risk of neural tube defects

A 'dapsone syndrome' may occur after 3 to 6 weeks of therapy. Symptoms include, rash (always present), fever, and eosinophilia. If dapsone is not discontinued immediately, the syndrome may progress to exfoliative dermatitis, hepatitis, albuminuria, and psychosis. Deaths have been recorded. Most patients require steroid therapy for several weeks.

Pregnancy and Lactation

Pregnancy

Use dapsone with caution in pregnancy.

Briggs suggests the use of dapsone does not appear to present major risk to the foetus or newborn, Schaefer suggests during pregnancy, dapsone should only be used for specific indications. The manufacturer suggests that the benefits of dapsone in the treatment of leprosy outweigh any potential risk to the pregnant patient.

Cases of neonatal haemolysis and methaemoglobinaemia have been reported.

Some leprologists recommend 5 mg folic acid per day throughout the pregnancy.

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

Use dapsone with caution in breastfeeding.

The Drugs and Lactation Database (LactMed) suggest dapsone can be used during breastfeeding, however haemolytic anaemia may occur in newborns and those with G6PD deficiency. The infant should be monitored for signs of haemolysis. Hale (2010) suggests dapsone should be used very cautiously during breastfeeding, if at all. The manufacturer suggests, in general, treatment for leprosy is continued in breastfeeding.

Dapsone is secreted in significant amounts in breast milk.

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

Agranulocytosis
Albuminuria
Anorexia
Cutaneous reactions
Dapsone syndrome
Death
Eosinophilia
Exfoliative dermatitis
Fever
Fixed drug eruption
Haemolysis
Haemolytic anaemia
Headache
Hepatitis
Hypoalbuminaemia
Insomnia
Maculopapular rash
Methaemoglobinaemia
Motor disturbances
Nausea
Peripheral neuropathy
Pruritus
Psychosis
Rash
Severe lepra reactions
Stevens-Johnson syndrome
Tachycardia
Toxic epidermal necrolysis
Vomiting

Presentation

Tablets containing dapsone

Drugs List

Therapeutic Indications

Uses

Dermatitis herpetiformis
Dermatoses
Leprosy
Malaria - prophylaxis
Prophylaxis of pneumocystis jirovecii pneumonia in immunodeficiency

Dapsone is indicated for the following indications:

Treatment of all forms of leprosy as part of a multi-drug regimen
Treatment of dermatitis herpetiformis and other dermatoses
Prophylaxis of malaria in combination with pyrimethamine
Prophylaxis of pneumocystis jirovecii pneumonia in immunodeficient subjects, especially AIDS patients

For up to date advice on geographical resistance patterns and appropriate prophylaxis, current guidelines should be consulted.
Guidelines for Malaria Prevention from the Health Protection Agency specifically developed for travellers from the United Kingdom may be obtained on the HPA website: https://www.hpa.org.uk/webw

Advice from a member of the Panel of Leprosy Opinion is essential for the treatment of leprosy. The Memorandum on Leprosy 2012 on behalf of the Panel of Leprosy Opinion (https://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1317137370320) should be consulted.

Dosage

Adults

Children

Patients with Renal Impairment

Patients with Hepatic Impairment

Contraindications

Neonates under 1 month
Galactosaemia
Porphyria
Severe anaemia
Severe G6PD deficiency

Precautions and Warnings

Children under 6 years
Anaemia
Breastfeeding
Cardiac disorder
G6PD deficiency
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Methaemoglobin reductase deficiency
Methaemoglobinaemia
Pregnancy
Pulmonary disease
Renal impairment - glomerular filtration rate below 20ml/minute

Reduce dose in patients with hepatic impairment
Advice available from specialist unit for the use of this drug
Correct severe anaemia before starting treatment
Drugs for malaria prophylaxis are not prescribable on the NHS
Contains lactose
Monitor blood counts regularly
Advise patient/carer to see Dr immed'ly if signs of blood disorder develop
Consult Dr.at once if rash, sore throat, mouth ulcers, bruising,fever occur
Dapsone syndrome: steroid therapy may be required for several weeks
Discontinue immediately if dapsone syndrome (btw 3-6 wks of therapy) occurs
Discontinue or reduce dosage if eye or nerve trunk lepra reactions
Pregnancy: Advise taking folate supplement as risk of neural tube defects

A 'dapsone syndrome' may occur after 3 to 6 weeks of therapy. Symptoms include, rash (always present), fever, and eosinophilia. If dapsone is not discontinued immediately, the syndrome may progress to exfoliative dermatitis, hepatitis, albuminuria, and psychosis. Deaths have been recorded. Most patients require steroid therapy for several weeks.

Pregnancy and Lactation

Pregnancy

Use dapsone with caution in pregnancy.

Briggs suggests the use of dapsone does not appear to present major risk to the foetus or newborn, Schaefer suggests during pregnancy, dapsone should only be used for specific indications. The manufacturer suggests that the benefits of dapsone in the treatment of leprosy outweigh any potential risk to the pregnant patient.

Cases of neonatal haemolysis and methaemoglobinaemia have been reported.

Some leprologists recommend 5 mg folic acid per day throughout the pregnancy.

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

Use dapsone with caution in breastfeeding.

The Drugs and Lactation Database (LactMed) suggest dapsone can be used during breastfeeding, however haemolytic anaemia may occur in newborns and those with G6PD deficiency. The infant should be monitored for signs of haemolysis. Hale (2010) suggests dapsone should be used very cautiously during breastfeeding, if at all. The manufacturer suggests, in general, treatment for leprosy is continued in breastfeeding.

Dapsone is secreted in significant amounts in breast milk.

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

Agranulocytosis
Albuminuria
Anorexia
Cutaneous reactions
Dapsone syndrome
Death
Eosinophilia
Exfoliative dermatitis
Fever
Fixed drug eruption
Haemolysis
Haemolytic anaemia
Headache
Hepatitis
Hypoalbuminaemia
Insomnia
Maculopapular rash
Methaemoglobinaemia
Motor disturbances
Nausea
Peripheral neuropathy
Pruritus
Psychosis
Rash
Severe lepra reactions
Stevens-Johnson syndrome
Tachycardia
Toxic epidermal necrolysis
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: March 2014

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.

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

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Dapsone tablets 100 mg. Actavis UK Ltd. August 2010.

The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 31 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
Dapsone. Last revised: September 9, 2013.
Last accessed: March 11, 2014.

Memorandum on Leprosy 2012 on behalf of the Panel of Leprosy Opinion
https://www.hpa.org.uk/webc/HPAwebFile/HPAweb_C/1317137370320
Last accessed: March 11, 2014.