Drugs List

Therapeutic Indications

Uses

For the prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as seborrhoeic dermatitis, dandruff, tinea (pityriasis) versicolor.

Not all products are licensed for all indications.

Contraindications

None known.

Precautions and Warnings

Avoid contact with eyes. If any shampoo does enter the eyes, bathe with water.

To prevent a rebound effect after stopping prolonged treatment with topical corticosteroids, it is recommended to gradually withdraw the steroid therapy over a period of 2-3 weeks, while using ketoconazole shampoo.

For the P and GSL products, advise patients to seek professional advice if the condition has not cleared within 4 weeks.

Pregnancy and Lactation

Pregnancy

Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child.

No ketoconazole has been detected in plasma following topical administration of ketoconazole shampoo on the scalp of non-pregnant humans.

Plasma levels were detected after topical administration of ketoconazole shampoo on the whole body.
Animal studies have shown reproductive toxicity following oral administration of ketoconazole.

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

No ketoconazole has been detected in plasma following topical administration of ketoconazole shampoo on the scalp of non-pregnant humans. Plasma levels were detected after topical administration of ketoconazole shampoo on the whole body.

The use of ketoconazole shampoo or topical use on the skin by the mother poses little or no risk to the breastfed infant. However, topical use on the breast or nipples should be avoided in breastfeeding mothers because of possible oral ingestion by the infant. Its absorption and distribution in children is not known. Ketoconazole requires acidic conditions to be absorbed. Its absorption could be reduced in infants due to the alkaline condition induced by milk ingestion.

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

Burning sensation (local)
Contact dermatitis
Alopecia
Rash
Urticaria
Dry skin
Application site reaction
Hypersensitivity reactions
Folliculitis
Dysgeusia
Increased lacrimation
Changes in hair colour
Acne
Changes in hair texture
Skin disorder
Erythema at application site
Irritation at application site
Formation of pustules
Pruritus
Eye irritation
Angioedema

Presentation

Shampoo containing 2% w/w ketoconazole

Drugs List

Therapeutic Indications

Uses

For the prevention and treatment of infections in which the yeast Malassezia (previously called Pityrosporum) is likely to be involved, such as seborrhoeic dermatitis, dandruff, tinea (pityriasis) versicolor.

Not all products are licensed for all indications.

Dosage

Wash affected areas and leave for 3 - 5 minutes before rinsing thoroughly.

Treatment of seborrhoeic dermatitis and dandruff
Wash hair twice weekly for 2-4 weeks.

Prophylaxis of seborrhoeic dermatitis and dandruff
Use once every 1-2 weeks.

Treatment of Tinea (pityriasis) versicolor
Use once daily for a maximum of 5 days.

Prophylaxis of Tinea (pityriasis) versicolor
Before exposure to sun, use once daily for a maximum of 3 days.

Additional Dosage Information

Contraindications

None known.

Precautions and Warnings

Avoid contact with eyes. If any shampoo does enter the eyes, bathe with water.

To prevent a rebound effect after stopping prolonged treatment with topical corticosteroids, it is recommended to gradually withdraw the steroid therapy over a period of 2-3 weeks, while using ketoconazole shampoo.

For the P and GSL products, advise patients to seek professional advice if the condition has not cleared within 4 weeks.

Pregnancy and Lactation

Pregnancy

Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child.

No ketoconazole has been detected in plasma following topical administration of ketoconazole shampoo on the scalp of non-pregnant humans.

Plasma levels were detected after topical administration of ketoconazole shampoo on the whole body.
Animal studies have shown reproductive toxicity following oral administration of ketoconazole.

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

No ketoconazole has been detected in plasma following topical administration of ketoconazole shampoo on the scalp of non-pregnant humans. Plasma levels were detected after topical administration of ketoconazole shampoo on the whole body.

The use of ketoconazole shampoo or topical use on the skin by the mother poses little or no risk to the breastfed infant. However, topical use on the breast or nipples should be avoided in breastfeeding mothers because of possible oral ingestion by the infant. Its absorption and distribution in children is not known. Ketoconazole requires acidic conditions to be absorbed. Its absorption could be reduced in infants due to the alkaline condition induced by milk ingestion.

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

P and GSL products: Advise patients to seek professional advice if the condition has not cleared within 4 weeks.

This shampoo product may also be prescribed topically for the treatment of tinea (pityriasis) versicolor: wash affected areas and leave for 3 - 5 minutes before rinsing thoroughly.

Side Effects

Burning sensation (local)
Contact dermatitis
Alopecia
Rash
Urticaria
Dry skin
Application site reaction
Hypersensitivity reactions
Folliculitis
Dysgeusia
Increased lacrimation
Changes in hair colour
Acne
Changes in hair texture
Skin disorder
Erythema at application site
Irritation at application site
Formation of pustules
Pruritus
Eye irritation
Angioedema

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 ).

Reference Sources

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

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

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

Summary of Product Characteristics: Boots Anti-Dandruff Ketocconazole 2% shampoo. Revised July 2007.

Summary of Product Characteristics: Ketopine Ketoconazole 2% shampoo. Revised August 2009.

Summary of Product Characteristics: Ketopine Dandruff shampoo. Revised March 2009.

Summary of Product Characteristics: Nizoral 2% Shampoo. Janssen - Cilag Ltd. Revised April 2011.

Summary of Product Characteristics: Nizoral Dandruff Shampoo. McNeil Ltd. Revised April 2011.

Summary of Product Characteristics: Nizoral Antidandruff Shampoo. McNeil Ltd. Revised April 2011.

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
Ketoconazole. Last revised: January 31, 2011
Last accessed: December 8, 2011