Ketoconazole Shampoo 2%

What ketoconazole shampoo is and what it is used for

Ketoconazole 2% shampoo is a medicated shampoo used for the treatment and prevention of infections of the scalp and skin associated with the fungus Pityrosporum such as:

• Seborrheic dermatitis - a dry or greasy scaling of the scalp and other parts of the body
• Dandruff (Pityriasis capitis)

Dosage and how to use

Always use ketoconazole shampoo exactly as your doctor or pharmacist has told you. You should check with your doctor or pharmacist if you are not sure.

Ketoconazole shampoo is for use on your skin only. Do not swallow it.

For adolescents and adults (including the elderly):

• Wet hair and scalp thoroughly with water.
• Apply sufficient ketoconazole shampoo to produce enough lather to wash the scalp and hair.
• Gently massage the lather over the entire scalp.
• Leave for 3-5 minutes, before rinsing off thoroughly.

Your usual shampoo can be used as necessary between treatments with ketoconazole shampoo.

Frequency of application:

For dandruff or dry/greasy scaling of the scalp, use ketoconazole shampoo:

• twice a week for 2-4 weeks to relieve the condition
• once every 1-2 weeks to stop it returning

What to do if I missed a dose?

Do not worry if you miss an application of ketoconazole shampoo. Restart your treatment as soon as your remember.

What are the possible side effects of ketoconazole shampoo?

Like all medicines, ketoconazole shampoo can cause side effects ,although not everybody gets them.

Stop using ketoconazole shampoo and tell your doctor straight away if you notice any of the following. You may need urgent medical treatment.

• Allergic reaction, swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing. This can affect fewer than 1 in 1000 people.
• Severe irritation or reddening of the skin where the shampoo has been used, or other signs of allergy during the first few days of treatment. This can affect fewer than 1 in 100 people.
• Peeling or blistering of the skin. This can affect fewer than 1 in 1000 people.

Tell your doctor or pharmacist if you notice or suspect any of the following side effects:

Uncommon side effects (affects fewer than 1 in 100 people):

• Infection of the hair roots
• Increase in production of tears
• Unusual hair loss or thinning
• Dry skin, rash, burning feeling
• Changes in how your hair feels

Rare side effects (affects fewer than 1 in 1000 people):

• Taste impairment
• Irritation of the eyes
• Acne
• Flaking skin

The following side effects have been reported, however the precise frequency cannot be identified and therefore how often they occur is classed as unknown:

• Hives (also known as nettle rash or urticaria
• Hair colour changes

What precautions should I take?

Do not use ketoconazole shampoo if you are allergic to ketoconazole or any other ingredients in the shampoo.

Take special care with ketoconazole shampoo if you:

• get it in your eyes as it may irritate. If this happens, bathe them gently with cold water.
• have been using steroids such as betamethasone or hydrocortisone for a long period of time. You must gradually reduce the application of these over 2 to 3 weeks as you start to use ketoconazole shampoo. If you have any questions about stopping your steroid treatment, speak to your doctor or pharmacist.

If you are pregnant or breastfeeding, ask your doctor or pharmacist for advice before using ketoconazole shampoo. Generally, ketoconazole shampoo can be used during pregnancy and breastfeeding.

What other medications or food should I avoid when using ketoconazole shampoo?

Please tell your doctor if you are having or have recently taken any other medicines, including medicines obtained without a prescription.

Handling and storage

• Do not store about 25 degrees Celsius.
• Keep out of sight and reach of children.
• Store in the original container, and keep the cap tightly closed.
• Do not use ketoconazole after the expiry date which is stated on the label or carton. The expiry date refers to the last day of that month. Unused medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

The above information answers some common questions about this medicine. It does not contain all the available information. It also does not take the place of talking to your doctor or pharmacist.

References

https://www.medicines.org.uk/emc/files/pil.4559.pdf