Nizoral

Generic Name: Ketoconazole
Product Name: Nizoral

Indication

Nizoral is a medication used to treat systemic and deep fungal infections that does not respond to other treatment. Conditions treated include resistant pityriasis versicolor, prevention of mucocutaneous candidiasis in mmunocompromised, mucocutaneous candidiasis and vaginal thrush where topical treatment has failed.

Action

Nizoral contains ketoconazole which belongs to a group of medicine called antifungals. It works by killing or stopping the growth of certain types of fungi or yeasts that cause the infection.

Dose advice

Dose information:

• Nizoral may be used for various fungal infections. The usual dose for adults is one 200mg tablet once daily. However, the dose may vary depending on the type of fungal infections.
• The period of treatment may vary between 2 weeks to 6 months.
• If you are taking Nizoral tablets for longer than 2 weeks, you are advised to have a regular blood test (about once a month) for early detection of liver problems. Liver problems can be recognised by the following symptoms: unusual tiredness, nausea and vomiting, jaundice, dark urine, pale stools, lack of appetite, abdominal pain and fever.
• Nizoral tablets should be taken during meals or with food for maximal absorption.
• Do not take antacids or medicines that suppress the production of stomach acid within 2 hours of taking Nizoral. This is because sufficient stomach acid is required to ensure that Nizoral tablet is properly absorbed by the body.

Contraindications:

Do not take Nizoral tablets if:

• you have an allergy to Nizoral
• you have liver diseases or are recovering from hepatitis
• you are taking disopyramide, domperidone, eplerenone, ergot alkaloids, oral midazolam, pimozide, simvastatin and triazolam concomitantly

Precautions:

You must tell your doctor if:

• you are pregnant or planning to become pregnant
• you are breast feeding or wish to breastfeed
• you know you have a liver problem
• you have recently taken any antifungals, especially griseofulvin
• you have an allergy to penicillin
• if you are taking any other medicines, including medicines you can buy without a prescription from a pharmacy, supermarket or health food shop

Use in pregnancy (Category B3):

Safety has not been established regarding use of Nizoral in pregnancy. Nizoral should not be used unless the expected benefits outweigh the potential risks. You should discuss with your doctor if you are pregnant or intend to become pregnant.

Lactation:

Nizoral is excreted into breast milk. Its safety has not been established in breastfeeding mothers. If you are under treatment with Nizoral tablets, you should discuss with your doctors regarding the potential risks to the baby.

Schedule

Nizoral is Schedule 4.

Common side effects

All medicines have side effects. Most commonly the side effects are minor, however some can be more serious. Usually the benefits of taking a medication outweigh the associated side effects. Your doctor would have considered these side effects before starting you on Nizoral.

Common side effects are those which occur in more than 1% of patients given Nizoral. These include:

• nausea
• vomiting
• abdominal pain
• itch

Uncommon side effects

Side effects which occur in less than 1% of patients given Nizoral are considered uncommon. Patients do not necessarily experience any of these side effects, so do not become alarmed by this list:

• diarrhoea
• headache
• dizziness
• skin rash
• lack of energy
• swelling of the breast in males
• somnolence

The following side effects are very rare (occurrence ≤ 0.01%) but can be potentially serious:

• change in mental status
• a change in menstrual pattern
• inability to get or maintain an erection
• unusual hair loss or thinning
• oligospermia or azoospermia
• high blood pressure
• bleeding or bruising more easily than normal
• blurred vision
• numb feeling in your fingers or toes
• sensitivity to light or sunlamps,
• abnormal tiredness, dark urine, pale stools, yellowing of the skin or eyes, nausea, vomiting, lack of appetite, abdominal pain and/or fever
• sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing

If you experience any of the listed side effects, or any other symptoms which appear abnormal or unusual, please tell your doctor.

References

1. Australian Medicines Handbook. Nizoral. January 2008 [cited 2008 July 13]. Available from: [URL Link]
2. MIMS Online. Nizoral. 26 February 2008 [cited 2008 July 13]. Available from: [URL Link]

For further information talk to your doctor.