Ketoconazole Cream

Ketoconazole shampoo, 2% is indicated for the treatment of tinea (pityriasis) versicolor caused by or presumed to be caused by Pityrosporum orbiculare (also known as Malassezia furfur or M. orbiculare ) . Note: Tinea (pityriasis) versicolor may give rise to hyperpigmented or hypopigmented patches on the trunk which may extend to the neck, arms and upper thighs. Treatment of the infection may not immediately result in normalization of pigment to the affected sites. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure. …

• Apply the shampoo to the damp skin of the affected area and a wide margin surrounding this area
• Lather, leave in place for 5 minutes, and then rinse off with water
• One application of the shampoo should be sufficient

Safety and effectiveness in children have not been established.

• Patients should be advised of the following: Ketoconazole shampoo, 2% may be irritating to mucous membranes of the eyes and contact with this area should be avoided
• The following have been reported with the use of ketoconazole shampoo, 2%: hair discoloration and abnormal hair texture, removal of the curl from permanently waved hair, itching, skin burning sensation and contact dermatitis, hypersensitivity, angioedema, alopecia, rash, urticaria, skin irritation, dry skin, and application site reactions. …

Ketoconazole shampoo, 2% is contraindicated in persons who have known hypersensitivity to the active ingredient or excipients of this formulation.

PRECAUTIONS Severe hypersensitivity reactions, including anaphylaxis, have been reported during post-marketing use of ketoconazole shampoo. If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. INFORMATION FOR PATIENTS Patients should be advised of the following: Ketoconazole shampoo, 2% may be irritating to mucous membranes of the eyes and contact with this area should be avoided. …

Clinical Trials Experience In 11 double-blind trials in 264 patients using ketoconazole shampoo, 2% for the treatment of dandruff or seborrheic dermatitis, an increase in normal hair loss and irritation occurred in less than 1% of patients. In three open label safety trials in which 41 patients shampooed 4-10 times weekly for six months, the following adverse experiences each occurred once: abnormal hair texture, scalp pustules, mild dryness of the skin, and itching. As with other shampoos, oiliness and dryness of hair and scalp have been reported. …

PREGNANCY Teratogenic effects: Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Ketoconazole should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In humans, ketoconazole is not detected in plasma after chronic shampooing on the scalp. …

Ketoconazole shampoo, 2% is intended for external use only. In the event of accidental ingestion, supportive and symptomatic measures should be employed. Induced emesis and gastric lavage should not be performed to avoid aspiration.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.