This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history.
This medication should be used only if clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding. Read the package labeling or ask your pharmacist for the storage requirements for the product you are using. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so.
Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Your healthcare professionals e. Do not start, stop or change the dosage of any medicine before checking with them first. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. This medicine may be harmful if swallowed.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call Otherwise, call a poison control center right away.
US residents can call their local poison control center at Canada residents can call a provincial poison control center. If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. This shampoo may remove the curl from a permanent wave in the hair. When treating pityriasis, this medication may not cause an immediate return to normal skin color.
It may take several months after treatment is completed for your natural skin color to return. This copyrighted material has been downloaded and Licensed data provider and is not for distribution in professional healthcare settings. This information is generalized and not intended as specific medical advice. Consult your healthcare professional before taking any drug or commencing or discontinuing any course of treatment. Normalization of pigment following successful therapy is variable and may take months, depending on individual skin type and incidental sun exposure.
Although tinea versicolor is not contagious, it may recur because the organism that causes the disease is part of the normal skin flora. 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.
Patients should be advised of the following: Patients who develop allergic reactions, such as generalized rash, skin reactions, severe swelling, angioedema, or shortness of breath should discontinue ketoconazole and contact their physician immediately.
Carcinogenesis, Mutagenesis, Impairment of Fertility: A long-term feeding study of ketoconazole in Swiss Albino mice and in Wistar rats showed no evidence of oncogenic activity.
The Ames Salmonella microsomal activator assay was also negative. 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. However, these effects may be related to maternal toxicity, which was seen at this and higher dose levels.
There are no adequate and well-controlled studies in nursing women. Ketoconazole is not detected in plasma after chronic shampooing on the scalp. Safety and effectiveness in children have not been established. 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: As with other shampoos, oiliness and dryness of hair and scalp have been reported.
Post-marketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency. In the event of accidental ingestion, supportive and symptomatic measures should be employed.
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