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Carac® Prescribing Information. Dermik Laboratories, 2006.
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Treatment Considerations
- Carac® is for external use only
- Patients should avoid contact with eyes, eyelids, nostrils, and mouth
- Patients should cleanse affected area and wait 10 minutes before applying Carac®
- Patients should wash hands immediately after applying Carac®
- Patient should avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment, as the intensity of the reaction may be increased.
- Most patients using Carac® get skin reactions where the medicine is used. These reactions include redness, dryness, burning, pain, erosion (loss of the upper layer of skin), and swelling. Irritation at the application site may persist for two or more weeks after therapy is discontinued. Treated areas may be unsightly during and after therapy.
- If patients develop abdominal pain, bloody diarrhea, vomiting, fever, or chills while on Carac® therapy, stop the medication and contact your physician and/or pharmacist.
- Patients should report any side effects to the physician and/or pharmacist
Important Safety Information
Carac® is contraindicated in women who are nursing, pregnant or may become pregnant as fluorouracil may cause fetal harm. Carac® is also contraindicated in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency, or in patients with known hypersensitivity to any of its components. Carac® should be discontinued if abdominal pain, diarrhea, vomiting, fever, or chills develop when using the product.
There is a potential for a delayed hypersensitivity reaction to fluorouracil. Patch testing to determine hypersensitivity may be inconclusive. Applications to mucous membranes should be avoided due to the possibility of local inflammation and ulceration.
In clinical trials, the most common drug-related adverse event was application site reaction (94.6%), which included: erythema, dryness, burning, erosion, pain, and edema. Skin irritation generally began on day 4 and persisted for up to two weeks after treatment discontinuation. Some patients also experienced eye irritation (5.4%), including stinging and burning.
Indication
Carac® is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.
For more information, please see Full Prescribing Information for Carac®.