Carac® Safety
What are the possible side effects of Carac®?
Most patients using Carac® get skin reactions. These reactions include redness,
dryness, burning, pain, erosion (loss of the upper layer
of skin), and swelling. Irritation may continue for 2 or
more weeks after treatment is over. The treated area
may become unsightly during therapy.
Some patients get eye irritation. Eye irritation might
consist of burning, sensitivity, itching, stinging, and
watering. Remember to avoid contact with you eyes. If you are concerned about side effects,
talk to your doctor.
Some patients have reported side effects such as
stomach pain, diarrhea, vomiting, fever, or chills, possibly
due to the lack of a specific enzyme, dihydropyrimidine dehydrogenase (DPD), in their body.
If you experience any of these symptoms, discontinue
therapy immediately and contact your doctor. Be sure to tell your doctor if you have DPD enzyme deficiency.
What should I avoid while using Carac®?
- Avoid sunlight or other ultraviolet light (such as tanning booths) while using Carac®. Sunlight
may increase your side effects. When exposed to sunlight, wear a hat and use sunscreen.
- Do not cover the treated skin with a dressing.
- Do not breast feed or become pregnant while using Carac®. If you do become pregnant, stop using Carac®
and tell your doctor right away.
Who should not use Carac®?
Do not use Carac®:
- if you are pregnant or might become pregnant. Carac® may harm your unborn child.
- if you are nursing a baby. We do not know if Carac® can pass to the baby through the milk.
- if you have DPD enzyme deficiency. The active ingredient in Carac®,
5-fluorouracil 0.5%, can cause serious side effects in patients who are DPD enzyme deficient. If you have DPD
enzyme deficiency and use medications containing fluorouracil, you may develop serious side effects
such as stomach pain, bloody diarrhea, vomiting, fever, or chills.
- if you are allergic to the ingredients in Carac®. Ask your doctor or pharmacist about the inactive ingredients.
- if you are under 18 years of age. Carac® should not be used in children.
Tell your doctor if you are able to become pregnant. Your doctor may advise you about birth control to
avoid pregnancy.
Treatment Considerations
- Carac® is for external use only
- Avoid contact with eyes, eyelids, nostrils, and mouth
- Cleanse affected area and wait 10 minutes before applying Carac®
- Wash hands immediately after applying Carac®
- 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 you develop abdominal pain, bloody diarrhea, vomiting, fever, or chills while on Carac® therapy, stop the medication and contact your physician and/or pharmacist.
- Report any side effects to the physician and/or pharmacist
Important Safety Information
Carac® should not be used by women who are pregnant, considering becoming pregnant, or nursing. Carac® should not be used by people with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency or in people allergic to any of the ingredients in the product. If you develop abdominal pain, diarrhea, vomiting, fever, or chills while using Carac®, stop the medication immediately and contact your doctor.
Carac® is for external use only. Avoid contact with the eyes, eyelids, nostrils, and mouth. Wash hands immediately after applying Carac®. Avoid prolonged exposure to sunlight or other forms of UV light.
Most patients using Carac® get skin reactions where the medicine is used, and the treatment areas may become unsightly during and after therapy. The most common skin reactions include redness, dryness, burning, pain, erosion (loss of upper layer of skin), swelling and eye irritation. These skin reactions can last for two or more weeks after therapy is discontinued.
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®.