Carac
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Questions & Answers
Side Effects & Adverse Reactions
The potential for a delayed hypersensitivity reaction to fluorouracil exists. Patch testing to prove hypersensitivity may be inconclusive.
Patients should discontinue therapy with Carac if symptoms of DPD enzyme deficiency develop.
Rarely, unexpected, systemic toxicity (e.g. stomatitis, diarrhea, neutropenia, and neurotoxicity) associated with parenteral administration of fluorouracil has been attributed to deficiency of dihydropyrimidine dehydrogenase "DPD" activity. One case of life threatening systemic toxicity has been reported with the topical use of 5% fluorouracil in a patient with a complete absence of DPD enzyme activity. Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills. Physical examination revealed stomatitis, erythematous skin rash, neutropenia, thrombocytopenia, inflammation of the esophagus, stomach, and small bowel. Although this case was observed with 5% fluorouracil cream, it is unknown whether patients with profound DPD enzyme deficiency would develop systemic toxicity with lower concentrations of topically applied fluorouracil.
Applications to mucous membranes should be avoided due to the possibility of local inflammation and ulceration.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Carac is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.
History
There is currently no drug history available for this drug.
Other Information
Carac® (fluorouracil cream) Cream, 0.5%, contains fluorouracil for topical dermatologic use. Chemically, fluorouracil is 5-fluoro-2,4(1H, 3H)-pyrimidinedione. The molecular formula is C4H3FN2O2. Fluorouracil has a molecular weight of 130.08.
Carac Cream contains 0.5% fluorouracil, with 0.35% being incorporated into a patented porous microsphere (Microsponge®)1 composed of methyl methacrylate / glycol dimethacrylate crosspolymer and dimethicone. The cream formulation contains the following other inactive ingredients: Carbomer Homopolymer Type C, dimethicone, glycerin, methyl gluceth-20, methyl methacrylate / glycol dimethacrylate crosspolymer, methylparaben, octyl hydroxy stearate, polyethylene glycol 400, polysorbate 80, propylene glycol, propylparaben, purified water, sorbitan monooleate, stearic acid, and trolamine.
- 1
- Microsponge is a registered trademark of Amcol International Corp. or one of its subsidiaries.
Sources
Carac Manufacturers
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Dermik Laboratories
![Carac (Fluorouracil) Cream [Dermik Laboratories]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Carac | Dermik Laboratories
Carac cream should be applied once a day to the skin where actinic keratosis lesions appear, using enough to cover the entire area with a thin film. Carac cream should not be applied near the eyes, nostrils or mouth. Carac cream should be applied ten minutes after thoroughly washing, rinsing, and drying the entire area. Carac cream may be applied using the fingertips. Immediately after application, the hands should be thoroughly washed. Carac should be applied up to 4 weeks as tolerated. Continued treatment up to 4 weeks results in greater lesion reduction. Local irritation is not markedly increased by extending treatment from 2 to 4 weeks, and is generally resolved within 2 weeks of cessation of treatment.
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Valeant Pharmaceuticals North America Llc
Carac | Valeant Pharmaceuticals North America Llc
Carac cream should be applied once a day to the skin where actinic keratosis lesions appear, using enough to cover the entire area with a thin film. Carac cream should not be applied near the eyes, nostrils or mouth. Carac cream should be applied ten minutes after thoroughly washing, rinsing, and drying the entire area. Carac cream may be applied using the fingertips. Immediately after application, the hands should be thoroughly washed. Carac should be applied up to 4 weeks as tolerated. Continued treatment up to 4 weeks results in greater lesion reduction. Local irritation is not markedly increased by extending treatment from 2 to 4 weeks, and is generally resolved within 2 weeks of cessation of treatment.
![Carac (Fluorouracil) Cream [Valeant Pharmaceuticals North America Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6795f2b1-1381-4a4f-ad34-2c28ebd1cfaf&name=carac-04.jpg)
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