Carac

What is Carac?

• Carac contains fluorouracil for topical dermatologic use.

Fluorouracil

What are the uses of this medicine?

• Carac (Fluorouracil) is a cream used by adults to treat skin conditions on the face and front part of the scalp called solar keratosis or actinic keratosis.

How does this medicine work?

• Fluorouracil is believed to block thymidylate synthase and decrease production of thymidylate, a necessary precursor of DNA.
• This action interferes with the synthesis of DNA, RNA and protein and blocks cell division.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are pregnant or might become pregnant.
• are nursing a baby.
• have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
• are allergic to the ingredients in Carac.
• are under 18 years of age.

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with Carac.

Is this medicine FDA approved?

• Fluorouracil was patented in 1956 and came into medical use in 1962.

How should this medicine be used?

Recommended dosage:

• 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 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.

Administration:

• Use Carac once a day as instructed by your doctor. Use it only on your skin. You should use Carac for up to 4 weeks.
• Clean the area where you will apply Carac. Rinse well and dry the area with a towel and wait 10 minutes before applying Carac.
• Put Carac on your face as directed by your physician, using your fingertips. Use enough to cover the affected skin.
• Avoid contact with your eyes, nostrils, and mouth.
• Wash your hands as soon as you finish putting Carac on your skin.
• A moisturizer/sunscreen may be applied 2 hours after Carac has been applied. Do not use any other skin products, including creams, lotions, medications, or cosmetics – unless instructed by your doctor.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Cream, 0.5%, contains fluorouracil for topical dermatologic use.

This medicine is available in fallowing brand namesː

• Carac

What side effects can this medication cause?

The most common side effects of this medicine include:

• redness
• dryness
• burning
• pain
• erosion (loss of the upper layer of skin)
• swelling

• Some patients get eye irritation.
• A few patients have reported side effects such as stomach pain, diarrhea, vomiting, fever, or chills, possibly due to the lack of a specific enzyme, DPD, in their body.

What special precautions should I follow?

• Avoid sunlight or other ultraviolet light (such as tanning booths) as much as possible 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.
• Carac may be fatal to your pet if your pet licks or ingests Carac. Avoid allowing pets to contact the Carac container or your skin where you applied Carac.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• Ordinarily, topical overdosage will not cause acute problems.

Management of overdosage:

• If Carac is accidentally ingested, induce emesis and gastric lavage.
• Administer symptomatic and supportive care as needed.
• If contact is made with the eye, flush with water.

Can this medicine be used in pregnancy?

• Fluorouracil may cause fetal harm when administered to a pregnant woman.
• Fluorouracil is contraindicated in women who are or may become pregnant.

Can this medicine be used in children?

• Actinic keratosis is not a condition seen within the pediatric population, except in association with rare genetic diseases.
• Carac should not be used in children.
• The safety and effectiveness of Carac have not been established in patients less than 18 years old.

What are the active and inactive ingredients in this medicine?

Active ingredients include:

• fluorouracil

Inactive ingredients include:

• CARBOMER HOMOPOLYMER TYPE C
• glycerin
• methyl gluceth-20
• methylparaben
• polyethylene glycol 400
• polysorbate 80
• propylene glycol
• propylparaben
• water
• sorbitan monooleate
• stearic acid
• trolamine
• dimethicone

Who manufactures and distributes this medicine?

Distributed by:

• Bausch Health US, LLC
• Bridgewater, NJ USA

Manufactured by:

• Bausch Health Companies Inc.
• Laval, Quebec, Canada

What should I know about storage and disposal of this medication?

• Keep this medicine at room temperature 68° to 77° F (20° to 25° C).
• Throw away unused medicine.
• Keep this medicine out of reach of children.

• Dailymed label info on Carac
• FDA Carac