TOLAK- fluorouracil cream

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

FLUOROURACIL (UNII: U3P01618RT) (FLUOROURACIL - UNII:U3P01618RT)

Beschikbaar vanaf:

Pierre Fabre Pharmaceuticals, Inc.

INN (Algemene Internationale Benaming):

FLUOROURACIL

Samenstelling:

FLUOROURACIL 40 mg in 1 g

Toedieningsweg:

TOPICAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

Tolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp. Tolak Cream is contraindicated: - During pregnancy [see Warnings and Precautions (5.5, 8.1)] - In patients with dihydropyrimidine dehydrogenase (DPD) deficiency [see Warnings and Precautions (5.6)] Tolak Cream may cause fetal harm when administered during pregnancy and is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus. Tolak Cream is contraindicated in patients with dihydropyrimidine dehydrogenase (DPD) deficiency. Teratogenic Effects: Pregnancy Category X [see Contraindications (4.1)] . Cases of miscarriage and birth defects (including cleft lip and cleft palate) have been reported wh

Product samenvatting:

Tolak (fluorouracil) Cream, 4% containing 40 mg of fluorouracil per gram of white cream is available in a 40 gram tube (NDC 64370-421-40). Store at 25°C (77°F), with excursion permitted from 15°C to 30°C (59°F - 86°F) [See USP Controlled Room Temperature]. Do not freeze.

Autorisatie-status:

New Drug Application

Productkenmerken

TOLAK- FLUOROURACIL CREAM
PIERRE FABRE PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TOLAK CREAM SAFELY AND EFFECTIVELY. SEE
FULL PRESCRIBING INFORMATION FOR TOLAK CREAM.
TOLAK (FLUOROURACIL) CREAM, 4%, FOR TOPICAL USE
INITIAL U.S. APPROVAL: 1962
INDICATIONS AND USAGE
Tolak (fluorouracil) Cream, 4%, is a nucleoside metabolic inhibitor
indicated for the topical treatment of actinic keratosis
lesions of the face, ears, and scalp ( 1).
DOSAGE AND ADMINISTRATION
Apply Tolak Cream after washing, rinsing, and drying the treatment
area(s) ( 2).
Apply Tolak Cream once daily in an amount sufficient to cover the
lesions of the face, ears, and/or scalp with a thin film,
using the fingertips to gently massage the medication uniformly into
the skin ( 2).
Tolak Cream should be applied for a period of 4 weeks as tolerated (
2).
Wash hands thoroughly following Tolak Cream application ( 2).
Tolak Cream is for topical use only. Do not apply to eyes, nose, mouth
or mucous membranes ( 2).
Not for ophthalmic, oral, or intravaginal use ( 2).
DOSAGE FORMS AND STRENGTHS
Cream: 40 mg of fluorouracil per gram of cream (4%) ( 3).
CONTRAINDICATIONS
Pregnancy ( 4.1, 8.1).
Dihydropyrimidine dehydrogenase (DPD) deficiency ( 4.2).
WARNINGS AND PRECAUTIONS
Application site adverse reactions are likely to occur during and for
4 weeks after treatment of actinic keratosis with
Tolak Cream ( 5.1).
Hypersensitivity reactions may occur with Tolak Cream ( 5.2).
Avoid treatment in the periocular area. Eye disorders, including
corneal reactions have occurred with topical
fluorouracil use. Avoid accidental transfer of the drug into eyes and
to the periocular area. If accidental exposure
occurs, seek medical care ( 5.3).
Increased sensitivity to ultraviolet light may occur during and
immediately after treatment with Tolak Cream ( 5.4).
Fluorouracil may cause fetal harm when administered to a pregnant
woman. Advise females of reproductive potential to
use effective co