TOLAK Cream (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

HILL DERMACEUTICALS, INC.

Λέξεις κλειδιά

28105-421

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1. Indications and Usage

Tolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp.

2. Dosage and Administration

Prior to application of Tolak Cream, wash, rinse, and dry the treatment areas. Apply Tolak Cream once daily in an amount sufficient to cover the lesions of the face, ears, and/or scalp with a thin film, ...

3. Dosage Forms and Strengths

Cream: 40 mg of fluorouracil per gram (4%) of white cream in 40 gram tubes.

4. Contraindications

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)] ...

5. Warnings and Precautions

5.1 Application Site Adverse Reactions Application site reactions (erythema, scaling/dryness, edema, crusting, erosions, stinging/burning, and pruritus) were observed in almost all patients during treatment ...

6. Adverse Reactions

The following serious adverse reactions are discussed in more detail in other sections of the labeling: Application Site Adverse Reactions [see Warnings and Precautions (5.1)] Hypersensitivity ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of topical fluorouracil. Because these reactions are reported voluntarily from a population of uncertain size, it is not always ...

7. Drug Interactions

Subjects using systemic steroids, immunosuppressants, and immunomodulators were generally excluded from the clinical studies of Tolak Cream, as were subjects who used retinoids, topical steroids, glycolic ...

8.1. Pregnancy

Teratogenic Effects: Pregnancy Category X [see Contraindications (4.1)]. Cases of miscarriage and birth defects (including cleft lip and cleft palate) have been reported when pregnant women were ...

8.3. Nursing Mothers

Because many drugs are excreted in human milk and there is some systemic absorption of fluorouracil after topical administration, and because of the potential for serious adverse reactions in nursing infants, ...

8.4. Pediatric Use

Actinic keratosis is not usually observed in the pediatric population except in the case of rare genetic diseases. Tolak Cream is not intended for use in pediatric patients. Safety and effectiveness in ...

8.5. Geriatric Use

No dose adjustment is required for elderly patients [see Clinical Studies (14)]. The mean age of the 403 subjects treated with Tolak Cream in the clinical trials was 68 years. Of the Tolak Cream-treated ...

11. Description

Tolak (fluorouracil) Cream, 4% contains 40 mg of fluorouracil per gram of white cream for topical application. It is a nucleoside metabolic inhibitor. Chemically, fluorouracil is 5-fluoro-2,4 (1H,3H)-pyrimidinedione. ...

12.1. Mechanism of Action

There is evidence that the metabolism of fluorouracil in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. In this manner, fluorouracil interferes with the ...

12.3. Pharmacokinetics

A systemic absorption study of topically applied Tolak Cream was performed in 21 patients with at least 3 actinic keratosis lesions (4 mm or greater in diameter). The steady state concentration of 5-fluorouracil ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Adequate long-term studies in animals to evaluate carcinogenic potential of fluorouracil have not been conducted. Studies with the active ingredient of Tolak, fluorouracil, have shown mutagenic effects ...

14. Clinical Studies

The efficacy and safety of Tolak Cream was evaluated in two double-blind multi-center trials (Trial 1 and Trial 2) in subjects with at least 5 visible actinic keratosis lesions on the face, scalp, and/or ...

16.1. How Supplied

Tolak (fluorouracil) Cream, 4% containing 40 mg of fluorouracil per gram of white cream is available in a 40 gram tube (NDC 28105-421-40). Manufactured and Distributed by: Hill Dermaceuticals, Inc., Sanford, ...

16.2. Storage and Handling

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.

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Important Administration Instructions: Advise patients of the following: Tolak Cream is for external use only. ...