EFUDEX Topical solution / Cream (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US LLC

Λέξεις κλειδιά

0187-3202 0187-3203 0187-3204

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

1. Description

EFUDEX Solutions and Cream are topical preparations containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite. EFUDEX Solution consists of 2% or 5% fluorouracil on a weight/weight ...

2. Clinical Pharmacology

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 ...

3. Indications and Usage

EFUDEX is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods ...

4. Contraindications

EFUDEX may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. One ...

5. Warnings

<b>Application to mucous membranes should be avoided due to the possibility of local inflammation and ulceration. Additionally, cases of miscarriage and a birth defect (ventricular septal defect) have ...

6.1. General

There is a possibility of increased absorption through ulcerated or inflamed skin.

6.2. Information for Patients

Patients should be forewarned that the reaction in the treated areas may be unsightly during therapy and, usually, for several weeks following cessation of therapy. Patients should be instructed to avoid ...

6.3. Laboratory Tests

Solar keratoses which do not respond should be biopsied to confirm the diagnosis. Follow-up biopsies should be performed as indicated in the management of superficial basal cell carcinoma.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with fluorouracil. Studies with the active ingredient of EFUDEX, 5-fluorouracil, have shown positive effects ...

6.7. Pregnancy

See CONTRAINDICATIONS.

6.9. Nursing Mothers

It is not known whether EFUDEX is excreted in human milk. Because there is some systemic absorption of fluorouracil after topical administration (see CLINICAL PHARMACOLOGY), because many drugs are excreted ...

6.10. Pediatric Use

Safety and effectiveness in children have not been established.

7. Adverse Reactions

The most frequent adverse reactions to EFUDEX occur locally and are often related to an extension of the pharmacological activity of the drug. These include burning, crusting, allergic contact dermatitis, ...

9. Overdosage

There have been no reports of overdosage with EFUDEX. The oral LD<sub>50</sub> for the 5% topical cream was 234 mg/kg in rats and 39 mg/kg in dogs. These doses represented 11.7 and 1.95 mg/kg of fluorouracil, ...

10. Dosage and Administration

When EFUDEX is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion, and re-epithelialization. EFUDEX should be applied ...

11. How Supplied

EFUDEX Solution is available in 10 mL drop dispensers containing either 2% (NDC 0187-3202-10) or 5% (NDC 0187-3203-10) fluorouracil and 25 mL drop dispensers containing either 2% (NDC 0187-3202-02) or ...

12. Storage and Handling

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F).