Fluorouracil 50 mg/mL
Fluorouracil · INJECTION, SOLUTION · Alembic Pharmaceuticals Inc.
Fluorouracil is a injection, solution containing fluorouracil at 50 mg/mL, taken intravenous. Manufactured by Alembic Pharmaceuticals Inc..
Key Facts
- Brand Name
- Fluorouracil
- Generic Name
- Fluorouracil
- NDC Code (Product)
62332-751- Manufacturer
- Alembic Pharmaceuticals Inc.
- Strength
- 50 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA217295
- Drug Class
- Nucleoside Metabolic Inhibitor [EPC]
- Marketing Start
- 03/03/2023
Recall History
The Medicine Shoppe Pharmacy
Lack of Processing Control
Natures Pharmacy & Compounding Center
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Taro Pharmaceuticals U.S.A., Inc.
Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.
Infusion Options, Inc.
Lack of Assurance of Sterility
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Specialty Medicine Compounding Pharmacy
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Lincare, Inc.
Lack of Assurance of Sterility: Sterility of product is not assured.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Fluorouracil Cream 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 are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil Cream is approximately 93%, based on 113 lesions in 54 patients. Eighty-eight lesions treated with the cream produced 7 failures.
Dosage & Administration
DOSAGE AND ADMINISTRATION When Fluorouracil Cream is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion, and re-epithelialization. Fluorouracil Cream should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil Cream is applied with the fingers, the hands should be washed immediately afterward. Actinic or Solar Keratosis Apply cream twice daily in an amount sufficient to cover the lesions. Medication should be continued until the inflammatory response reaches the erosion stage, at which time use of the drug should be terminated. The usual duration of therapy is from 2 to 4 weeks. Complete healing of the lesions may not be evident for 1 to 2 months following cessation of Fluorouracil Cream therapy. Superficial Basal Cell Carcinomas Only the 5% strength is recommended. Apply cream twice daily in an amount sufficient to cover the lesions. Treatment should be continued for at least 3 to 6 weeks. Therapy may be required for as long as 10 to 12 weeks before the lesions are obliterated. As in any neoplastic condition, the patient should be followed for a reasonable period of ti…
Warnings
WARNINGS 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 been reported when Fluorouracil Cream was applied to mucous membrane areas during pregnancy. Occlusion of the skin with resultant hydration has been shown to increase percutaneous penetration of several topical preparations. If any occlusive dressing is used in treatment of basal cell carcinoma, there may be an increase in the severity of inflammatory reactions in the adjacent normal skin. A porous gauze dressing may be applied for cosmetic reasons without increase in reaction. Exposure to ultraviolet rays should be minimized during and immediately following treatment with Fluorouracil Cream because the intensity of the reaction may be increased. Patients should discontinue therapy with Fluorouracil Cream if symptoms of DPD enzyme deficiency develop (see CONTRAINDICATIONS ). Rarely, life-threatening toxicities such as stomatitis, diarrhea, neutropenia, and neurotoxicity have been reported with intravenous administration of fluorouracil in patients with DPD enzyme deficiency. One…
Contraindications
CONTRAINDICATIONS Fluorouracil Cream 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 birth defect (cleft lip and palate) has been reported in the newborn of a patient using Fluorouracil Cream as recommended. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when Fluorouracil Cream was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil. Animal reproduction studies have not been conducted with Fluorouracil Cream. Fluorouracil administered parenterally has been shown to be teratogenic in mice, rats, and hamsters when given at doses equivalent to the usual human intravenous dose; however, the amount of fluorouracil absorbed systemically after topical administration to actinic keratoses is minimal (see CLINICAL PHARMACOLOGY ). Fluorouracil exhibited maximum teratogenicity when given to mice as single intraperitoneal injections of 10 to 40 mg/kg on Day 10 or 12 of gestation. Similarly, intraperitoneal doses of 12 to 3…
Adverse Reactions
ADVERSE REACTIONS The most frequent adverse reactions to Fluorouracil Cream occur locally and are often related to an extension of the pharmacological activity of the drug. These include burning, crusting, allergic contact dermatitis, pruritus, scarring, rash, soreness, and ulceration. Ulcerations, other local reactions, cases of miscarriage, and a birth defect (ventricular septal defect) have been reported when Fluorouracil Cream was applied to mucous membrane areas. Leukocytosis is the most frequent hematological side effect. Although a causal relationship is remote, other adverse reactions which have been reported infrequently are: Central Nervous System: Emotional upset, insomnia, irritability. Gastrointestinal: Medicinal taste, stomatitis. Hematological: Eosinophilia, thrombocytopenia, toxic granulation. Integumentary: Alopecia, blistering, bullous pemphigoid, discomfort, ichthyosis, scaling, suppuration, swelling, telangiectasia, tenderness, urticaria, skin rash. Special Senses: Conjunctival reaction, corneal reaction, lacrimation, nasal irritation. Miscellaneous: Herpes simplex. To report SUSPECTED ADVERSE REACTIONS contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-…
Frequently Asked Questions
What is Fluorouracil used for?
Fluorouracil contains Fluorouracil. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Fluorouracil a controlled substance?
Fluorouracil is not classified as a controlled substance by the DEA.
What is the generic name for Fluorouracil?
The generic name for Fluorouracil is Fluorouracil. There are 3 other brand versions of Fluorouracil.
What is the NDC code for Fluorouracil 50 mg/mL?
The NDC (National Drug Code) for Fluorouracil 50 mg/mL is 62332-751, listed by Alembic Pharmaceuticals Inc..