Fluorouracil
Generic: FLUOROURACIL
Basic Information
Manufacturer
Alembic Pharmaceuticals Limited
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
b6b0d9e2-c6f0-4523-a33b-b958d32d3a28
Indications & Usage
1 INDICATIONS & USAGE Fluorouracil is indicated for the treatment of patients with: Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with Adenocarcinoma of the Colon and Rectum (1.1) Adenocarcinoma of the Breast (1.2) Gastric Adenocarcinoma (1.3) Pancreatic Adenocarcinoma (1.4) 1.1.
Adenocarcinoma of the Colon and Rectum .
1.2.
Adenocarcinoma of the Breast .
1.3.
Gastric Adenocarcinoma .
1.4.
Pancreatic Adenocarcinoma .
Adenocarcinoma of the Colon and Rectum .
1.2.
Adenocarcinoma of the Breast .
1.3.
Gastric Adenocarcinoma .
1.4.
Pancreatic Adenocarcinoma .
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Increased risk of serious or fatal adverse reactions in patients with low or absent dipyrimidine dehydrogenase activity [see Warnings and Precautions (5.1)] Cardiotoxicity [see Warnings and Precautions (5.2)] Hyperammonemic encephalopathy [see Warnings and Precautions (5.3)] Neurologic toxicity [see Warnings and Precautions (5.4)] Diarrhea [see Warnings and Precautions (5.5)] Palmar-plantar erythrodysesthesia (hand-foot syndrome) [see Warnings and Precautions (5.6)] Myelosuppression [see Warnings and Precautions (5.7)] Mucositis [see Warnings and Precautions (5.8)] Increased risk of elevated INR when administrated with warfarin [see Warnings and Precautions (5.9)] To report SUSPECTED ADVERSE REACTIONS, contact Alembic Pharmaceuticals, Inc.
at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.2.
Postmarketing Experience The following adverse reactions have been identified during postapproval use of fluorouracil.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hematologic: pancytopenia [see Warnings and Precautions (5.7)] Gastrointestinal: gastrointestinal ulceration, nausea, vomiting Allergic Reactions: anaphylaxis and generalized allergic reactions Neurologic: nystagmus, headache Dermatologic: dry skin; fissuring; photosensitivity, as manifested by erythema or increased pigmentation of the skin; vein pigmentation Ophthalmic: lacrimal duct stenosis, visual changes, lacrimation, photophobia Psychiatric: euphoria Miscellaneous: thrombophlebitis, epistaxis, nail changes (including loss of nails)
at 1-866-210-9797 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.2.
Postmarketing Experience The following adverse reactions have been identified during postapproval use of fluorouracil.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Hematologic: pancytopenia [see Warnings and Precautions (5.7)] Gastrointestinal: gastrointestinal ulceration, nausea, vomiting Allergic Reactions: anaphylaxis and generalized allergic reactions Neurologic: nystagmus, headache Dermatologic: dry skin; fissuring; photosensitivity, as manifested by erythema or increased pigmentation of the skin; vein pigmentation Ophthalmic: lacrimal duct stenosis, visual changes, lacrimation, photophobia Psychiatric: euphoria Miscellaneous: thrombophlebitis, epistaxis, nail changes (including loss of nails)