Adrucil

Name: Adrucil

What Is Fluorouracil?

Fluorouracil is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Fluorouracil is used to treat cancer of the colon, rectum, breast, stomach, or pancreas.

Fluorouracil may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have bone marrow depression, a serious infection, or if you are malnourished or are not receiving proper nutrition.

You should not receive this medicine if you are allergic to fluorouracil, or if you have:

  • bone marrow depression;
  • a serious infection; or
  • if you are malnourished or are not receiving proper nutrition.

To make sure fluorouracil is safe for you, tell your doctor if you have:

  • cancer that has spread to your bone marrow;
  • liver disease;
  • kidney disease; or
  • if you have ever had radiation treatment of your pelvic area.

Tell your doctor about all other cancer medications you have received in the past, especially BiCNU, CeeNU, Cytoxan, DTIC-Dome, Gliadel, Leukeran, Myeleran, Neosar, Temodar, or Zanosar.

Do not use fluorouracil if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether fluorouracil passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Missed dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule.

Manufacturer

  • Pharmacia, Inc.

  • Teva Parenteral Medicines, Inc.

Adrucil Drug Class

Adrucil is part of the drug class:

  • Pyrimidine analogues

Adrucil Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of fluorouracil, there are no specific foods that you must exclude from your diet.

Inform MD

Before using fluorouracil, tell your doctor about all of your medical conditions including if you:

  • are allergic to any ingredient in fluorouracil or any other medications
  • have or have ever had dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
  • are less than 18 years of age
  • have an infection. Your doctor may not want you to receive fluorouracil injection.
  • have previously received radiation (x-ray) therapy or treatment with other chemotherapy medications
  • have or have ever had kidney or liver disease
  • are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Adrucil and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Adrucil Usage

Injectable:

This medication is available in an injectable form to be given directly into a vein (IV) by a healthcare professional.

Topical:

  • Cream
    • Use fluorouracil once a day as instructed by your doctor. Use it only on your skin.
      • Clean the area where you will apply fluorouracil. Rinse well and dry the area with a towel and wait 10 minutes before applying fluorouracil.
      • Use enough to cover the affected area of skin.
      • Avoid contact with your eyes, nostrils, and mouth.
      • Wash your hands as soon as you finish putting the fluorouracil on your skin.
      • Do not use any other skin products including creams, lotions, medications or cosmetics unless instructed by your doctor.
  • Topical solution
    • Apply solution preferably with a nonmetal applicator or suitable glove. If applied with the fingers, the hands should be washed immediately afterward.
  • What you should avoid while using fluorouracil cream or topical solution:
    • Avoid sunlight or other ultraviolet light (such as tanning booths) as much as possible while using fluorouracil. Sunlight may increase your side effects. When exposed to sunlight, wear a hat and use sunscreen.
    • Do not cover the treated skin with a dressing.
    • Do not breast feed or become pregnant while using fluorouracil. If you do become pregnant, stop using fluorouracil and tell your doctor right away.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Adrucil, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Adrucil (fluorouracil (systemic)). It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Adrucil.

Review Date: October 4, 2017

How Supplied/Storage and Handling

How Supplied

For intravenous use. Adrucil® (fluorouracil injection USP) is available as follows:

SINGLE DOSE VIALS

NDC Number Adrucil Volume

0703-3015-13

50 mg/mL

500 mg/10 mL vial

10 mL vials are packaged 10 vials per shelf pack.

Storage and Handling

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. Retain in carton until time of use.

Fluorouracil is a cytotoxic drug. Follow applicable special handling and disposable procedures [see References (15)].

Dosing & Uses

Dosage Forms & Strengths

injectable solution

  • 50mg/mL

Cancers of Colon, Breast, Ovary, Liver, Pancreas, Rectum, Stomach

Various protocols exist

500 mg/sq.meter IV on Days 1-5, OR 

450-600 mg/sq.meter IV weekly, OR

200-400 mg/sq.meter IV continuous infusion qD

Not to exceed 800 mg/day

Glioblastoma Multiforme (Orphan)

Orphan indication sponsor

  • Ethypharm SA; 194 Bureaux de la Colline - Batiment D; 92213 Saint-Cloud Cedex

Advanced Colorectal Carcinoma (Orphan)

Use in combination with recombinant interferon alpha-2a

Orphan indication sponsor

  • Hoffmann-La Roche, Inc; 340 Kingsland Street; Nutley, NJ 07110-1199

Esophageal Carcinoma (Orphan)

Use in combination with recombinant interferon alpha-2a

Orphan indication sponsor

  • Hoffmann-La Roche, Inc; 340 Kingsland Street; Nutley, NJ 07110-1199

Other Information

May use leucovorin concomitantly

Monitor: CBC

Other Indications & Uses

Off-label use for cervical, bladder, hepatic, prostate, endometrial, and head and neck carcinoma

Safety & efficacy not established

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