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ADRUCIL- fluorouracil injection, solution


Patient Information

Advise:

  • Patients to notify their healthcare provider if they have a known DPD deficiency. Advise patients if they have complete or near complete absence of DPD activity, they are at an increased risk of severe and life-threatening mucositis, diarrhea, neutropenia and neurotoxicity[see Warnings and Precautions (5.1)].
  • Patients of the risk of cardiotoxicity. Advise patients to immediately contact their healthcare provider or to go to an emergency room for new onset of chest pain, shortness of breath, dizziness, or lightheadedness[see Warnings and Precautions (5.2)].
  • Patients to immediately contact their healthcare provider or go to an emergency room for new onset of confusion, disorientation, or otherwise altered mental status; difficulty with balance or coordination; or visual disturbances[seeWarnings and Precautions (5.3,5.4)].
  • Patients to contact their healthcare provider for severe diarrhea or for painful mouth sores with decreased oral intake of food or fluids[see Warnings and Precautions (5.5,5.8)].
  • Patients to contact their healthcare provider for tingling or burning, redness, flaking, swelling, blisters, or sores on the palms of their hands or soles of their feet[see Warnings and Precautions (5.6)].
  • Patients of the importance of keeping appointments for blood tests. Instruct patients to monitor their temperature on a daily basis and to immediately contact their healthcare provider for fever or other signs of infection[see Warnings andPrecautions (5.7)].
  • Patients to notify their healthcare provider of all drugs they are taking, including warfarin or other coumarin-derivative anticoagulants. Advise patients of the importance of keeping appointments for blood tests[see Warnings and Precautions (5.9)].
  • Females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment with fluorouracil and for up to 3 months after the last dose of fluorouracil. Instruct female patients to contact their healthcare provider if they become pregnant, if pregnancy occurs during fluorouracil treatment or during the 3 months following the last dose[see Warnings and Precautions (5.10), Use in Specific Populations (8.1and8.6), and Nonclinical Toxicology (13.1)].
  • Females and males of reproductive potential may have impaired fertility while receiving fluorouracil, based on animal data[see Use in Specific Populations (8.6) and Nonclinical Toxicology (13.1)].
  • Nursing mothers to discontinue nursing[see Use in Specific Populations (8.3)].

Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. C 10/2016



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