Hydroxyurea (Page 4 of 4)
17 PATIENT COUNSELING INFORMATION
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- There is a risk of myelosuppression. Monitoring blood counts weekly throughout the duration of therapy should be emphasized to patients taking hydroxyurea capsules [see Warnings and Precautions (5.1)]. Advise patients to report signs and symptoms of infection or bleeding immediately.
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- Advise patients that there is a risk of cutaneous vasculitic toxicities and secondary malignancies including leukemia and skin cancers [see Warnings and Precautions (5.2, 5.4)].
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- Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy. Advise females and males of reproductive potential to use contraception during and after treatment with hydroxyurea capsules [see Warnings and Precautions (5.3) and Use in Specific Populations (8.1,8.3)].
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- Advise patients to inform their healthcare provider if they have received or are planning to receive vaccinations while taking hydroxyurea capsules as this may result in a severe infection [see Warnings and Precautions (5.5) ].
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- Advise females to discontinue breastfeeding during treatment with hydroxyurea capsules [see Use in Specific Populations (8.2)].
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- Patients with HIV infection should contact their physician for signs and symptoms of pancreatitis, hepatic events, and peripheral neuropathy [see Warnings and Precautions (5.6)].
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- Post-irradiation erythema can occur in patients who have received previous irradiation therapy [see Warnings and Precautions (5.7)].
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- Advise patients of the symptoms of potential pulmonary toxicity and instruct them to seek prompt medical attention in the event of pyrexia, cough, dyspnea, or other respiratory symptoms [see Warnings and Precautions (5.9)].
For more information, go to www.parpharm.com or call 1-800-828-9393.
Manufactured by:
Par Pharmaceutical
Chestnut Ridge, NY 10977
Packaged and Distributed By:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268 USA
Refer to package label for Distributor’s NDC Number
Issued: 06/2021
Package/Label Display Panel
Hydroxyurea Capsules, USP
500 mg
100 Capsules
HYDROXYUREA hydroxyurea capsule | ||||||||||||||||||
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Labeler — Major Pharmaceuticals (191427277) |
Revised: 08/2023 Major Pharmaceuticals
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