hydroxyurea capsule
1 INDICATIONS AND USAGE Hydroxyurea capsules, USP is indicated for the treatment of: Resistant chronic myeloid leukemia. Locally advanced squamous cell carcinomas of the head and neck (excluding the lip) in combination with chemoradiation. Hydroxyurea capsules, USP is an antimetabolite indicated for the treatment of: • Resistant chronic myeloid leukemia. (1) • Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. (1)
leading pharma, llc
CAPSULE GREEN LP 164 LP 164
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied
HYDROXYUREA capsules, USP is supplied as 500 mg capsules in HDPE bottles with heat induction Child Resistant Closures. Each bottle contains 100 capsules. The cap is opaque green, and the body is opaque light pink. The capsules are imprinted on both sections with “LP 164” in black ink (NDC 69315-164-01). 16.2 Storage Store at 20-25°C (68-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature]. Keep tightly closed. 16.3 Handling and Disposal
HYDROXYUREA capsules is a cytotoxic drug. Follow applicable special handling and disposal procedures [see References (15) ]. To decrease the risk of contact, advise caregivers to wear disposable gloves when handling
HYDROXYUREA capsules or bottles containing
HYDROXYUREA capsules. Wash hands with soap and water before and after contact with the bottle or capsules when handling
HYDROXYUREA capsules. Do not open
HYDROXYUREA capsules. Avoid exposure to crushed or opened capsules. If contact with crushed or opened capsules occurs on the skin, wash affected area immediately and thoroughly with soap and water. If contact with crushed or opened capsules occurs on the eye(s), the affected area should be flushed thoroughly with water or isotonic eyewash designated for that purpose for at least 15 minutes. If the powder from the capsule is spilled, immediately wipe it up with a damp disposable towel and discard in a closed container, such as a plastic bag; as should the empty capsules. The spill areas should then be cleaned three times using a detergent solution followed by clean water. Keep the medication away from children and pets. Contact your doctor for instructions on how to dispose of outdated capsules.
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