Hydroxyurea
Hydroxyurea Prescribing Information
Warnings and Precautions, Hemolytic Anemia (5.2) 07/2021
Hydroxyurea capsules are 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.
Capsules:
500 mg dark green opaque (cap) printed “724” in white ink/ pink opaque (body) printed “par” in black ink.
Hydroxyurea capsules are contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.
The following clinically significant adverse reactions are described in detail in other labeling sections:
- Myelosuppression [see Warnings and Precautions ]
- Hemolytic anemia [see Warnings and Precautions ]
- Malignancies [see Warnings and Precautions ]
- Vasculitic toxicities [see Warnings and Precautions ]
- Risks with concomitant use of antiretroviral drugs [see Warnings and Precautions ]
- Radiation recall [see Warnings and Precautions ]
- Pulmonary Toxicity [see Warnings and Precautions (5.10)]
Hydroxyurea Capsules, USP are an antimetabolite available for oral use as capsules containing 500 mg hydroxyurea. Inactive ingredients include colloidal silicon dioxide, magnesium stearate, colorants (D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40), gelatin and titanium dioxide. Imprinting ink constituents: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, shellac glaze, propylene glycol, ammonium hydroxide, simethicone, synthetic black iron oxide and titanium dioxide.
Hydroxyurea is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. The empirical formula is CH4N2O2 and it has a molecular weight of 76.05. Its structural formula is:
