Hydroxyurea
Hydroxyurea Prescribing Information
| Warnings and Precautions, Pulmonary Toxicity | 7/2019 |
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 purple opaque cap and pink opaque body imprinted in black ink stylized barr 882.
Hydroxyurea is 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 (5.1)]
- 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 ]
- Macrocytosis [see Warnings and Precautions ]
- Pulmonary Toxicity [see Warnings and Precautions ]
Hydroxyurea Capsules, USP are an antimetabolite available for oral use as capsules containing 500 mg hydroxyurea, USP.
Inactive ingredients: anhydrous citric acid, black iron oxide, D&C red no. 28, D&C yellow no. 10 aluminum lake, dibasic sodium phosphate anhydrous, FD&C blue no. 1, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40, FD&C red no. 40 aluminum lake, gelatin, lactose monohydrate, magnesium stearate, propylene glycol, red iron oxide, shellac glaze, sodium lauryl sulfate, and titanium dioxide.
Hydroxyurea, USP is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. Its structural formula is:
CH4N2O2 M.W. 76.05