Overview
11 DESCRIPTION Hydroxyurea Capsules USP is an antimetabolite available for oral use as capsules containing 500 mg hydroxyurea, USP. Inactive ingredients include Colorants (D&C Yellow No. 10, FD&C Red No.3, FD&C Blue No.1), gelatin, lactose anhydrous, magnesium stearate and silicon dioxide and titanium dioxide. Hydroxyurea is a White or almost white, crystalline powder.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The precise mechanism by which hydroxyurea produces its antineoplastic effects cannot, at present, be described. However, the reports of various studies in tissue culture in rats and humans lend support to the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein. This hypothesis explains why, under certain conditions, hydroxyurea may induce teratogenic effects. Three mechanisms of action have been postulated for the increased effectiveness of concomitant use of hydroxyurea therapy with irradiation on squamous cell (epidermoid) carcinomas of the head and neck.
Indications
- 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)
Common Doses
- 60 mL
Dosage
2 DOSAGE AND ADMINISTRATION Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards. (2.1) Renal impairment: Reduce the dose of hydroxyurea by 50% in patients with creatinine clearance less than 60 mL/min. ( 2.3 , 8.6, 12.3 ) 2.1 Dosing Information Hydroxyurea is used alone or in conjunction with other antitumor agents or radiation therapy to treat neoplastic diseases.
Contraindications
- 4 CONTRAINDICATIONS Hydroxyurea capsules is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. • In patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. (4)
Side Effects
- 6 ADVERSE REACTIONS • Myelosuppression [see Warnings and Precautions (5.1) ] • Hemolytic anemia [see Warnings and Precautions (5.2) ] • Malignancies [see Warnings and Precautions (5.3) ] • Vasculitic toxicities [see Warnings and Precautions (5.5) ] • Risks with concomitant use of antiretroviral drugs [see Warnings and Precautions (5.7) ] • Radiation recall [see Warnings and Precautions (5.8) ] • Macrocytosis [see Warnings and Precautions (5.9) ] • Pulmonary Toxicity [see Warnings and Precautions (5.
Interactions
- 7 DRUG INTERACTIONS Antiretroviral drugs (7.1) Laboratory Test Interference. (7.2) 7.1 Increased Toxicity with Concomitant Use of Antiretroviral Drugs Pancreatitis In patients with HIV infection during therapy with hydroxyurea and didanosine, with or without stavudine, fatal and nonfatal pancreatitis have occurred. Hydroxyurea is not indicated for the treatment of HIV infection; however, if patients with HIV infection are treated with hydroxyurea, and in particular, in combination with didanosine and/or stavudine, close monitoring for signs and symptoms of pancreatitis is recommended.