Hydroxyurea
Generic Name: hydroxyurea
Brand Names:
Hydroxyurea
11 DESCRIPTION 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.
Overview
11 DESCRIPTION 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.
Uses
1 INDICATIONS AND USAGE 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. Hydroxyurea capsules are 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)
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 capsules by 50% in patients with creatinine clearance less than 60 mL/min. (2.3 , 8.6 , 12.3) 2.1 Dosing Information Hydroxyurea capsules are used alone or in conjunction with other antitumor agents or radiation therapy to treat neoplastic diseases. Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards. Base all dosage on the patient’s actual or ideal weight, whichever is less. Hydroxyurea capsules are a cytotoxic drug.
Side Effects
6 ADVERSE REACTIONS 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 (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 (5.10) ] Most common adverse reactions (≥30%) are hematological, gastrointestinal symptoms, and anorexia.
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. Permanently discontinue therapy with hydroxyurea in patients who develop signs and symptoms of pancreatitis.
Warnings
5 WARNINGS AND PRECAUTIONS Myelosuppression: Do not give if bone marrow function is markedly depressed. Monitorblood counts at baseline and throughout treatment. Interrupt treatment and reduce doseas necessary. (5.1) Hemolytic anemia: Monitor blood counts throughout treatment. If hemolysis persists, discontinue hydroxyurea capsules. (5.2) Malignancies: Advise protection from sun exposure and monitor for secondary malignancies. (5.3) Embryo-Fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (5.4 , 8.1 , 8.3) Vasculitic toxicities: Discontinue hydroxyurea capsules and initiate treatment if this occurs. (5.5) Live Vaccinations: Avoid live vaccine use in a patient taking hydroxyurea capsules. 4 CONTRAINDICATIONS Hydroxyurea capsules are 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)
Pregnancy
8.1 Pregnancy Risk Summary Hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1) ]. There are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. In animal reproduction studies, administration of hydroxyurea to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m 2 basis (see Data).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Hydroxyurea capsules, USP 500 mg are dark green opaque (cap) printed "724" in white ink/ pink opaque (body) printed "par" in black ink capsules. Supplied in: Unit dose packages of 100 (10 x 10) NDC 68084-284-01.
Frequently Asked Questions
What is Hydroxyurea used for?▼
1 INDICATIONS AND USAGE 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. Hydroxyurea capsules are 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)
What are the side effects of Hydroxyurea?▼
6 ADVERSE REACTIONS 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 (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 (5.10) ] Most common adverse reactions (≥30%) are hematological, gastrointestinal symptoms, and anorexia.
Can I take Hydroxyurea during pregnancy?▼
8.1 Pregnancy Risk Summary Hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see Clinical Pharmacology (12.1) ]. There are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. In animal reproduction studies, administration of hydroxyurea to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m 2 basis (see Data).
What are the important warnings for Hydroxyurea?▼
5 WARNINGS AND PRECAUTIONS Myelosuppression: Do not give if bone marrow function is markedly depressed. Monitorblood counts at baseline and throughout treatment. Interrupt treatment and reduce doseas necessary. (5.1) Hemolytic anemia: Monitor blood counts throughout treatment. If hemolysis persists, discontinue hydroxyurea capsules. (5.2) Malignancies: Advise protection from sun exposure and monitor for secondary malignancies. (5.3) Embryo-Fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. (5.4 , 8.1 , 8.3) Vasculitic toxicities: Discontinue hydroxyurea capsules and initiate treatment if this occurs. (5.5) Live Vaccinations: Avoid live vaccine use in a patient taking hydroxyurea capsules. 4 CONTRAINDICATIONS Hydroxyurea capsules are 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)
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.