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Hydroxyurea.

Structure

Hydroxyurea capsule:
- 500 mg - Hydroxyurea;

Without a Prescription

Significant tumor response to Hydroxyurea has been demonstrated in:
- Resistant chronic myelocytic leukemia;
- Recurrent;
- Metastatic;
- Melanoma;
- Inoperable carcinoma of the ovary;

Hydroxyurea used concomitantly with irradiation therapy is intended for use in the local control of primary squamous cell carcinomas of the head and neck, excluding the lip.

Dosage

To minimize the risk of dermal exposure, always wear impervious gloves when handling bottles containing Hydroxyurea capsules. This includes all handling activities in:
- Storerooms;
- Pharmacies;
- Home healthcare settings;
- Clinical settings;
including during unpacking and inspection, transport within a facility, and dose preparation and administration.

Procedures for proper handling and disposal of antineoplastic drugs should be considered. Several guidelines on this subject have been published. There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate.

Because of the rarity of melanoma, resistant chronic myelocytic leukemia, carcinoma of the ovary, and carcinomas of the head and neck in pediatric patients, dosage regimens have not been established.

All dosage should be based on the patient`s actual or ideal weight, whichever is less. Concurrent use of Hydroxyurea with other myelosuppressive agents may require adjustment of dosages.

Hepatic Insufficiency
There are no data that support specific guidance for dosage adjustment in patients with hepatic impairment. Close monitoring of hematologic parameters is advised in these patients.

Renal Insufficiency
As renal excretion is a pathway of elimination, consideration should be given to decreasing the dosage of Hydroxyurea in patients with renal impairment. Close monitoring of hematologic parameters is advised in these patients.

Resistant Chronic Myelocytic Leukemia
Until the intermittent therapy regimen has been evaluated, continuous therapy (20 to 30 mg/kg administered orally as a single dose daily ) is recommended.

Pain or discomfort from inflammation of the mucous membranes at the irradiated site (mucositis) is usually controlled by measures such as topical anesthetics and orally administered analgesics. If the reaction is severe, hydroxyurea therapy may be temporarily interrupted; if it is extremely severe, irradiation dosage may, in addition, be temporarily postponed. However, it has rarely been necessary to terminate these therapies.

Severe gastric distress, such as nausea, vomiting, and anorexia, resulting from combined therapy may usually be controlled by temporary interruption of hydroxyurea administration.

Concomitant Therapy with Irradiation
Carcinoma of the head and neck -80 mg/kg administered orally as a single dose every third day

Administration of hydroxyurea should begin at least seven days before initiation of irradiation and continued during radiotherapy as well as indefinitely afterwards provided that the patient may be kept under adequate observation and evidences no unusual or severe reactions.

Continuous Therapy
20 to 30 mg/kg administered orally as a single dose daily

Solid Tumors
Intermittent Therapy
80 mg/kg administered orally as a single dose every third day

Contraindications

Hydroxyurea is contraindicated in patients:
- who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation.
- with marked bone marrow depression, i.e., leukopenia (<2500 WBC) or thrombocytopenia (<100,000), or severe anemia.

Form

Strip pack of 10 capsules.

Prescription drugs without a script
Prescription drugs no script
Prescription drugs no prescription
Prescription drugs without a prescription
RX no RX
RX without RX
2004 - 2017