Buy Hydrea Online

Hydrea (hydroxyurea)

THERAPEUTIC CLASS

Ribonucleotide reductase (RNR) inhibitor

DEA CLASS

RX

INDICATIONS

Significant tumor response demonstrated in melanoma, resistant chronic myelocytic leukemia (CML), and recurrent, metastatic, or inoperable carcinoma of the ovary. Used concomitantly with irradiation therapy for local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip.

ADULT DOSAGE

Solid Tumors

Intermittent Therapy:
80mg/kg as a single dose every 3rd day

Continuous Therapy:
20-30mg/kg as a single dose daily

Squamous Cell Carcinoma of the Head and Neck

Used concomitantly w/ irradiation therapy for local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip

80mg/kg as a single dose every 3rd day

Begin administration at least 7 days before initiation of irradiation and continue during radiotherapy as well as indefinitely afterwards, provided that the patient may be kept under adequate observation and evidences no unusual or severe reactions

Resistant Chronic Myelocytic Leukemia

Continuous Therapy:
20-30mg/kg as a single dose daily

Continue therapy indefinitely when there is regression in tumor size or arrest in tumor growth

Other Indications

Melanoma and recurrent, metastatic, or inoperable carcinoma of the ovary

DOSING CONSIDERATIONS

Renal Impairment
May require a dose reduction

Elderly
May require a lower dose regimen

Adverse Reactions
WBC Count Drops <2500/mm3 or Platelet Count <100,000/mm3: Interrupt therapy and reevaluate counts after 3 days; resume therapy when counts return to acceptable levels
If prompt rebound has not occurred during combined hydroxyurea and irradiation therapy, irradiation may also be interrupted

Severe Anemia: Correct w/o interrupting therapy

Pain/Discomfort from Mucositis: Usually controlled by measures such as topical anesthetics and orally administered analgesics
If Reaction is Severe: Therapy may be temporarily interrupted
If Reaction is Extremely Severe: Irradiation dosage may, in addition, be temporarily postponed

Severe Gastric Distress from Combined Therapy: May usually be controlled by temporary interruption of hydroxyurea administration

ADMINISTRATION

Oral route

Do not open caps; if contact w/ crushed or opened caps occurs, wash immediately and thoroughly

HOW SUPPLIED

Cap: 500mg

CONTRAINDICATIONS

Marked bone marrow depression, eg, leukopenia (<2500 WBC count) or thrombocytopenia (<100,000), or severe anemia.

WARNINGS/PRECAUTIONS

Bone marrow suppression; caution in patients who have previously received radiotherapy or cytotoxic cancer chemotherapeutic agents. Patients with previous irradiation therapy may have exacerbation of postirradiation erythema. Correct severe anemia before initiating therapy. Megaloblastic erythropoiesis reported. May delay plasma iron clearance and reduce the rate of iron utilization by erythrocytes. Cutaneous vasculitic toxicities reported in patients with myeloproliferative disorders; d/c and initiate alternative cytoreductive agents as indicated if cutaneous vasculitic ulcerations develop. Secondary leukemia reported with long-term use for myeloproliferative disorders. May cause fetal harm during pregnancy. Determine complete status of the blood, including bone marrow examination, if indicated, and kidney/liver function prior to and repeatedly during therapy. Monitor Hgb, total leukocyte counts, and platelet counts at least once a week; interrupt therapy until values rise to normal levels if WBC <2500/mm3 or platelet count <100,000/mm3. Manage severe anemia without interrupting therapy. May increase risk of hepatotoxicity, which may be fatal. Caution with marked renal dysfunction. Caution in elderly. Not indicated for the treatment of HIV infection.

ADVERSE REACTIONS

Leukopenia, anemia, thrombocytopenia, stomatitis, anorexia, N/V, diarrhea, constipation, dermatological reactions, dysuria, alopecia, headache, dizziness, fever.

DRUG INTERACTIONS

Fatal and nonfatal pancreatitis reported with didanosine (with or without stavudine) in HIV-infected patients; closely monitor for signs and symptoms of pancreatitis and permanently d/c therapy with hydroxyurea if develop. Hepatotoxicity and hepatic failure resulting in death and peripheral neuropathy reported in HIV-infected patients with other antiretroviral agents; avoid combination with didanosine and stavudine. Cutaneous vasculitic toxicities reported most often with history of, or currently receiving, interferon therapy. Other myelosuppressive agents or radiation therapy may increase risk of bone marrow depression or other adverse events; may require dosage adjustment with other myelosuppressive agents. Combination with didanosine, stavudine, and indinavir showed a median decline in CD4 cells of approximately 100/mm3. May raise serum uric acid level; dosage adjustment of uricosuric medication may be necessary.

PREGNANCY AND LACTATION

Category D, not for use in nursing.

MECHANISM OF ACTION

Ribonucleotide reductase inhibitor; has not been established. Hypothesized to cause an immediate inhibition of DNA synthesis without interfering with the synthesis of ribonucleic acid or of protein.

PHARMACOKINETICS

Absorption: Readily absorbed. Tmax=1-4 hrs. Distribution: Vd=total body water; crosses placenta, found in breast milk. Metabolism: Hepatic (saturable); degradation by urease found in intestinal bacteria (minor). Elimination: Renal.

ASSESSMENT

Assess for bone marrow depression, severe anemia, history of radiotherapy or cytotoxic chemotherapeutic agent use, renal/hepatic impairment, HIV infection, previous hypersensitivity to the drug, pregnancy/nursing status, and possible drug interactions. Assess complete status of the blood and kidney/liver function.

MONITORING

Monitor for signs/symptoms of bone marrow suppression, secondary leukemia (in patients receiving long-term therapy for myeloproliferative disorders), cutaneous vasculitic toxicities, severe anemia, pancreatitis, exacerbation of postirradiation erythema (with previous irradiation therapy), and other adverse reactions. Monitor complete status of the blood, kidney/liver function; monitor Hgb, total leukocyte counts, and platelet counts at least once a week.

PATIENT COUNSELING

Inform that medication must be handled with care and people who are not taking the drug should not be exposed to it. Advise to wear disposable gloves when handling the drug or bottles containing the drug. Instruct to wash hands before and after contact with bottle or caps. If powder from cap is spilled, advise to wipe immediately with damp disposable towel and discard in a closed container (eg, plastic bag). Instruct to contact physician for instructions on how to dispose of outdated caps. Advise to notify physician if pregnant, nursing, or if any adverse reactions develop.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F). Keep tightly closed.

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