Please sign in so that we can notify you about a reply
Indications/Uses
Melanoma, resistant chronic myelocytic leukemia; Recurrent, metastatic, or inoperable carcinoma of the ovary; Hydroxyurea used concomitantly with irradiation therapy is intended for use in the local control of primary squamous cell (epidermoid) carcinomas of the head and neck, excluding the lip.
Dosage/Direction for Use
All dosages should be based on the patient's actual or ideal weight, whichever is less.
Treatment of Malignancies: Single dose of 20-30 mg/kg body weight daily or as prescribed by the physician; Or in a single dose of 60-80 mg/kg of body weight every third day; If a beneficial effect is evident after 6 weeks, therapy may be continued indefinitely.
Or as prescribed by the physician.
Treatment of Malignancies: Single dose of 20-30 mg/kg body weight daily or as prescribed by the physician; Or in a single dose of 60-80 mg/kg of body weight every third day; If a beneficial effect is evident after 6 weeks, therapy may be continued indefinitely.
Or as prescribed by the physician.
Overdosage
Acute mucocutaneous toxicity has been reported in patients receiving hydroxycarbamide at a dosage several times greater than that recommended. Soreness, violet erythema, oedema on palms and foot soles followed by scaling of hands and feet, intense generalised hyperpigmentation of skin, and severe acute stomatitis were observed.
Immediate treatment consists of gastric lavage, followed by supportive therapy for the cardiorespiratory systems if required. In the long term, careful monitoring of the haemopoietic system is essential and, if necessary, blood should be transfused.
Immediate treatment consists of gastric lavage, followed by supportive therapy for the cardiorespiratory systems if required. In the long term, careful monitoring of the haemopoietic system is essential and, if necessary, blood should be transfused.
Administration
May be taken with or without food: May open cap & empty contents into water while wearing protective clothing. Avoid skin and mucous membrane contact w/ powder.
Contraindications
Hypersensitivity to Hydroxyurea. Patients with the following: Marked bone marrow depression, i.e., leukopenia (<2500 WBC) or thrombocytopenia (<100000); Severe anemia; Pregnancy.
Special Precautions
Hydroxyurea should be used with caution in the following: Patients with marked bone marrow depression (leukopenia is generally its first and most common manifestation. Thrombocytopenia and anemia occur less often and are seldom seen without a preceding leukopenia); Patients who have previously received radiotherapy or cytotoxic cancer chemotherapeutic agents because bone marrow depression is more likely to occur in these kinds of patients; Patients who have received irradiation therapy in the past may have an exacerbation of post irradiation erythema; Patients with severe anemia. Anemia must be corrected with whole blood replacement before initiating therapy with Hydroxyurea;
Patients with marked renal dysfunction; Other side effects reported have included gastro-intestinal disturbances, pulmonary oedema, mild dermatological reactions, alopecia, and neurological reactions such as headache, dizziness, drowsiness, disorientation, hallucinations and convulsions.
Therapy with Hydroxyurea requires close supervision. The complete status of the blood, including bone marrow examination, if indicated, as well as kidney function and liver function should be determined prior to, and repeatedly during treatment. The determination of the hemoglobin level, total leukocyte counts and platelet counts should be performed at least once a week throughout the course of Hydroxyurea therapy. If the white blood cell count falls down to less than 2500/mm3, or the platelet count to less than 100,000/mm3, therapy should be interrupted until the values rise significantly toward normal levels. If anemia occurs, it should be managed with whole blood replacement, without interrupting Hydroxyurea therapy. Pre-existing anemia should be corrected before beginning therapy with Hydroxyurea. Pain or discomfort from inflammation of the mucous membranes at the irradiated site (mucositis) is usually controlled by measures, e.g. 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.
Use in Pregnancy: Hydroxyurea is a known teratogenic agent in animals. Therefore, Hydroxyurea should not be used in women who are or may become pregnant unless in the judgment of the physician, the potential benefits outweigh the possible hazards.
Use in Elderly: Elderly patients may be more sensitive to the effects of Hydroxyurea; therefore, may require a lower dose regimen.
Patients with marked renal dysfunction; Other side effects reported have included gastro-intestinal disturbances, pulmonary oedema, mild dermatological reactions, alopecia, and neurological reactions such as headache, dizziness, drowsiness, disorientation, hallucinations and convulsions.
Therapy with Hydroxyurea requires close supervision. The complete status of the blood, including bone marrow examination, if indicated, as well as kidney function and liver function should be determined prior to, and repeatedly during treatment. The determination of the hemoglobin level, total leukocyte counts and platelet counts should be performed at least once a week throughout the course of Hydroxyurea therapy. If the white blood cell count falls down to less than 2500/mm3, or the platelet count to less than 100,000/mm3, therapy should be interrupted until the values rise significantly toward normal levels. If anemia occurs, it should be managed with whole blood replacement, without interrupting Hydroxyurea therapy. Pre-existing anemia should be corrected before beginning therapy with Hydroxyurea. Pain or discomfort from inflammation of the mucous membranes at the irradiated site (mucositis) is usually controlled by measures, e.g. 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.
Use in Pregnancy: Hydroxyurea is a known teratogenic agent in animals. Therefore, Hydroxyurea should not be used in women who are or may become pregnant unless in the judgment of the physician, the potential benefits outweigh the possible hazards.
Use in Elderly: Elderly patients may be more sensitive to the effects of Hydroxyurea; therefore, may require a lower dose regimen.
Adverse Reactions
Dermatological Problems: Alopecia occurs very rarely. Occasionally, maculopapular rash and facial erythema may occur. Hydroxyurea may exacerbate the erythema caused by irradiation therapy.
Gastrointestinal Disturbances: Stomatitis, inappetence, nausea, vomiting, diarrhea and constipation may occur.
Hematological Problems: Primarily, bone marrow depression (leukopenia, anemia, thrombocytopenia) may occur.
Megaloblastic erythropoiesis, which is self-limiting, is often seen in the early course of Hydroxyurea therapy.
Hepatic Abnormalities: Abnormal BSP retention and elevation of hepatic enzymes have been reported.
Neurotoxicity: At a higher dose, a general lethargic state may occur and flush, chill and malaise have been reported.
Psychoneural Disturbances: Rarely, headache, dizziness, drowsiness, disorientation, hallucinations and convulsions may occur.
Renal Problems: Dysuria occurs very rarely. Hydroxyurea occasionally, may cause temporary impairment of renal tubular function accompanied by elevations in serum uric acid, BUN and creatinine levels.
Others: Edema has been reported to occur.
Gastrointestinal Disturbances: Stomatitis, inappetence, nausea, vomiting, diarrhea and constipation may occur.
Hematological Problems: Primarily, bone marrow depression (leukopenia, anemia, thrombocytopenia) may occur.
Megaloblastic erythropoiesis, which is self-limiting, is often seen in the early course of Hydroxyurea therapy.
Hepatic Abnormalities: Abnormal BSP retention and elevation of hepatic enzymes have been reported.
Neurotoxicity: At a higher dose, a general lethargic state may occur and flush, chill and malaise have been reported.
Psychoneural Disturbances: Rarely, headache, dizziness, drowsiness, disorientation, hallucinations and convulsions may occur.
Renal Problems: Dysuria occurs very rarely. Hydroxyurea occasionally, may cause temporary impairment of renal tubular function accompanied by elevations in serum uric acid, BUN and creatinine levels.
Others: Edema has been reported to occur.
Drug Interactions
Hydroxyurea when used concomitantly with radiation therapy may cause additive bone marrow depression.
Therapeutic doses of irradiation alone produce the same adverse reactions as Hydroxyurea; combined therapy may cause an increase in the incidence and severity of these side effects.
Hydroxyurea may decrease antibody response to live virus vaccines and increase the risk of adverse reactions.
Therapeutic doses of irradiation alone produce the same adverse reactions as Hydroxyurea; combined therapy may cause an increase in the incidence and severity of these side effects.
Hydroxyurea may decrease antibody response to live virus vaccines and increase the risk of adverse reactions.
Caution For Usage
Hydroxyurea is a potent medication; therefore, patients who take it by emptying the contents of the capsule into water should be careful while handling Hydroxyurea. Patients must be advised not to allow the powder to come in contact with the skin or mucous membranes.
Urine produced for up to 48 hours after a dose of Hydroxyurea should be handled wearing protective clothing.
Urine produced for up to 48 hours after a dose of Hydroxyurea should be handled wearing protective clothing.
Storage
Store at a temperature not exceeding 30°C. Protect from light.
Action
Pharmacology: The exact mechanism of action of Hydroxyurea has not been fully elucidated. However, it has been reported that the drug is cell cycle specific and acts on the S phase where concentrations of the enzyme, ribonucleoside diphosphate reductase which catalyzes the reductive conversion of ribonucleotide to deoxyribonucleotide (an important step in the biosynthesis of DNA) are greater. Reports have shown that Hydroxyurea interferes with the synthesis of DNA without interfering with the synthesis of RNA or protein. Although Hydroxyurea may have multiple sites of action, it appears likely that the drug inhibits the incorporation of thymidine into DNA in addition to directly damaging the DNA. Hydroxyurea can also destroy the tyrosyl free radical that is formed as the catalytic center of ribonucleoside diphosphate reductase.
Pharmacokinetics: Following oral administration, Hydroxyurea undergoes absorption readily in the GIT and attains its peak CSF concentrations within 3 hours. Hydroxyurea can also cross the blood-brain barrier. Half of an orally administered dose is degraded in the liver and is excreted in urine as urea and unchanged drug. Some are excreted as respiratory carbon dioxide via the lungs. Blood concentrations decline rapidly and there is no cumulative effect with repeated administration. For this reason, higher blood concentrations are attained if the regular dosage is given in a large, single oral dose than if it is administered in divided doses.
Carcinogenicity, Mutagenicity and Impairment of Fertility: Drugs, which affect DNA synthesis, e.g. Hydroxyurea, may be potential mutagenic agents. The physician should carefully consider this possibility before administering this drug to male or female patients who contemplate conception.
Pharmacokinetics: Following oral administration, Hydroxyurea undergoes absorption readily in the GIT and attains its peak CSF concentrations within 3 hours. Hydroxyurea can also cross the blood-brain barrier. Half of an orally administered dose is degraded in the liver and is excreted in urine as urea and unchanged drug. Some are excreted as respiratory carbon dioxide via the lungs. Blood concentrations decline rapidly and there is no cumulative effect with repeated administration. For this reason, higher blood concentrations are attained if the regular dosage is given in a large, single oral dose than if it is administered in divided doses.
Carcinogenicity, Mutagenicity and Impairment of Fertility: Drugs, which affect DNA synthesis, e.g. Hydroxyurea, may be potential mutagenic agents. The physician should carefully consider this possibility before administering this drug to male or female patients who contemplate conception.
MedsGo Class
Cytotoxic Chemotherapy
Features
Dosage
500 mg
Ingredients
- Hydroxyurea
Packaging
Capsule 1's
Generic Name
Hydroxyurea
Registration Number
DR-XY25365
Classification
Prescription Drug (RX)
Product Questions
Questions
