Hydrogem 500mg Capsule

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. - Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

Myelosuppression: Do not give if bone marrow function is markedly depressed. Monitor blood counts at baseline and throughout treatment. Interrupt treatment and reduce dose as necessary. Hemolytic anemia: Monitor blood counts throughout treatment. If hemolysis persists, discontinue Hydroxyurea. Malignancies: Advise protection from sun exposure and monitor for secondary malignancies. Embryo-Fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. Vasculitic toxicities: Discontinue Hydroxyurea and initiate treatment if this occurs. Live Vaccinations: Avoid live vaccine use in a patient taking Hydroxyurea capsules. Risks with concomitant use of antiretroviral drugs: Pancreatitis, hepatotoxicity, and neuropathy have occurred. Monitor for signs and symptoms in patients with HIV infection using antiretroviral drugs; discontinue Hydroxyurea capsules and implement treatment. Radiation recall: Monitor for skin erythema in patients who previously received radiation and manage symptomatically. Myelosuppression s ion Hydroxyurea causes severe myelosuppression. Treatment with Hydroxyurea should not be initiated if bone marrow function is markedly depressed. Bone marrow suppression may occur, and leukopenia is generally its first and most common manifestation. Thrombocytopenia and anemia occur less often and are seldom seen without a preceding leukopenia. Bone marrow depression is more likely in patients who have previously received radiotherapy or cytotoxic cancer chemotherapeutic agents; use Hydroxyurea cautiously in such patients. Evaluate hematologic status prior to and during treatment with Hydroxyurea capsules. Provide supportive care and modify dose or discontinue Hydroxyurea as needed. Recovery from myelosuppression is usually rapid when therapy is interrupted. Hemolytic Anemia Cases of hemolytic anemia in patients treated with Hydroxyurea for myeloproliferative diseases have been reported. Patients who develop acute jaundice or hematuria in the presence of persistent or worsening of anemia should have laboratory tests evaluated for hemolysis (e.g., measurement of serum lactate dehydrogenase, haptoglobin, reticulocyte, unconjugated bilirubin levels, urinalysis, and direct and indirect antiglobulin [Coombs] tests). In the setting of confirmed diagnosis of hemolytic anemia and in the absence of other causes, discontinue Hydroxyurea. Malignancies Hydroxyurea is a human carcinogen. In patients receiving long-term Hydroxyurea for myeloproliferative disorders, secondary leukemia has been reported. Skin cancer has also been reported in patients receiving long-term Hydroxyurea. Advise protection from sun exposure and monitor for the development of secondary malignancies. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

• Myelosuppression - Hemolytic anemia - Malignancies - Vasculitic toxicities - Risks with concomitant use of antiretroviral drugs - Radiation recall - Macrocytosis - Pulmonary Toxicity Most common adverse reactions (≥30%) are hematological, gastrointestinal symptoms, and anorexia.. Postmarketing Experience The following adverse reactions have been identified during post-approval use of Hydroxyurea capsules. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency. Reproductive System and Breast disorders: azoospermia, and oligospermia Gastrointestinal disorders: stomatitis, nausea, vomiting, diarrhea, and constipation Metabolism and Nutrition disorders: anorexia, tumor lysis syndrome Skin and subcutaneous tissue disorders: maculopapular rash, skin ulceration, cutaneous lupus erythematosus, dermatomyositis-like skin changes, peripheral and facial erythema, hyperpigmentation, nail hyperpigmentation, atrophy of skin and nails, scaling, violet papules, and alopecia Renal and urinary disorders: dysuria, elevations in serum uric acid, blood urea nitrogen (BUN), and creatinine levels Nervous system disorders: headache, dizziness, drowsiness, disorientation, hallucinations, and convulsions General Disorders: fever, chills, malaise, edema, and asthenia Hepatobiliary disorders: elevation of hepatic enzymes, cholestasis, and hepatitis Respiratory disorders: diffuse pulmonary infiltrates, dyspnea, and pulmonary fibrosis, interstitial lung disease, pneumonitis, alveolitis, allergic alveolitis and cough Immune disorders: systemic lupus erythematosus Hypersensitivity: Drug-induced fever (pyrexia) (>39°C, >102°F) requiring hospitalization has been reported concurrently with gastrointestinal, pulmonary, musculoskeletal, hepatobiliary, dermatological or cardiovascular manifestations. Onset typically occurred within 6 weeks of initiation and resolved upon discontinuation of Hydroxyurea. Upon re-administration fever re- occurred typically within 24 hours. Blood and lymphatic system disorders: hemolytic anemia Adverse reactions observed with combined Hydroxyurea and irradiation therapy are similar to those reported with the use of Hydroxyurea or radiation treatment alone. These effects primarily include bone marrow depression (anemia and leukopenia), gastric irritation, and mucositis. Almost all patients receiving an adequate course of combined Hydroxyurea and irradiation therapy will demonstrate concurrent leukopenia. Abridged from the full prescribing information.

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Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.