Mylan-Hydroxyurea

Mylan-Hydroxyurea Uses, Dosage, Side Effects, Food Interaction and all others data.

Mylan-Hydroxyurea is converted to a free radical nitroxide (NO) in vivo, and transported by diffusion into cells where it quenches the tyrosyl free radical at the active site of the M2 protein subunit of ribonucleotide reductase, inactivating the enzyme. The entire replicase complex, including ribonucleotide reductase, is inactivated and DNA synthesis is selectively inhibited, producing cell death in S phase and synchronization of the fraction of cells that survive. Repair of DNA damaged by chemicals or irradiation is also inhibited by hydroxyurea, offering potential synergy between hydroxyurea and radiation or alkylating agents. Mylan-Hydroxyurea also increases the level of fetal hemoglobin, leading to a reduction in the incidence of vasoocclusive crises in sickle cell anemia. Levels of fetal hemoglobin increase in response to activation of soluble guanylyl cyclase (sGC) by hydroxyurea-derived NO.

Mylan-Hydroxyurea has dose-dependent synergistic activity with cisplatin in vitro. In vivo Mylan-Hydroxyurea showed activity in combination with cisplatin against the LX-1 and CALU-6 human lung xenografts, but minimal activity was seen with the NCI-H460 or NCI-H520 xenografts. Mylan-Hydroxyurea was synergistic with cisplatin in the Lewis lung murine xenograft. Sequential exposure to Mylan-Hydroxyurea 4 hours before cisplatin produced the greatest interaction.

Mylan-Hydroxyurea
Uses
Dosage
Side Effect
Precautions
Interactions
Uses during Pregnancy
Uses during Breastfeeding
Accute Overdose
Food Interaction
Half Life
Volume of Distribution
Clearance
Interaction With other Medicine
Contradiction
Storage

Trade Name	Mylan-Hydroxyurea
Availability	Prescription only
Generic	Hydroxyurea
Hydroxyurea Other Names	Carbamohydroxamic acid, Carbamohydroximic acid, Carbamoyl oxime, Carbamyl hydroxamate, Hidroxicarbamida, Hydrea, Hydroxycarbamid, Hydroxycarbamide, Hydroxycarbamidum, Hydroxyharnstoff, Hydroxyurea, N-Carbamoylhydroxylamine, N-Hydroxyurea, Oxyurea
Related Drugs	methotrexate, Keytruda, pembrolizumab, vitamin e, cyclophosphamide, imatinib, Gleevec, Sprycel, dostarlimab, Hydrea
Type
Formula	CH₄N₂O₂
Weight	Average: 76.0547 Monoisotopic: 76.027277382
Groups	Approved
Therapeutic Class	Cytotoxic Chemotherapy
Manufacturer
Available Country	Canada, United States
Last Updated:	September 19, 2023 at 7:00 am

Uses

Mylan-Hydroxyurea is used 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.

Mylan-Hydroxyurea is also used to associated treatment for these conditions: Essential Thrombocythemia (ET), Head and Neck Carcinoma, Hypereosinophilic Syndromes, Melanomas, Meningiomas, Ovarian Cancer Metastatic, Polycythemia Vera (PV), Sickle Cell Anemia, Chronic, refractory Myeloid Leukemia, Inoperable Ovarian cancer

How Mylan-Hydroxyurea works

Dosage

Mylan-Hydroxyurea dosage

Malignancies Chronic myeloid leukaemia: 20-30 mg/kg/day.

Solid tumours: 80 mg/kg every third day. With radiotherapy, start treatment 7 days before initiation of radiotherapy.

Sickle-cell disease: Initial: 15 mg/kg/day. Max: 35 mg/kg/ day. Adjust based on response and blood counts.

Essential thrombocythemia: 15 mg/kg/day. Adjust based on platelet counts.

Side Effects

Gl disturbances, Nausea, Vomiting, Constipation, Diarrhea, Hyperuricemia, Renal failure, Rash, Hyperpigmentation. Pulmonary oedema, dermatological reactions, headache, dizziness. Disorientation, drowsiness, hallucinations, convulsions, alopecia.

Toxicity

Oral, mouse: LD₅₀ = 7330 mg/kg; Oral, rat: LD₅₀ = 5760 mg/kg Teratogenicity: Teratogenic effects have occurred in experimental animals.Mylan-Hydroxyurea use during a small number of human pregnancies has been reported. Adverse effects have not been observed in any of the exposed newborns. Reproductive Effects: Adverse reproductive effects have occurred in experimental animals. Mutagenicity: Mutagenic effects have occurred in experimental animals.Mutagenic effects have occurred in humans.

Precaution

Regular monitoring of uric acid concentrations, blood counts, renal and hepatic function is recommended. Prior irradiation therapy. Elderly. Avoid use of live vaccines.

Interaction

Impairs immune response to vaccines; possible infection with live vaccines, zidovudine, zalcitabine. May alter action of oral anticoagulants and phenytoin.

Food Interaction

Drink plenty of fluids.
Take with or without food.

Mylan-Hydroxyurea Drug Interaction

Unknown: aspirin, aspirin, aspirin, aspirin, apixaban, apixaban, omega-3 polyunsaturated fatty acids, omega-3 polyunsaturated fatty acids, furosemide, furosemide, clopidogrel, clopidogrel, acetaminophen, acetaminophen, cyanocobalamin, cyanocobalamin, ascorbic acid, ascorbic acid, cholecalciferol, cholecalciferol

Mylan-Hydroxyurea Disease Interaction

Major: myelosuppression, renal dysfunctionModerate: hepatic dysfunction, seizure disordersMinor: neurologic disorders

Elimination Route

Well absorbed from the gastrointestinal tract.

Half Life

3-4 hours

Elimination Route

Renal excretion is a pathway of elimination.

Pregnancy & Breastfeeding use

Pregnancy category D. There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Lactation: Excreted in breast milk, do not nurse