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Hydroxyurea (Hydrea)

Trade Name : HYDREA

E.R. Squibb & Sons, L.L.C.

CAPSULE

Strength 500 mg/1

HYDROXYUREA Antimetabolite [EPC],Urea [CS]

Delivery Process

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Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Hydroxyurea (Hydrea) which is also known as HYDREA and Manufactured by E.R. Squibb & Sons, L.L.C.. It is available in strength of 500 mg/1 per ml. Read more

Hydroxyurea (Hydrea) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Warnings and Precautions, Pulmonary Toxicityu00a0(5.9)u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 7/2019
  • HYDREA is indicated for the treatment of:
  • HYDREA is an antimetabolite indicated for the treatment of:
  • No data
  • Capsules: 500 mg opaque green cap and opaque pink body imprinted with u201cHYDREAu201d and u201c830u201d.
  • Capsules: 500 mg n
  • HYDREA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.
  • In patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of its formulation. n
  • No data
  • Myelosuppression: Do not give if bone marrow function is markedly depressed. Monitor hematology labs and interrupt, reduce dose as appropriate. n
  • Malignancies: Advise protection from sun exposure and monitor for secondary malignancies. n
  • Embryo-Fetal toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. , , n
  • Vasculitic toxicities: Discontinue HYDREA and initiate treatment if this occurs. n
  • Live Vaccinations: Avoid live vaccine use in a patient taking HYDREA. n
  • 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 HYDREA and implement treatment. n
  • Radiation recall: Monitor for skin erythema in patients who previously received radiation and manage symptomatically. n
  • The following clinically significant adverse reactions are described in detail in other labeling sections:
  • The following adverse reactions have been identified during post-approval use of HYDREA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
  • 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. Platelet depression (<100,000 cells/mm) has occurred in the presence of marked leukopenia. HYDREA may potentiate some adverse reactions usually seen with irradiation alone, such as gastric distress and mucositis.
  • Most common adverse reactions (u226530%) are hematological, gastrointestinal symptoms, and anorexia. n
  • No data
  • Antiretroviral drugs n
  • Laboratory Test Interference. ()
  • No data
  • Lactation:u00a0Advise women not to breastfeed. n
  • Geriatric Use: Care should be taken in dose selection and may require a lower dose regimen and monitoring of renal function. n
  • Acute mucocutaneous toxicity has been reported in patients receiving hydroxyurea at dosages several times the therapeutic dose. Soreness, violet erythema, edema on palms and soles followed by scaling of hands and feet, severe generalized hyperpigmentation of the skin, and stomatitis have also been observed.
  • HYDREA (hydroxyurea capsules, USP) is an antimetabolite available for oral use as capsules containing 500 mg hydroxyurea. Inactive ingredients include citric acid, colorants (D&C Yellow No. 10, FD&C Blue No. 1, FD&C Red No. 40, and D&C Red No. 28), gelatin, lactose, magnesium stearate, sodium phosphate, and titanium dioxide.
  • Hydroxyurea is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. The empirical formula is CHn Nn On and it has a molecular weight of 76.05. Its structural formula is:
  • No data
  • Conventional long-term studies to evaluate the carcinogenic potential of hydroxyurea have not been performed. However, intraperitoneal administration of 125 to 250 mg/kg hydroxyurea (about 0.6-1.2 times the maximum recommended human oral daily dose on a mg/m basis) thrice weekly for 6 months to female rats increased the incidence of mammary tumors in rats surviving to 18 months compared to control. Hydroxyurea is mutagenic to bacteria, fungi, protozoa, and mammalian cells. Hydroxyurea is clastogenic (hamster cells, human lymphoblasts) and (SCE assay in rodents, mouse micronucleus assay). Hydroxyurea causes the transformation of rodent embryo cells to a tumorigenic phenotype.
  • Hydroxyurea administered to male rats at 60 mg/kg/day (about 0.3 times the maximum recommended human daily dose on a mg/m basis) produced testicular atrophy, decreased spermatogenesis, and significantly reduced their ability to impregnate females.
  • OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.
  • No data
  • No data
  • Manufactured for:Bristol-Myers Squibb CompanyPrinceton, New Jersey 08543 USA
  • [1374777A2]u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 Revised: July 2019
  • See HOW SUPPLIED section for a complete list of available packages of HYDREA.
  • 100 CAPSULESNDC 0003-0830-50HYDREAn (hydroxyurea capsules, USP)500 mg per capsuleRx onlyBristol-Myers Squibb

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