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HYDROXYUREA

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Overview

What is HYDREA?

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 CHNO and it has a molecular weight of 76.05. Its structural formula is:



What does HYDREA look like?



What are the available doses of HYDREA?

Capsules: 500 mg opaque green cap and opaque pink body imprinted with “HYDREA” and “830.”

What should I talk to my health care provider before I take HYDREA?

How should I use HYDREA?

HYDREA is indicated for the treatment of:

HYDREA is used alone or in conjunction with other antitumor agents or radiation therapy to treat neoplastic diseases. Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards.

Base all dosage on the patient’s actual or ideal weight, whichever is less.

HYDREA is a cytotoxic drug. Follow applicable special handling and disposal procedures

Patients should swallow HYDREA capsules whole and not to open, since hydroxurea is a cytotoxic drug.

Prophylactic administration of folic acid is recommended .


What interacts with HYDREA?

Sorry No Records found


What are the warnings of HYDREA?

Sorry No Records found


What are the precautions of HYDREA?

Sorry No Records found


What are the side effects of HYDREA?

Sorry No records found


What should I look out for while using HYDREA?

HYDREA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.


What might happen if I take too much HYDREA?

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.


How should I store and handle HYDREA?

Store at 20°C to 25°C (68 °F to 77°F) [See USP Controlled Room Temperature]. Protect from light.Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg NDC 51079-777-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg NDC 51079-778-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg NDC 51079-779-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg NDC 51079-777-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg NDC 51079-778-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg NDC 51079-779-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg NDC 51079-777-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg NDC 51079-778-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg NDC 51079-779-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg NDC 51079-777-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg NDC 51079-778-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg NDC 51079-779-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg NDC 51079-777-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg NDC 51079-778-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg NDC 51079-779-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 5 mg/325 mg NDC 51079-777-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5 mg/325 mg NDC 51079-778-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg NDC 51079-779-20 – Unit dose blister packages of 100 (10 cards of 10 tablets each).


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Clinical Information

Chemical Structure

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Clinical Pharmacology

The precise mechanism by which hydroxyurea produces its antineoplastic effects cannot, at present, be described. However, the reports of various studies in tissue culture in rats and humans lend support to the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein. This hypothesis explains why, under certain conditions, hydroxyurea may induce teratogenic effects.

Three mechanisms of action have been postulated for the increased effectiveness of concomitant use of hydroxyurea therapy with irradiation on squamous cell (epidermoid) carcinomas of the head and neck. studies utilizing Chinese hamster cells suggest that hydroxyurea (1) is lethal to normally radioresistant S-stage cells, and (2) holds other cells of the cell cycle in the G1 or pre-DNA synthesis stage where they are most susceptible to the effects of irradiation. The third mechanism of action has been theorized on the basis of studies of HeLa cells. It appears that hydroxyurea, by inhibition of DNA synthesis, hinders the normal repair process of cells damaged but not killed by irradiation, thereby decreasing their survival rate; RNA and protein syntheses have shown no alteration.

Non-Clinical Toxicology
HYDREA is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.

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 HYDREA. Provide supportive care and modify dose or discontinue HYDREA as needed. Recovery from myelosuppression is usually rapid when therapy is interrupted.

The following adverse reactions are described in detail in other labeling sections:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Interactions

Interactions

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