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Hydroxyurea

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Overview

What is HYDROXYUREA?

Hydroxyurea Capsules USP are an antineoplastic available for oral use as capsules providing 500 mg hydroxyurea, USP. Inactive ingredients: anhydrous citric acid, benzyl alcohol, black iron oxide, butylparaben, carboxymethylcellulose sodium, D&C red no. 28, D&C yellow no. 10 aluminum lake, dibasic sodium phosphate, edetate calcium disodium, FD&C blue no. 1, FD&C blue no. 1 aluminum lake, FD&C blue no. 2 aluminum lake, FD&C red no. 40, FD&C red no. 40 aluminum lake, gelatin, lactose monohydrate, magnesium stearate, methylparaben, pharmaceutical glaze, propylparaben, propylene glycol, red iron oxide, sodium lauryl sulfate, sodium propionate, and titanium dioxide.

Hydroxyurea, USP is a white to off-white crystalline powder. It is hygroscopic and freely soluble in water, but practically insoluble in alcohol. Its structural formula is:

CHNO M.W. 76.05



What does HYDROXYUREA look like?



What are the available doses of HYDROXYUREA?

Capsules: 500 mg purple opaque cap and pink opaque body imprinted in black ink stylized barr 882.

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

How should I use HYDROXYUREA?

Hydroxyurea capsules are indicated for the treatment of:

Hydroxyurea capsules are 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.

Hydroxyurea capsules are a cytotoxic drug. Follow applicable special handling and disposal procedures [].

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

Prophylactic administration of folic acid is recommended


What interacts with HYDROXYUREA?

Sorry No Records found


What are the warnings of HYDROXYUREA?

Sorry No Records found


What are the precautions of HYDROXYUREA?

Sorry No Records found


What are the side effects of HYDROXYUREA?

Sorry No records found


What should I look out for while using HYDROXYUREA?

Hydroxyurea 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 HYDROXYUREA?

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 HYDROXYUREA?

ORTHO-NOVUM 7/7/7 ORTHO-NOVUM 7/7/7ORTHO-NOVUM 7/7/7 ORTHO-NOVUM 1/35 ORTHO-NOVUM 1/35ORTHO-NOVUM 7/7/7 ORTHO-NOVUM 7/7/7ORTHO-NOVUM 7/7/7 ORTHO-NOVUM 1/35 ORTHO-NOVUM 1/35ORTHO-NOVUM 7/7/7 ORTHO-NOVUM 7/7/7ORTHO-NOVUM 7/7/7 ORTHO-NOVUM 1/35 ORTHO-NOVUM 1/35ORTHO-NOVUM 7/7/7 ORTHO-NOVUM 7/7/7ORTHO-NOVUM 7/7/7 ORTHO-NOVUM 1/35 ORTHO-NOVUM 1/35ORTHO-NOVUM 7/7/7 ORTHO-NOVUM 7/7/7ORTHO-NOVUM 7/7/7 ORTHO-NOVUM 1/35 ORTHO-NOVUM 1/35


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Clinical Information

Chemical Structure

No Image found
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
Hydroxyurea is contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation.

Consult the labeling of concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

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 capsules as needed. Recovery from myelosuppression is usually rapid when therapy is interrupted.

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

6.1 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of hydroxyurea. 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. Hydroxyurea may potentiate some adverse reactions usually seen with irradiation alone, such as gastric distress and mucositis.

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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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