Drug Catalog - Product Detail
HYDROXYUREA CAP 500 MG 100 CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 49884-0724-01 | PAR PHARMACEUTICAL | 100 | 500MG | CAPSULE |
PACKAGE FILES
Generic Name
HYDROXYUREA
Substance Name
HYDROXYUREA
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA075340
Description
11 DESCRIPTION Hydroxyurea Capsules, USP are an antimetabolite available for oral use as capsules containing 500 mg hydroxyurea. Inactive ingredients include colloidal silicon dioxide, magnesium stearate, colorants (D&C Yellow No. 10, FD&C Blue No. 1 and FD&C Red No. 40), gelatin and titanium dioxide. Imprinting ink constituents: D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, shellac glaze, propylene glycol, ammonium hydroxide, simethicone, synthetic black iron oxide 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 CH 4 N 2 O 2 and it has a molecular weight of 76.05. Its structural formula is: This is the structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Hydroxyurea capsules, USP 500 mg are dark green opaque (cap) printed "724" in white ink/ pink opaque (body) printed "par" in black ink capsules. They are supplied in bottles of 100 (NDC# 49884-724-01). Dispense in a tight container as defined in the USP. 16.2 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed. 16.3 Handling and Disposal Hydroxyurea capsule are a cytotoxic drug. Follow applicable special handling and disposal procedures [see References(15) ] . To decrease the risk of contact, advise caregivers to wear disposable gloves when handling hydroxyurea capsules or bottles containing hydroxyurea capsules. Wash hands with soap and water before and after contact with the bottle or capsules when handling hydroxyurea capsules. Do not open hydroxyurea capsules. Avoid exposure to crushed or opened capsules. If contact with crushed or opened capsules occurs on the skin, wash affected area immediately and thoroughly with soap and water. If contact with crushed or opened capsules occurs on the eye(s), the affected area should be flushed thoroughly with water or isotonic eyewash designated for that purpose for at least 15 minutes. If the powder from the capsule is spilled, immediately wipe it up with a damp disposable towel and discard in a closed container, such as a plastic bag; as should the empty capsules. The spill areas should then be cleaned three times using a detergent solution followed by clean water. Keep the medication away from children and pets. Contact your doctor for instructions on how to dispose of outdated capsules.
Indications & Usage
1 INDICATIONS AND USAGE Hydroxyurea capsules are 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 are an antimetabolite indicated for the treatment of: Resistant chronic myeloid leukemia. ( 1) Locally advanced squamous cell carcinomas of the head and neck, (excluding lip) in combination with concurrent chemoradiation. ( 1 )
Dosage and Administration
2 DOSAGE AND ADMINISTRATION Individualize treatment based on tumor type, disease state, response to treatment, patient risk factors, and current clinical practice standards. (2.1) Renal impairment: Reduce the dose of hydroxyurea capsules by 50% in patients with creatinine clearance less than 60 mL/min. (2.3, 8.6, 12.3) 2.1 Dosing Information 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 [see References (15) ]. Swallow hydroxyurea capsules whole. Do NOT open, break, or chew capsules because hydroxyurea capsules are a cytotoxic drug. Prophylactic administration of folic acid is recommended [ see Warnings and Precautions (5.8) ]. Monitor blood counts at least once a week during hydroxyurea capsules therapy. Severe anemia must be corrected before initiating therapy with hydroxyurea capsules. 2.2 Dose Modifications for Toxicity Monitor for the following and reduce the dose or discontinue hydroxyurea capsules accordingly: Myelosuppression [ see Warnings and Precautions (5.1) ]. Cutaneous vasculitis [ see Warnings and Precautions (5.5) ] Consider dose modifications for other toxicities. 2.3 Dose Modifications for Renal Impairment Reduce the dose of hydroxyurea capsules by 50% in patients with measured creatinine clearance of less than 60 mL/min or with end-stage renal disease (ESRD) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3) ]. Creatinine Clearance (mL/min) Recommended Hydroxyurea Capsules Initial Dose (mg/kg once daily) ≥60 15 <60 or ESRD* 7.5 *On dialysis days, administer hydroxyurea capsules to patients following hemodialysis. Close monitoring of hematologic parameters is advised in these patients.