HYDROXYUREA capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

HYDROXYUREA (UNII: X6Q56QN5QC) (HYDROXYUREA - UNII:X6Q56QN5QC)

متاح من:

Golden State Medical Supply, Inc.

INN (الاسم الدولي):

HYDROXYUREA

تركيب:

HYDROXYUREA 500 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Hydroxyurea capsules, USP is 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 contraindicated in patients who have demonstrated a previous hypersensitivity to hydroxyurea or any other component of the formulation. Risk Summary Hydroxyurea capsules can cause fetal harm based on findings from animal studies and the drug’s mechanism of action [see  Clinical Pharmacology (12.1) ]. There are no data with hydroxyurea capsules use in pregnant women to inform a drug-associated risk. In animal reproduction studies, administration of hydroxyurea to pregnant rats and rabbits during organogenesis produced embryotoxic and teratogenic effects at doses 0.8 times and 0.3 times, respectively, the maximum recommended human daily dose on a mg/m 2 basis ( see Data ). Advise women of the potential risk to a fetus and to avo

ملخص المنتج:

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# 60429-265-01). Dispense in a tight container as defined in the USP. Store at 20 to 25°C (68 to77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep tightly closed. Hydroxyurea capsules is 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.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

HYDROXYUREA- HYDROXYUREA CAPSULE
GOLDEN STATE MEDICAL SUPPLY, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
HYDROXYUREA. THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION
NEEDED TO USE
HYDROXYUREA CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
HYDROXYUREA CAPSULES. HYDROXYUREA CAPSULES, USP, FOR ORAL USE
INITIAL U.S. APPROVAL: 1967
---------------------RECENT MAJOR CHANGES--------------
WARNINGS AND PRECAUTIONS, PULMONARY TOXICITY (5.9) 7/2019
INDICATIONS AND USAGE
Hydroxyurea capsules, USP is 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
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 by 50% in patients
with creatinine clearance less
than 60 mL/min. (2.3, 8.6, 12.3)
DOSAGE FORMS AND STRENGTHS
Capsules: 500 mg (3)
CONTRAINDICATIONS
In patients who have demonstrated a previous hypersensitivity to
hydroxyurea or any other component
of its formulation. ( 4)
WARNINGS AND PRECAUTIONS
Myelosuppression: Do not give if bone marrow function is markedly
depressed. Monitor hematology
labs and interrupt, reduce dose as appropriate. (5.1)
Malignancies: Advise protection from sun exposure and monitor for
secondary malignancies. (5.2)
Embryo-fetal toxicity: Can cause fetal harm. Advise of potential risk
to a fetus and use of effective
contraception. ( 5.3, 8.1, 8.3)
Vasculitic toxicities: Discontinue hydroxyurea and initiate treatment
if this occurs. (5.4)
Live Vaccinations: Avoid live vaccine use in a patient taking
hydroxyurea capsules. (5.5)
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;
disco