HYDROXYUREA capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

AvKARE

INN (الاسم الدولي):

HYDROXYUREA

تركيب:

HYDROXYUREA 500 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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 is 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

ملخص المنتج:

Hydroxyurea Capsules USP 500 mg are available as a two-piece hard gelatin capsule with purple opaque cap and pink opaque body filled with white powder, imprinted in black ink stylized barr 882 and packaged in bottles of 100 capsules (NDC 42291-321-01). Store at 20º to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). STORE IN A DRY ATMOSPHERE AND AVOID EXCESSIVE HEAT. WEAR GLOVES AT ALL TIMES WHEN HANDLING CONTAINERS. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Hydroxyurea Capsules USP 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 USP or bottles containing Hydroxyurea Capsules USP. Wash hands with soap and water before and after contact with the bottle or capsules when handling Hydroxyurea Capsules USP. Do not open Hydroxyurea Capsules USP. 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
AVKARE
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
HYDROXYUREA CAPSULES USP
RX ONLY
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, FOR ORAL USE
INITIAL U.S. APPROVAL: 1967
INDICATIONS AND USAGE
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
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)
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;
discontinue hydroxyurea capsules, and implement treatment. ( 5.6)
Radiation recall: Monitor for skin erythema in pati