ANAGRELIDE HYDROCHLORIDE capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

ANAGRELIDE HYDROCHLORIDE (UNII: VNS4435G39) (ANAGRELIDE - UNII:K9X45X0051)

متاح من:

Carilion Materials Management

INN (الاسم الدولي):

ANAGRELIDE HYDROCHLORIDE

تركيب:

ANAGRELIDE 0.5 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Anagrelide capsules USP are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative neoplasms, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events [see Clinical Studies (14), Dosage and Administration (2)] . None. Teratogenic Effects Pregnancy Category C Risk Summary There are no adequate and well-controlled studies with anagrelide in pregnant women. In animal embryo-fetal studies, delayed development (delayed skeletal ossification and reduced body weight) was observed in rats administered anagrelide hydrochloride during organogenesis at doses substantially higher than the maximum clinical dose of 10 mg/day. Anagrelide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal Data Anagrelide hydrochloride was administered orally to pregnant rats and rabbits during the period of organogenesis at doses up to 900 mg/kg/day in rats and

ملخص المنتج:

Product: 68151-2959 NDC: 68151-2959-6 1 CAPSULE in a PACKAGE

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

ANAGRELIDE HYDROCHLORIDE- ANAGRELIDE HYDROCHLORIDE CAPSULE
CARILION MATERIALS MANAGEMENT
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ANAGRELIDE CAPSULES USP SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ANAGRELIDE CAPSULES
USP.
ANAGRELIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
Dosage and Administration (2) 10/2014
Contraindications (4) 10/2014
Warnings and Precautions (5) 10/2014
INDICATIONS AND USAGE
Anagrelide is a platelet reducing agent indicated for the treatment of
thrombocythemia, secondary to myeloproliferative
neoplasms, to reduce the elevated platelet count and the risk of
thrombosis and to ameliorate associated symptoms
including thrombo-hemorrhagic events. (1)
DOSAGE AND ADMINISTRATION
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•
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•
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DOSAGE FORMS AND STRENGTHS
Capsules: 0.5 mg, 1 mg (3)
CONTRAINDICATIONS
None (4)
WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
The most common adverse reactions (incidence ≥ 5%) are headache,
palpitations, diarrhea, asthenia, edema, nausea,
abdominal pain, dizziness, pain, dyspnea, cough, flatulence, vomiting,
fever, peripheral edema, rash, chest pain, anorexia,
tachycardia, malaise, paresthesia, back pain, pruritus, dyspepsia
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT TEVA USA,
PHARMACOVIGILANCE AT 1-866-832-8537
OR [e-mail]; OR FDA AT 1-800-FDA-1088 OR
www.fda.gov/medwatch.
DRUG INTERACTIONS
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USE IN SPECIFIC POPULATIONS
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 8/2016
The starting dose for adults is 0.5 mg four times a day or 1 mg twice
a day (2.1)
The starting dose for pediatric patients is 0.5 mg per day (2.1)
Maintain the starting dose for at least one week and then titrate to
maintain target platelet counts (2.2)
Do not exceed a dose increment of 0.5 mg/day in any one week. Do not
exceed 10 mg/day or 2.5 mg in a single dose.
(2.2)
Moderate hepatic impairment: Start with 0.5 mg per day (2.3)
Cardiovascular Toxicity: QT prolo