ANAGRELIDE HYDROCHLORIDE capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Avera McKennan Hospital

INN (Tarptautinis Pavadinimas):

ANAGRELIDE HYDROCHLORIDE

Sudėtis:

ANAGRELIDE 0.5 mg

Recepto tipas:

PRESCRIPTION DRUG

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

ANAGRELIDE HYDROCHLORIDE- ANAGRELIDE HYDROCHLORIDE CAPSULE
AVERA MCKENNAN HOSPITAL
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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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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: 1/2016
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 prolongatio