ANAGRELIDE HYDROCHLORIDE capsule

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

ANAGRELIDE HYDROCHLORIDE (UNII: YTM763Y5C8) (ANAGRELIDE - UNII:K9X45X0051)

Boleh didapati daripada:

Teva Pharmaceuticals USA, Inc.

INN (Nama Antarabangsa):

ANAGRELIDE HYDROCHLORIDE

Komposisi:

ANAGRELIDE 0.5 mg

Laluan pentadbiran:

ORAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Anagrelide capsules 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. None. Risk Summary Available data from case reports with anagrelide use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. In animal embryo-fetal studies, delayed fetal development (delayed skeletal ossification and reduced body weight) was observed in rats administered anagrelide hydrochloride during organogenesis at doses approximately 97 times the maximum clinical dose (10 mg/day) based on body surface area (see Data) . There are adverse effects on maternal and fetal outcomes associated with thrombocythemia in pregnancy (see Clinical Considerations). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown

Ringkasan produk:

Anagrelide Capsules USP, 0.5 mg are available as light gray opaque cap/white opaque body hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5241” on the cap and “0.5 mg” on the body containing 0.5 mg of anagrelide base (as anagrelide hydrochloride, USP). NDC 0172-5241 -60 0.5 mg packaged in bottles of 100 capsules Anagrelide Capsules USP, 1 mg are available as white opaque hard gelatin capsules, spin printed in black ink “Ivax hourglass logo” “5240” on the cap and “1 mg” on the body containing 1 mg of anagrelide base (as anagrelide hydrochloride, USP). NDC 0172-5240 -60 1 mg packaged in bottles of 100 capsules Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

ANAGRELIDE HYDROCHLORIDE- ANAGRELIDE HYDROCHLORIDE CAPSULE
TEVA PHARMACEUTICALS USA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ANAGRELIDE CAPSULES
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
ANAGRELIDE CAPSULES.
ANAGRELIDE CAPSULES, FOR ORAL USE
INITIAL U.S. APPROVAL: 1997
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
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)
DOSAGE FORMS AND STRENGTHS
Capsules: 0.5 mg and 1 mg. (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Cardiovascular Toxicity: QT prolongation and ventricular tachycardia
have been reported with
anagrelide. Obtain a pre-treatment cardiovascular examination
including an ECG in all patients. Monitor
patients for cardiovascular effects. (5.1)
Pulmonary Hypertension: Assess underlying cardiopulmonary disease
prior to initiating therapy. (5.2)
Bleeding Risk: Monitor patients for bleeding, including those
receiving concomitant therapy with other
drugs known to cause bleeding. (5.3)
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, and dyspep