ANAGRELIDE HYDROCHLORIDE capsule

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

Anagrelide Hydrochloride (UNII: VNS4435G39) (Anagrelide - UNII:K9X45X0051)

זמין מ:

Physicians Total Care, Inc.

INN (שם בינלאומי):

Anagrelide Hydrochloride

הרכב:

Anagrelide 0.5 mg

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Anagrelide hydrochloride capsules are indicated for the treatment of patients with thrombocythemia, secondary to myeloproliferative disorders, to reduce the elevated platelet count and the risk of thrombosis and to ameliorate associated symptoms including thrombo-hemorrhagic events (see CLINICAL STUDIES , DOSAGE AND ADMINISTRATION ). Anagrelide is contraindicated in patients with severe hepatic impairment. Exposure to anagrelide is increased 8 fold in patients with moderate hepatic impairment (see CLINICAL PHARMACOLOGY ). Use of anagrelide in patients with severe hepatic impairment has not been studied (see also WARNINGS, Hepatic ).

leaflet_short:

Anagrelide Hydrochloride Capsules are available as light gray cap/white body hard gelatin capsules, spin printed in black ink “5241” on the cap and "0.5 mg" on the body containing 0.5 mg of anagrelide base (as anagrelide hydrochloride) packaged in bottles of 30 capsules. PHARMACIST: Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Manufactured In India By: Cipla Ltd. Goa, India Manufactured For: TEVA PHARMACEUTICALS USA Sellersville, PA 18960 Rev. C 2/2011 ANAGRELIDE HYDROCHLORIDE CAPSULES Relabeling and Repackaging by: Physicians Total Care, Inc. Tulsa, Oklahoma        74146

מצב אישור:

Abbreviated New Drug Application

מאפייני מוצר

ANAGRELIDE HYDROCHLORIDE - ANAGRELIDE HYDROCHLORIDE CAPSULE
PHYSICIANS TOTAL CARE, INC.
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ANAGRELIDE HYDROCHLORIDE CAPSULES
RX ONLY
DESCRIPTION
Anagrelide hydrochloride is an off white powder that is very slightly
soluble in water and sparingly
soluble in dimethyl sulfoxide and in dimethylformamide. Anagrelide
hydrochloride is a platelet-
reducing agent with a chemical name of
6,7-dichloro-1,5-dihydroimidazo[2,1-b] quinazolin-2(3H)-one
monohydrochloride monohydrate, and it has the following structural
formula:
C
H Cl
N O·HCl·H O M.W. 310.55
Each anagrelide hydrochloride capsule, for oral administration,
contains either 0.5 mg or 1 mg of
anagrelide base (as anagrelide hydrochloride) and has the following
inactive ingredients: black iron
oxide, crospovidone, D&C yellow #10 aluminum lake, FD&C blue
#1/brilliant blue aluminum lake,
FD&C blue #2/indigo carmine aluminum lake, FD&C red #40/allura red
aluminum lake, gelatin, lactose
anhydrous, lactose monohydrate, magnesium stearate, microcrystalline
cellulose, povidone, propylene
glycol, shellac glaze and titanium dioxide.
CLINICAL PHARMACOLOGY
The mechanism by which anagrelide reduces blood platelet count is
still under investigation. Studies in
patients support a hypothesis of dose-related reduction in platelet
production resulting from a decrease
in megakaryocyte hypermaturation. In blood withdrawn from normal
volunteers treated with anagrelide,
a disruption was found in the postmitotic phase of megakaryocyte
development and a reduction in
megakaryocyte size and ploidy. At therapeutic doses, anagrelide does
not produce significant changes
in white cell counts or coagulation parameters, and may have a small,
but clinically insignificant effect
on red cell parameters. Anagrelide inhibits cyclic AMP
phosphodiesterase III (PDEIII). PDEIII
inhibitors can also inhibit platelet aggregation. However, significant
inhibition of platelet aggregation
is observed only at doses of anagrelide higher than those required to
reduce platelet count.
Following oral administrat