TICLOPIDINE HYDROCHLORIDE- ticlopidine hydrochloride tablet, film coated

Nchi: Marekani

Lugha: Kiingereza

Chanzo: NLM (National Library of Medicine)

Viambatanisho vya kazi:

TICLOPIDINE HYDROCHLORIDE (UNII: A1L4914FMF) (TICLOPIDINE - UNII:OM90ZUW7M1)

Inapatikana kutoka:

Eon Labs, Inc.

INN (Jina la Kimataifa):

TICLOPIDINE HYDROCHLORIDE

Tungo:

TICLOPIDINE HYDROCHLORIDE 250 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

Ticlopidine hydrochloride tablets are indicated: - to reduce the risk of thrombotic stroke (fatal or nonfatal) in patients who have experienced stroke precursors, and in patients who have had a completed thrombotic stroke. Because ticlopidine is associated with a risk of life-threatening blood dyscrasias including thrombotic thrombocytopenic purpura (TTP), neutropenia/agranulocytosis and aplastic anemia (see BOX WARNING  and WARNINGS ), ticlopidine should be reserved for patients who are intolerant or allergic to aspirin therapy or who have failed aspirin therapy. - as adjunctive therapy with aspirin to reduce the incidence of subacute stent thrombosis in patients undergoing successful coronary stent implantation (see CLINICAL TRIALS ). The use of ticlopidine is contraindicated in the following conditions: - Hypersensitivity to the drug - Presence of hematopoietic disorders such as neutropenia and thrombocytopenia or a past history of either TTP or aplastic anemia - Presence of a hemostatic disorder or active

Bidhaa muhtasari:

Ticlopidine hydrochloride tablets are available in off-white, unscored, oval, film-coated 250-mg tablets, imprinted E 115 on one side and plain on the other side. They are provided in bottles of 30 tablets, 60 tablets and 500 tablets. Store at 20°-25ºC (68º-77º F) [See USP Controlled Room Temperature.] Dispense contents with a child-resistant closure as required, and in a tight, light-resistant container as defined in the USP.

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

TICLOPIDINE HYDROCHLORIDE- TICLOPIDINE HYDROCHLORIDE TABLET, FILM
COATED
EON LABS, INC.
----------
TICLOPIDINE HYDROCHLORIDE TABLETS, 250 MG
BOX WARNING
WARNING: TICLOPIDINE HYDROCHLORIDE TABLETS CAN CAUSE LIFE-THREATENING
HEMATOLOGICAL
ADVERSE REACTIONS, INCLUDING NEUTROPENIA/AGRANULOCYTOSIS, THROMBOTIC
THROMBOCYTOPENIC
PURPURA (TTP) AND APLASTIC ANEMIA.
_NEUTROPENIA/AGRANULOCYTOSIS: _AMONG 2048 PATIENTS IN CLINICAL TRIALS
IN STROKE PATIENTS, THERE
WERE 50 CASES (2.4%) OF NEUTROPENIA (LESS THAN 1200 NEUTROPHILS/MM ),
AND THE NEUTROPHIL
COUNT WAS BELOW 450/MM IN 17 OF THESE PATIENTS (0.8% OF THE TOTAL
POPULATION).
_TTP: _ONE CASE OF THROMBOTIC THROMBOCYTOPENIC PURPURA WAS REPORTED
DURING CLINICAL TRIALS
IN STROKE PATIENTS. BASED ON POSTMARKETING DATA, US PHYSICIANS
REPORTED ABOUT 100 CASES
BETWEEN 1992 AND 1997. BASED ON AN ESTIMATED PATIENT EXPOSURE OF 2
MILLION TO 4 MILLION,
AND ASSUMING AN EVENT REPORTING RATE OF 10% (THE TRUE RATE IS NOT
KNOWN), THE INCIDENCE OF
TICLOPIDINE-ASSOCIATED TTP MAY BE AS HIGH AS ONE CASE IN EVERY 2000 TO
4000 PATIENTS
EXPOS ED.
_APLASTIC ANEMIA: _APLASTIC ANEMIA WAS NOT SEEN DURING CLINICAL TRIALS
IN STROKE PATIENTS, BUT
US PHYSICIANS REPORTED ABOUT 50 CASES BETWEEN 1992 AND 1998. BASED ON
AN ESTIMATED
PATIENT EXPOSURE OF 2 MILLION TO 4 MILLION, AND ASSUMING AN EVENT
REPORTING RATE OF 10% (THE
TRUE RATE IS NOT KNOWN), THE INCIDENCE OF TICLOPIDINE-ASSOCIATED
APLASTIC ANEMIA MAY BE AS
HIGH AS ONE CASE IN EVERY 4000 TO 8000 PATIENTS EXPOSED.
_MONITORING OF CLINICAL AND HEMATOLOGIC STATUS: _SEVERE HEMATOLOGICAL
ADVERSE REACTIONS MAY
OCCUR WITHIN A FEW DAYS OF THE START OF THERAPY. THIS INCIDENCE OF TTP
PEAKS AFTER ABOUT 3 TO
4 WEEKS OF THERAPY AND NEUTROPENIA PEAKS AT APPROXIMATELY 4 TO 6
WEEKS. THE INCIDENCE OF
APLASTIC ANEMIA PEAKS AFTER ABOUT 4 TO 8 WEEKS OF THERAPY. THE
INCIDENCE OF THE HEMATOLOGIC
ADVERSE REACTIONS DECLINES THEREAFTER. ONLY A FEW CASES OF
NEUTROPENIA, TTP, OR APLASTIC
ANEMIA HAVE ARISEN AFTER MORE THAN 3 MONTHS OF THERAPY.
HEMATOLOGICAL ADVERSE REACTIONS CANNOT BE