TICLOPIDINE HYDROCHLORIDE tablet film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ticlopidine hydrochloride (UNII: A1L4914FMF) (ticlopidine - UNII:OM90ZUW7M1)

Available from:

Apotex Corp.

INN (International Name):

Ticlopidine hydrochloride

Composition:

Ticlopidine hydrochloride 250 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TICLOPIDINE HYDROCHLORIDE- TICLOPIDINE HYDROCHLORIDE TABLET, FILM
COATED
APOTEX CORP.
----------
TICLOPIDINE HYDROCHLORIDE TABLETS, USP 250 MG
RX ONLY
WARNING: TICLOPIDINE 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. THE 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 RELIABLY PREDICTED BY AN