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:

Carilion Materials Management

INN (International Name):

TICLOPIDINE HYDROCHLORIDE

Composition:

TICLOPIDINE HYDROCHLORIDE 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Ticlopidine Hydrochloride Tablets USP 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 and ), ticlopidine should be reserved for patients who are intolerant or allergic to aspirin therapy or who have failed aspirin therapy. BOXED WARNING WARNINGS - 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

Product summary:

NDC:68151-0079-0 in a BOTTLE of 1 TABLET, FILM COATEDS

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TICLOPIDINE HYDROCHLORIDE- TICLOPIDINE HYDROCHLORIDE TABLET, FILM
COATED
CARILION MATERIALS MANAGEMENT
----------
TICLOPIDINE HYDROCHLORIDE TABLETS USP 0154 RX ONLY
WARNING
TICLOPIDINE CAN CAUSE LIFE-THREATENING HEMATOLOGICAL ADVERSE
REACTIONS, INCLUDING
NEUTROPENIA/AGRANULOCYTOSIS, THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP)
AND APLASTIC
ANEMIA.
NEUTROPENIA/AGRANULOCYTOS IS
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