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:

Caraco Pharmaceutical Laboratories, Ltd.

INN (Jina la Kimataifa):

TICLOPIDINE HYDROCHLORIDE

Tungo:

TICLOPIDINE HYDROCHLORIDE 250 mg

Njia ya uendeshaji:

ORAL

Dawa ya aina:

PRESCRIPTION DRUG

Matibabu dalili:

INDICATIONS AND USAGE: 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 BOXED 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 ). CONTRAINDICATIONS: 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 an

Bidhaa muhtasari:

Ticlopidine hydrochloride tablets, USP 250 mg, are available as white to off-white, oval shaped, biconvex, film coated tablets, debossed with “327” on one side and plain on the other side. NDC 57664-327-83 bottle of 30 NDC 57664-327-86 bottle of 60 NDC 57664-327-06 bottle of 60 NDC 57664-327-88 bottle of 100 NDC 57664-327-13 bottle of 500 Store at controlled room temperature 15° to 30° C (59° to 86° F). (See USP Controlled Room Temperature). Dispense in a tight, light-resistant container with a child-resistant closure (as required).

Idhini hali ya:

Abbreviated New Drug Application

Tabia za bidhaa

TICLOPIDINE HYDROCHLORIDE- TICLOPIDINE HYDROCHLORIDE TABLET, FILM
COATED
CARACO PHARMACEUTICAL LABORATORIES, LTD.
----------
TICLOPIDINE HYDROCHLORIDE TABLETS, USP
250MG
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 RELIA