Ticlopidine (Ticlopidine Hydrochloride) - Indications and Dosage

INDICATIONS AND USAGE

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 hydrochloride 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 hydrochloride 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).

DOSAGE AND ADMINISTRATION

Stroke

The recommended dose of ticlopidine hydrochloride tablets is 250 mg bid taken with food. Other doses have not been studied in controlled trials for these indications.

Coronary Artery Stenting

The recommended dose of ticlopidine hydrochloride tablets is 250 mg bid taken with food together with antiplatelet doses of aspirin for up to 30 days of therapy following successful stent implantation.

HOW SUPPLIED

Ticlopidine hydrochloride is available in white to off-white, oval, biconvex, unscored, film-coated 250 mg tablets, debossed with “G” on one side and "T250" on the other. They are provided:

- in unit of use bottles of 30 tablets (NDC 55567-054-13)

- in bottles of 100 tablets (NDC 55567-054-18)

- in bottles of 500 tablets (NDC 55567-054-25)

- in cartons of 98 blister packed tablets (NDC 55567-054-07).

Store at 15° to 30°C (59° to 86°F). Dispense in a tight light-resistant container. A Patient Package Insert should be dispensed with each prescription.

IMPORTANT INFORMATION ABOUT TICLOPIDINE HCl TABLETS

The information in this leaflet is intended to help you use ticlopidine hydrochloride safely. Please read the leaflet carefully. Although it does not contain all the detailed medical information that is provided to your doctor, it provides facts about ticlopidine hydrochloride that are important for you to know. If you still have questions after reading this leaflet or if you have questions at any time during your treatment with ticlopidine hydrochloride, check with your doctor.

Why Ticlopidine Hydrochloride was Prescribed by Your Doctor