Chronic Stable Angina (Classic Effort-Associated Angina)

VASCOR (bepridil hydrochloride) is indicated for the treatment of chronic stable angina (classic effort-associated angina). Because VASCOR has caused serious ventricular arrhythmias, including torsades de pointes type ventricular tachycardia, and the occurrence of cases of agranulocytosis associated with its use (see WARNINGS), it should be reserved for patients who have failed to respond optimally to, or are intolerant of, other anti-anginal medication.

VASCOR may be used alone or in combination with beta blockers and/or nitrates. Controlled clinical studies have shown an added effect when VASCOR is administered to patients already receiving propranolol.

Therapy with VASCOR (bepridil hydrochloride) should be individualized according to each patient's response and the physician's clinical judgement. The usual starting dose of VASCOR is 200 mg once daily. After 10 days, dosage may be adjusted upward depending upon the patient's response (e.g., ability to perform activities of daily living, QT interval, heart rate, and frequency and severity of angina). This long interval for dosage adjustment is needed because steady-state blood levels are not achieved until 8 days of therapy. In clinical trials, most patients were maintained at a dose of VASCOR of 300 mg once daily. The maximum daily dose of VASCOR is 400 mg and the established minimum effective dose is 200 mg daily.

The starting dose for elderly patients does not differ from that for young patients. After therapeutic response is demonstrated, however, elderly patients may require more frequent monitoring.

Food does not interfere with the absorption of VASCOR. (see CLINICAL PHARMACOLOGY Pharmacokinetics and Metabolism). If nausea is experienced with VASCOR, the drug may be given at meals or at bedtime.

VASCOR has not been studied adequately in patients with impaired hepatic or renal function. It is therefore possible that dosage adjustments may be necessary in these patients.

Concomitant Use with Other Agents

The concomitant use of VASCOR and beta-blocking agents in patients without heart failure is safely tolerated. Physicians wishing to switch patients from beta-blocker therapy to VASCOR therapy may initiate VASCOR before terminating the beta blocker in the usual gradual fashion (see CLINICAL PHARMACOLOGY and PRECAUTIONS ).

VASCOR® (bepridil hydrochloride) tablets 200 mg (film coated light blue, scored, printed VASCOR and 200), 90 tablets (3 bottles of 30) (NDC 0045-0682-33)

VASCOR® (bepridil hydrochloride) tablets 300 mg (film coated blue, printed VASCOR and 300), 90 tablets (3 bottles of 30) (NDC 0045-0683-33).

Store at 15°-25° C (59°-77° F). Protect from light.

OMP Division
ORTHO-MCNEIL PHARMACEUTICAL, INC.
RARITAN, NEW JERSEY 08869

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