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Vascor

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Vascor

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

Side Effects
Interactions

SIDE EFFECTS

Adverse reactions were assessed in placebo and active-drug controlled trials of 4-12 weeks duration and longer-term uncontrolled studies. The most common side effects occurring more frequently than in control groups were upper gastrointestinal complaints (nausea, dyspepsia or GI distress) in about 22%, diarrhea in about 8%, dizziness in about 15%, asthenia in about 10% and nervousness in about 7%. The adverse reactions seen in at least 2% of bepridil patients in controlled trials are shown in the following table.

 

Adverse Experiences by Body System and Treatment in Greater
Than 2% of Bepridil Patients in Controlled Trials
Bepridil HCl
(N = 529)
Nifedipine
(N = 50)
Propranolol
(N = 88)
Diltiazem
(N = 41)
Placebo
(N = 190)
Body as a Whole
  Asthenia
 9.83 22.00 22.73 12.20  7.37
  Headache
11.34 22.00 13.64  7.32 14.21
 2.08  8.00  2.27 a  1.05
Cardiovascular/Respiratory
 2.27  6.00  2.27  0.00  1.58
  Dyspnea
 3.59  4.00  5.68  4.88  2.11
 2.84  4.00  3.41  4.88  3.68
Gastrointestinal
  Dyspepsia
 6.81  4.00  5.68  4.88  1.58
  G.I. Distress
 4.35 10.00  6.82 a  2.11
  Nausea
12.29 14.00 11.36  2.44  3.68
 3.40  0.00  0.00  2.44  2.63
 3.02  0.00  2.27  0.00  1.58
  Diarrhea
 7.75  2.00  9.09  2.44  2.63
 3.02  4.00  1.14 a  3.16
  Constipation
 2.84  6.00  1.14  4.88  2.11
  Drowsy
 3.78  4.00  4.55 a  3.68
 2.65  6.00  3.41 a  1.05
  Dizziness
14.74 30.00 10.23  4.88  9.47
  Tremor
 4.91  4.00  0.00 a  1.05
  Tremor of Hand
 3.02  4.00  0.00 a  0.53
 2.46  2.00  1.14  4.88  3.16
  Nervous
 7.37 16.00  1.14  2.44  3.68
a No data available.

In one twelve week controlled study, daily doses of 200, 300, and 400 mg were compared to placebo. The following table shows the rates of more common reactions (at least 5% in at least one bepridil group).

 

Adverse Experiences by Body System and Treatment In Greater Than 5%
of Bepridil Patients in Controlled Trials
Adverse Reaction
Bepridil HCl
200 mg
Bepridil HCl
300 mg
Bepridil HCl
400 mg
Placebo
 
(N = 43)
(N = 46)
(N = 44)
(N = 44)
Body as a Whole
  Asthenia
13.95  6.52 11.36  2.27
  Headache
 6.98  8.70 13.64 15.91
Cardiovascular/Respiratory
  Palpitations
 0.00  6.52  4.55  0.00
  Dyspnea
 2.33  8.70  0.00  2.27
Gastrointestinal
  G.I. Distress
 6.98  0.00  4.55  4.55
  Nausea
 6.98 26.09 18.18  2.27
  Anorexia
 0.00  2.17  6.82  2.27
  Diarrhea
 0.00 10.87  6.82  0.00
Central Nervous System
  Drowsy
 6.98  6.52  0.00  4.55
  Dizziness
11.63 15.22 27.27  6.82
  Tremor
 6.98  0.00  4.55  0.00
  Tremor of Hand
 9.30  0.00  4.55  0.00
Psychiatric
  Nervous
11.63  8.70 11.36  0.00
Special Senses
 0.00  6.52  2.27  2.27

Adverse experiences in long-term open studies were generally similar to those seen in controlled trials.

Although adverse experiences were frequent (at least one being reported in 71% of patients participating in controlled clinical trials), most were well-tolerated. About 15% of patients however, discontinued bepridil treatment because of adverse experiences. In controlled clinical trials, these were principally gastrointestinal (1.0%), dizziness (1.0%) ventricular arrhythmias (1.0%) and syncope (0.6%). The major reasons for discontinuation, with comparison to control agents, are shown below.

 

Most Common Events Resulting in Discontinuation
Adverse Reaction
Bepridil
(N = 515)
n (%)
Placebo
(N = 288)
n (%)
Positive Control
(N = 119)
n (%)
Dizziness
5 (0.97) 0 (0.0) 2 (1.68)
Gastrointestinal Symptoms
5 (0.97) 0 (0.0) 5 (4.20)
5 (0.97) 0 (0.0) 0 (0.0) 
Syncope
3 (0.58) 0 (0.0) 0 (0.0) 

Across all controlled and uncontrolled trials, VASCOR (bepridil) was evaluated in over 800 patients with chronic angina. In addition to the adverse reactions noted above, the following were observed in 0.5 to 2.0% of the VASCOR (bepridil) patients or are rarer, but potentially important events seen in clinical studies or reported in post marketing experience. In most cases it is not possible to determine whether there is a causal relationship to bepridil treatment.

Body as a Whole:   Fever, pain, myalgic asthenia, superinfection, flu syndrome.

Cardiovascular/Respiratory:   Sinus tachycardia, sinus bradycardia, hypertension, vasodilation, edema, ventricular premature contractions, ventricular tachycardia, prolonged QT interval, rhinitis, cough, pharyngitis.

Gastrointestinal:   Flatulence, gastritis, appetite increase, dry mouth, constipation.

Musculoskeletal:   Arthritis.

Central Nervous System:   Fainting, vertigo, akathisia, drowsiness, insomnia, tremor.

Psychiatric:   Depression, anxiousness, adverse behavior effect.

Skin:   Rash, sweating, skin irritation.

Special Senses:   Blurred vision, tinnitus, taste change.

Urogenital:   Loss of libido, impotence.

Abnormal Lab Values:   Abnormal liver function test, SGPT increase.

In postmarketing experience with other calcium blockers, gynecomastia has been rarely observed.

Certain cardiovascular events, such as acute myocardial infarction (about 3% of patients) worsened heart failure (1.9%), worsened angina (4.5%), severe arrhythmia (about 2.4% VT/VF) and sudden death (1.6%) have occurred in patients receiving bepridil, but have not been included as adverse events because they appear to be, and cannot be distinguished from, manifestations of the patient's underlying cardiac disease. Such events as torsades de pointes arrhythmias, prolonged QT/QTc, bradycardia, first degree heart block, which are probably related to bepridil, are included in the tables.

 

Read the Vascor (bepridil) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Nitrates:   The concomitant use of VASCOR (bepridil) with long- and short-acting nitrates has been safely tolerated in patients with stable angina pectoris. Sublingual nitroglycerin may be taken if necessary for the control of acute angina attacks during VASCOR (bepridil) therapy.

Beta-blocking Agents:   The concomitant use of VASCOR (bepridil) and beta-blocking agents has been well tolerated in patients with stable angina. Available data are not sufficient, however, to predict the effects of concomitant medication on patients with impaired ventricular function or cardiac conduction abnormalities (see CLINICAL PHARMACOLOGY and DOSAGE AND ADMINISTRATION ).

Digoxin:   In controlled studies in healthy volunteers, bepridil hydrochloride either had no effect (one study) or was associated with modest increases, about 30% (two studies) in steady-state serum digoxin concentrations. Limited clinical data in angina patients receiving concomitant bepridil hydrochloride and digoxin therapy indicate no discernible changes in serum digoxin levels. Available data are neither sufficient to rule out possible increases in serum digoxin with concomitant treatment in some patients, nor other possible interactions, particularly in patients with cardiac conduction abnormalities (Also see WARNINGS Congestive Heart Failure).

Oral Hypoglycemics:   VASCOR (bepridil) has been safely used in diabetic patients without significantly lowering their blood glucose levels or altering their need for insulin or oral hypoglycemic agents.

General Interactions:   Certain drugs could increase the likelihood of potentially serious adverse effects with bepridil hydrochloride. In general, these are drugs that have one or more pharmacologic activities similar to bepridil hydrochloride, including anti-arrhythmic agents such as quinidine and procainamide, cardiac glycosides and tricyclic anti-depressants. Anti-arrhythmics and tricyclic anti-depressants could exaggerate the prolongation of the QT interval observed with bepridil hydrochloride. Cardiac glycosides could exaggerate the depression of AV nodal conduction observed with bepridil hydrochloride.

Last reviewed on RxList: 3/30/2007
This monograph has been modified to include the generic and brand name in many instances.

Side Effects
Interactions
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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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