Verelan Information
Verelan (Verapamil)
Verelan (Verapamil) Description
Verelan (Verapamil) (verapamil hydrochloride capsules) is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). Verelan (Verapamil) is available for oral administration as a 360 mg hard gelatin capsule (lavender cap/yellow body), a 240 mg hard gelatin capsule (dark blue cap/yellow body), a 180 mg hard gelatin capsule (light grey cap/yellow body), and a 120 mg hard gelatin capsule (yellow cap/yellow body). These pellet filled capsules provide a sustained-release of the drug in the gastrointestinal tract.
The structural formula of verapamil HCl is given below:
Chemical name: Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)-ethyl]methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl), monohydrochloride.
Verapamil HCl is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform and methanol. Verapamil HCl is not structurally related to other cardioactive drugs.
In addition to verapamil HCl the Verelan (Verapamil) capsule contains the following inactive ingredients: fumaric acid, talc, sugar spheres, povidone, shellac, gelatin, FD&C red #40, yellow iron oxide, titanium dioxide, methylparaben, propylparaben, silicon dioxide, and sodium lauryl sulfate. In addition, the Verelan (Verapamil) 240 mg and 360 mg capsules contain FD&C blue #1 and D&C red #28; and the Verelan (Verapamil) 180 mg capsule contains black iron oxide.
Verelan (Verapamil) Clinical Pharmacology
Verelan (Verapamil) is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist) which exerts its pharmacologic effects by modulating the influx of ionic calcium across the cell membrane of the arterial smooth muscle as well as in conductile and contractile myocardial cells.
Normal sinus rhythm is usually not affected by verapamil HCl. However in patients with sick sinus syndrome, verapamil HCl may interfere with sinus node impulse generation and may induce sinus arrest or sinoatrial block. Atrioventricular block can occur in patients without preexisting conduction defects. (See) Verapamil HCl does not alter the normal atrial action potential or intraventricular conduction time, but depresses amplitude, velocity of depolarization and conduction in depressed atrial fibers. Verapamil HCl may shorten the antegrade effective refractory period of accessory bypass tracts. Acceleration of ventricular rate and/or ventricular fibrillation has been reported in patients with atrial flutter or atrial fibrillation and a coexisting accessory AV pathway following administration of verapamil. (See)
Verapamil HCl has a local anesthetic action that is 1.6 times that of procaine on an equimolar basis. It is not known whether this action is important at the doses used in man.
Verelan (Verapamil) Indications And Usage
Verelan (Verapamil) (verapamil HCl) is indicated for the management of essential hypertension.
Verelan (Verapamil) Contraindications
Verapamil HCl is contraindicated in:
Verelan (Verapamil) Warnings
Some patients with paroxysmal and/or chronic atrial flutter or atrial fibrillation and a coexisting accessory AV pathway have developed increased antegrade conduction across the accessory pathway bypassing the AV node, producing a very rapid ventricular response or ventricular fibrillation after receiving intravenous verapamil (or digitalis). Although a risk of this occurring with oral verapamil has not been established, such patients receiving oral verapamil may be at risk and its use in these patients is contraindicated. (See)
Treatment is usually DC-cardioversion. Cardioversion has been used safely and effectively after oral verapamil.
The effect of verapamil on AV conduction and the SA node may lead to asymptomatic first-degree AV block and transient bradycardia, sometimes accompanied by nodal escape rhythms. PR interval prolongation is correlated with verapamil plasma concentrations, especially during the early titration phase of therapy. Higher degrees of AV block, however, were infrequently (0.8%) observed.
Marked first-degree block or progressive development to second- or third-degree AV block requires a reduction in dosage or, in rare instances, discontinuation of verapamil HCl and institution of appropriate therapy depending upon the clinical situation.
Verelan (Verapamil) Precautions
Verelan (Verapamil) Adverse Reactions
Serious adverse reactions are uncommon when verapamil HCl therapy is initiated with upward dose titration within the recommended single and total daily dose. Seefor discussion of heart failure, hypotension, elevated liver enzymes, AV block, and rapid ventricular response. Reversible (upon discontinuation of verapamil) non-obstructive, paralytic ileus has been infrequently reported in association with the use of verapamil.
In clinical trials involving 285 hypertensive patients on Verelan (Verapamil) for greater than 1 week the following adverse reactions were reported in greater than 1.0% of the patients:
In clinical trials of other formulations of verapamil HCl (N=4,954) the following reactions have occurred at rates greater than 1.0%:
In clinical trials related to the control of ventricular response in digitalized patients who had atrial fibrillation or atrial flutter, ventricular rate below 50/min at rest occurred in 15% of patients and asymptomatic hypotension occurred in 5% of patients.
The following reactions, reported in 1.0% or less of patients, occurred under conditions (open trials, marketing experience) where a causal relationship is uncertain; they are listed to alert the physician to a possible relationship:
Verelan (Verapamil) Overdosage
There is no specific antidote for verapamil overdosage; treatment should be supportive. Delayed pharmacodynamic consequences may occur with sustained-release formulations, and patients should be observed for at least 48 hours, preferably under continuous hospital care. Reported effects include hypotension, bradycardia, cardiac conduction defects, arrhythmias, hyperglycemia, and decreased mental status. In addition, there have been literature reports of non-cardiogenic pulmonary edema in patients taking large overdoses of verapamil (up to approximately 9g).
In acute overdosage, gastrointestinal decontamination with cathartics and whole bowel irrigation should be considered. Calcium, inotropes (i.e., isoproterenol, dopamine, and glucagon), atropine, vasopressors (i.e., norepinephrine, and epinephrine), and cardiac pacing have been used with variable results to reverse hypotension and myocardial depression. In a few reported cases, overdose with calcium channel blockers that was initially refractory to atropine became more responsive to this treatment when the patients received large doses (close to 1g/hour for more than 24 hours) of calcium chloride. Calcium chloride is preferred to calcium gluconate since it provides 3 times more calcium per volume. Asystole should be handled by the usual measures including cardiopulmonary resuscitation. Verapamil cannot be removed by hemodialysis.
Verelan (Verapamil) Dosage And Administration
The dose of Verelan (Verapamil) should be individualized by titration. The usual daily dose of sustained-release verapamil, Verelan (Verapamil) , in clinical trials has been 240 mg given by mouth once daily in the morning. However, initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (e.g., elderly, small people, etc.). Upward titration should be based on therapeutic efficacy and safety evaluated approximately 24 hours after dosing. The antihypertensive effects of Verelan (Verapamil) are evident within the first week of therapy.
If adequate response is not obtained with 120 mg of Verelan (Verapamil) , the dose may be titrated upward in the following manner:
(a) 180 mg in the morning.
(b) 240 mg in the morning.
(c) 360 mg in the morning.
(d) 480 mg in the morning.
Verelan (Verapamil) sustained-release capsules are for once-a-day administration. When switching from immediate-release verapamil to Verelan (Verapamil) capsules, the same total daily dose of Verelan (Verapamil) capsules can be used.
As with immediate-release verapamil, dosages of Verelan (Verapamil) capsules should be individualized and titration may be needed in some patients.
Verelan (Verapamil) How Supplied
Verelan (Verapamil) (verapamil hydrochloride) sustained-release pellet filled capsules are supplied in four dosage strengths:
Verelan (Verapamil)
Verelan (Verapamil) Principal Display Panel - Mg Bottle Label
sustained-release pellet filled capsules
Rx only
Verelan (Verapamil) Principal Display Panel - Mg Bottle Label
sustained-release pellet filled capsules
Rx only
Verelan (Verapamil) Principal Display Panel - Mg Bottle Label
sustained-release pellet filled capsules
Rx only
Verelan (Verapamil) Principal Display Panel - Mg Bottle Label
sustained-release pellet filled capsules
Rx only
