Isoptin Sr
Loading...Isoptin Sr Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Heart Failure: Verapamil has a negative inotropic effect which, in most patients, is compensated by its afterload reduction (decreased systemic vascular resistance) properties without a net impairment of ventricular performance. In clinical experience with 4,954 patients, 87 (1.8%) developed congestive heart failure or pulmonary edema. Verapamil should be avoided in patients with severe left ventricular dysfunction (e.g., ejection fraction less than 30%, or moderate to severe symptoms of cardiac failure) and in patients with any degree of ventricular dysfunction if they are receiving a beta adrenergic blocker (see DRUG INTERACTIONS). Patients with milder ventricular dysfunction should, if possible, be controlled with optimum doses of digitalis and/or diuretics before verapamil treatment (Note interactions with digoxin under: PRECAUTIONS).
Hypotension: Occasionally, the pharmacologic action of verapamil may produce a decrease in blood pressure below normal levels which may result in dizziness or symptomatic hypotension. The incidence of hypotension observed in 4,954 patients enrolled in clinical trials was 2.5%. In hypertensive patients, decreases in blood pressure below normal are unusual. Tilt table testing (60 degrees) was not able to induce orthostatic hypotension.
Elevated Liver Enzymes: Elevations of transaminases with and without concomitant elevations in alkaline phosphatase and bilirubin have been reported. Such elevations have sometimes been transient and may disappear even in the face of continued verapamil treatment. Several cases of hepatocellular injury related to verapamil have been proven by rechallenge; half of these had clinical symptoms (malaise, fever, and/or right upper quadrant pain) in addition to elevations of SGOT, SGPT and alkaline phosphatase. Periodic monitoring of liver function in patients receiving verapamil is therefore prudent.
Accessory Bypass Tract (Wolff-Parkinson-White or Lown-Ganong-Levine): Some patients with paroxysmal and/or chronic atrial fibrillation or atrial flutter 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 CONTRAINDICATIONS).
Treatment is usually DC-cardioversion. Cardioversion has been used safely and effectively after oral ISOPTIN.
Atrioventricular Block: The effect of verapamil on AV conduction and the SA node may cause 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 phases 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 HCI and institution of appropriate therapy depending upon the clinical situation.
Patients with Hypertrophic Cardiomyopathy (IHSS): In 120 patients with hypertrophic cardiomyopathy (most of them refractory or intolerant to propranolol) who received therapy with verapamil at doses up to 720 mg/day, a variety of serious adverse effects were seen. Three patients died in pulmonary edema; all had severe left ventricular outflow obstruction and a past history of left ventricular dysfunction. Eight other patients had pulmonary edema and/or severe hypotension; abnormally high (greater than 20 mmHg) pulmonary wedge pressure and a marked left ventricular outflow obstruction were present in most of these patients. Concomitant administration of quinidine (see DRUG INTERACTIONS) preceded the severe hypotension in 3 of the 8 patients (2 of whom developed pulmonary edema). Sinus bradycardia occurred in 11% of the patients, second-degree AV block in 4% and sinus arrest in 2%. It must be appreciated that this group of patients had a serious disease with a high mortality rate. Most adverse effects responded well to dose reduction and only rarely did verapamil have to be discontinued.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
ISOPTIN SR (verapamil HCI) is indicated for the management of essential hypertension.
History
There is currently no drug history available for this drug.
Other Information
ISOPTIN® SR (verapamil hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or calcium ion antagonist). ISOPTIN SR is available for oral administration as light green, capsule shaped, scored, film-coated tablets containing 240 mg verapamil hydrochloride, as light pink, oval shaped, scored, film-coated tablets containing 180 mg verapamil hydrochloride, and as light violet, oval shaped, film-coated tablets containing 120 mg verapamil hydrochloride. The tablets are designed for sustained release of the drug in the gastrointestinal tract, sustained release characteristics are not altered when the tablet is divided in half.
The structural formula of verapamil HCI is given below:
C27H38N2O4•HCl M.W. 491.08
Benzeneacetronitrile, α [3-[[2-(3, 4-dimethoxyphenyl) ethyl] methylamino] propyl]-3, 4- dimethoxy-α-(1-methylethyl) hydrochloride
Verapamil HCI is an almost white, crystalline powder, practically free of odor, with a bitter taste.
It is soluble in water, chloroform and methanol. Verapamil HCI is not chemically related to other cardioactive drugs.
In addition to verapamil HCI, the ISOPTIN SR tablet contains the following ingredients: alginate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl pyrrolidone, talc, and titanium dioxide. The following are the color additives per tablet strength:
Strength (mg) Color Additive(s)
120 Iron Oxide
180 Iron Oxide
240 D&C yellow #10 Lake dye, and FD&C blue #2 Lake dye
Sources
Isoptin Sr Manufacturers
-
Ranbaxy Laboratories Inc.
![Isoptin Sr (Verapamil Hydrochloride) Tablet, Coated [Ranbaxy Laboratories Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Isoptin Sr | Ranbaxy Laboratories Inc.
Essential Hypertension
The dose of ISOPTIN SR should be individualized by titration and the drug should be administered with food. Initiate therapy with 180 mg of sustained-release verapamil HCI, ISOPTIN SR, given in the morning. Lower, initial doses of 120 mg a day may be warranted in patients who may have an increased response to verapamil (e.g., the elderly or small people etc.). Upward titration should be based on therapeutic efficacy and safety evaluated weekly and approximately 24 hours after the previous dose. The antihypertensive effects of ISOPTIN SR are evident within the first week of therapy.
If adequate response is not obtained with 180 mg of ISOPTIN SR, the dose may be titrated upward in the following manner:
a) 240 mg each morning,
b) 180 mg each morning plus 180 mg each evening, or 240 mg each morning plus 120 mg each evening
c) 240 mg every twelve hours.
When switching from immediate release ISOPTIN to ISOPTIN SR, the total daily dose in milligrams may remain the same.
Login To Your Free Account