Isoptin SR

Verapamil may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of verapamil.

Grapefruit and grapefruit juice may interact with verapamil and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects .

Low blood pressure (hypotension) may occur while taking this medicine. Check with your doctor right away if you have the following symptoms: blurred vision; confusion; severe dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly; sweating; or unusual tiredness or weakness .

While you are taking this medicine be careful to limit the amount of alcohol that you drink. Alcohol increases dizziness and drowsiness and also lowers blood pressure .

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blue lips and fingernails
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chest pain
• confusion
• coughing that sometimes produces a pink frothy sputum
• difficult, fast, noisy breathing, sometimes with wheezing
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• increased sweating
• lightheadedness, dizziness, or fainting
• pale skin
• shortness of breath
• slow or irregular heartbeat
• sore throat
• sweating
• swelling in legs and ankles
• unusual tiredness or weakness

• Chills
• cold sweats
• feeling of warmth
• redness of the face, neck, arms and occasionally, upper chest

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Difficulty having a bowel movement (stool)
• headache

• Acid or sour stomach
• belching
• difficulty in moving
• heartburn
• indigestion
• joint pain
• muscle aching or cramping
• muscle pains or stiffness
• nausea
• rash
• stomach discomfort, upset, or pain
• trouble sleeping
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• swollen joints

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

• It is used to treat high blood pressure.
• It may be given to you for other reasons. Talk with the doctor.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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

Verapamil HCI is contraindicated in:

1. Severe left ventricular dysfunction (see WARNINGS)

2. Hypotension (systolic pressure less than 90 mmHg) or cardiogenic shock

3. Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker)

4. Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker).

5. Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (e.g., Wolff-Parkinson-White, Lown-Ganong-Levine syndromes). (see WARNINGS).

6. Patients with known hypersensitivity to verapamil hydrochloride.

Serious adverse reactions are uncommon when verapamil therapy is initiated with upward dose titration within the recommended single and total daily dose. See WARNINGS for 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. The following reactions to orally administered verapamil occurred at rates greater than 1.0% or occurred at lower rates but appeared clearly drug-related in clinical trials in 4,954 patients.

Constipation 7.3%

Fatigue 1.7%

Dizziness 3.3%

Dyspnea 1.4%

Nausea 2.7%

Bradycardia (HR <50/min) 1.4%

Hypotension 2.5%

AV Block-total (1 °, 2 °, 3 °) 1.2%

Headache 2.2%

2 ° and 3 ° 0.8%

Edema 1.9%

Rash 1.2%

CHF/Pulmonary Edema 1.8%

Flushing 0.6%

Elevated Liver Enzymes (see WARNING)

In clinical trials related to the control of ventricular response in digitalized patients who had atrial fibrillation or atrial flutter, ventricular rates 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.

Cardiovascular: angina pectoris, atrioventricular dissociation, chest pain, claudication, myocardial infarction, palpitations, purpura (vasculitis), syncope.

Digestive System: diarrhea, dry mouth, gastrointestinal distress, gingival hyperplasia.

Hemic and Lymphatic: ecchymosis or bruising.

Nervous System: cerebrovascular accident, confusion, equilibrium disorders, insomnia, muscle cramps, parasthesia, psychotic symptoms, shakiness, somnolence, extrapyramidal symptoms.

Skin: arthralgia and rash, exanthema, hair loss hyperkeratosis, maculae, sweating, urticaria, Stevens-Johnson syndrome, erythema multiforme.

Special Senses: blurred vision, tinnitus.

Urogenital: gynecomastia, impotence, galactorrhea/hyperprolactinemia, increased urination, spotty menstruation.

Treatment of Acute Cardiovascular Adverse Reactions: The frequency of cardiovascular adverse reactions that require therapy is rare, hence, experience with their treatment is limited. Whenever severe hypotension or complete AV block occurs following oral administration of verapamil, the appropriate emergency measures should be applied immediately, e.g., intravenously administered isoproterenol HCI, norepinephrine bitartrate, atropine sulfate (all in the usual doses), or calcium gluconate (10% solution). In patients with hypertrophic cardiomyopathy (IHSS), alpha-adrenergic agents (phenylephrine HCl, metaraminol bitartrate or methoxamine HCl) should be used to maintain blood pressure, and isoproterenol and norepinephrine should be avoided. If further support is necessary, (dopamine HCl or dobutamine HCl) may be administered. Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.

ISOPTIN® SR 240 mg tablets are supplied as light green, capsule shaped, scored, film-coated tablets containing 240 mg of verapamil hydrochloride. The tablet is embossed with “pp” on one side and “ST” on the other side. ISOPTIN® SR 180 mg tablets are supplied as light pink, oval shaped, scored, film-coated tablets containing 180 mg of verapamil hydrochloride. The tablet is embossed with “pp” on one side, and “SK” on the other side. The ISOPTIN® SR 120 mg tablets are supplied as light violet, oval shaped, film-coated tablets containing 120 mg of verapamil hydrochloride. The tablet is embossed with “p” on one side and “SC” on the other side.

240 mg (light green) -Bottle of 100-NDC # 10631-490-01

Bottle of 500- NDC # 10631-490-05

180 mg (light pink) -Bottle of 100- NDC # 10631-489-01

120 mg (light violet) -Bottle of 100- NDC # 10631-488-01

Storage: Store at 25 ° C (77 ° F); excursions permitted to 15 °–30 ° C (59 °–86 ° F) [see USP Controlled Room Temperature].

Protect from light and moisture.

Dispense in a tight, light-resistant container as defined in the USP.

Manufactured by:

Abbott Laboratories

North Chicago, IL 60064 USA

Manufactured for:

FSC Laboratories, Inc.

Charlotte, NC 28210 USA

January 2005