Isoptin

(Verapamil Hydrochloride)

The active ingredient in Isoptin is verapamil hydrochloride. This medication belongs to a class of medications known as calcium channel blockers. It works to relax the muscles of the heart and blood vessels.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Isoptin. However, the following is a synopsis of the general guidelines for the use of Isoptin:

• Take this medication orally with food exactly as directed by your healthcare provider.
• Adult starting dose: 240 – 480 mg daily in 2 or 3 divided doses not exceeding 160 mg.
• Children starting dose: 40 – 360 mg daily in 2 or 3 divided doses not exceeding 120 mg.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose.

The most common side effects of Isoptin seen in clinical trials as compared to placebo include:

• Constipation.
• Headache.
• Dizziness.
• Abnormal liver function tests.

Some individuals may experience serious side effects while using Isoptin. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reaction - hives, swelling, trouble breathing, skin rash.-
• Chest pain.
• Fast or slow heart rate.
• Heart failure - shortness of breath, rapid weight gain, unusual weakness.
• Slow heartbeat (bradycardia) - feeling lightheaded.
• Liver injury.
• Low blood pressure (hypotension).

These are not all of the possible side effects of Isoptin. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Isoptin, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Congestive heart failure.
• Low blood pressure (hypotension).
• Kidney disease.
• Liver disease.
• Pulmonary edema (fluid in the lungs).
• Nerve-muscle disorder (myasthenia gravis, duchenne muscular dystrophy).
• Heart block (abnormal heart rhythm, irregular heartbeat).
• Heart problems (Wolff-Parkinson-White syndrome, Lown-Ganong-Levine syndrome).
• Sick sinus syndrome.

Boxed Warning

• Warning in patients who have heart failure, low blood pressure (hypotension), AV block, elevated liver enzymes, accessory bypass tract (Wolff-Parkinson-White or Lown-Ganong-Levine), or hypertrophic cardiomyopathy (IHSS).

• Severe left ventricular dysfunction.
• Hypotension (systolic pressure less than 90 mmHg) or cardiogenic shock.
• Sick sinus syndrome (except in patients with a functioning artificial ventricular pacemaker).
• Second- or third-degree AV block (except in patients with a functioning artificial ventricular pacemaker).
• Patients with atrial flutter or atrial fibrillation and an accessory bypass tract (WolffParkinson-White, Lown-Ganong-Levine syndromes).
• Previous hypersensitivity/allergic reaction to verapamil hydrochloride.

This medication takes effect within a few hours.

When Isoptin is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Aspirin.
• Imatinib.
• Lithium.
• Nefazodone.
• St. John's wort.
• Colchicine.
• Cimetidine.
• Buspirone.
• Midazolam.
• Disopyramide.
• Amiodarone.
• Theophylline.
• Prazosin.
• Ritonavir.
• Grapefruit juice consumption.
• Other heart or blood pressure medications (digoxin, flecainide, ivabradine, quinidine).
• Antibiotic (clarithromycin, telithromycin, erythromycin).
• Antifungal medication (itraconazole, ketoconazole).
• Beta blocker (atenolol, metoprolol, propranolol).
• Cholesterol-lowering medications (atorvastatin, rosuvastatin, simvastatin).
• Seizure medications (carbamazepine, phenobarbital, phenytoin).
• Tuberculosis medications (rifampin).

Isoptin comes in a variety of dosage forms, including:

• Extended-release oral capsules: 100 mg, 120 mg, 180 mg, 200 mg, 240 mg, 300 mg, 360 mg.
• Extended-release oral tablets: 120 mg, 180 mg, 240 mg.
• Oral tablets: 40 mg, 80 mg, 120 mg.

Store this medication at room temperature and keep out of reach of children.

BGP PHARMA ULC is the pharmaceutical company that manufactures Isoptin.

There are lower-cost generics available of the brand name Isoptin.

Do not stop or adjust your use of this medication without first consulting your healthcare provider.

It is unknown if or how this medication could affect pregnancy or harm an unborn baby. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

This medication is known to pass into breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.