Norpace

DRUG DESCRIPTION

Norpace (disopyramide phosphate) is an anti-arrhythmic drug available for oral administration in immediate-release and controlled-release capsules containing 100 mg or 150 mg of disopyramide base, present as the phosphate. The base content of the phosphate salt is 77.6%. The structural formula of Norpace (disopyramide phosphate) is:

Norpace® (disopyramide phosphate)  Structural Formula Illustration

?-[2-(diisopropylamino) ethyl]-?-phenyl-2-pyridineacetamide phosphate

Norpace (disopyramide phosphate) is freely soluble in water, and the free base (pKa 10.4) has an aqueous solubility of 1mg/ml. The chloroform: water partition coefficient of the base is 3.1 at pH 7.2.

Norpace (disopyramide phosphate) is a racemic mixture of d- and l- isomers. This drug is not chemically related to other anti-arrhythmic drugs.

Norpace (disopyramide phosphate) CR (controlled-release) capsules are designed to afford a gradual and consistent release of disopyramide. Thus, for maintenance therapy, Nor-pace CR provides the benefit of less-frequent dosing (every 12 hours) as compared with the every-6-hour dosage schedule of immediate-release Norpace (disopyramide phosphate) capsules.

Inactive ingredients of Norpace (disopyramide phosphate) include corn starch, edible ink, FD&C Red No. 3, FD&C Yellow No. 6, gelatin, lactose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Blue No.1.

Inactive ingredients of Norpace (disopyramide phosphate) CR include corn starch, D&C Yellow No. 10, edible ink, ethylcellulose, FD&C Blue No. 1, gelatin, shellac, sucrose, talc, and titanium dioxide; the 150-mg capsule also contains FD&C Red No. 3 and FD&C Yellow No. 6.

What are the possible side effects of disopyramide (Norpace, Norpace CR)?

If you experience any of the following serious side effects, stop taking disopyramide and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • a new or a worsening irregular heartbeat pattern;
  • chest pain, chest discomfort, shortness of breath, or swelling of your legs or feet; or
  • severe dizziness.

Other, less serious side effects may be more likely to occur. Talk to your...

Read All Potential Side Effects and See Pictures of Norpace »

What are the precautions when taking disopyramide phosphate (Norpace)?

Before taking disopyramide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, glaucoma, kidney disease, liver problems, myasthenia gravis, urinary problems (such as due to enlarged prostate, urinary retention).

This drug may rarely make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this...

Read All Potential Precautions of Norpace »


Norpace Consumer (continued)

SIDE EFFECTS: See also Warning section.

Dry mouth, constipation, nausea, abdominal pain/gas/bloating, blurred vision, dry nose/eyes/throat, and urination problems (such as difficulty urinating or unusual frequent urge to urinate) may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: symptoms of low blood sugar (such as shakiness with unusual hunger/headache/sweating), signs of liver problems (such as persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine), muscle weakness, worsening symptoms of heart failure (such as ankle/leg swelling, increased tiredness, increased shortness of breath when lying down).

Seek immediate medical attention if any of these rare but serious side effects occur: fainting, faster/more irregular heartbeat, severe dizziness.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking disopyramide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, glaucoma, kidney disease, liver problems, myasthenia gravis, urinary problems (such as due to enlarged prostate, urinary retention).

This drug may rarely make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist that you are using this medication.

Disopyramide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using disopyramide, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using disopyramide safely.

This drug may cause low blood sugar (hypoglycemia), especially if you have diabetes, heart failure, decreased kidney/liver function, or nutrition problems. Tell your doctor immediately if you have symptoms of low blood sugar including sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. If you have diabetes, your diabetes medication, exercise program, or diet may need to be adjusted.

Older adults may be more sensitive to the side effects of this drug, especially urination problems.

During pregnancy, this medication should be used only when clearly needed. Rarely, disopyramide may cause early labor during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk, and the effect on a nursing infant is unknown. Consult your doctor before breast-feeding.


Norpace Patient Information Including Side Effects

Brand Names: Norpace, Norpace CR

Generic Name: disopyramide (Pronunciation: DYE soe PIR a mide)

  • What is disopyramide (Norpace)?
  • What are the possible side effects of disopyramide (Norpace)?
  • What is the most important information I should know about disopyramide (Norpace)?
  • What should I discuss with my healthcare provider before taking disopyramide (Norpace)?
  • How should I take disopyramide (Norpace)?
  • What happens if I miss a dose (Norpace)?
  • What happens if I overdose (Norpace)?
  • What should I avoid while taking disopyramide (Norpace)?
  • What other drugs will affect disopyramide (Norpace)?
  • Where can I get more information?

What is disopyramide (Norpace)?

Disopyramide affects the way that your heart beats.

Disopyramide is used to treat seriously irregular heartbeat patterns.

Disopyramide may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of disopyramide (Norpace)?

If you experience any of the following serious side effects, stop taking disopyramide and seek emergency medical attention:

  • an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
  • a new or a worsening irregular heartbeat pattern;
  • chest pain, chest discomfort, shortness of breath, or swelling of your legs or feet; or
  • severe dizziness.

Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

  • mild dizziness or tiredness,
  • headache,
  • blurred vision,
  • dry mouth,
  • rash, itching,
  • muscle aches or pains, or
  • difficulty urinating.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about disopyramide (Norpace)?

Do not skip doses or change your dosing schedule without talking to your doctor. Changing your schedule could make your condition much worse.

Use caution when driving, operating machinery, or performing other hazardous activities. Disopyramide may cause dizziness, drowsiness, or blurred vision. If you experience dizziness, drowsiness, or blurred vision, avoid these activities.

Do not crush, chew, or break any controlled-release (CR) forms of disopyramide. Swallow them whole. They are specially formulated to release slowly in your body.

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