Sample Content Directory Canada: Norpace CR

Generic Name: disopyramide (Oral route)

dye-soe-PIR-a-mide

Oral route(Capsule;Capsule, Extended Release)

Considering the known proarrhythmic properties of disopyramide and the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, the use of disopyramide as well as other antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias .

Commonly used brand name(s)

In the U.S.

Norpace

Norpace CR

Available Dosage Forms:

Capsule

Tablet, Extended Release

Capsule, Extended Release

Therapeutic Class: Antiarrhythmic, Group IA

Uses For Norpace CR

Disopyramide is used to treat abnormal heart rhythms.

It is available only with your doctor's prescription.

Before Using Norpace CR

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

This medicine has been tested in children and has not been shown to cause different side effects or problems than it does in adults.

Geriatric

Some side effects, such as difficult urination and dry mouth, may be especially likely to occur in elderly patients, who are usually more sensitive than younger adults to the effects of disopyramide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Bepridil

Cisapride

Dronedarone

Levomethadyl

Mesoridazine

Pimozide

Posaconazole

Sparfloxacin

Terfenadine

Thioridazine

Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Ajmaline

Alfuzosin

Amiodarone

Amisulpride

Amitriptyline

Amoxapine

Apomorphine

Aprindine

Arsenic Trioxide

Asenapine

Astemizole

Atazanavir

Azithromycin

Betaxolol

Chloral Hydrate

Chloroquine

Chlorpromazine

Chlorpropamide

Ciprofloxacin

Citalopram

Clarithromycin

Clomipramine

Clozapine

Crizotinib

Dasatinib

Desipramine

Disopyramide

Dofetilide

Dolasetron

Doxepin

Droperidol

Enflurane

Erythromycin

Etravirine

Fingolimod

Flecainide

Fluconazole

Fluoxetine

Foscarnet

Gatifloxacin

Gemifloxacin

Glimepiride

Glipizide

Glyburide

Granisetron

Halofantrine

Haloperidol

Halothane

Hydroquinidine

Ibutilide

Iloperidone

Imipramine

Isoflurane

Isradipine

Itraconazole

Lapatinib

Levofloxacin

Lidocaine

Lidoflazine

Lorcainide

Lumefantrine

Mefloquine

Methadone

Mexiletine

Moxifloxacin

Nalidixic Acid

Nilotinib

Norfloxacin

Nortriptyline

Octreotide

Ofloxacin

Ondansetron

Paliperidone

Pazopanib

Pentamidine

Perflutren Lipid Microsphere

Pimozide

Pirmenol

Prajmaline

Prilocaine

Probucol

Procainamide

Prochlorperazine

Promethazine

Propafenone

Protriptyline

Quetiapine

Quinidine

Quinine

Ranolazine

Risperidone

Salmeterol

Sertindole

Sodium Phosphate

Sodium Phosphate, Dibasic

Sodium Phosphate, Monobasic

Solifenacin

Sorafenib

Sotalol

Spiramycin

Sulfamethoxazole

Sultopride

Sunitinib

Telavancin

Telithromycin

Tetrabenazine

Tolazamide

Tolbutamide

Toremifene

Trazodone

Trifluoperazine

Trimethoprim

Trimipramine

Vandetanib

Vardenafil

Vasopressin

Vemurafenib

Voriconazole

Ziprasidone

Zolmitriptan

Zotepine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Atenolol

Dalfopristin

Digoxin

Fosphenytoin

Nevirapine

Phenytoin

Propranolol

Quinupristin

Rifampin

Rifapentine

Ritonavir

Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of disopyramide

This section provides information on the proper use of a number of products that contain disopyramide. It may not be specific to Norpace CR. Please read with care.

Take disopyramide exactly as directed by your doctor even though you may feel well. Do not take more medicine than ordered.

For patients taking the extended-release capsules :

Swallow the capsule whole without breaking, crushing, or chewing.

For patients taking the extended-release tablets:

Do not crush or chew the tablet.

This medicine works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take the doses at evenly spaced times day and night. For example, if you are to take four doses a day, the doses should be spaced about 6 hours apart. If this interferes with your sleep or other daily activities, or if you need help in planning the best times to take your medicine, check with your health care professional.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For treatment of arrhythmias:
- For short-acting oral dosage form (capsules):
  - Adults—100 to 150 mg taken every six to eight hours.
  - Children—Dose is based on body weight and age and must be determined by your doctor. The dose is usually 6 to 30 mg per kilogram (kg) (2.73 to 13.64 mg per pound) of body weight per day. This dose is evenly divided and taken every six hours.
- For long-acting oral dosage forms (extended-release capsules or tablets):
  - Adults—200 or 400 mg every twelve hours.
  - Children—Use is not recommended.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Norpace CR

Your doctor should check your progress at regular visits to make sure the medicine is working properly.

Do not stop taking this medicine without first checking with your doctor. Stopping suddenly may cause a serious change in heart function .

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position. This is due to lowered blood pressure. Getting up slowly may help. This effect does not occur often at doses of disopyramide usually used; however, make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert. If the problem continues or gets worse, check with your doctor.

Disopyramide may rarely cause hypoglycemia (low blood sugar) in some people. (See the Side Effects of This Medicine section below.) If these signs appear, eat or drink a food containing sugar and call your doctor right away.

This medicine may cause blurred vision or other vision problems. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well.

Disopyramide may cause dryness of the eyes, mouth, and nose. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and oral yeast infections.

This medicine often will make you sweat less, allowing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since becoming overheated could possibly result in heatstroke.

Norpace CR Side Effects

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 as soon as possible if any of the following side effects occur:

More common

Dizziness, feeling of faintness

fainting

heartbeat sensations

shortness of breath

unusual tiredness

Less common

Chest pain

fast or slow heartbeat, rapid weight gain, swelling of feet or lower legs

lightheadedness

rash and/or itching

Rare

Enlargement of breasts in men

fever

mental depression

nosebleeds or bleeding gums

sore throat and fever

yellow eyes or skin

Signs and symptoms of hypoglycemia (low blood sugar)

Anxious feeling

chills

cold sweats

confusion

cool, pale skin

drowsiness

fast heartbeat

headache

hunger (excessive)

nausea

nervousness

shakiness

unsteady walk

unusual tiredness or weakness

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:

More common

Blurred vision

constipation

dry eyes, mouth, nose, or throat

problems with urination

Less common

Bloating or stomach pain

diarrhea

headache

impotence

loss of appetite

muscle weakness

nausea

nervousness

trouble in sleeping

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.

See also: Norpace CR side effects (in more detail)

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More Norpace CR resources

Norpace CR Side Effects (in more detail)
Norpace CR Use in Pregnancy & Breastfeeding
Drug Images
Norpace CR Drug Interactions
Norpace CR Support Group
2 Reviews for Norpace CR - Add your own review/rating

Norpace CR Concise Consumer Information (Cerner Multum)

Norpace CR Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)

Disopyramide Prescribing Information (FDA)

Disopyramide MedFacts Consumer Leaflet (Wolters Kluwer)

Disopyramide Phosphate Monograph (AHFS DI)

Norpace Prescribing Information (FDA)

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Arrhythmia

Sample Content Directory Canada

Saturday 4 August 2012

Norpace CR