Norpace CR

Pregnancy Category: C

Lactation: crosses into breast milk, discontinue drug or do not nurse

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Norpace CR is a prescription medication used to treat life-threatening abnormal heart rhythms (arrhythmias). This medication belongs to a group of drugs called antiarrhythmics. It works by affecting sodium channels in the heart which slows electrical signals, stabilizing heart rhythm.

Norpace CR comes in an extended release capsule and is taken twice daily. Do not cut, crush, or chew extended-release capsules. Swallow them whole.

Common side effects include dry mouth, difficult urination, blurred vision, and dizziness. Do not drive or operate heavy machinery until you know how Norpace CR affects you.

Norpace CR is part of the drug class:

• Antiarrhythmics, class Ia

If you take too much Norpace CR, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

You should not use disopyramide if you are allergic to it, or if you have:

• long QT syndrome; or

• a serious heart condition such as "AV block" (unless you have a pacemaker).

Do not use disopyramide to treat any heart rhythm disorder that has not been checked and diagnosed by your doctor.

To make sure disopyramide is safe for you, tell your doctor if you have:

• other heart rhythm disorders ("sick sinus syndrome", bundle branch block, Wolff-Parkinson-White syndrome);

• congestive heart failure, or if you have recently had a heart attack;

• low blood pressure;

• low potassium levels in your blood (hypokalemia);

• low blood sugar, or diabetes;

• liver or kidney disease;

• enlarged prostate, bladder obstruction or other urination problems;

• glaucoma;

• myasthenia gravis; or

• if you are malnourished.

FDA pregnancy category C. It is not known whether disopyramide will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medicine.

Disopyramide can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Disopyramide is used to treat abnormal heart rhythms.

It is available only with your doctor's prescription.

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

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.

• Amifampridine
• Amisulpride
• Bepridil
• Cisapride
• Dronedarone
• Fingolimod
• Itraconazole
• Ketoconazole
• Levomethadyl
• Mesoridazine
• Pimozide
• Piperaquine
• Posaconazole
• Sparfloxacin
• Terfenadine
• Thioridazine
• Vernakalant
• 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
• Amitriptyline
• Amoxapine
• Anagrelide
• Apomorphine
• Aprindine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Betaxolol
• Buserelin
• Chloral Hydrate
• Chloroquine
• Chlorpromazine
• Chlorpropamide
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clomipramine
• Clozapine
• Cobicistat
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasabuvir
• Dasatinib
• Degarelix
• Delamanid
• Desipramine
• Deslorelin
• Deutetrabenazine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Efavirenz
• Enflurane
• Erythromycin
• Escitalopram
• Etravirine
• Flecainide
• Fluconazole
• Fluoxetine
• Foscarnet
• Gatifloxacin
• Gemifloxacin
• Glimepiride
• Glipizide
• Glyburide
• Gonadorelin
• Goserelin
• Granisetron
• Halofantrine
• Haloperidol
• Halothane
• Histrelin
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Isoflurane
• Isradipine
• Ivabradine
• Lapatinib
• Leuprolide
• Levofloxacin
• Lidocaine
• Lidoflazine
• Lorcainide
• Lumefantrine
• Mefloquine
• Methadone
• Metronidazole
• Mexiletine
• Mifepristone
• Moxifloxacin
• Nafarelin
• Nalidixic Acid
• Nilotinib
• Norfloxacin
• Nortriptyline
• Octreotide
• Ofloxacin
• Ombitasvir
• Ondansetron
• Paliperidone
• Panobinostat
• Paritaprevir
• Pasireotide
• Pazopanib
• Pentamidine
• Pimavanserin
• Pirmenol
• Pitolisant
• Prilocaine
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Ribociclib
• Risperidone
• Salmeterol
• Sertindole
• Sevoflurane
• Simeprevir
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Spiramycin
• Sulfamethoxazole
• Sulpiride
• Sultopride
• Sunitinib
• Tacrolimus
• Telavancin
• Telithromycin
• Tetrabenazine
• Tizanidine
• Tolazamide
• Tolbutamide
• Toremifene
• Trazodone
• Trifluoperazine
• Trimethoprim
• Trimipramine
• Triptorelin
• Vandetanib
• Vardenafil
• Vasopressin
• Vemurafenib
• Vinflunine
• Voriconazole
• Zolmitriptan
• Zotepine
• Zuclopenthixol

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.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes mellitus (sugar diabetes)—Disopyramide may cause low blood sugar

• Difficult urination or
• Enlarged prostate—Disopyramide may cause difficult urination

• Electrolyte disorders—Disopyramide may worsen heart rhythm problems

• Glaucoma (history of) or
• Myasthenia gravis—Disopyramide may aggravate these conditions

• Kidney disease or
• Liver disease—Effects may be increased because of slower removal of disopyramide from the body

• Low blood pressure or
• Other heart disorders—Effects of disopyramide on the heart may make these conditions worse

• Malnutrition, long term—Disopyramide may cause low blood sugar

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:

• Dizziness, feeling of faintness
• fainting
• heartbeat sensations
• shortness of breath
• unusual tiredness

• Chest pain
• fast or slow heartbeat, rapid weight gain, swelling of feet or lower legs
• lightheadedness
• rash and/or itching

• Enlargement of breasts in men
• fever
• mental depression
• nosebleeds or bleeding gums
• sore throat and fever
• yellow eyes or skin

• 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:

• Blurred vision
• constipation
• dry eyes, mouth, nose, or throat
• problems with urination

• 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.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Hard stools (constipation).
• Dry mouth.
• Dry nose.
• Dry eyes.
• Feeling tired or weak.
• Dizziness.
• Bloating.
• Gas.
• Upset stomach.
• Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• 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.