Norpace

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Do not skip doses or change your dosing schedule without your doctor's advice. Sudden changes in the way you take disopyramide can make your condition worse.

Store at room temperature away from moisture and heat.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of disopyramide can be fatal.

Overdose symptoms may include trouble breathing, irregular heartbeats, and loss of consciousness.

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.

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.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Norpace falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Mortality

In the National Heart, Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multi-center, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had had a myocardial infarction more than 6 days but less than 2 years previously, an excessive mortality or non-fatal cardiac arrest rate (7.7%) was seen in patients treated with encainide or flecainide compared with that seen in patients assigned to carefully matched placebo-treated groups (3.0%). The average duration of treatment with encainide or flecainide in this study was 10 months.

The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain. Considering the known proarrhythmic properties of Norpace and the lack of evidence of improved survival for any antiarrhythmic drug in patients without life-threatening arrhythmias, the use of Norpace as well as other antiarrhythmic agents should be reserved for patients with life-threatening ventricular arrhythmias.

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may want to give your first dose of this medicine in a hospital or clinic setting to quickly treat any serious side effects that occur.

Do not crush, chew, break, or open an extended-release capsule. Swallow it whole.

Your heart function may need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Do not skip doses or change your dosing schedule without your doctor's advice. Sudden changes in the way you take disopyramide can make your condition worse.

Store at room temperature away from moisture and heat.

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

• It is used to treat certain types of abnormal heartbeats.
• It may be given to you for other reasons. Talk with the doctor.

• If you have an allergy to disopyramide or any other part of Norpace (disopyramide capsules).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have any of these health problems: Heart block without a working pacemaker, heart failure, a long QT on ECG, or low blood pressure.
• If you have any of these health problems: Glaucoma or myasthenia gravis.
• If you have trouble passing urine.
• If you have kidney disease.
• If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Norpace with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take Norpace or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Norpace. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.

Review Date: October 4, 2017

NDC 0025-2762-31

100 Capsules
Rx only

Norpace®
disopyramide phosphate
capsules USP

150 mg*

Pfizer
Distributed by
G.D. Searle LLC
Division of Pfizer Inc, NY, NY 10017