Propafenone (oral route)

Brand Name

US Brand Name

Rythmol

Rythmol SR


Description

Propafenone is used to prevent irregular heartbeats such as atrial fibrillation (AF) from occurring again in patients who do not have structural heart disease.

Propafenone belongs to the group of medicines known as antiarrhythmics. It works directly on the heart tissue and will slow the nerve impulses in the heart. This helps keep the heart rhythm normal.

There is a chance that propafenone may cause new or make worse existing heart rhythm problems when it is used. Since it has been shown to cause severe problems in some patients, propafenone is only used to treat serious heart rhythm problems. Discuss this possible effect with your doctor.

This medicine is available only with your doctor’s prescription.

This product is available in the following dosage forms:

  • Capsule, Extended Release
  • Tablet

Before Using

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

Appropriate studies have not been performed on the relationship of age to the effects of propafenone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of propafenone in the elderly.

Breastfeeding

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.

Drug Interactions

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
  • Fluconazole
  • Ketoconazole
  • Levoketoconazole
  • Levomethadyl
  • Mavorixafor
  • Mesoridazine
  • Nelfinavir
  • Nirmatrelvir
  • Pimozide
  • Piperaquine
  • Posaconazole
  • Ritonavir
  • Saquinavir
  • Sparfloxacin
  • Terfenadine
  • Thioridazine
  • Tipranavir
  • 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.

  • Abiraterone Acetate
  • Abiraterone Acetate, Micronized
  • Acecainide
  • Adagrasib
  • Ajmaline
  • Alfuzosin
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Anagrelide
  • Apomorphine
  • Aprindine
  • Aripiprazole
  • Aripiprazole Lauroxil
  • Arsenic Trioxide
  • Artemether
  • Asenapine
  • Astemizole
  • Atazanavir
  • Azimilide
  • Azithromycin
  • Bedaquiline
  • Boceprevir
  • Bretylium
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Celecoxib
  • Ceritinib
  • Chloral Hydrate
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clomipramine
  • Clothiapine
  • Clozapine

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.

  • Metoprolol
  • Rifapentine
  • Theophylline
  • Tolterodine

Other Interactions

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. 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 is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Grapefruit Juice
  • 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:

  • Asthma or
  • Bronchitis or
  • Emphysema—Propafenone can increase trouble in breathing.
  • AV block (type of abnormal heart rhythm), with no pacemaker or
  • Bradycardia (slow heartbeat) or
  • Breathing problems or lung disease (eg, bronchospasm, severe obstructive pulmonary disease) or
  • Brugada syndrome (a genetic heart rhythm disorder) or
  • Cardiogenic shock (shock caused by heart attack) or
  • Heart failure or
  • Hypotension (low blood pressure) or
  • Mineral imbalance or
  • Sick sinus node syndrome (type of abnormal heart rhythm), with no pacemaker—Should not be used in patients with these conditions.
  • Blood or bone marrow problems (eg, agranulocytosis, granulocytopenia) or
  • Coronary artery disease or
  • Heart rhythm problems (eg, QT prolongation) or
  • Myasthenia gravis (severe muscle weakness) or
  • Torsade de pointes or
  • Ventricular fibrillation or tachycardia—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
  • If you have a permanent pacemaker—Use with caution. Propafenone may interfere with the pacemaker and require more careful follow-up by the doctor.

Proper Use

Take this medicine exactly as directed by your doctor. Do not take more or less of this medicine, and do not take it more often than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

For patients taking the extended-release capsules:

  • Swallow the capsules whole. Do not crush, break, or chew them.
  • This medicine may be taken with or without food.

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 each dose at evenly spaced times day and night. For example, if you are to take 3 doses a day, doses should be spaced about 8 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.

Your doctor may want you to carry a medical identification card or bracelet stating that you are using this medicine.

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.

  • The number of extended-release capsules or tablets that you take depends on the strength of the medicine.
  • For atrial fibrillation (AF):
    • For oral dosage form (extended-release capsules):
      • Adults—At first, 225 milligrams (mg) every 12 hours. Your doctor may adjust your dose as needed. However, the dose is usually not more than 425 mg every 12 hours.
      • Children—Use and dose must be determined by your doctor.
    • For oral dosage form (tablets):
      • Adults—150 milligrams (mg) every 8 hours. Your doctor may increase your dose if needed.
      • Children—Use and dose must be determined by your doctor.

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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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