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Drugs reference index «Rythmol SR»

Rythmol SR


Rythmol SR

Generic Name: propafenone (Oral route)

proe-PA-fen-one

Oral routeTabletCapsule, Extended Release

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 a myocardial infarction more than six days but less than two years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with encainide or flecainide (Class 1C antiarrhythmics) compared with that seen in patients assigned to placebo (3%; 22/725). The average duration of treatment with encainide or flecainide in this study was ten months.

The applicability of the CAST results to other populations (eg, those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present, it is prudent to consider any 1C antiarrhythmic to have a significant risk in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs .

It is prudent to consider any Class 1C antiarrhythmic to have a significant risk in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs .

Commonly used brand name(s):

In the U.S.

  • Rythmol
  • Rythmol SR

Available Dosage Forms:

  • Capsule, Extended Release
  • Tablet

Therapeutic Class: Antiarrhythmic, Group IC

Chemical Class: Propiophenone

Uses For Rythmol SR

Propafenone belongs to the group of medicines known as antiarrhythmics. It is used to treat abnormal heart rhythms.

Propafenone produces its helpful effects by slowing nerve impulses in the heart and making the heart tissue less sensitive.

There is a chance that propafenone may cause new heart rhythm problems or make worse those that already exist. Since similar medicines have 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.

Before Using Rythmol SR

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

Propafenone can cause serious side effects in any patient. Therefore, it is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of propafenone in the elderly with use in other age groups.

Pregnancy

Pregnancy CategoryExplanation
All TrimestersCAnimal 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

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
  • Levomethadyl
  • Mesoridazine
  • Pimozide
  • Ritonavir
  • Saquinavir
  • Terfenadine
  • Thioridazine
  • Tipranavir
  • 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.

  • Acecainide
  • Ajmaline
  • Alatrofloxacin
  • Amiodarone
  • Amisulpride
  • Amitriptyline
  • Amoxapine
  • Aprindine
  • Arsenic Trioxide
  • Astemizole
  • Azimilide
  • Azithromycin
  • Balofloxacin
  • Bretylium
  • Chloral Hydrate
  • Chloroquine
  • Chlorpromazine
  • Ciprofloxacin
  • Clarithromycin
  • Clinafloxacin
  • Darunavir
  • Delavirdine
  • Desipramine
  • Dibenzepin
  • Digoxin
  • Disopyramide
  • Dofetilide
  • Dolasetron
  • Droperidol
  • Duloxetine
  • Eltrombopag
  • Enflurane
  • Enoxacin
  • Erythromycin
  • Etravirine
  • Flecainide
  • Fleroxacin
  • Fluconazole
  • Flumequine
  • Fluoxetine
  • Foscarnet
  • Gatifloxacin
  • Gemifloxacin
  • Grepafloxacin
  • Halofantrine
  • Haloperidol
  • Halothane
  • Hydroquinidine
  • Ibutilide
  • Imipramine
  • Isoflurane
  • Isradipine
  • Levofloxacin
  • Lidocaine
  • Lidoflazine
  • Lomefloxacin
  • Lorcainide
  • Mefloquine
  • Moxifloxacin
  • Norfloxacin
  • Nortriptyline
  • Octreotide
  • Ofloxacin
  • Pefloxacin
  • Pentamidine
  • Pirmenol
  • Prajmaline
  • Prilocaine
  • Probucol
  • Procainamide
  • Prochlorperazine
  • Propafenone
  • Protriptyline
  • Prulifloxacin
  • Quetiapine
  • Quinidine
  • Risperidone
  • Rufloxacin
  • Sematilide
  • Sertindole
  • Sotalol
  • Sparfloxacin
  • Spiramycin
  • Sulfamethoxazole
  • Sultopride
  • Tedisamil
  • Telithromycin
  • Temafloxacin
  • Tizanidine
  • Tosufloxacin
  • Trifluoperazine
  • Trimethoprim
  • Trimipramine
  • Vasopressin
  • 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.

  • Bupropion
  • Clozapine
  • Cyclosporine
  • Metoprolol
  • Paroxetine
  • Rifampin
  • Rifapentine
  • Sertraline
  • Theophylline
  • Tolterodine
  • 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:

  • Asthma or
  • Bronchitis or
  • Emphysema—Propafenone can increase trouble in breathing
  • Bradycardia (unusually slow heartbeat)—There is a risk of further decreased heart function
  • Congestive heart failure or other heart disease or
  • Myasthenia gravis or
  • Severe low blood pressure—Propafenone may make these conditions worse
  • Electrolyte (i.e., potassium) disorders—Propafenone may worsen heart rhythm problems
  • Kidney disease or
  • Liver disease—Effects of propafenone may be increased because of slower removal from the body
  • If you have a pacemaker—Propafenone may interfere with the pacemaker and require more careful follow-up by the doctor

Proper Use of propafenone

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

Take propafenone 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.

For patients taking the extended-release capsule form of this medicine

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

Grapefruit and grapefruit juice may increase the effects of propafenone by increasing the amount of this medicine in the body. You should not eat grapefruit or drink grapefruit juice while you are taking this medicine.

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 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.

  • The number of extended-release capsule or tablets that you take depends on the strength of the medicine.
  • For oral extended-release dosage form (capsules):
    • Adults—At first, 225 milligrams (mg) once every twelve hours. Your doctor may increase your dose as needed. However, the dose usually is not more than 450 mg every 12 hours
    • Children: Use and dose must be determined by your doctor
  • For oral dosage forms (tablets):
    • Adults: 150 milligrams every eight 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.

Precautions While Using Rythmol SR

It is important that your doctor check your progress at regular visits to make sure the medicine is working properly. This will allow changes to be made in the amount of medicine you are taking, if necessary.

Tell your doctor about all medications you are taking, prescription and over-the-counter (OTC)

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

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Propafenone may cause some people to become dizzy or lightheaded. 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 dizzy.

Rythmol SR 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:

Less common
  • Chest pain
  • shortness of breath
  • fast, irregular, or slow heartbeat, dizziness, and/or fainting
  • swelling of feet or lower legs
  • weight gain
Rare
  • Chills, fever, and weakness
  • joint pain
  • trembling or shaking

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
  • Change in taste or bitter or metallic taste
Less common
  • Blurred vision
  • constipation or diarrhea
  • dryness of mouth
  • headache
  • nausea and/or vomiting
  • skin rash
  • unusual tiredness or weakness

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.

The information contained in the Thomson Healthcare (Micromedex) products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

The use of the Thomson Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Healthcare does not assume any responsibility or risk for your use of the Thomson Healthcare products.

  • Rythmol SR Prescribing Information (FDA)
  • Rythmol SR Concise Consumer Information (Cerner Multum)
  • Rythmol SR Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)
  • Propafenone Prescribing Information (FDA)
  • Propafenone Detailed Consumer Information (PDR)
  • Propafenone Professional Patient Advice (Wolters Kluwer)
  • Propafenone MedFacts Consumer Leaflet (Wolters Kluwer)
  • Rythmol Prescribing Information (FDA)