Rythmol SR
- Generic Name: propafenose hydrochloride extended release capsules
- Brand Name: Rythmol SR
- Drug Class: Antidysrhythmics, Ic
Rythmol SR(Propafenose Hydrochloride Extended Release Capsules) side effects drug center
Rythmol SR Side Effects Center
What Is Rythmol SR?
Rythmol SR (propafenone hydrochloride) is a Class IC anti-arrhythmic used in certain situations to prevent serious heart rhythm disorders. Rythmol SR is available in generic form.
What Are Side Effects of Rythmol SR?
Common side effects of Rythmol SR include dizziness, headache, metallic/salty or unpleasant taste in the mouth, nausea, vomiting, loss of appetite, constipation, anxiety, tiredness, loss of balance or coordination, flushing (warmth, redness, or tingly feeling under your skin), ringing in your ears, unusual dreams, or blurred vision.
Dosage for Rythmol SR
The starting dose of Rythmol SR is 225 mg every 12 hours. Dosage may be increased by your doctor at a minimum of 5-day intervals to 325 mg every 12 hours, or if prescribed up to 425 mg every 12 hours.
What Drugs, Substances, or Supplements Interact with Rythmol SR?
Rythmol SR may interact with cimetidine, digoxin, ketoconazole, orlistat, quinidine, rifampin, blood thinners, antidepressants, HIV or AIDS medications, other heart rhythm medications, medicine to treat psychiatric disorders, or beta-blockers. Tell your doctor all medications and supplements you use.
Rythmol SR During Pregnancy and Breastfeeding
During pregnancy, Rythmol SR should be used only when prescribed. This medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.
Additional Information
Our Rythmol SR (propafenone hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Rythmol SR Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Propafenone may cause a new or worsening heartbeat pattern. Call your doctor at once if you have fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out)
Also call your doctor at once if you have:
- shortness of breath (even with mild exertion);
- swelling in your arms or legs;
- sudden weight gain; or
- fever, chills, sore throat.
Common side effects may include:
- irregular heartbeats;
- nausea, vomiting, constipation;
- headache, dizziness, tiredness; or
- unusual or unpleasant taste in your mouth.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Rythmol SR (Propafenose Hydrochloride Extended Release Capsules)
Rythmol SR Professional Information
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to RYTHMOL SR 225 mg twice daily in 126 patients, to RYTHMOL SR 325 mg twice daily in 135 patients, to RYTHMOL SR 425 mg twice daily in 136 patients, and to placebo in 126 patients for up to 39 weeks (mean: 20 weeks) in a placebo-controlled trial (RAFT) conducted in the U.S. The most commonly reported adverse events with propafenone (greater than 5% and greater than placebo) excluding those not reasonably associated with the use of the drug or because they were associated with the condition being treated, were dizziness, palpitations, chest pain, dyspnea, taste disturbance, nausea, fatigue, anxiety, constipation, upper respiratory tract infection, edema, and influenza. The frequency of discontinuation due to adverse events was 17%, and the rate was highest during the first 14 days of treatment.
Cardiac-related adverse events occurring in greater than or equal to 2% of the patients in any of the RAFT propafenone SR treatment groups and more common with propafenone than with placebo, excluding those that are common in the population and those not plausibly related to drug therapy, included the following: angina pectoris, atrial flutter, AV block first-degree, bradycardia, congestive cardiac failure, cardiac murmur, edema, dyspnea, rales, wheezing, and cardioactive drug level above therapeutic.
Propafenone prolongs the PR and QRS intervals in patients with atrial and ventricular arrhythmias. Prolongation of the QRS interval makes it difficult to interpret the effect of propafenone on the QT interval [see CLINICAL PHARMACOLOGY].
Non-cardiac related adverse events occurring in greater than or equal to 2% of the patients in any of the RAFT propafenone SR treatment groups and more common with propafenone than with placebo, excluding those that are common in the population and those not plausibly related to drug therapy, included the following: blurred vision, constipation, diarrhea, dry mouth, flatulence, nausea, vomiting, fatigue, weakness, upper respiratory tract infection, blood alkaline phosphatase increased, hematuria, muscle weakness, dizziness (excluding vertigo), headache, taste disturbance, tremor, somnolence, anxiety, depression, ecchymosis.
No clinically important differences in incidence of adverse reactions were noted by age or gender. Too few non-Caucasian patients were enrolled to assess adverse events according to race.
Adverse events occurring in 2% or more of the patients in any of the ERAFT [see Clinical Studies] propafenone SR treatment groups and not listed above include the following: bundle branch block left, bundle branch block right, conduction disorders, sinus bradycardia, and hypotension.
Other adverse events reported with propafenone clinical trials not already listed elsewhere in the prescribing information include the following adverse events by body system and preferred term.
Blood And Lymphatic System
Anemia, lymphadenopathy, spleen disorder, thrombocytopenia.
Cardiac
Unstable angina, atrial hypertrophy, cardiac arrest, coronary artery disease, extrasystoles, myocardial infarction, nodal arrhythmia, palpitations, pericarditis, sinoatrial block, sinus arrest, sinus arrhythmia, supraventricular extrasystoles, ventricular extrasystoles, ventricular hypertrophy.
Ear And Labyrinth
Hearing impaired, tinnitus, vertigo.
Eye
Eye hemorrhage, eye inflammation, eyelid ptosis, miosis, retinal disorder, visual acuity reduced.
Gastrointestinal
Abdominal distension, abdominal pain, duodenitis, dyspepsia, dysphagia, eructation, gastritis, gastroesophageal reflux disease, gingival bleeding, glossitis, glossodynia, gum pain, halitosis, intestinal obstruction, melena, mouth ulceration, pancreatitis, peptic ulcer, rectal bleeding, sore throat.
General Disorders And Administration Site Conditions
Chest pain, feeling hot, hemorrhage, malaise, pain, pyrexia.
Hepatobiliary
Hepatomegaly.
Investigations
Abnormal heart sounds, abnormal pulse, carotid bruit, decreased blood chloride, decreased blood pressure, decreased blood sodium, decreased hemoglobin, decreased neutrophil count, decreased platelet count, decreased prothrombin level, decreased red blood cell count, decreased weight, glycosuria present, increased alanine aminotransferase, increased aspartate aminotransferase, increased blood bilirubin, increased blood cholesterol, increased blood creatinine, increased blood glucose, increased blood lactate dehydrogenase, increased blood pressure, increased blood prolactin, increased blood triglycerides, increased blood urea, increased blood uric acid, increased eosinophil count, increased gammaglutamyltransferase, increased monocyte count, increased prostatic specific antigen, increased prothrombin level, increased weight, increased white blood cell count, ketonuria present, proteinuria present.
Metabolism And Nutrition
Anorexia, dehydration, diabetes mellitus, gout, hypercholesterolemia, hyperglycemia, hyperlipidemia, hypokalemia.
Musculoskeletal, Connective Tissue, And Bone
Arthritis, bursitis, collagen-vascular disease, costochondritis, joint disorder, muscle cramps, muscle spasms, myalgia, neck pain, pain in jaw, sciatica, tendonitis.
Nervous System
Amnesia, ataxia, balance impaired, brain damage, cerebrovascular accident, dementia, gait abnormal, hypertonia, hypothesia, insomnia, paralysis, paresthesia, peripheral neuropathy, speech disorder, syncope, tongue hypoesthesia.
Psychiatric
Decreased libido, emotional disturbance, mental disorder, neurosis, nightmare, sleep disorder.
Renal And Urinary
Dysuria, nocturia, oliguria, pyuria, renal failure, urinary casts, urinary frequency, urinary incontinence, urinary retention, urine abnormal.
Reproductive System And Breast
Breast pain, impotence, prostatism.
Respiratory, Thoracic, And Mediastinal
Atelectasis, breath sounds decreased, chronic obstructive airways disease, cough, epistaxis, hemoptysis, lung disorder, pleural effusion, pulmonary congestion, rales, respiratory failure, rhinitis, throat tightness.
Skin And Subcutaneous Tissue
Alopecia, dermatitis, dry skin, erythema, nail abnormality, petechiae, pruritus, sweating increased, urticaria.
Vascular
Arterial embolism limb, deep limb venous thrombosis, flushing, hematoma, hypertension, hypertensive crisis, hypotension, labile blood pressure, pallor, peripheral coldness, peripheral vascular disease, thrombosis.
Read the entire FDA prescribing information for Rythmol SR (Propafenose Hydrochloride Extended Release Capsules)
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&Copy; Rythmol SR Patient Information is supplied by Cerner Multum, Inc. and Rythmol SR Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.