divulge to [0.0001:<0.0001 -- Hazard Ratio compared with placebo 0.67 0.43 0.35 -- 95% CI for Hazard Ratio (0.49, 0.93) (0.31, 0.61) (0.24, 0.51) -- a Terminating events comprised 91% AF, 5% atrial flutter, and 4% PSVT. b Not Applicable: Fewer than 50% of the patients had events. The median time is not calculable. There was a dose response for Rythmol SR for the tachycardia-free period as shown in the proportional hazard analysis and the Kaplan-Meier curves presented in Figure 1. Figure 1. RAFT Kaplan-Meier Analysis for the Tachycardia-Free Period from Day 1 of Randomization: In additional analyses, Rythmol SR (225 mg twice daily, 325 mg twice daily, and 425 mg twice daily) was also shown to prolong time to the first recurrence of symptomatic AF from Day 5 (steady-state pharmacokinetics were attained). The antiarrhythmic effect of Rythmol SR was not influenced by age, gender, history of cardioversion, duration of AF, frequency of AF, or use of medication that lowers heart rate. Similarly, the antiarrhythmic effect of Rythmol SR was not influenced by the individual use of calcium channel blockers, beta-blockers, or digoxin. Too few non-white patients were enrolled to assess the influence of race on effects of Rythmol SR. No difference in the average heart rate during the first recurrence of symptomatic arrhythmia between Rythmol SR and placebo was observed. ERAFT In a European multicenter trial [European Rythmonorm SR Atrial Fibrillation Trial (ERAFT)], 2 doses of Rythmol SR (325 mg twice daily and 425 mg twice daily) and placebo were compared in 293 patients with documented electrocardiographic evidence of symptomatic paroxysmal AF. The patient population in this trial was 61% male, 100% white with a mean age of 61 years. Patients had a median duration of AF of 3.3 years, and 61% were taking medications that lowered heart rate. At baseline, 15% of the patients were treated with calcium channel blockers (verapamil and diltiazem), 42% with beta-blockers, and 8% with digoxin. During a qualifying period of up to 28 days, patients had to have 1 ECG-documented incident of symptomatic AF. The double-blind treatment phase consisted of a 4- day loading period followed by a 91-day efficacy period. Symptomatic arrhythmias were documented by electrocardiogram monitoring. In ERAFT, Rythmol SR was shown to prolong the time to the first recurrence of symptomatic atrial arrhythmia from Day 5 of randomization (primary efficacy analysis). The proportional hazard analysis revealed that both doses of Rythmol SR were superior to placebo. The antiarrhythmic effect of propafenone SR was not influenced by age, gender, duration of AF, frequency of AF or use of medication that lowers heart rate. It was also not influenced by the individual use of calcium channel blockers, beta-blockers, or digoxin. Too few non-white patients were enrolled to assess the influence of race on the effects of Rythmol SR. There was a slight increase in the incidence of centrally diagnosed asymptomatic AF or atrial flutter in each of the 2 treatment groups receiving Rythmol SR compared with placebo. How Supplied/Storage and Handling Rythmol SR (propafenone HCl) capsules are supplied as white, opaque, hard gelatin capsules containing either 225 mg, 325 mg, or 425 mg of propafenone HCl. The 225-mg strength is imprinted in red with GS EUG followed by 225. The 325-mg strength is imprinted in red with GS F1Y followed by 325, and also has a single red band around of the circumference of the body. The 425-mg strength is imprinted in red with GS UY2 followed by 425, and also has 3 red bands around of the circumference of the body. Capsule Strength 60-count bottle NDC 225 mg 0173-0823-18 325 mg 0173-0824-18 425 mg 0173-0826-18 Storage: Store at 25 C (77 F); excursions permitted to 15 C to 30 C (59 F to 86 F). Dispense in a tight container. Patient Counseling Information Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients should be instructed to notify their healthcare providers of any change in over-the-counter, prescription, and supplement use. The healthcare provider should assess the patients medication history including all over-the-counter, prescription, and herbal/natural preparations for those that may affect the pharmacodynamics or kinetics of Rythmol SR [see Warnings and Precautions (5.4)] . Patients should also check with their healthcare providers prior to taking a new over-the-counter medicine. If patients experience symptoms that may be associated with altered electrolyte balance, such as excessive or prolonged diarrhea, sweating, vomiting, or loss of appetite or thirst, these conditions should be immediately reported to their healthcare provider. Patients should be instructed NOT to double the next dose if a dose is missed. The next dose should be taken at the usual time. Rythmol SR is a registered trademark of G. Petrik used under license by Abbott Laboratories. Manufactured for: GlaxoSmithKline Research Triangle Park, NC 27709 2016 the GSK group of companies. All rights reserved. RMS:10PI PHARMACIST DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT PATIENT INFORMATION Rythmol SR (RITH-Mall) (propafenone hydrochloride) extended-release capsules Read this Patient Information Leaflet before you start taking Rythmol SR and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. What is Rythmol SR? Rythmol SR is a prescription medicine that is used: in certain people who have a heart rhythm disorder called atrial fibrillation (AF) to increase the amount of time between having symptoms of AF It is not known if Rythmol SR is safe and effective in children. Who should not take Rythmol SR? Do not take Rythmol SR if you have: heart failure (weak heart) had a recent heart attack have a heart condition called Brugada Syndrome a heart rate that is too slow, and you do not have a pacemaker very low blood pressure certain breathing problems that make you short of breath or wheeze certain abnormal body salt (electrolyte) levels in your blood Talk to your doctor before taking Rythmol SR if you think you have any of the conditions listed above. What should I tell my doctor before taking Rythmol SR? Before you take Rythmol SR, tell your doctor if you: have liver or kidney problems have breathing problems have symptoms including diarrhea, sweating, vomiting, or loss of appetite or thirst that are severe. These symptoms may be a sign of abnormal electrolyte levels in your blood. have myasthenia gravis have lupus erythematosis have been told you have or had an abnormal blood test called Antinuclear Antibody Test or ANA Test are pregnant or plan to become pregnant. It is not known if Rythmol SR will harm your unborn baby. are breastfeeding or plan to breastfeed. Rythmol SR can pass into your milk and may harm your baby. You and your doctor should decide if you will breastfeed or take Rythmol SR. You should not do both. have any other medical conditions Tell your doctor about all the medicines you take , including prescription and non-prescription medicines, vitamins, and herbal supplements. Rythmol SR and certain other medicines can affect each other and cause serious side effects. Rythmol SR may affect the way other medicines work, and other medicines may affect how Rythmol SR works. Especially tell your doctor if you take: amiodarone or other medicines for your abnormal heart beats an antidepressant medicine a medicine to treat anxiety ritonavir (for example, KALETRA , NORVIR ) or saquinavir (for example, INVIRASE ) an antibiotic medicine ketoconazole (for example, NIZORAL ) digoxin (LANOXIN ) warfarin sodium (for example, COUMADIN , JANTOVEN ) Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine. How should I take Rythmol SR? Take Rythmol SR exactly as prescribed. Your doctor will tell you how many capsules to take and how often to take them. To help reduce the chance of certain side effects, your doctor may start you with a low dose of Rythmol SR, and then slowly increase the dose. Do not open or crush the capsule. You may take Rythmol SR with or without food. You should not drink grapefruit juice during treatment with Rythmol SR. If you miss a dose of Rythmol SR, take your next dose at the usual time. Do not take 2 doses at the same time. If you take too much Rythmol SR, call your doctor or go to the nearest hospital emergency room right away. Call your doctor if your heart problems get worse. What are possible side effects of Rythmol SR? Rythmol SR can cause serious side effects including: New or worsened abnormal heart beats, that can cause sudden death or be life-threatening. Your doctor may do an electrocardiogram (ECG or EKG) before and during treatment to check your heart for these problems. New or worsened heart failure. Tell your doctor about any changes in your heart symptoms, including: o any new or increased swelling in your arms or legs o trouble breathing o sudden weight gain Effects on pacemaker function. Rythmol SR may affect how an implanted pacemaker or defibrillator works. Your doctor should check how your pacemaker or defibrillator is working during and after treatment with Rythmol SR. They may need to be re-programmed. Very low white blood cell levels in your blood (agranulocytosis). Your bone marrow may not produce enough of a certain type of white blood cells called neutrophils. If this happens, you are more likely to get infections. Tell your doctor right away if you have any of these symptoms, especially during the first 3 months of treatment: o fever o sore throat o chills Worsening of myasthenia gravis in people who already have this condition. Tell your doctor about any change in your symptoms. Rythmol SR may cause lower sperm counts in men. This could affect the ability to father a child. Talk to your doctor if this is a concern for you. Common side effects of Rythmol SR include: dizziness fast or irregular heart beats chest pain trouble breathing taste changes nausea tiredness feeling anxious constipation upper respiratory infection or flu swelling Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of Rythmol SR. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. How should I store Rythmol SR? Store Rythmol SR at room temperature between 59 F to 86 F (15 C to 30 C). Keep the bottle tightly closed. Keep Rythmol SR and all medicines out of the reach of children. General information about Rythmol SR Medicines are sometimes prescribed for conditions other than those described in patient information leaflets. Do not use Rythmol SR for a condition for which it was not prescribed by your doctor. Do not give Rythmol SR to other people, even if they have the same symptoms you have. It may harm them. This leaflet summarizes the most important information about Rythmol SR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Rythmol SR that is written for healthcare professionals. For more information about Rythmol SR, call 1-888-825-5249. What are the ingredients in Rythmol SR? Active Ingredient: Propafenone hydrochloride Inactive Ingredients: Antifoam, gelatin, hypromellose, magnesium stearate, red iron oxide, shellac, sodium dodecyl sulfate, sodium lauryl sulfate, soy lecithin and titanium dioxide. RYTHMOL is a registered trademark of G. Petrik used under license by Abbott Laboratories. The other brands listed are trademarks of their respective owners and are not trademarks of the GlaxoSmithKline group of companies. The makers of these brands are not affiliated with and do not endorse the GlaxoSmithKline group of companies or its products. Manufactured for: GlaxoSmithKline Research Triangle Park, NC 27709 2016 the GSK group of companies. All rights reserved. October 2016 RMS:5PIL PRINCIPAL DISPLAY PANEL NDC 0173-0823-18 (propafenone HCl) Extended-Release Capsules 225 mg R x only 60 Capsules Do not accept if seal over bottle opening is broken or missing. Usual Dosage : See accompanying prescribing information. Store at 25 o C (77 o F); excursions permitted to 15 o -30 o C (59 o -86 o F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Manufactured for GlaxoSmithKline Research Triangle Park, NC 27709 Made in Germany Rev. 4/14 10000000124513 PRINCIPAL DISPLAY PANEL NDC 0173-0824-18 Rythmol SR (propafenone HCl) Extended-Release Capsules 325 mg R x only 60 Capsules Do not accept if seal over bottle opening is broken or missing. Usual Dosage : See accompanying prescribing information. Store at 25 o C (77 o F); excursions permitted to 15 o -30 o C (59 o -86 o F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Manufactured for GlaxoSmithKline Research Triangle Park, NC 27709 Made in Germany Rev. 4/14 10000000124515 PRINCIPAL DISPLAY PANEL NDC 0173-0826-18 Rythmol SR (propafenone HCl) Extended-Release Capsules 425 mg R x only 60 Capsules Do not accept if seal over bottle opening is broken or missing. Usual Dosage : See accompanying prescribing information. Store at 25 o C (77 o F); excursions permitted to 15 o -30 o C (59 o -86 o F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Manufactured for GlaxoSmithKline Research Triangle Park, NC 27709 Made in Germany Rev. 4/14 10000000124512 RYTHMOL SR propafenone hydrochloride capsule, extended release Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0823 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 225 mg Inactive Ingredients Ingredient Name Strength GELATIN HYPROMELLOSES MAGNESIUM STEARATE FERRIC OXIDE RED SHELLAC SODIUM LAURYL SULFATE LECITHIN, SOYBEAN TITANIUM DIOXIDE Product Characteristics Color WHITE (Opaque) Score no score Shape CAPSULE Size 19mm Flavor Imprint Code GS;EUG;225 Contains Packaging # Item Code Package Description 1 NDC:0173-0823-18 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021416 03/17/2011 RYTHMOL SR propafenone hydrochloride capsule, extended release Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0824 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 325 mg Inactive Ingredients Ingredient Name Strength GELATIN HYPROMELLOSES MAGNESIUM STEARATE FERRIC OXIDE RED SHELLAC SODIUM LAURYL SULFATE LECITHIN, SOYBEAN TITANIUM DIOXIDE Product Characteristics Color WHITE (Opaque) , RED (single band) Score no score Shape CAPSULE Size 21mm Flavor Imprint Code GS;F1Y;325 Contains Packaging # Item Code Package Description 1 NDC:0173-0824-18 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021416 03/17/2011 RYTHMOL SR propafenone hydrochloride capsule, extended release Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0173-0826 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PROPAFENONE HYDROCHLORIDE (PROPAFENONE) PROPAFENONE HYDROCHLORIDE 425 mg Inactive Ingredients Ingredient Name Strength GELATIN HYPROMELLOSES MAGNESIUM STEARATE FERRIC OXIDE RED SHELLAC SODIUM LAURYL SULFATE LECITHIN, SOYBEAN TITANIUM DIOXIDE Product Characteristics Color WHITE (Opaque) , RED (3 bands) Score no score Shape CAPSULE Size 23mm Flavor Imprint Code GS;UY2;425 Contains Packaging # Item Code Package Description 1 NDC:0173-0826-18 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021416 03/17/2011 Labeler - GlaxoSmithKline LLC (167380711) Revised: 10/2016 GlaxoSmithKline LLC Next Interactions Print this page Add to My Med List More about Rythmol SR (propafenone) Side Effects During Pregnancy or Breastfeeding Dosage Information Drug Images Drug Interactions Support Group Pricing & Coupons En Español 16 Reviews Add your own review/rating Generic Availability Drug class: group I antiarrhythmics Consumer resources Rythmol SR Rythmol SR (Advanced Reading) Professional resources Rythmol Extended Release (FDA) Propafenone Hydrochloride (AHFS Monograph) Other Formulations Rythmol Related treatment guides Atrial Fibrillation Atrial Flutter Ventricular Tachycardia Wolff-Parkinson-White Syndrome> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer GlaxoSmithKline Drug Class Group I antiarrhythmics Related Drugs group I antiarrhythmics lidocaine , flecainide , Dilantin , phenytoin , propafenone Atrial Fibrillation diltiazem , Xarelto , propranolol , digoxin , sotalol , flecainide , More... Wolff-Parkinson-White Syndrome flecainide , propafenone , Rythmol , adenosine , Tambocor , Adenocard , More... Atrial Flutter diltiazem , sotalol , flecainide , Multaq , propafenone , Rythmol , More... 1 more conditions... Rythmol SR Rating 16 User Reviews 8.9 /10 16 User Reviews 8.9 Rate it! Rythmol SR Images Rythmol SR 225 mg (a 225 ) View all images} } extensive
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