Propafenone Hydrochloride - Sr (Rythmol)

Trade Name : RYTHMOL

GlaxoSmithKline LLC

CAPSULE, EXTENDED RELEASE

Strength 225 mg/1

PROPAFENONE HYDROCHLORIDE Antiarrhythmic [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Propafenone Hydrochloride - Sr (Rythmol) which is also known as RYTHMOL and Manufactured by GlaxoSmithKline LLC. It is available in strength of 225 mg/1 per ml. Read more

Propafenone Hydrochloride - Sr (Rythmol) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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WARNING: MORTALITY
See full prescribing information for complete boxed warning

An increased rate of death or reversed cardiac arrest rate was seen in patients treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in patients assigned to placebo. At present, it is prudent to consider any IC antiarrhythmic to have a significant risk of provoking proarrhythmic events 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.

RYTHMOL SR is indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease.
Usage Considerations:
RYTHMOL SR is an antiarrhythmic indicated to prolong the time to recurrence of symptomatic atrial fibrillation (AF) in patients with episodic (most likely paroxysmal or persistent) AF who do not have structural heart disease. ()
Usage Considerations:

RYTHMOL SR can be taken with or without food. Do not crush or further divide the contents of the capsule.
The dose of RYTHMOL SR must be individually titrated on the basis of response and tolerance. Initiate therapy with RYTHMOL SR 225u00a0mg given every 12 hours. Dosage may be increased at a minimum of 5-day intervals to 325u00a0mg given every 12 hours. If additional therapeutic effect is needed, the dose of RYTHMOLu00a0SR may be increased to 425 mg given every 12 hours.
In patients with hepatic impairment or those with significant widening of the QRS complex or second- or third-degree AV block, consider reducing the dose.
The combination of cytochrome P450 3A4 (CYP3A4) inhibition and either cytochrome P450 2D6 (CYP2D6) deficiency or CYP2D6 inhibition with the simultaneous administration of propafenone may significantly increase the concentration of propafenone and thereby increase the risk of proarrhythmia and other adverse events. Therefore, avoid simultaneous use of RYTHMOL SR with both a CYP2D6 inhibitor and a CYP3A4 inhibitor .

RYTHMOL SR (propafenone HCl) capsules are supplied as white, opaque, hard gelatin capsules containing either 225 mg, 325 mg, or 425u00a0mg 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 u00be 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 u00be of the circumference of the body.
Capsules: 225 mg, 325 mg, 425 mg. ()

RYTHMOL SR is contraindicated in the following circumstances:

No data

4n- 5.2
5.9n- 5.10

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 225u00a0mg twice daily in 126 patients, to RYTHMOL SR 325u00a0mg twice daily in 135 patients, to RYTHMOL SR 425u00a0mg 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 .
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 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.
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 included the following: dizziness, palpitations, chest pain, dyspnea, taste disturbance, nausea, fatigue, anxiety, constipation, upper respiratory tract infection, edema, and influenza. ()
To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

No data

7.2n- 7.3

No data

The symptoms of overdosage may include hypotension, somnolence, bradycardia, intra-atrial and intraventricular conduction disturbances, and rarely, convulsions and high-grade ventricular arrhythmias. Defibrillation, as well as infusion of dopamine and isoproterenol, has been effective in controlling abnormal rhythm and blood pressure. Convulsions have been alleviated with intravenous diazepam. General supportive measures such as mechanical respiratory assistance and external cardiac massage may be necessary.
The hemodialysis of propafenone in patients with an overdose is expected to be of limited value in the removal of propafenone as a result of both its high protein binding (greater than 95%) and large volume of distribution.

RYTHMOL SR (propafenone hydrochloride) is an antiarrhythmic drug supplied in extended-release capsules of 225, 325, and 425u00a0mg for oral administration.
Chemically, propafenone hydrochloride is 2u2019-[2-hydroxy-3-(propylamino)-propoxy]-3-phenylpropiophenone hydrochloride, with a molecular weight of 377.92. The molecular formula is CHNOu2022HCl.
Propafenone HCl has some structural similarities to beta-blocking agents. The structural formula of propafenone HCl is given below:
Propafenone HCl occurs as colorless crystals or white crystalline powder with a very bitter taste. It is slightly soluble in water (20u00b0C), chloroform, and ethanol. RYTHMOL SR capsules are filled with cylindrical-shaped 2 x 2 mm microtablets containing propafenone and the following inactive ingredients: antifoam, gelatin, hypromellose, magnesium stearate, red iron oxide, shellac, sodium dodecyl sulfate, sodium lauryl sulfate, soy lecithin, and titanium dioxide.

No data

No data

RYTHMOL SR has been evaluated in patients with a history of electrocardiographically documented recurrent episodes of symptomatic AF in 2 randomized, double-blind, placebo-controlled trials.
RAFT
In one U.S. multicenter trial (RAFT), 3 doses of RYTHMOL SR (225 mg twice daily, 325 mg twice daily, and 425 mg twice daily) and placebo were compared in 523 patients with symptomatic, episodic AF. The patient population in this trial was 59% male with a mean age of 63 years, 91% white, and 6% black. The patients had a median history of AF of 13 months and documented symptomatic AF within 12 months of trial entry. Over 90% were NYHA Class I, and 21% had a prior electrical cardioversion. At baseline, 24% were treated with calcium channel blockers, 37% with beta-blockers, and 38% with digoxin. Symptomatic arrhythmias after randomization were documented by transtelephonic electrocardiogram and centrally read and adjudicated by a blinded adverse event committee. RYTHMOL SR administered for up to 39 weeks was shown to prolong significantly the time to the first recurrence of symptomatic atrial arrhythmia, predominantly AF, from Day 1 of randomization (primary efficacy variable) compared with placebo, as shown in .
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 (225u00a0mg twice daily, 325u00a0mg twice daily, and 425u00a0mg 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.

RYTHMOL SR (propafenone HCl) capsules are supplied as white, opaque, hard gelatin capsules containing either 225 mg, 325 mg, or 425u00a0mg 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 u00be 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 u00be of the circumference of the body.
Storage:

Advise the patient to read the FDA-approved patient labeling (Patient Information).
Trademark is owned by or licensed to the GSK group of companies.
Manufactured for:
GlaxoSmithKline
Research Triangle Park, NC 27709
u00a92018 GSK group of companies or its licensor.
RMS:11PI
PHARMACIST u2013 DETACH HERE AND GIVE INSTRUCTIONS TO PATIENT
---------------------------------------------------------------------------------------------

PATIENT INFORMATION
RYTHMOL SR (RITH-Mall)
(propafenone hydrochloride) extended-release capsules
What is RYTHMOL SR?
RYTHMOL SR is a prescription medicine that is used:
Who should not take RYTHMOL SR?
Do not take RYTHMOL SR if you have:
Talk to your doctor before taking RYTHMOL SR if you think you have any of the conditions listed above.n
What should I tell my doctor before taking RYTHMOL SR?
Before you take RYTHMOL SR, tell your doctor if you:
Tell your doctor about all the medicines you take
Especially tell your doctor if you take:
How should I take RYTHMOL SR?
What are possible side effects of RYTHMOL SR?
RYTHMOL SR can cause serious side effects including:
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?
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.n
What are the ingredients in RYTHMOL SR?
Active Ingredient:
Inactive Ingredients:
RYTHMOL SR is a trademark owned by or licensed to the GSK group of companies. The other brands listed are trademarks owned by or licensed to their respective owners and are not trademarks owned by or licensed to 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.n
Manufactured for:GlaxoSmithKline
Research Triangle Park, NC 27709n
u00a92018 GSK group of companies or its licensor.n November 2018
RMS:6PILn

PRINCIPAL DISPLAY PANEL
NDC 0173-0823-18
Arrayn- Rythmol SR
(propafenone HCl)
Arrayn- Extended-Release Capsules
Arrayn- 225 mg
R only
Arrayn- 60 Capsules
Do not accept if seal over bottle opening is broken or missing.
Usual Dosage
Store at 25C (77F); excursions permitted to 15C-30C (59F-86F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.
Trademark owned or licensed by GSK.
u00a92017 GSK or licensor.
Manufactured for
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Germany
Rev. 6/17
10000000146369

PRINCIPAL DISPLAY PANEL
NDC 0173-0824-18
Arrayn- Rythmol SR
(propafenone HCl)
Arrayn- Extended-Release Capsules
Arrayn- 325 mg
R only
Arrayn- 60 Capsules
Do not accept if seal over bottle opening is broken or missing.
Usual Dosage
Store at 25C (77F); excursions permitted to 15C-30C (59F-86F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.
Trademark owned or licensed by GSK.
u00a92017 GSK or licensor.
Manufactured for
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Germany
Rev. 6/17
10000000146368

PRINCIPAL DISPLAY PANEL
NDC 0173-0826-18
Arrayn- Rythmol SR
(propafenone HCl)
Arrayn- Extended-Release Capsules
Arrayn- 425 mg
R only
Arrayn- 60 Capsules
Do not accept if seal over bottle opening is broken or missing.
Usual Dosage
Store at 25C (77F); excursions permitted to 15C-30C (59F-86F) [see USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP.
Trademark owned or licensed by GSK.
u00a92017 GSK or licensor.
Manufactured for
GlaxoSmithKline
Research Triangle Park, NC 27709
Made in Germany
Rev. 6/17
10000000146370

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Propafenone Hydrochloride - Sr (Rythmol)

Trade Name : RYTHMOL

CAPSULE, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Propafenone Hydrochloride - Sr (Rythmol)

Trade Name : RYTHMOL

CAPSULE, EXTENDED RELEASE

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

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