Medication info

Ritmole Tablet 150mg (Propafenone Hydrochloride)

Prescription medicationTabletOralApproval withdrawn
Ingredient · strength
Propafenone Hydrochloride›150mg / 1 tablet
Manufacturer / importer
Hanall Biopharma Co., Ltd.
Appearance
White, round, film-coated tablets
Packaging
30 tablets/bottle, 60 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201400559 · Approved 2014.02.07

This product's status changed to Approval withdrawn on 2023.12.20. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of symptomatic supraventricular tachyarrhythmia and severe symptomatic ventricular arrhythmia
Who takes it
Adults
Adult dose
The individual maintenance dose should be determined under cardiac monitoring, including ECG monitoring and repeated blood pressure measurements. Adults: Administer 450-600㎎ of propafenone hydrochloride orally per day (one 150mg tablet 3 times daily or one 300mg tablet 2 times daily). In some cases, the dose may be increased to 900㎎ per day (one 300mg tablet or two 150mg tablets 3 times daily). This dosage regimen applies to patients weighing approximately 70㎏. For patients weighing less, the daily dose should be reduced according to body weight. The daily dose may be exceeded only in exceptional circumstances under the strict supervision of a cardiologist. In particular, in elderly patients, patients with a history of myocardial injury, and patients with hepatic or renal impairment, begin treatment at a low dose and increase cautiously while monitoring whether the blood concentration is appropriate. The first dose increase should be made after at least 3-4 days. Patients with ventricular arrhythmias require careful cardiac examination at the start of treatment. In these patients, treatment should be initiated only when emergency cardiac equipment is available and monitoring can be ensured; regular examinations are required during treatment (for example, standard ECG at one-month intervals, Holter monitoring at 3-month intervals, and exercise ECG if possible). If ECG changes occur, such as a QRS widening or QT prolongation greater than 25%, PR prolongation greater than 50%, QT prolongation greater than 500ms, or an increase in the frequency or severity of arrhythmias, a decision must be made as to whether to continue treatment. This medicine has a bitter taste and surface anesthetic effect, so swallow it with a small amount of liquid after meals. When prescribing this medicine, consider that there is no evidence that treatment with ClassⅠ antiarrhythmic agents helps prolong life.

Ingredients

Manufacturer
Hanall Biopharma Co., Ltd.

Efficacy & effects

Treatment of symptomatic supraventricular tachyarrhythmia and severe symptomatic ventricular arrhythmia

  • Symptomatic atrial fibrillation
  • loss of rhythm associated with paroxysmal atrial fibrillation
  • atrioventricular nodal reentrant tachycardia
  • severe symptomatic ventricular arrhythmias.
View approved original text

This medication is used to treat symptomatic loss of rhythm, particularly loss of rhythm accompanied by Wolff-Parkinson-White syndrome or paroxysmal atrial fibrillation, as well as arrhythmias such as atrioventricular nodal reentrant tachycardia. It is also effective for severe symptomatic ventricular arrhythmias that are life-threatening or that the physician deems require treatment. This drug helps restore normal heart rhythms by regulating abnormal electrical signals in the heart, thereby helping to reduce symptoms and risks associated with arrhythmias. Patients can stabilize heart rhythms and maintain healthy heart function through this medication. Therefore, this drug is used for the treatment of such serious arrhythmias.

How to take

Adult dose

The individual maintenance dose should be determined under cardiac monitoring, including ECG monitoring and repeated blood pressure measurements. Adults: Administer 450-600㎎ of propafenone hydrochloride orally per day (one 150mg tablet 3 times daily or one 300mg tablet 2 times daily). In some cases, the dose may be increased to 900㎎ per day (one 300mg tablet or two 150mg tablets 3 times daily). This dosage regimen applies to patients weighing approximately 70㎏. For patients weighing less, the daily dose should be reduced according to body weight. The daily dose may be exceeded only in exceptional circumstances under the strict supervision of a cardiologist. In particular, in elderly patients, patients with a history of myocardial injury, and patients with hepatic or renal impairment, begin treatment at a low dose and increase cautiously while monitoring whether the blood concentration is appropriate. The first dose increase should be made after at least 3-4 days. Patients with ventricular arrhythmias require careful cardiac examination at the start of treatment. In these patients, treatment should be initiated only when emergency cardiac equipment is available and monitoring can be ensured; regular examinations are required during treatment (for example, standard ECG at one-month intervals, Holter monitoring at 3-month intervals, and exercise ECG if possible). If ECG changes occur, such as a QRS widening or QT prolongation greater than 25%, PR prolongation greater than 50%, QT prolongation greater than 500ms, or an increase in the frequency or severity of arrhythmias, a decision must be made as to whether to continue treatment. This medicine has a bitter taste and surface anesthetic effect, so swallow it with a small amount of liquid after meals. When prescribing this medicine, consider that there is no evidence that treatment with ClassⅠ antiarrhythmic agents helps prolong life.

Precautions

This drug is specifically used for the treatment of cardiac arrhythmias and can affect cardiac function, so patients with heart disease should be particularly cautious. Caution should be exercised when used in patients with ventricular arrhythmias within 2 years after a myocardial infarction, as it may increase the risk of death. It should not be used in patients with severe heart failure with significantly reduced left ventricular function, cardiogenic shock, or certain cardiac conduction disorders. Patients with Brugada syndrome, severe bradycardia, those within 3 months post-myocardial infarction, severe obstructive pulmonary disease, or myasthenia gravis should also refrain from taking this medication. Patients with impaired liver or kidney function may have increased drug concentrations, so dose adjustments and monitoring of their condition are necessary. Various side effects can occur, including decreased heart rate, ECG abnormalities, lowered blood pressure, dizziness, nausea, liver function abnormalities, etc. If any abnormal symptoms appear, immediate consultation with healthcare providers is advised. Particularly, cardiac-related adverse reactions can be serious, so regular ECG tests and monitoring of the patient's condition are important. Caution is needed when driving or operating machinery while taking this medication, and alcohol consumption can exacerbate these side effects. There is a high possibility of drug interactions, so co-administration should be discussed with a doctor or pharmacist, and some drugs are prohibited from being taken together. During pregnancy, fetal and neonatal signs of arrhythmia should be carefully monitored, and during breastfeeding, administration should be avoided or breastfeeding should be discontinued if possible. Safety in children has not been established, so pediatric use must be decided with caution. The elderly are at greater risk of side effects due to decreased liver and kidney function, so start with a lower dose and frequently monitor the patient's condition. In case of overdose, symptoms like cardiac dysfunction, seizures, and hypotension may occur, necessitating immediate emergency treatment. This drug should only be administered when other antiarrhythmic medications are ineffective or not available, and the patient's condition must be closely monitored during treatment.

Side effects

Significant decrease in heart rate (bradycardia), conduction disorders (atrioventricular block or ventricular block), increase in heart rate (palpitations), ventricular fibrillation, total arrhythmia, ventricular tachycardia (including torsades de pointes), ventricular flutter, worsening heart failure, orthostatic hypotension, postural hypotension, nausea, decreased appetite, abdominal bloating, vomiting, constipation, thirst, abdominal pain, bitter taste, numbness of the mouth, diarrhea, gastric pain, liver cell damage, cholestasis, jaundice, hepatitis, dizziness, headache, syncope, extrapyramidal symptoms, fatigue, ataxia, sensory disturbances, anxiety, nightmares, sleep disorders, seizures, restlessness, confusion, unsteady symptoms, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, skin erythema, itching, urticaria, erythema, rash, hepatitis, allergic reactions, hypersensitivity reactions, anorexia nervosa, blurred vision, lupus syndrome, erectile dysfunction, fatigue, chest pain, elevated liver enzymes, warm sensation, flushing, lethargy, myalgia, edema, increased triglycerides, convulsions, bronchospasm, decreased libido, decreased sperm count, symptoms of Brugada syndrome or changes in electrocardiogram

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container to prevent air or moisture ingress. The recommended storage temperature is room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White, round, film-coated tablets

Package unit

30 tablets/bottle, 60 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.