Indications:
In patients without structural heart disease, Propafenone HCl is indicated to prolong the time to recurrence of
- Paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.
- Paroxysmal supraventricular tachycardia (PSVT) associated with disabling symptoms.
As with other agents, some patients with atrial flutter treated with Propafenone have developed 1:1 conduction, producing an increase in ventricular rate. Concomitant treatment with drugs that increase the functional AV refractory period is recommended.
The use of Propafenone in patients with chronic atrial fibrillation has not been evaluated. Propafenone should not be used to control ventricular rate during atrial fibrillation.
Propafenone is also indicated for the treatment of
-Documented ventricular arrhythmias, such as sustained ventricular tachycardia, that, in the judgment of the physician, are life-threatening. Because of the proarrhythmic effects of Propafenone, its use with lesser ventricular arrhythmias is not recommended, even if patients are symptomatic, and any use of the drug should be reserved for patients in whom, in the opinion of the physician, the potential benefits out-weigh the risks.
Initiation of Propafenone treatment, as with other antiarrhythmics used to treat life-threatening ventricular arrhythmias, should be carried out in the hospital.
Propafenone, like other antiarrhythmic drugs, has not been shown.

Dosage:
Adult dose: 2 to 5 mg injected into a vein, dose can be repeated as necessary until a satisfactory
fall in blood pressure.
Children dose: 1 mg for a child over 8 years old.

Side effect:
Adverse reactions associated with Propafenone HCI occur most frequently in the gastrointestinal, cardiovascular, and central nervous systems. About 20% of patients treated with Propafenone HCI have discontinued treatment because of adverse reactions.
The most common adverse reactions in controlled clinical trials appeared dose-related (but note that most patients spent more time at the larger doses), especially dizziness, nausea and/or vomiting, unusual taste, constipation, and blurred vision. Some less common reactions may also have been dose-related such as first degree AV block, congestive heart failure, dyspepsia, and weakness.

The principal causes of discontinuation were the most common events and are :
-Dizziness ,
-Nausea and/or Vomiting,
-Unusual Taste,
-Constipation,
-Fatigue,
-Dyspnea,
-Proarrhythmia,
-Angina,
-Headache,
-Blurred Vision,
-CHF,
-Ventricular tachycardia,
-Dyspepsia,
-Palpitations,
-Rash,
-AV Block first degree,
-Diarrhea,
-Weakness,
-Dry Mouth,
-Syncope/Near Syncope,
-QRS Duration Increased,
-Chest Pain,
-Anorexia,
-Abdominal Pain, Cramps,
-Ataxia,
-Insomnia,
-Premature Ventricular Contraction,
-Bradycardia,
-Anxiety,
-Edema,
-Tremors,
-Diaphoresis,
-Bundle Branch Block,
-Drowsiness,
-Atrial Fibrilation,
-Flatulence,
-Hypotension,
-Intraventricular Conduction Delay, -Pain Joints,
In addition, the following adverse reactions were reported less frequently than 1% either in clinical trials or in marketing experience.
Causality and relationship to Propafenone therapy cannot necessarily be judged from these events.
Cardiovascular System: Atrial flutter, AV dissociation, cardiac arrest, flushing, hot flashes, sick sinus syndrome, sinus syndrome, sinus pause or arrest, supraventricular tachycardia.
Nervous System: Abnormal dreams, abnormal speech, abnormal vision, apnea, coma, confusion, depression, memory loss, numbness, paresthesias, psychosis/mania, seizures (0.3%), tinnitus, unusual smell sensation, vertigo.
Gastrointestinal: A number of patients with liver abnormalities associated with Propafenone therapy have been reported in post-marketing experience. Some appeared due to hepatocellular injury, some were cholestatic and some showed a mixed picture. Some of these reports were simply discovered through clinical chemistries, others because of clinical symptoms including fulminant hepatitis and death. One case was rechallenged with a positive outcome. Cholestasis (0.1%), elevated liver enzymes (alkaline phosphatase, serum transaminases) (0.2%), gastroenteritis, hepatitis (0.03%).
Hematologic: Agranulocytosis, anemia, bruising, granulocytopenia, increased bleeding time, leukopenia, purpura, thrombocytopenia.
Other: Alopecia, eye irritation, hyponatremia/inappropriate ADH secretion, impotence, increased glucose, kidney failure, positive ANA (0.7%), lupus erythematosis, muscle cramps, muscle weakness, nephrotic syndrome, pain, pruritus.

Drug interaction:
The dosage is as follows unless otherwise prescribed by the physician.
For initial and maintenance treatment a daily dose of 450 - 600 mg (l/2 tablet of Normapafenone 300mg 3 times daily or up to 1 tablets of Normapafenone 300 mg twice daily) is recommended . Occasionally an increase of the daily dose to 900 mg may be necessary (1 tablets of Normapafenone 300 mg 3 times a day).
This daily dose should be exceeded only in exceptional circumstances and under strict cardiological control .
The individual maintenance dose should be determined under cardiological surveillance including ECG monitoring and blood pressure control (adjustment phase). If the QRS phase is prolonged by These doses apply to patients with a body weight of about 70 kg.
The daily doses are to be reduced accordingly for patients with a lower body weight.
In the elderly or in patients with marked previous myocardial damage the dose of Normapafenone should,in conformity with other antiarrhythmic agents, be increased only slowly and gradually during the initial phase of treatment .
-Because of its bitter taste and its surface anaesthetic action the tab

Packages:
10 Scored Film Coated Tablets