Propanorm® 150 mg, 300 mg
film-coated tablets
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- Manufacturer:
- PRO.MED.CS Praha a.s.
- Marketing authorisation holder:
- PRO.MED.CS Praha a.s.
- Composition:
- Propafenone hydrochloride 150 mg, 300 mg in film coated tablets.
- Indication group:
- antiarhythmicum
The following information is for health professionals only.
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Characteristics:
Propafenone hydrochloride ranks among membrane antiarhythmics of the Ic group in classification after Vaughan Williams. Propafenone is antiarhythmicum with local anaesthetic and a direct membrane stabilising effect on myocardium cells. Additionally it has some beta- blocking and Ca2+ blocking abilities. Biotransformation polymorphism was demonstrated in the human population. The biologically half time of elimination ranges about 6.2 hours with variations from 2.3 to 11.8 hours (in poor metabolisators it is prolonged approximately twice).
Indications:
Supravetricular tachyarrhythmias including Wolf-Parkinson-White syndrome, atrial fibrillation, AV - nodal reentry tachycardia. Propafenone is also effective in suppressing ventricular premature complexes and nonsustained ventricular tachycardias. However, because of potential proarrhythmic effects, its use in these arrhythmias must be considered after a careful analysis of the risk-benefit profile. Propanorm® is designated to treat adult patients and children over 15 years of age.
Contraindications:
Hypersensitivity to preparation components, digoxin intoxication. Serious hypotension, serious heart failure and cardiogenic shock (exclusive, hypotension evoked by tachyarrhytmia itself), serious bradycardia, sick sinus syndrome, SA-blocade, bifascicular blocade, AV-block of the II-III degree. Propafenone is contraindicated within the first three months after acute myocardial infarction or for patients with decreased cardiac output (ejection fraction below 35 per cent), except for patients with life-threatening ventricular arrhythmia. Precaution is necessary in patients with Tawara´s bundle blocks, AV blocade of the first degree, serious obstruction bronchopulmonal disease, asthma bronchiale, electrolyte dysballance, hepatic failure, myasthenia gravis, during pregnancy (particularly in the first trimester) and during lactation.
Undesirable effects:
Adverse effects are dependent of dosage, they appear particularly when starting the therapy and are reversible.
Cardiac: Bradycardia, SA or AV block, bundle block, hypotension. Using high dosage re-entry mechanism can be incited particularly where inhomogeneous re-polarisation occurs. It is also possible to develop ventricular tachycardia, flutter and atrial fibrillation, heart insufficiency can get worse.
Extracardial: Loss of appetite, nausea, vomiting, bitter gustatory sense, dryness in the mouth, constipation, headache ,fatigue, restlesness, sleeping disorders, dizziness, tremor, paraesthaesia. Rarely cholestatic icterus, leucopenia or thrombocytopenia may occur, allergic rashes may occur.
Interactions:
The plasmatic levels of metoprolol, warfarin, ciclosporin, theophylline and dilthiazem are increased in concomitant administration of propafenone (drug interference with cytochromes P-450 isoenzymes). Propafenone increases the plasmatic levels of digoxin 30 - 100 % (monitoring of digoxin plasma levels are recommended). Combined treatment with local anesthetics results in an excessive increase of effect of propafenone (dental surgery). Phenobarbital and rifampicin decrease the effect of propafenone. Concomitantly administration of propafenone and tricyclic antidepressants, ritonavir or other antiarrhythmics (particular of class I according to Vaughan-Williams classification) is not recommended due to the increased risk of arrhythmias.
Caution:
Propafenone, particularly in the beginning of treatment and (in older patients), can cause dizziness and thus it can unfavourably influence activities requiring attention and quick decisions. Indication and dosage must be determined very carefully in patients with cardiostimulator indwelling. Patients with a long term therapy (anticoagulancia, antidiabetics) must be monitored both clinically and in laboratory. If SA or AV blocks of higher degree or multiple or polymorphous extrasystols appear the treatment must be stopped.
Dosage:
The dose is strictly determined on the physician in each individual case. At the propafenone peroral administration it is appropriate to increase the dosage gradually from 150 mg 3 times daily after 8 hours up to 300 mg twice daily or 300 mg three times daily at the maximum. During a long term therapy the ability to transform propafenone biologically can decrease and in such cases the dosage must be decreased. A lower dosage is necessary in cardiac failure in patients over 70 years or under 70 kg, and also in hepatic insufficiency. For patients with hepatic insufficiency it is recommended to administer 20-30 per cent of the common dosage. During the treatment ECG monitoring must be performed in regular intervals. The dosage must be decreased when the QRS complex or the QT interval is prolonged by more than 25 per cent, when the QT interval is prolonged to more than 500 ms or the incidence and seriousness of heart arrhytmia increases. Tablets shall be swallowed unchewed with a small amount of water, after meal.
Package:
50 film-coated tablets of 150 mg,
50 film-coated tablets of 300 mg.
Complete information about the preparation is included in the drug information sheet.
Date of the latest revision of the text: December 3, 2008.
The preparation is available on medical prescription only.