Propanorm 35 mg / 10 ml injection / infusion solution

Basic information

Composition

3.5 mg of propafenone hydrochloride in 1 ml of injection / infusion solution

Pharmacotherapeutic group

Vaughan-Williams class Ic antiarrhythmic drug (ATC code: C01BC03)

Therapeutic indications

Symptomatic conditions of tachycardial supraventricular heart arrhythmia requiring treatment, i.e. atrioventricular reentrant tachycardia, supraventricular tachycardia in Wolff-Parkinson-White (WPW) syndrome or paroxysmal atrial fibrillation.Severe symptomatic ventricular tachyarrhythmia if considered to be a life-threatening condition by a physician.

Pharmacological properties

Propafenone belongs to Vaughan-Williams class Ic. It acts as a sodium channel blocker, and as a non-selective blocker of beta-adrenergic receptors. The effect of propafenone, its undesirable effects and drug interactions are dependent on the biotransformation phenotype of the patient. Biological elimination half-life significantly differs in people with fast biotransformation (t1/2 2—10 hours) and in people with slow biotransformation (t1/2 12—32 hours).

Pharmaceutical form

injection / infusion solution

More information

Posology and method of administration

Dosage is individual based on ECG and blood pressure monitoring. If an infusion is to be administered, a thorough ECG examination (QRS complex, PR and QTc interval) and circulation parameters are required. A single dose is 1—2 mg/kg. An intravenous injection must be applied slowly for a period of 3—5 minutes. The interval between individual injections may not be less than 90—120 minutes. Administration of the product by injection must be stopped immediately should the QRS complex be extended or changed heart frequency dependant QT interval be prolonged by more than 20 %. Short-term infusion: lasting 1—3 hours: the dosage is 0.5—1 mg/min. Slow intravenous infusion: the highest daily dosage should be 560 mg (corresponds to 160 ml of Propanorm 35 mg / 10 ml injection solution). Glucose (5%) solutions should be used to prepare the infusion.

Contraindications

Hypersensitivity to propafenone or excipients. Marked structural myocardial disease (uncontrolled congestive heart failure with ejection fraction of the left ventricle of less than 35 %; cardiogenic shock, besides shock due to arrhythmia); severe symptomatic bradycardia; sick sinus syndrome, sinoatrial blockade, second and third degree atrioventricular blockade, bundle branch blocks or intraventricular block with the absence of pacemaker; severe hypotension; manifest electrolyte imbalance (e.g. disorders of potassium metabolism); severe obstructive bronchopulmonary disease. Propafenone may be administered during pregnancy and lactation only if the potential benefit of treatment exceeds any possible risk to the foetus.

Interactions

The plasma levels of metoprolol, warfarin, cyclosporine, theophylline and digoxin are increased in concomitant administration with propafenone. Combined treatment with local anaesthetics results in an excessive increase of the effect of propafenone (anaesthesia in stomatology!). Rifampicin and phenobarbital decrease the effect of propafenone. Amiodarone taken concomitantly with propafenone increases the risk of cardiac undesirbale effects; concomitant administration of propafenone and tricyclic antidepressants or ritonavir is not recommended.

Undesirable effects

Cardial: bradycardia, AV block, bundle branch block, hypotension.

Extracardial: nausea, possibly also vomiting, dryness in the mouth, bitter gustatory sense, constipation, stomach pain, fatigue, dizziness, faintness. Less often: headache, cholestatic icterus or allergic skin reaction. Rarely: leucopenia or thrombocytopenia.

Special warnings and precautions for use

The drug may cause dizziness and thus unfavourably influence activities requiring increased attention. Indication and dosage must be determined very carefully in patients fitted with a pacemaker. Patients with a long term anticoagulant therapy must be monitored with increased attention both clinically and in a laboratory. Treatment should be interrupted if SA or AV blocks of a higher degree or multiple or polymorphous extrasystoles appear.

For more detailed product information, see the Summary of Product Characteristics.

Availability

The medicinal product is available on prescription only and is not covered by health insurance.

Contents of container

10 × 10 ml

Package available in the Czech Republic

10 × 10 ml

SPC and PIL

Marketing authorisation holder

PRO.MED.CS Praha a.s., Telčská 377/1, Michle, 140 00 Prague 4, Czech Republic

Date of revision of the text

11 May 2018

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