Amiodaron tab 200mg #30

Amiodarone 200 mg Tablet

Composition:

Each tablet contains:

• Active substance: Amiodarone hydrochloride – 200 mg

• Excipients: Lactose monohydrate, potato starch, povidone, calcium stearate

Indications:

Prevention of Recurrences:

• Life-threatening ventricular arrhythmias, including ventricular tachycardia and ventricular fibrillation (treatment must be initiated in a hospital setting under close cardiac monitoring).

• Supraventricular paroxysmal tachycardias (SVT):

• Recurrent, persistent SVT episodes documented in patients with structural heart disease.

• Recurrent, persistent SVT episodes documented in patients without structural heart disease when other classes of antiarrhythmic drugs are ineffective or contraindicated.

• Recurrent, persistent SVT episodes in patients with Wolff-Parkinson-White syndrome.

• Atrial fibrillation and atrial flutter

• Prevention of sudden arrhythmic death in high-risk patients:

• Post-myocardial infarction patients with more than 10 ventricular extrasystoles per hour, signs of chronic heart failure, and reduced left ventricular ejection fraction (<40%).

Amiodarone may also be used for treating rhythm disorders in patients with ischemic heart disease and/or left ventricular dysfunction.

Administration and Dosage:

Amiodarone should only be taken under medical supervision.The tablets are taken orally, before meals, with a sufficient amount of water.

Loading Dose:

• The initial loading dose is 600 mg daily (i.e., 1 tablet 3 times per day) for 8–10 days.

• In some cases, a higher dose of 800–1000 mg per day (i.e., 4–5 tablets daily) may be used for a short period under ECG monitoring.

• Amiodarone causes prolongation of the QT interval on ECG (due to delayed repolarization), and U waves may appear.

Maintenance Dose:

• The minimum effective dose should be chosen. Depending on the individual response, it usually ranges from ½ tablet per day (or 1 tablet every other day) up to 2 tablets per day.

• Regular ECG monitoring is required during treatment.

Special Populations:

Renal impairment:

• No dose adjustment is required, although clinical experience is limited in this group.

Hepatic impairment:

• No sufficient clinical data are available. Use with caution.

Elderly:

• Limited data on use in elderly patients. Use with extra caution.

Pediatric patients (<18 years):

• Safety and efficacy have not been established in children and adolescents. Contraindicated in this age group.

Storage Conditions:

• Store in a cool, dry place, protected from light and moisture, at a temperature not exceeding 25°C (77°F).

• Keep out of reach of children.