Composition
lnj: Per 3 ml amp: Amiodarone HCI 150 mg. Tab 100 mg/200 mg:Amiodarone HCI 100 mg/ 200 mg
Indications & Dosage
Treatment of arrhythmias, particularly when other drugs are ineffective or contraindicated, including paroxysmal supraventricular, nodal and ventricular tachycardias, atrial fibrillation and flutter, ventricular fibrillation, and tachyarrhythmias associated with Wolff-Parkinson-White syndrome: ORAL: Adult: 200 mg 3 times a day for 1 week, then reduced to200 mg twice daily for a further week, followed by maintenance dose, usually 200mg daily or the minimum dose required to control arrhythmia BY IV INF: Adult: Initially 5 mg/kg, to be given over 20-120 minutes with ECG monitoring, subsequent INFs given if necessary according to response; max. 1.2 g per day ORAL: Children 3-12 yrs: Initially 5-10 mg/kg (max 200 mg) twice daily for 7-10 days, then reduced to maintenance dose of 5-10 mg/kg once daily (max 200 mg daily); 12-18 yrs: 200 mg 3 times daily for 1 wk then 200 mg twice daily for 1 wk then usually 200mg daily adjusted according to response. BY IV INF: Children 3-18 yrs: Initially 5-10 mg/kg over 20 minutes-2 hr then by continuous INF 300 mcg/ kg/hr, increased according to response to max. 1.5 mg/kg/ hr; do not exceed 1.2 gm/24 hr. Ventricular fibrillation or pulseless ventricular tachycardia refractory to defibrillation for cardiopulmonary resuscitation: BY IV INJ: Adult: Initially 300 mg, dose to be considered after administration of adrenaline, dose should be given from a pre-filled syringe or diluted in 20ml Glucose 5%, then by IV Inj 150 mg if required, followed by (by IV INF) 900 mg/24 hours BY IV INJ: Children3-18 yr: 5 mg/ kg (max 300 mg) over at least 3 minutes below 3 yr, not recommended.
Administration
IV infusion over a period of 20 min to 2 hour. Diluted in 250 ml in 5% DW; may be followed by repeated infusions up to 1200 mg i.e. (approximately 15 mg/kg body wt) in up to 500 ml 5% DW per 24 hour, the rate of infusion based on clinical judgment. May be given by slow IV inj of 150-300 mg in 10-20 ml of 5% DW over 1-2 min.
Compatibility
Stable in D5W, KCI. .
Stability
Store at controlled room temperature, 20C-25C (68F-77%). Excursions are permitted to 15C-30C (59F-86F). Protect from light. Dispense in a light-resistant, tight container, keep tightly closed.
Contraindications
Avoid in severe conduction disturbances and in sinus node disease (unless pacemaker fitted), iodine sensitivity, sino-atrial heartblock and sinus bradycardia (except in cardiac arrest), thyroid dysfunction. With intravenous use avoid bolus injection in cardiomyopathy, avoid bolus injection in congestive heart failure, circulatory collapse, severe arterial hypotension, severe respiratory failure, all kinds of conduction delays, pulmonary fibrosis, severe liver parenthetic damage, women of child bearing age.
Precautions
Acute porphyrias, conduction disturbances (in excessive dosage), elderly, heart failure, hypokalaemia, severe bradycardia, with intravenous use moderate and transient fall in blood pressure; risk of circulatory collapse precipitated by rapid administration or overdosage), severe hepatocellulartoxicity. Avoid prolonged sun or UV exposure during therapy & several months after discontinuation. Pregnancy should be avoided for the first year after therapy.
Interactions
MAO inhibitors.
Pregnancy
Positive evidence of risk, use only when no safer alternative exists for a serious problem.
Lactation
Contraindicated, risk of neonatal hypothyroidism from release of iodine.
Side Effects
Pulmonary toxicity, disturbances of liver & thyroid function, bradycardia, hyperthyroidism, hypothyroidism, jaundice, nausea, phototoxicity, raised serum transaminases, reversible corneal Microdeposits, taste disturbances, tremor, vomiting, hot flushes, hypotension, respiratory distress syndrome, sweating. Rare: Peripheral myopathy and peripheral neuropathy (reversible onwithdrawal). Rare: Alopecia, haemolyticanaemia, aplastic anaemia, ataxia, chronic liver disease, sinus arrest, thrombocytopenia, vasculitis, vertigo.