Metro Drug
Concise Prescribing Info
Amiodarone HCl
Tab: Prevention of recurrence of life-threatening ventricular tachycardia: Treatment should be in a hospital under monitoring; documented symptomatic & incapacitating ventricular tachycardia; documented supraventricular tachycardia in patients refractory to therapy or in whom treatments are contraindicated; ventricular fibrillation. Treatment of supraventricular tachycardia: Slowing or reduction in atrial fibrillation or atrial flutter. Can be used in the presence of CAD &/or impaired left ventricular function. Inj: Serious arrhythmias when oral route is not appropriate, particularly atrial arrhythmia w/ ventricular tachycardia; tachyarrhythmias associated w/ Wolff-Parkinson-White syndrome; documented & symptomatic & incapacitating ventricular arrhythmia. Cardiopulmonary resuscitation of shock-resistant ventricular fibrillation in patients experiencing cardiac arrest.
Dosage/Direction for Use
Tab Loading dose: 3 tab daily for 8-10 days, may be increased to 4-5 tab daily. Maintenance: Use min effective dose ranging from ½ tab daily (1 tab every 2 days) to 2 tab daily. Other serious arrhythmias IV infusion Loading dose: 5 mg/kg in glucose soln over 20 min-2 hr, repeat 2 or 3 times per 24 hr period. Maintenance: 10-20 mg/kg/day in 250 mL glucose soln. Cardiopulmonary resuscitation of shock resistant ventricular fibrillation IV Initially 300 mg (or 5 mg/kg) diluted in 20 mL of 5% glucose soln as rapid inj. Additional 150 mg (or 2.5 mg/kg) IV dose may be considered if ventricular fibrillation persists.
May be taken with or without food.
Hypersensitivity to iodine or amiodarone. Sinus bradycardia, SA heart block, sinus node disease, high-degree AV conduction disorders in unpaced patients. Hyperthyroidism. Concomitant use w/ torsadogenic medicinal products, telaprevir, cobicistat. Pregnancy (2nd & 3rd trimester) & lactation. Inj: Circulatory collapse, severe hypotension. Premature neonates, full-term newborns & childn <3 yr due to presence of benzyl alcohol.
Special Precautions
New arrhythmias or worsening of treated arrhythmias. QT interval prolongation. Onset of dyspnea or non-productive cough, this requires chest x-ray. Monitor liver function at the start of treatment, then regularly throughout treatment. Discontinue use if Stevens-Johnson syndrome or toxic epidermal necrolysis occur. Severe bradycardia. Concomitant use w/ sofosbuvir & another direct-acting antiviral drug for hepatitis C eg, daclatasvir, simeprevir or ledipasvir; β-blockers other than sotalol & esmolol, verapamil & diltiazem; ciclosporin, certain antiparasitic agents (halofantrine, lumefantrine & pentamidine), certain neuroleptics (amisulpride, chlorpromazine, cyamemazine, droperidol, flupentixol, fluphenazine, haloperidol, levomepromazine, pimozide, pipamperone, pipotiazine, sertindole, sulpiride, sultopride, tiapride, zuclopenthixol), fluoroquinolones (other than levofloxacin & moxifloxacin), stimulant laxatives, methadone or fingolimod. Electrolyte disturbance, particularly hypokalemia. Hemodynamic risk associated w/ general or local anesth. Closely monitor when patients w/ acute resp distress syndrome after surgery is mechanically ventilated. Tab: Perform ECG prior starting treatment. Discontinue use if 2nd or 3rd degree AV, SA or bifascicular block occur. Increased monitoring if 1st degree AV block occurs. Contains iodine which interferes w/ certain thyroid function tests. History of thyroid dysfunction. Assay of TSH prior starting treatment, then regularly throughout treatment & several mth after discontinuation, & if dysthyroidism is suspected. Peripheral sensorimotor or mixed neuropathy & myopathy. Perform promptly a complete ophthalmologic exam including funduscopy if blurred or decreased vision occurs. Discontinue use if neuropathy or optic neuritis is induced. Contains lactose. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption syndrome. Avoid exposure to sun & use protective protection during treatment. Patients w/ implantable cardiac defibrillator or pacemaker. Check threshold before & several times after treatment initiation & whenever doses are adjusted. Childn. Elderly. Inj: Peripheral venous route may lead to inj site reactions eg, local venous irritation. May exacerbate hypotension, heart failure or severe resp failure. Supervision in an ICU w/ continuous monitoring of arterial BP & ECG. Contains benzyl alcohol. Gasping syndrome in premature & full-term newborns.
Adverse Reactions
Dissociated blood thyroid hormone levels (increased T4, normal or slightly lower T3); nausea. Hypothyroidism; bradycardia (tab: moderate, dose-dependent). Tab: Corneal micro-deposits; photosensitivity; moderate, isolated elevation in transaminases; mild GI disorders (vomiting, dysgeusia). Lilac or slate-grey colored skin pigmentation; diffuse interstitial or alveolar pneumonitis & bronchiolitis obliterans organizing pneumonia, dyspnea or dry cough; tremor or other extrapyramidal symptoms, sleep disorder (nightmares), peripheral sensorimotor or mixed neuropathy; acute liver damage w/ high serum transaminases &/or jaundice. Inj: Inflammatory reactions eg, local venous irritation, inj site reactions eg, pain, erythema, edema, necrosis, extravasation, infiltration, inflammation, phlebitis, cellulitis; moderate & transient fall in BP, severe hypotension or collapse.
Drug Interactions
Increased risk of ventricular arrhythmias/rhythm disorders, particularly Torsades de pointes w/ class Ia (quinidine, hydroquinidine, disopyramide) & III (dofetilide, ibutilide, sotalol) antiarrhythmics; arsenic compd, bepridil, cisapride, citalopram, escitalopram, diphemanil, dolasetron IV, domperidone, dronedarone, erythromycin IV, levofloxacin, mequitazine, mizolastine, moxifloxacin, prucalopride, spiramycin IV, toremifene, vincamine IV; antiparasitics (halofantrine, lumefantrine, pentamidine); neuroleptics (amisulpride, chlorpromazine, cyamemazine, droperidol, flupentixol, fluphenazine, haloperidol, levomepromazine, pimozide, pipamperone, pipotiazine, sertindole, sulpiride, sultopride, tiapride, zuclopenthixol); methadone; fluoroquinolones; stimulant laxatives; β-blockers in heart failure (bisoprolol, carvedilol, metoprolol, nebivolol); macrolides (azithromycin, clarithromycin, roxithromycin); hypokalemic diuretics (alone or in combination), amphotericin B (IV route), glucocorticoids (systemic route), tetracosactide; bradycardic agents; as metabolism may be decreased w/ voriconazole. Cardiac automaticity & conduction disorders w/ risk of excessive bradycardia w/ telaprevir; β-blockers in heart failure (bisoprolol, carvedilol, metoprolol, nebivolol); other β-blockers. Risk of increased adverse effects due to decreased metabolism w/ cobicistat. Possibly symptomatic or even fatal bradycardia w/ dual therapy w/ daclatasvir/sofosbuvir or ledipasvir/sofosbuvir. Increased plasma conc of CYP3A4 substrates, potentially increasing the toxicity of these substrates (lidocaine, tacrolimus, sildenafil, midazolam, dihydroergotamine, ergotamine, colchicine, triazolam); fidaxomicine; CYP2C9 substrates eg, vit K antagonists & phenytoin; flecainide by inhibiting cytochrome CYP2D6. Increased blood ciclosporin conc, due to reduced liver metabolism, w/ a risk of nephrotoxic effects. Risk of bradycardia & AV heart block w/ diltiazem inj & verapamil inj; particularly in the elderly w/ oral diltiazem & oral verapamil. Potentiation of bradycardia-inducing effects w/ potentially fatal outcome w/ fingolimod. Inhibits P-glycoprotein & may lead to increased exposure of P-glycoprotein substrates. Suppressed automaticity (excessive bradycardia) & AV conduction disorders w/ digitalis drugs (digoxin). Increased plasma dabigatran conc, w/ a higher risk of bleeding. Increased effect & risk of bleeding of vit K antagonist. Increased plasma phenytoin conc w/ signs of overdose, particularly neurological signs (decreased liver metabolism of phenytoin). Increased risk of muscle toxicity (eg, rhabdomyolysis) w/ statins (simvastatin, atorvastatin, lovastatin). Risk of increased lidocaine plasma conc, potentially leading to neurological & cardiac adverse effects, due to decreased liver metabolism. Increased blood tacrolimus conc due to inhibition of its metabolism. Contractility, automaticity & conduction disorders (suppressed compensatory sympathetic mechanisms) w/ esmolol. Risk of decreased plasma conc of amiodarone & its active metabolite w/ orlistat. Risk of increased tamsulosin-induced adverse effects due to inhibition of its hepatic metabolism. Risk of excessive bradycardia (cumulative bradycardia-inducing effects) w/ pilocarpine.
MIMS Class
Cardiac Drugs
ATC Classification
C01BD01 - amiodarone ; Belongs to class III antiarrhythmics.
Cordarone inj 150 mg
3 mL x 6 × 1's (P1,830/box)
Cordarone tab 200 mg
30's (P3,050/pack)
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