Cordarone

Cordarone

amiodarone

Manufacturer:

sanofi-aventis

Distributor:

Metro Drug
Concise Prescribing Info
Contents
Amiodarone HCl
Indications/Uses
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.
Administration
May be taken with or without food.
Contraindications
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.
Presentation/Packing
Form
Cordarone inj 150 mg
Packing/Price
3 mL x 6 × 1's (P1,830/box)
Form
Cordarone tab 200 mg
Packing/Price
30's (P3,050/pack)
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