Sedacoron

Sedacoron

amiodarone

Manufacturer:

Sandoz

Distributor:

Maxxcare

Marketer:

Mega Lifesciences
Concise Prescribing Info
Contents
Amiodarone HCl
Indications/Uses
Symptomatic & tachycardiac supraventricular arrhythmias requiring treatment eg, A-V-junctional tachycardia, supraventricular tachycardia associated w/ Wolff Parkinson-White syndrome, paroxysmal atrial fibrillation. Severe symptomatic tachycardiac ventricular arrhythmias in patients who do not respond to other antiarrhythmics or for whom other antiarrhythmics are not indicated.
Dosage/Direction for Use
Saturation dose: 600 mg/day for 8-10 days. May be increased to 1,200 mg/day if necessary. Maintenance dose: 200 mg/day for 5 days/wk. In long-term therapy, 200-600 mg/day may be taken.
Administration
Should be taken with food: Do not chew tab.
Contraindications
Hypersensitivity. Sinus bradycardia (<55 pulse beats/min); all forms of delayed conduction (eg, sinoauricular & nodal) including sick sinus syndrome, 2nd/3rd degree AV-blocks & bifascicular & trifascicular blocks if no pacemaker is used; thyropathy; preexisting QT prolongation; hypokalaemia; iodine allergy. Concomitant treatment w/ MAOIs & drugs which may induce torsades de pointes. Pregnancy & lactation.
Special Precautions
Discontinue treatment if pronounced bradycardia or sinus node arrest, alveolar/interstitial pneumonitis, Stevens-Johnson syndrome or toxic epidermal necrolysis, optic neuropathy/neuritis occur & transaminase levels increase to >3x the norm. W/draw therapy in cases of hyperthyroidism, hypersensitivity pneumonitis. Increased risk of torsades de pointes. May cause peripheral neuropathy &/or myopathy. Closely monitor patients before initiating sofosbuvir in combination w/ another HCV direct acting antiviral eg, daclatasvir, simeprevir, ledipasvir. Not recommended for concomitant use w/ β-blockers, Ca channel blockers (eg, verapamil, diltiazem), hypokalaemia-causing laxatives. Not to be used concomitantly w/ CYP3A4-metabolized statins (eg, simvastatin, atorvastatin, lovastatin). Perform thoracic roentgenography & pulmonary function test prior to onset of treatment & if dyspnoea occurs then repeat at approx 3-6 mth intervals. Perform liver function tests at the start & regularly during treatment. Perform regular ophth investigations & cardiologic check-ups during treatment. Check cardiac function (ECG), serum K & liver values, thyroid & lung function & perform X-ray before treatment. May produce false result in thyroid tests eg, iodine binding test. Avoid sunlight, UV light or solaria exposure during therapy. May affect ability to drive & use machines. Not to be used during pregnancy. Women who want to conceive should plan the beginning of a pregnancy 6 mth at the earliest after treatment. Lactation. Not recommended in childn.
Adverse Reactions
Cornea verticillata, blurred vision, coloured halos around light sources; nausea, vomiting, taste disturbances; isolated elevation of serum transaminases; photosensitisation w/ increased tendency to sunburns. Hyperthyroidism, hypothyroidism; extrapyramidal tremors, nightmares, dyssomnia; bradycardia; atypical pneumonia, non-productive cough, dyspnoea, wt loss, fever, asthenia; constipation; acute hepatitis w/ high serum transaminases &/or cholestatic icterus including hepatic failure; eczema; muscle weakness.
Drug Interactions
Increased risk of torsades de pointes w/ class Ia (eg, quinidine, procainamide, disopyramide) & III (eg, sotalol, bretylium) anti-arrhythmics; IV erythromycin, co-trimoxazole or pentamidine inj; anti-psychotics eg, chlorpromazine, thioridazine, fluphenazine, pimozide, haloperidol, amisulpiride, sertindole; lithium & TCAs eg, doxepin, maprotiline, amitriptyline; antihistamines eg, terfenadine, astemizole, mizolastine; anti-malarials eg, quinine, mefloquine, chloroquine, halofantrine; moxifloxacin; QT-interval prolonging drugs (eg, clarithromycin). Avoid concomitant use w/ fluoroquinolones. Potentiated negative chronotropic properties & conduction slowing effects may occur w/ β-blockers & Ca channel inhibitors eg, diltiazem, verapamil. Combined therapy w/ stimulant laxatives is not recommended. May cause hypokalaemia &/or hypomagnesaemia w/ diuretics, systemic corticosteroids, teracosactide, IV amphotericin. Potential severe complications w/ general anaesth & high dose O2 therapy. May inhibit CYP1A1, CYP1A2, CYP3A4, CYP2C9, CYP2D6 & P-gp & increase exposure to their substrates. Increased plasma conc of digoxin, oral anticoagulants (eg, warfarin), phenytoin. Risk of bleeding w/ dabigatran. May increase plasma levels of ciclosporin, drugs metabolized by CYP3A4 (eg, lidocaine, tacrolimus, sildenafil, fentanyl, midazolam, triazolam, dihydroergotamine, ergotamine, colchicine), flecainide. May potentiate pharmacological effects of fentanyl. Increased risk of muscular toxicity eg, rhabdomyolysis w/ statins metabolized by CYP3A4 eg, simvastatin, atorvastatin, lovastatin. CYP3A4 & CYP2C8 inhibitors may inhibit metabolism & increase exposure. May increase plasma conc w/ grapefruit juice. Potential serious symptomatic bradycardia w/ sofosbuvir in combination w/ another HCV direct-acting antiviral eg, daclatasvir, simeprevir, ledipasvir.
MIMS Class
ATC Classification
C01BD01 - amiodarone ; Belongs to class III antiarrhythmics.
Presentation/Packing
Form
Sedacoron tab 200 mg
Packing/Price
50's
Form
Sedacoron soln for infusion 150 mg/3 mL
Packing/Price
5's
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