Rythma

Rythma

amiodarone

Manufacturer:

Therapharma

Distributor:

United Lab
Concise Prescribing Info
Contents
Amiodarone HCl
Indications/Uses
Life-threatening ventricular & supraventricular arrhythmias refractory to other antiarrhythmics.
Dosage/Direction for Use
Tab Saturation dose: 600 mg/day for 8-10 days, may increase up to 1,200 mg/day. Maintenance dose: Reduce to 200 mg for 5 days/wk. Long-term therapy: 200-600 mg/day. Childn Dosage adjusted according to BSA or body wt. IV Initial rapid infusion phase: 150 mg (3 mL) over 10 min. Rate: 15 mg/min. Slow infusion phase: 360 mg over 6 hr. Rate: 1 mg/min. Maintenance infusion: 540 mg over 18 hr. Rate: 0.5 mg/min.
Administration
May be taken with or without food: Take during or after meals.
Contraindications
Hypersensitivity to amiodarone or to iodine. Sinus bradycardia & SA heart block, sick sinus syndrome or sinus node disease, AV heart block, bi- & trifascicular blocks if no pacemaker used, evidence or history of thyroid dysfunction, preexisting QT prolongation, hypokalemia. Concomitant treatment w/ MAOIs, drug-inducing Torsades de pointes & >20 mg simvastatin daily. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Circulatory collapse, severe arterial hypotension. Pregnancy & lactation.
Special Precautions
Increased risk of myopathy/rhabdomyolysis. Perform regular ophth exam including funduscopy & slit-lamp exam during treatment. Avoid exposure to sunlight. Risk of developing thyroid dysfunction (hyper- or hypothyroidism) & severe inflammatory pneumopathy (alveolar or interstitial, hypersensitivity pneumonitis), severe hepatopathies. Thyroid & pulmonary function test should be performed prior to treatment. Monitor liver values at regular intervals particularly at high dosage. Increased risk of Torsades de pointes in excessive QT prolongation. Possibility of syndrome of inappropriate secretion of antidiuretic hormone (SIADH) in patients experiencing asthenia during amiodarone therapy. Measure serum & urine osmolality & Na levels/conc. Hypotension by slow infusion. May affect ability to drive or operate machinery. Elderly. Childn.
Adverse Reactions
Reversible corneal microdeposits; pulmonary toxicity; nausea & vomiting; sinus bradycardia. Hypotension, asystole/cardiac arrest/EMD, cardiogenic shock, CHF, bradycardia, liver function test abnormalities, VT, AV block; Stevens-Johnson syndrome, resp disorder. Occasionally, photosensitization, hypo- or hyperthyroidism.
Drug Interactions
HIV-PIs. Prolonged QT interval & Torsades de pointes w/ loratadine, trazodone, cisapride, halofantrine, pimozide, disopyramide, fluoroquinolones, macrolides, azole antifungals. Increased serum levels w/ cimetidine. Elevated plasma conc of cyclosporine. HMG-CoA reductase inhibitors. Possible potentiation of bradycardia, sinus arrest & AV block w/ antihypertensives. Increased prothrombin time w/ warfarin & vit K antagonist. Inhibit platelet aggregation w/ clopidogrel. Decreased serum conc w/ rifampin. May cause hypotension, bradycardia & decreased cardiac output w/ fentanyl. Increased conc of lidocaine. Impair metabolism w/ dextromethorphan. Reduced amiodarone levels w/ St. John's wort. Increased plasma levels w/ grapefruit juice. Increased serum conc of digoxin. Antiarrhythmics. Reduced serum levels w/ cholestyramine. Impair metabolism of phenytoin & increased conc of hydantoin. Increased risk of potentially lethal Torsades de pointes w/ vincamine, sultopride, sparfloxacin, erythromycin IV & pentamidine. Elevate risk of ventricular arrhythmias w/ K-wasting diuretics, amphotericin B, cation exchange resins, stimulant laxatives. Increased toxicity of methotrexate. Decreased serum conc w/ rifamycin.
MIMS Class
Cardiac Drugs
ATC Classification
C01BD01 - amiodarone ; Belongs to class III antiarrhythmics.
Presentation/Packing
Form
Rythma inj 50 mg/mL
Packing/Price
3 mL x 6 × 1's (P1,592.1/box)
Form
Rythma tab 200 mg
Packing/Price
30's (P1,537.87/pack)
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