Pacet Tablet
Amiodarone Hydrochloride
200mg
Beximco Pharmaceuticals Ltd.
| Pack size | 1 |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 15.50 NPR |
Indications
Pacet Tablet is used for:
Ventricular arrhythmias, Ventricular fibrillation, Ventricular tachycardia, Atrial fibrillation, Hypertrophic cardiomyopathy, Supraventricular arrhythmias
Adult Dose
Ventricular Arrhythmias
PO
Load: 800-1600 mg PO qDay for 1-3 weeks until response; once adequate arrhythmia control achieved, reduce dose to 600-800 mg/day for 1 mo; THEN reduce to maintenance dose
Maintenance dose: 400 mg PO qDay
IV
150 mg over first 10 min (15mg/min), followed by 360 mg over next 6 hr (1 mg/min), THEN 540 mg over remaining 18 hr (0.5 mg/min), for a total of 1000 mg over 24 hr before administering maintenance infusion
Maintenance: 0.5 mg/min for a total 720 mg/24hr at a concentration of 1-6 mg/mL (360 mg/200mL), or 1.8 mg/mL Nexterone at rate of 278 mL/min
Duration of therapy: May continue to administer 0.5 mg/min for 2-3 weeks regardless of patient's age, renal function or ventricular function
Lower doses may be used for supraventricular arrhythmias. Daily doses may be divided. Close monitoring of the patient is recommended. Use the minimum effective dose.
Elderly: Recommended to start dosing at the lower end of the dosing range because elderly may be predisposed to toxicity.
Hepatic impairment: Dosage reduction may be necessary.
Child Dose
Renal Dose
Administration
May be taken with or without food. Take consistently w/ or w/o meals. Take w/ meals if high dose or to reduce GI discomfort.
Reconstitution: To make solution for 1st rapid loading infusion or supplemental infusion: Add 3 ml of amiodarone HCl concentrate (50 mg/ml) to 100 ml of dextrose 5% to give a final conc of 1.5 g/ml; for slow infusion: Add 18 ml of amiodarone HCl concentrate (50 mg/ml) to 500 ml of dextrose 5% to give a final conc of 1.8 mg/ml; for subsequent maintenance infusions, diluted solutions with conc ranging from 1-6 mg/ml may be used. Solutions with conc ?2 mg/ml should be administered via a central venous catheter.
Contra Indications
Hypersensitivity to amiodarone or iodine. Severe sinus node dysfunction, 2nd and 3rd degree heart block (except in patients with a functioning artificial pacemaker), cardiogenic shock, pregnancy.
Precautions
Close monitoring is recommended as amiodarone may worsen arrhythmia especially when used concurrently with other anti-arrhythmic drugs or drugs that prolong QT interval. May cause hypotension and bradycardia. May increase risk of liver toxicity. May cause visual disturbance/impairment; corneal refractive laser surgery is not recommended in patients on amiodarone treatment. May cause lung damage; monitor for pulmonary toxicity e.g. acute respiratory distress syndrome. Monitor liver functions regularly. May affect defibrillation or pacing thresholds of cardiac devices. Correct electrolyte imbalance before starting treatment. Caution when used in patients undergoing surgery. Avoid excessive sunlight exposure due to increased risk of photosensitivity. Hepatic impairment, thyroid disease, elderly. Lactation.
Lactation: Excreted into breast milk; not recommended
Pregnancy-Lactation
Interactions
Potentiation of antiarrhythmic drugs. Possible increased risk of adverse effects when used with anaesthetic agents. Monitor plasma levels of amiodarone when used with HIV protease inhibitors. Cimetidine may increase serum levels of amiodarone. Concurrent use may increase serum levels of ciclosporin. May increase risk of myopathy or rhabdomyolysis when used with HMG-CoA reductase inhibitors. Rifampin may reduce the serum levels of amiodarone.
Potentially Fatal: Potentiates the effect of warfarin and other anticoagulants hence dose of warfarin generally needs to be reduced approx half. Raised plasma concentrations of digoxin, phenytoin and quinidine. Additive effect with beta-blockers and calcium-channel blockers (e.g. verapamil and diltiazem).
Adverse Effects
Side effects of Amiodarone Hydrochloride :
>10%
Increased liver AST or ALT levels (3-20%; as high as 40-50% in some studies),Hypotension (16%),Dizziness (3-40%),Headache (3-40%),Malaise (3-40%),Abnormal gait/ataxia (3-40%),Fatigue (3-40%),Impaired memory (3-40%),Involuntary movement (3-40%),Sleep disturbances (3-40%),Photosensitivity (10-75%),Hypothyroidism (1-22%),Constipation (10-33%),Anorexia (10-33%)
1-10%
CHF (3%),Bradycardia (3-5%),AV block (5%),SA node dysfunction (1-3%),Hyperthyroidism (3-10%),Hepatitis and cirrhosis (<3%),Visual disturbances (2-9%),Optic neuritis (1%)
Frequency Not Defined
Corneal microdeposits,Demyelinating polyneuropathy
Potentially Fatal: Pulmonary toxicity including pulmonary fibrosis and interstitial pneumonitis, hepatotoxicity, thyrotoxicity. Ventricular arrhythmias, pulmonary alveolitis, exacerbation of arrhythmias and rare serious liver injury. Generally in patients with high doses and having preexisting abnormalities of diffusion capacity.
Mechanism of Action
Amiodarone is a class III antiarrhythmic agent which inhibits stimulation, prolongs action potential and refractory period in myocardial tissues. It also decreases AV conduction and sinus node function. Sinus rate is reduced by 15-20%, PR and QT intervals are increased. Amiodarone can cause marked sinus bradycardia or sinus arrest and heart block. In acute IV doses, amiodarone may exert a mild negative inotropic effect.
Note
Pacet 200mg Tablet manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Amiodarone Hydrochloride. Pacet is availble in Nepal.
Farmaco Nepal drug index information on Pacet Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.