Pacet 200 Tablet

Pacet 200 Tablet is used for: Ventricular arrhythmias, Ventricular fibrillation, Ventricular tachycardia, Atrial fibrillation, Hypertrophic cardiomyopathy, Supraventricular arrhythmias

Ventricular Arrhythmias Oral Load: 800-1600 mg PO once daily for 1-3 weeks until response; once adequate arrhythmia control is achieved, reduce dose to 600-800 mg/day for 1 mo; THEN reduce to the maintenance dose Maintenance dose: 400 mg PO once daily IV 150 mg over first 10 min (15mg/min), followed by 360 mg over the next 6 hr (1 mg/min), THEN 540 mg over the 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.

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. IV Preparation Loading IV infusion: Dilute 150 mg (3 mL) in 100 mL to form 1.5 mg/mL concentration Slow/maintenance infusion: Dilute 900 mg (18 mL) of amiodarone with 500 mL to form 1.8 mg/mL concentration Conventional amiodarone: Dilute only with D5W Nexterone: May dilute with either D5W or 0.9% NaCl For subsequent maintenance infusion, may use 1-6 mg/mL concentrations IV Administration Concentrations >2 mg mL associated with venous irritation If concentration >2 mg/mL, administer via central venous catheter; in-line filter should be used during administration Administer IV via volumetric infusion pump Do not use evacuated glass containers for admixing, as incompatibility with a buffer in the container may cause precipitation Does not need to be protected from light during administration

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.

Amiodarone is intended for use only in patients with the indicated life-threatening arrhythmias because its use is accompanied by substantial toxicity. Amiodarone can cause pulmonary toxicity (hypersensitivity pneumonitis or interstitial/alveolar pneumonitis) that has resulted in clinically manifest disease at rates as high as 17% in some series of patients. Pulmonary toxicity has been fatal about 10% of the time. Obtain a baseline chest X-ray and pulmonary function tests, including diffusion capacity, when Amiodarone therapy is initiated. Repeat history, physical exam, and chest X-ray every 3 to 6 months. Amiodarone can cause hepatoxicity, which can be fatal. Obtain baseline and periodic liver transaminases and discontinue or reduce dose if the increase exceeds three times normal, or doubles in a patient with an elevated baseline. Discontinue Amiodarone if the patient experiences signs or symptoms of clinical liver injury. Amiodarone can exacerbate arrhythmias. Initiate Amiodarone in a clinical setting where continuous electrocardiograms and cardiac resuscitation are available. May cause hypotension and bradycardia. May increase the 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 the increased risk of photosensitivity. Hepatic impairment, thyroid disease, elderly. Lactation. Monitoring Parameters Close monitoring is recommended as amiodarone may worsen arrhythmia especially when used concurrently with other anti-arrhythmic drugs or drugs that prolong QT interval. Thyroid function tests should be performed before treatment and then every 6 months. Monitor thyroid function prior to treatment and periodically thereafter, particularly in elderly patients, and in any patient with a history of thyroid nodules, goiter, or other thyroid dysfunction. Clinical assessment of thyroid function alone is unreliable. Thyroxine (T4) may be raised in the absence of hyperthyroidism; therefore triiodothyronine (T3), T4, and thyroid-stimulating hormone (thyrotrophin, TSH) should all be measured. A raised T3 and T4 with a very low or undetectable TSH concentration suggests the development of thyrotoxicosis. Monitor hepatic enzymes regularly in patients receiving relatively high-maintenance doses. Liver function tests are required before treatment and then every 6 months. Serum potassium concentration should be measured before treatment. Chest x-ray is required before treatment. If concomitant use of amiodarone with sofosbuvir and daclatasvir, simeprevir and sofosbuvir, or sofosbuvir and ledipasvir cannot be avoided because other antiarrhythmic are not tolerated or contra-indicated, patients should be closely monitored, particularly during the first weeks of treatment. Patients at high risk of bradycardia should be monitored continuously for 48 hours in an appropriate clinical setting after starting concomitant treatment. Patients who have stopped amiodarone within the last few months and need to start sofosbuvir and daclatasvir, simeprevir and sofosbuvir, or sofosbuvir and ledipasvir should be monitored. With intravenous use, ECG monitoring and resuscitation facilities must be available. Monitor liver transaminases closely. Monitor heart rate in patients taking or recently discontinuing amiodarone when starting antiviral treatment. Close perioperative monitoring is recommended in patients undergoing general anesthesia who are on amiodarone therapy as they may be more sensitive to the myocardial depressant and conduction effects of halogenated inhalational anesthetics.

Pregnancy Amiodarone can cause fetal harm when administered to a pregnant woman; fetal exposure may increase potential for adverse experiences including cardiac, thyroid, neurodevelopmental, neurological and growth effects in neonate; inform patient of potential hazard to fetus if amiodarone administered during pregnancy or if patient becomes pregnant while in therapy The incidence of ventricular tachycardia is increased and may be more symptomatic during pregnancy; ventricular arrhythmias most often occur in pregnant women with underlying cardiomyopathy, congenital heart disease, valvular heart disease, or mitral valve prolapse; most tachycardia episodes are initiated by ectopic beats and occurrence of arrhythmia episodes may therefore, increase during pregnancy due to increased propensity to ectopic activity; breakthrough arrhythmias may also occur during pregnancy, as therapeutic treatment levels may be difficult to maintain due to increased volume of distribution and increased drug metabolism inherent in pregnant state Amiodarone and its metabolite have been shown to cross the placenta; adverse fetal effects associated with maternal amiodarone use during pregnancy may include neonatal bradycardia, QT prolongation, and periodic ventricular extrasystoles, neonatal hypothyroidism (with or without goiter) detected antenatally or in the newborn and reported even after a few days of exposure, neonatal hyperthyroxinemia, neurodevelopmental abnormalities independent of thyroid function, including speech delay and difficulties with written language and arithmetic, delayed motor development, and ataxia, jerk nystagmus with synchronous head titubation, fetal growth restriction, and premature birth; monitor newborn for signs and symptoms of thyroid disorder and cardiac arrhythmias Labor and delivery Risk of arrhythmias may increase during labor and delivery; patients treated should be monitored continuously during labor and delivery Infertility Based on animal fertility studies, drug may reduce female and male fertility; not known if this effect is reversible Lactation Amiodarone and one of its major metabolites, DEA, are excreted in human milk, suggesting that breast-feeding could expose the nursing infant to a significant dose of the drug; risk of exposing infant to amiodarone and DEA must be weighed against potential benefit of arrhythmia suppression in the mother; advise mother to discontinue nursing There are cases of hypothyroidism and bradycardia in breastfed infants, although it is unclear if these effects are due to amiodarone exposure in breastmilk; breastfeeding is not recommended during treatment

Serious symptomatic bradycardia when co-administered with ledipasvir/sofosbuvir or with sofosbuvir with simeprevir; postmarketing cases of symptomatic bradycardia, some requiring pacemaker insertion and at least one fatal, have been reported when ledipasvir/sofosbuvir or sofosbuvir with simeprevir were initiated in patients on amiodarone; bradycardia generally occurred within hours to days, but in some cases up to 2 weeks after initiating antiviral treatment and resolved after discontinuation of antiviral treatment; Concomitant use of drugs with depressant effects on sinus and AV node (e.g., digoxin, beta blockers, verapamil, diltiazem, ivabradine, clonidine) can potentiate electrophysiologic and hemodynamic effects of amiodarone, resulting in bradycardia, sinus arrest, and AV block; monitor heart rate in patients on amiodarone and concomitant drugs that slow heart rate Potentiation of antiarrhythmic drugs. Possible increased risk of adverse effects when used with anesthetic 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). Contraindicated (27) dofetilide dronedarone droperidol eliglustat fingolimod flibanserin goserelin histrelin ibutilide indinavir lefamulin leuprolide lomitapide lonafarnib lopinavir nelfinavir nirmatrelvir nirmatrelvir/ritonavir pentamidine pimozide procainamide ritonavir saquinavir thioridazine tipranavir triptorelin ziprasidone

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.

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.

Pacet 200 200mg Tablet manufactured by Beximco Pharmaceuticals Ltd.. Its generic name is Amiodarone Hydrochloride. Pacet 200 is availble in Bangladesh. Farmaco BD drug index information on Pacet 200 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.