Amiodarone

Pacerone is indicated for the treatment of documented, life-threatening recurrent ventricular fibrillation and life-threatening recurrent hemodynamically unstable tachycardia in adults who have not responded to adequate doses of other available antiarrhythmics or when alternative agents cannot be tolerated. Pacerone is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1 ) Recurrent hemodynamically unstable ventricular tachycardia. ( 1 )

• Dosage must be individualized based on severity of arrhythmia and response
• Use the lowest effective dose
• Obtain baseline chest x-ray, pulmonary function tests, thyroid function tests, and liver aminotransferases
• Correct hypokalemia, hypomagnesemia, and hypocalcemia before initiating treatment
• Initiate treatment with a loading dose of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks)
• Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce Pacerone tablets dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day
• Recommended Dosage: Initiate treatment with a loading dose of 800 to 1600 mg/day until initial therapeutic response occurs (usually 1 to 3 weeks)
• Once adequate arrhythmia control is achieved, or if side effects become prominent, reduce Pacerone tablet dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day
• Administration: Administer Pacerone tablets consistently with regard to meals [see Clinical Pharmacology ]
• Administration of Pacerone tablets in divided doses with meals is suggested for total daily doses of 1000 mg or higher, or when gastrointestinal intolerance occurs

Pacerone tablets, 100 mg, are peach, round, flat-faced, uncoated tablets, debossed with "P" on one side, and "U-S" above "144" on the other side. Pacerone tablets, 200 mg, are pink, round, flat-faced, scored, uncoated tablets, debossed with "P 200 " on the unscored side, and "U-S" above and "0147" below the score on the reverse side. …

• The safety and effectiveness of Pacerone
• In pediatric patients have not been established

Normal subjects over 65 years of age show lower clearances and increased drug half-life than younger subjects [see Clinical Pharmacology (12.3) ] . In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

• Advise the patient to read the FDA-approved patient labeling (Medication Guide)
• Advise pregnant women of the potential risk to a fetus
• Advise females of reproductive potential to inform their prescriber of a known or suspected pregnancy [see Use in Specific Populations ]
• Advise women that breastfeeding is not recommended during treatment with Pacerone [see Use in Specific Populations ]
• Advise patients to avoid grapefruit juice and St
• John's Wort
• Advise patients to seek medical attention if they experience the signs and symptoms of pulmonary toxicity, worsening arrhythmia, bradycardia, visual impairment, or hypo- and hyperthyroidism. …

• Cardiogenic shock
• Sick sinus syndrome, second- or third-degree atrioventricular block, bradycardia leading to syncope without a functioning pacemaker
• Known hypersensitivity to the drug or to any of its components, including iodine
• Pacerone is contraindicated in patients with : Cardiogenic shock
• Sick sinus syndrome, second- or third-degree AV block, bradycardia leading to syncope without a functioning pacemaker
• Known hypersensitivity to the drug or any of its components

Because of amiodarone's long half-life, expect drug interactions to persist for weeks to months after discontinuation of amiodarone. Drug interactions with amiodarone are described in Table 1 below. Table 1: Amiodarone Drug Interactions Concomitant Drug Class/Name Examples Clinical Comment Pharmacodynamic Interactions QT Prolonging Drugs class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, azole antifungals, halogenated inhalation anesthetic agents Increased risk of Torsade de Pointes. Avoid concomitant use. …

Persistence of Adverse Effects: Adverse reactions and drug interaction can persist for several weeks following discontinuation. ( 5.1 ) Impaired Vision: Corneal microdeposits (common; reversible), optic neuropathy/neuritis (rare; may lead to blindness). ( 5.5 ) Thyroid Abnormalities: Hyperthyroidism or hypothyroidism. ( 5.6 ) 5.1 Persistence of Adverse Effects Because of the long half-life of amiodarone (15 to 142 days) and its active metabolite desethylamiodarone (14 to 75 days), adverse reactions and drug interactions can persist for several weeks following amiodarone discontinuation [see Clinical Pharmacology (12.3) ] . …

The following serious adverse reactions are described in more detail in other sections of the prescribing information: Pulmonary Toxicity [see Warnings and Precautions (5.2) ] Hepatic Injury [see Warnings and Precautions (5.3) ] Worsened Arrhythmia [see Warnings and Precautions (5.4) ] Visual Impairment and Loss of Vision [see Warnings and Precautions (5.5) ] Thyroid Abnormalities [see Warnings and Precautions (5.6) ] Bradycardia [see Warnings and Precautions (5.7) ] Peripheral Neuropathy [see Warnings and Precautions (5.10) ] Photosensitivity and Skin Discoloration [see Warnings and Precautions (5.11) ] The most common reactions (>1%) leading to discontinuation of amiodarone include pulmona …

8.1 Pregnancy Risk Summary Available data from post-marketing reports and published case series indicate that amiodarone use in pregnant women may increase the risk for fetal adverse effects including neonatal hypo- and hyperthyroidism, neonatal bradycardia, neurodevelopmental abnormalities, preterm birth and fetal growth restriction. Amiodarone and its metabolite, desethylamiodarone (DEA), cross the placenta. …

There have been cases, some fatal, of amiodarone hydrochloride overdose. Monitor the patient's cardiac rhythm and blood pressure, and, if bradycardia ensues, a β-adrenergic agonist or a pacemaker may be used. Treat hypotension with inadequate tissue perfusion with positive inotropic and vasopressor agents. Neither Pacerone nor its metabolite is dialyzable.

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container with a child-resistant closure.

تناولها عندما تتذكر، إلا إذا اقترب موعد الجرعة التالية. عندها تخطَّ الجرعة المنسية. لا تتناول جرعتين معًا أبدًا للتعويض. راجع النشرة، فبعض الأدوية مختلفة.