País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
AMIODARONE HYDROCHLORIDE (UNII: 976728SY6Z) (AMIODARONE - UNII:N3RQ532IUT)
Advagen Pharma Limited
ORAL
PRESCRIPTION DRUG
Amiodarone Hydrochloride Tablets 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. - 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. Risk Summary Available data from postmarketing 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
Amiodarone Hydrochloride Tablets are available in three strengths as follows: 100 mg, Mottled pink, round, flat-faced, bevelled-edge tablets, engraved “^ 53” on one side and plain on other side. Bottles of 30 (NDC 72888-060-30) 200 mg, Mottled pink, round, flat-faced, bevelled-edge tablets, engraved ‘^’ over score and ‘54’ below score on one side and plain on other side Bottles of 60 (NDC 72888-039-60) Bottles of 500 (NDC 72888-039-05) Carton of 100 (10 x 10) Unit dose blisters (NDC 72888-039-09) 400 mg, Mottled pink, round, flat-faced bevelled-edge tablets, engraved “^” over score and “055” below score on one side and plain on the other side. Bottles of 30 (NDC 72888-061-30) Store at 20°C to 25°C (68°F to 77°F) excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Protect from light. Dispense in a tight, light-resistant container [See USP].
Abbreviated New Drug Application
Advagen Pharma Limited ---------- MEDICATION GUIDE AMIODARONE HYDROCHLORIDE TABLETS (A-MEE-OH-DA-RONE) What is the most important information I should know about Amiodarone Hydrochloride Tablets? Amiodarone Hydrochloride tablets can cause serious side effects that can lead to death, including: • lung problems • liver problems • worsening of heartbeat problems Call your healthcare provider or get medical help right away if you have any of the following symptoms during treatment with Amiodarone Hydrochloride Tablets: • trouble breathing, wheezing, shortness of breath, coughing chest pain, spitting up of blood, or fever • nausea or vomiting, brown or dark-colored urine, feel more tired than usual, yellowing of your skin or the whites of your eyes (jaundice), or right upper stomach-area pain • heart pounding, skipping a beat, beating fast or slowly, feel light-headed, or if you faint • vision problems, including blurred vision, see halos, or your eyes become sensitive to light. You should have regular eye exams before and during treatment with Amiodarone Hydrochloride Tablets. Amiodarone Hydrochloride Tablets should be started in a hospital so that your medical condition can be carefully monitored. Amiodarone Hydrochloride Tablets should only be used to treat people who have been diagnosed with life-threatening heartbeat problems called ventricular arrhythmias, when other treatments did not work or you cannot tolerate them. Amiodarone Hydrochloride Tablets can cause other serious side effects. See “What are the possible side effects of Amiodarone Hydrochloride Tablets?” If you get serious side effects during treatment you may need to stop Amiodarone Hydrochloride Tablets, have your dose changed, or get medical treatment. Talk with your healthcare provider before you stop taking Amiodarone Hydrochloride Tablets. You may still have side effects after stopping Amiodarone Hydrochloride Tablets because the medicine stays in your body for months after treatment is stopped. You should have regular check-up Leia o documento completo
AMIODARONE HYDROCHLORIDE- AMIODARONE HYDROCHLORIDE TABLET ADVAGEN PHARMA LIMITED ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE AMIODARONE HYDROCHLORIDE TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR AMIODARONE HYDROCHLORIDE TABLETS. AMIODARONE HYDROCHLORIDE TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 1985 WARNING: PULMONARY, HEPATIC, AND CARDIAC TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ RESERVE AMIODARONE HYDROCHLORIDE TABLETS FOR PATIENTS WITH THE INDICATED LIFE- THREATENING ARRHYTHMIAS BECAUSE ITS USE IS ACCOMPANIED BY SUBSTANTIAL TOXICITY, SOME ALSO LIFE-THREATENING. UTILIZE ALTERNATIVE AGENTS FIRST. ( 1) AMIODARONE HYDROCHLORIDE TABLET’S LIFE-THREATENING TOXICITIES INCLUDE PULMONARY ( 5.2), HEPATIC ( 5.3), AND PROARRHYTHMIC ( 5.4). INITIATE UNDER HOSPITAL OR SPECIALIST SUPERVISION. ( 5) INDICATIONS AND USAGE Amiodarone Hydrochloride Tablets is an antiarrhythmic indicated for: Recurrent ventricular fibrillation. ( 1) Recurrent hemodynamically unstable ventricular tachycardia. ( 1) DOSAGE AND ADMINISTRATION Initiate treatment with a loading doses 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 Amiodarone Hydrochloride Tablets dose to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day. ( 2) DOSAGE FORMS AND STRENGTHS Tablets, 100 mg, 200 mg, 400 mg. ( 3) CONTRAINDICATIONS Amiodarone Hydrochloride Tablets is contraindicated in patients with ( 4): 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. WARNINGS AND PRECAUTIONS Persistence of Adverse Effects: Adverse reactions and drug interaction can persist for several weeks following discontinuation. ( 5.1) Impaired Vision: Corneal microde Leia o documento completo