Amiodarone Hydrochloride 100 mg/1
Amiodarone Hydrochloride · TABLET · Advagen Pharma Limited
Amiodarone Hydrochloride is a tablet containing amiodarone hydrochloride at 100 mg/1, taken oral. Manufactured by Advagen Pharma Limited.
Key Facts
- Brand Name
- Amiodarone Hydrochloride
- Generic Name
- Amiodarone Hydrochloride
- NDC Code (Product)
72888-060- Manufacturer
- Advagen Pharma Limited
- Strength
- 100 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078578
- Marketing Start
- 08/21/2020
Recall History
AuroMedics Pharma LLC
Crystallization: Presence of visible particulate matter.
AuroMedics Pharma LLC
Crystallization: Presence of visible particulate matter.
Mylan Institutional LLC
Labeling: Label Mix-Up; potential for cartons labeled as Tranexamic Acid Injection, USP to contain vials of Amiodarone HCl Injection, USP and cartons labeled as Amiodarone HCl Injection, USP to contain vials of Tranexamic Acid Injection, USP.
AuroMedics Pharma LLC
Crystallization: Presence of visible particulate matter.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Amiodarone injection is indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. Amiodarone also can be used to treat patients with VT/VF for whom oral amiodarone is indicated, but who are unable to take oral medication. During or after treatment with amiodarone, patients may be transferred to oral amiodarone therapy [see Dosage and Administration (2) ] . Use amiodarone for acute treatment until the patient's ventricular arrhythmias are stabilized. Most patients will require this therapy for 48 to 96 hours, but amiodarone may be safely administered for longer periods if necessary. Amiodarone hydrochloride injection is an antiarrhythmic agent indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation (VF) and hemodynamically unstable ventricular tachycardia (VT) in patients refractory to other therapy. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Amiodarone shows considerable interindividual variation in response. Although a starting dose adequate to suppress life-threatening arrhythmias is needed, close monitoring with adjustment of dose is essential. The recommended starting dose of amiodarone is about 1000 mg over the first 24 hours of therapy, delivered by the following infusion regimen: Table 1: AMIODARONE DOSE RECOMMENDATIONS: FIRST 24 HOURS Loading Infusions First Rapid: 150 mg over the FIRST 10 minutes (15 mg/min). Add 3 mL of amiodarone (150 mg) to 100 mL D 5 W (concentration = 1.5 mg/mL). Infuse 100 mL over 10 minutes. Followed by Slow: 360 mg over the NEXT 6 hours (1 mg/min). Add 18 mL of amiodarone (900 mg) to 500 mL D 5 W (concentration = 1.8 mg/mL). Infuse 200 mL at a rate of 0.556 mL/min. Maintenance Infusion 540 mg over the REMAINING 18 hours (0.5 mg/min). Decrease the rate of the slow loading infusion to 0.278 mL/min. After the first 24 hours, continue the maintenance infusion rate of 0.5 mg/min (720 mg per 24 hours) utilizing a concentration of 1 mg/mL to 6 mg/mL (Use a central venous catheter for amiodarone concentrations greater than 2 mg/mL). The rate of the maintenance infus…
Contraindications
4 CONTRAINDICATIONS Amiodarone is contraindicated in patients with: • Known hypersensitivity to any of the components of Amiodarone Hydrochloride Injection, USP, including iodine. Hypersensitivity reactions may involve rash, angioedema, cutaneous/mucosal hemorrhage (bleeding), fever, arthralgias (joint pains), eosinophilia (abnormal blood counts), urticaria (hives), thrombotic thrombocytopenic purpura, or severe periateritis (inflammation around blood vessels) • Cardiogenic shock • Marked sinus bradycardia • Second- or third-degree atrio-ventricular (AV) block unless of a functioning pacemaker is available. Amiodarone is contraindicated in patients with (4): • Known hypersensitivity to any of the components of amiodarone, including iodine • Cardiogenic shock • Marked sinus bradycardia • Second- or third-degree atrio-ventricular (AV) block unless of a functioning pacemaker is available.
Drug Interactions
7 DRUG INTERACTIONS Amiodarone is a substrate for CYP3A and CYP2C8, so inhibitors and inducers affect amiodarone exposure ( 7 ) Amiodarone inhibits p-glycoprotein and CYP1A2, CYP2C9, CYP2D6, and CYP3A, increasing exposure to other drugs ( 7 ) 7.1 Pharmacodynamic Interactions Drugs Prolonging the QT Interval Co-administration of drugs prolonging the QT interval (such as class I and III antiarrhythmics, lithium, certain phenothiazines, tricyclic antidepressants, certain fluoroquinolone and macrolide antibiotics, azole antifungals, halogenated inhalation anesthetic agents) increases the risk of Torsade de Pointes. In general, avoid concomitant use of drugs that prolong the QT interval [see Warnings and Precautions (5.4) ] . Drugs That Slow Heart Rate Concomitant use of drugs with depressant effects on the sinus and AV nodes (e.g., digoxin, beta blockers, verapamil, diltiazem, ivabradine, clonidine) can potentiate the 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. 7.2 Pharmacokinetic Interactions Effect of Other Drugs on Amiodarone Am…
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in labeling: • Hypotension [see Warnings and Precautions (5.1)] • Hepatic injury [see Warnings and Precautions (5.3)] • Rhythm disturbances [see Warnings and Precautions (5.4)] • Pulmonary injury [see Warnings and Precautions (5.5)] • Thyroid injury [see Warnings and Precautions (5.7)] • Hypersensitivity [see Warnings and Precautions (5.11)] • The most common adverse reactions (1% to 2%) leading to discontinuation of intravenous amiodarone therapy are hypotension, asystole/cardiac arrest/pulseless electrical activity, VT, and cardiogenic shock. (6) • Other important adverse reactions are, torsade de pointes, congestive heart failure, and liver function test abnormalities. (6) To report SUSPECTED ADVERSE REACTIONS, contact Zhejiang Poly Pharm. Co., Ltd. at 1-888-998-3988 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice…
Frequently Asked Questions
What is Amiodarone Hydrochloride used for?
Amiodarone Hydrochloride contains Amiodarone Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Amiodarone Hydrochloride a controlled substance?
Amiodarone Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Amiodarone Hydrochloride?
The generic name for Amiodarone Hydrochloride is Amiodarone Hydrochloride. There are 1 other brand versions of Amiodarone Hydrochloride.
What is the NDC code for Amiodarone Hydrochloride 100 mg/1?
The NDC (National Drug Code) for Amiodarone Hydrochloride 100 mg/1 is 72888-060, listed by Advagen Pharma Limited.
Other Amiodarone Hydrochloride Dosages
- Amiodarone Hydrochloride200 mg/175907-006
- Amiodarone Hydrochloride200 mg/160687-437
- Amiodarone Hydrochloride400 mg/162135-578
- Amiodarone Hydrochloride200 mg/170518-3439
- Amiodarone Hydrochloride200 mg/171335-0881
- Amiodarone Hydrochloride50 mg/mL71872-7163
- Amiodarone Hydrochloride50 mg/mL72673-073
- Amiodarone Hydrochloride200 mg/172888-039
- Amiodarone Hydrochloride200 mg/150090-3015
- Amiodarone Hydrochloride300 mg/151672-4056
Other Amiodarone Brands
See all →Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)