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Amiodarone HCl 50mg | 3mL Injectable SDV

FRE-63323061603
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Fresenius USA

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Antiarrhythmic

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Product Overview:

Amiodarone HCl 50mg | 3mL Injectable SDV (Single-Dose Vial) is a sterile solution intended for intravenous administration. Amiodarone is an antiarrhythmic medication used to manage and treat life-threatening ventricular arrhythmias such as ventricular fibrillation (VF) and ventricular tachycardia (VT). It is commonly utilized in emergency and critical care settings where rapid response to abnormal heart rhythms is required.

Key Features:

  1. Potent Antiarrhythmic Agent:
  • Amiodarone is a class III antiarrhythmic drug that works by prolonging the myocardial cell action potential duration and refractory period, thus stabilizing cardiac electrical activity and preventing abnormal heart rhythms.
  • Concentration and Volume:
    • Each vial contains 50mg of amiodarone hydrochloride per 3mL of solution, providing a precise dosage for accurate administration.
  • Single-Dose Vial (SDV):
    • Packaged in a single-dose vial, this product is designed for one-time use, ensuring sterility and minimizing the risk of contamination.
  • Sterile and Non-Pyrogenic:
    • The solution is sterile, non-pyrogenic, and free from harmful contaminants, making it safe for intravenous use in various clinical scenarios.

    Indications: Amiodarone HCl 50mg | 3mL Injectable SDV is indicated for:

    • Treatment of life-threatening recurrent ventricular fibrillation.
    • Treatment of unstable ventricular tachycardia that has not responded to other therapies.

    Contraindications and Precautions:

    • Contraindications: Amiodarone is contraindicated in patients with known hypersensitivity to amiodarone or iodine, severe sinus-node dysfunction, second- or third-degree atrioventricular (AV) block, and bradycardia-induced syncope.
    • Precautions: Use with caution in patients with preexisting lung disease, thyroid disorders, and liver impairment. Continuous monitoring of cardiac, hepatic, and pulmonary function is recommended during therapy.

    Side Effects: Potential side effects may include:

    • Hypotension (low blood pressure)
    • Bradycardia (slow heart rate)
    • Arrhythmias
    • Nausea, vomiting
    • Pulmonary toxicity (rare but serious)

    Storage and Handling:

    • Store at controlled room temperature, protected from light and moisture. Do not freeze.
    • Discard any unused portion of the vial after opening, as it is intended for single use only.

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    Amiodarone HCl 50mg | 3mL Injectable SDV

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