Sagent Pharmaceuticals, Inc., a privately-held specialty pharmaceutical company, announced that it has launched amiodarone HCl injection, USP, a class III antiarrhythmic indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia - a potentially life-threatening irregular heart beat.
According to a Sagent's press release, the amiodarone HCl injection will be available immediately in 150 mg/3 mL single dose prefilled syringes. According to IMS data, 2007 sales of injectable amiodarone in the United States were approximately $8 million. Amiodarone prefilled syringes are manufactured for Sagent by Gland Pharma.
"With our launch of the only multi-source, prefilled amiodarone syringe in the health care market, Sagent is making another essential product readily available to the emergency medicine community," said Jeffrey M. Yordon, chief executive officer, founder, and chairman of the board of Sagent. "In the emergency room, where seconds count, our product is ready-to-use - and with enhanced labelling, easy to find on a crash cart. We are proud that our innovations to this important product, including a tamper-evident tip cap, yield safety enhancements that will potentially assist in saving patient's lives."
Amiodarone is the seventh product introduced from Sagent's pipeline of more than 200 products since the launch of the company's first product in December 2007.
Amiodarone HCl Injection, USP, is a class III antiarrhythmic indicated for initiation of treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy. Intravenous amiodarone can also be used to treat patients with ventricular fibrillation or ventricular tachycardia for whom oral amiodarone is indicated but who are not able to take oral medication. During or after treatment with intravenous amiodarone, patients may be transferred to oral amiodarone therapy. Intravenous amiodarone should be used for acute treatment until the patient's ventricular arrhythmias are stabilized.
The most common adverse effects may include dizziness or drowsiness; nausea, vomiting, stomach pain; insomnia; weakness, lack of coordination; or warmth, tingling or redness under the skin. Less common adverse effects include a new or worsening irregular heartbeat; wheezing, cough, chest pain, trouble breathing, coughing up blood; blurred vision, headache or pain behind the eyes; rapid weight gain; weight loss, thinning hair, increased sweating, irregular menstrual periods, swelling in the neck; numbness, burning, pain or tingling in the hands or feet; loss of appetite, dark urine, clay-colored stools, jaundice.
Sagent Pharmaceuticals, founded in 2006, is a privately held specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products.