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(amiodarone HCl) Injection for Intravenous Use
NEXTERONE contains amiodarone HCl (C25H29I2NO3•HCl), a class III antiarrhythmic drug. Amiodarone HCl is (2-butyl-3-benzo-furanyl)[4-[2-(diethylamino)ethoxy]-3,5diiodophenyl]methanone hydrochloride.
Amiodarone HCl has the following structural formula:
Amiodarone HCl is a white to slightly yellow crystalline powder, and is very slightly soluble in water. It has a molecular weight of 681.78 and contains 37.3% iodine by weight. NEXTERONE Premixed Injection is a sterile clear, colorless to slightly yellow solution visually free from particulates. NEXTERONE Premixed Injection is available as a ready-to-use, nonpyrogenic, iso-osmotic solution for intravenous administration in 100mL GALAXY containers with 150 mg of amiodarone HCl, USP (1.5mg/mL) in dextrose; and 200mL GALAXY containers with 360 mg of amiodarone HCl, USP (1.8 mg/mL) in dextrose.
NEXTERONE Premixed Injection (150 mg/100 mL, 1.5 mg/mL)
Each mL contains 1.5 mg of amiodarone HCl, USP; 15 mg Betadex Sulfobutyl Ether Sodium, NF; 0.362 mg citric acid anhydrous, 0.183 mg sodium citrate dihydrate and 42.1 mg dextrose anhydrous in water for injection. Sodium hydroxide or hydrochloric acid may have been added to adjust pH.
NEXTERONE Premixed Injection (360 mg/200 mL, 1.8 mg/mL)
Each mL contains 1.8 mg of amiodarone HCl, USP; 18 mg Betadex Sulfobutyl Ether Sodium, NF; 0.362 mg citric acid anhydrous, 0.183 mg sodium citrate dihydrate and 41.4 mg dextrose anhydrous in water for injection. Sodium hydroxide or hydrochloric acid may have been added to adjust pH.
NEXTERONE does not contain polysorbate 80 or benzyl alcohol.
The GALAXY container is fabricated from a specially designed multilayered plastic (PL 2501). Solutions are in contact with the polyethylene layer of the container and can leach out certain chemical components of the plastic in very small amounts within the expiration period. The suitability and safety of the plastic have been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.
What are the possible side effects of amiodarone injection (Nexterone)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
You may continue to have side effects from amiodarone after you stop using it. It could take up to several months for the medicine to completely clear from your body.
Call your doctor at once if you have any of these serious side effects, even if they occur up to several months after you stop using amiodarone:
- a new or a worsening irregular heartbeat pattern;
- fast, slow, or pounding...
Last reviewed on RxList: 3/25/2015
This monograph has been modified to include the generic and brand name in many instances.
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