Amiodarone Hydrochloride (Page 7 of 7)
16 HOW SUPPLIED/ STORAGE AND HANDLING
Amiodarone Hydrochloride Injection, USP is supplied as:
150 mg per 3 mL
(50 mg per mL)
NDC: 70518-2792-00
NDC: 70518-2792-01
PACKAGING: 25 in 1 TRAY
PACKAGING: 3 mL in 1 VIAL, SINGLE DOSE TYPE 0
The container closure is not made with natural rubber latex.
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Protect from light and excessive heat.
Use carton to protect contents from light until used.
Repackaged and Distributed By:
Remedy Repack, Inc.
625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
17 PATIENT COUNSELING INFORMATION
Amiodarone has the potential to cause serious side effects that limit its use to life-threatening and hemodynamically unstable cardiac arrhythmias. Advise female patients to discontinue nursing while being treated with amiodarone, as breast-feeding could expose the nursing infant to a significant dose of the drug. Recommend that patients avoid grapefruit juice, over-the-counter cough medicines (which commonly contain dextromethorphan), and St. John’s Wort. Inform patients that most manufacturers of corneal refractive laser surgery devices contraindicate corneal refractive laser surgery in patients taking amiodarone. Discuss the symptoms of hypo- and hyper-thyroidism, particularly if patients will be transitioned to oral amiodarone.
Repackaged By / Distributed By: RemedyRepack Inc.
625 Kolter Drive, Indiana, PA 15701
(724) 465-8762
DRUG: Amiodarone Hydrochloride
GENERIC: AMIODARONE HYDROCHLORIDE
DOSAGE: INJECTION, SOLUTION
ADMINSTRATION: INTRAVENOUS
NDC: 70518-2792-0
NDC: 70518-2792-1
PACKAGING: 3 mL in 1 VIAL, SINGLE-DOSE
OUTER PACKAGING: 25 in 1 TRAY
ACTIVE INGREDIENT(S):
- AMIODARONE HYDROCHLORIDE 50mg in 1mL
INACTIVE INGREDIENT(S):
- WATER
- POLYSORBATE 80
- BENZYL ALCOHOL
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Labeler — REMEDYREPACK INC. (829572556) |
Revised: 03/2024 REMEDYREPACK INC.
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