Amiodarone Hydrochloride (Page 7 of 7)

Admixture Incompatibility

Amiodarone HCl injection in D 5 W is incompatible with the drugs shown below.

Y-SITE INJECTION INCOMPATIBILITY

Drug

Vehicle

Amiodarone Concentration

Comments

Aminophylline

D 5 W

4 mg/mL

Precipitate

Cefamandole Nafate

D 5 W

4 mg/mL

Precipitate

Cefazolin Sodium

D 5 W

4 mg/mL

Precipitate

Mezlocillin Sodium

D 5 W

4 mg/mL

Precipitate

Heparin Sodium

D 5 W

—-

Precipitate

Sodium Bicarbonate

D 5 W

3 mg/mL

Precipitate


Intravenous to Oral Transition

Patients whose arrhythmias have been suppressed by amiodarone HCl injection may be switched to oral amiodarone. The optimal dose for changing from intravenous to oral administration of amiodarone will depend on the dose of amiodarone HCl injection already administered, as well as the bioavailability of oral amiodarone. When changing to oral amiodarone therapy, clinical monitoring is recommended, particularly for elderly patients.

Since there are some differences between the safety and efficacy profiles of the intravenous and oral formulations, the prescriber is advised to review the package insert for oral amiodarone when switching from intravenous to oral amiodarone therapy.

Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, grapefruit juice should not be taken during treatment with oral amiodarone (see PRECAUTIONS, Drug Interactions).

The following table provides suggested doses of oral amiodarone to be initiated after varying durations of amiodarone HCl injection administration. These recommendations are made on the basis of a comparable total body amount of amiodarone delivered by the intravenous and oral routes, based on 50% bioavailability of oral amiodarone.

RECOMMENDATIONS FOR ORAL DOSAGE AFTER IV INFUSION

Duration of Amiodarone HCl Injection Infusion #

Initial Daily Dose of Oral Amiodarone

<1 week

800 to 1600 mg

1 to 3 weeks

600 to 800 mg

> 3 weeks *

400 mg

# Assuming a 720 mg/day infusion (0.5 mg/min).

* Amiodarone HCl Injection is not intended for maintenance treatment.

HOW SUPPLIED

50 mg/mL

NDC: 70518-2792-01 25 in 1 TRAY

NDC: 70518-2792-00 3 mL in 1 VIAL SINGLE DOSE

Repackaged and Distributed By:

Remedy Repack, Inc.

625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Vial stoppers do not contain 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.

logo

45887H

Revised: April 2008

DRUG: Amiodarone Hydrochloride

GENERIC: AMIODARONE HYDROCHLORIDE

DOSAGE: INJECTION, SOLUTION

ADMINSTRATION: INTRAVENOUS

NDC: 70518-2792-1

NDC: 70518-2792-0

OUTER PACKAGING: 25 in 1 TRAY

PACKAGING: 3 mL in 1 VIAL, SINGLE-DOSE

ACTIVE INGREDIENT(S):

  • AMIODARONE HYDROCHLORIDE 50mg in 1mL

INACTIVE INGREDIENT(S):

  • POLYSORBATE 80
  • BENZYL ALCOHOL
Remedy_Label
(click image for full-size original)
MM2
(click image for full-size original)
AMIODARONE HYDROCHLORIDE amiodarone hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70518-2792(NDC:63323-616)
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AMIODARONE HYDROCHLORIDE (AMIODARONE) AMIODARONE HYDROCHLORIDE 50 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL 20.2 mg in 1 mL
POLYSORBATE 80 100 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70518-2792-1 25 VIAL, SINGLE-DOSE in 1 TRAY contains a VIAL, SINGLE-DOSE (70518-2792-0)
1 NDC:70518-2792-0 3 mL in 1 VIAL, SINGLE-DOSE This package is contained within the TRAY (70518-2792-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA075761 06/19/2020
Labeler — REMEDYREPACK INC. (829572556)

Revised: 08/2020 REMEDYREPACK INC.

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2020. All Rights Reserved.