|OFIRMEV (acetaminophen) injection, solution|
|The authors make no claims of the accuracy of the information contained herein; and these suggested doses are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this program shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.|
Standard Dilution [Amount of drug] [Infusion volume] [Infusion rate]
[Prescribed dose] [Conc: 10 mg/ml] [Administered undiluted over 15
See Dosage and Administration below.
Stability / Miscellaneous
These highlights do not include all the information needed to use OFIRMEV™ safely and effectively. See full prescribing information for OFIRMEV.
INDICATIONS AND USAGE
OFIRMEV (acetaminophen) injection is indicated for the
Management of mild to moderate pain.
Management of moderate to severe pain with adjunctive opioid analgesics.
Reduction of fever.
DOSAGE AND ADMINISTRATION
OFIRMEV may be given as a single or repeated dose.
OFIRMEV should be administered only as a 15-minute intravenous infusion.
Adults and Adolescents Weighing 50 kg and Over:
1000 mg every 6 hours or 650 mg every 4 hours to a maximum of 4000 mg per day. Minimum dosing interval of 4 hours.
Adults and Adolescents Weighing Under 50 kg:
15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval of 4 hours.
Children 2 to 12 years old: 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours to a maximum of 75 mg/kg per day. Minimum dosing interval of 4 hours.
Instructions for Intravenous Administration
For adult and adolescent patients weighing 50 kg requiring 1000 mg doses of OFIRMEV, administer the dose by inserting a vented intravenous set through the septum of the 100 mL vial. OFIRMEV may be administered without further dilution. Examine the vial contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the vial intravenously over 15-minutes. Use aseptic technique when preparing OFIRMEV for intravenous infusion. Do not add other medications to the OFIRMEV vial or infusion device.
For doses less than 1000 mg, the appropriate dose must be withdrawn from the vial and placed into a separate container prior to administration. Using aseptic technique, withdraw the appropriate dose (650 mg or weight-based) from an intact sealed OFIRMEV vial and place the measured dose in a separate empty, sterile container (e.g. glass bottle, plastic intravenous container, or syringe) for intravenous infusion to avoid the inadvertent delivery and administration of the total volume of the commercially available container. The entire 100 mL vial of OFIRMEV is not intended for use in patients weighing less than 50 kg. OFIRMEV is a single-use vial and the unused portion must be discarded.
Place small volume pediatric doses up to 60 mL in volume in a syringe and administer over 15 minutes using a syringe pump.
Monitor the end of the infusion in order to prevent the possibility of an air embolism, especially in cases where the OFIRMEV infusion is the primary infusion.
Once the vacuum seal of the glass vial has been penetrated, or the contents transferred to another container, administer the dose of OFIRMEV within 6 hours.
Do not add other medications to the OFIRMEV solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with OFIRMEV, therefore do not administer simultaneously.
DOSAGE FORMS AND STRENGTHS
Injection for intravenous infusion.
Each 100 mL glass vial contains 1000 mg acetaminophen (10 mg/mL).
Acetaminophen is contraindicated:
WARNINGS AND PRECAUTIONS
The most common adverse reactions in patients treated with OFIRMEV were nausea, vomiting, headache, and insomnia in adult patients and nausea, vomiting, constipation, pruritus, agitation, and atelectasis in pediatric patients.
To report SUSPECTED ADVERSE REACTIONS, contact Cadence Pharmaceuticals Inc. at 1-877-647-2239 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
HOW SUPPLIED / STORAGE AND HANDLING
OFIRMEV is supplied in a 100 mL glass vial containing 1000 mg acetaminophen (10 mg/mL).
Carton of 24 vials, NDC 43825-102-01
OFIRMEV should be stored at 20 °C to 25 °C (68 °F to 77 °F) [See USP Controlled Room Temperature].
For single use only. The product should be used within 6 hours after opening. Do not refrigerate or freeze.
Principal Display Panel – Carton Label
NDC 43825-102-01 Quantity: 24 Vials
For Intravenous Use Only
Single Use Vial. Doses less than 1000 mg require aseptic transfer to a separate
container prior to dispensing. Discard unused portion.
Store at controlled room temperature, 20°C to 25°C (68°F to 77°F).
Do not refrigerate or freeze.
Each 100 mL contains 1000 mg acetaminophen, USP, 3850 mg mannitol, USP,
25 mg cysteine hydrochloride, monohydrate, USP, 10.4 mg dibasic sodium
phosphate, USP. pH may have been adjusted with hydrochloric acid
and/or sodium hydroxide.
See Package Insert for recommended dosage and Full Prescribing Information.
OFIRMEV (acetaminophen) injection
Cadence Pharmaceuticals, Inc.
San Diego, CA 92130
© 2010 Cadence Pharmaceuticals, Inc. All rights reserved.
OFIRMEV and CADENCE™ are trademarks of Cadence Pharmaceuticals, Inc.
U.S. PATENT NUMBERS: 6,028,222; 6,992,218 Label part number
|The authors make no claims of the accuracy of the information contained herein; and these suggested doses and/or guidelines are not a substitute for clinical judgment. Neither GlobalRPh Inc. nor any other party involved in the preparation of this document shall be liable for any special, consequential, or exemplary damages resulting in whole or part from any user's use of or reliance upon this material. PLEASE READ THE DISCLAIMER CAREFULLY BEFORE ACCESSING OR USING THIS SITE. BY ACCESSING OR USING THIS SITE, YOU AGREE TO BE BOUND BY THE TERMS AND CONDITIONS SET FORTH IN THE DISCLAIMER.|