||Do not refrigerate.
||Store at15° to 30°C (59° to 86°F). Protect from light.
||01 19 16
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.
Dosing for Adults and Adolescents
||Dose given every 4 hours
||Dose given every 6 hours
||Maximum single dose
||Maximum total daily dose of acetaminophen (by any routes)
|Adults and adolescents (13 years and older) weighing ≥ 50 kg
||4000 mg in 24 hours
|Adults and adolescents (13 years and older) weighing < 50 kg
(up to 750 mg)
|75 mg/kg in 24 hours
(up to 3750 mg)
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For doses less than 1000 mg, the appropriate dose must be withdrawn from the vial and placed into a separate container prior to administration.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:
- In patients with known hypersensitivity to acetaminophen or to any of the excipients in the IV formulation.
- In patients with severe hepatic impairment or severe active liver disease.
WARNINGS AND PRECAUTIONS
- Administration of acetaminophen in doses higher than recommended may result in hepatic injury, including the risk of severe hepatotoxicity and death.
- Do not exceed the maximum recommended daily dose of acetaminophen.
- Use caution when administering acetaminophen in patients with the following conditions: hepatic impairment or active hepatic disease, in cases of alcoholism, chronic malnutrition, severe hypovolemia, or severe renal impairment (creatinine clearance ≤ 30 mL/min).
- Discontinue OFIRMEV immediately if symptoms associated with allergy or hypersensitivity occur. Do not use in patients with acetaminophen allergy.
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.
- Substances that induce or regulate hepatic cytochrome enzyme CYP2E1 may alter the metabolism of acetaminophen and increase its hepatotoxic potential.
- Chronic oral acetaminophen use at a dose of 4000 mg/day has been shown to cause an increase in international normalized ratio (INR) in some patients who have been stabilized on sodium warfarin as an anticoagulant.
USE IN SPECIFIC POPULATIONS
- Pregnancy: Category C. There are no studies of intravenous acetaminophen in pregnant women. Use only if clearly needed.
- Nursing Mothers: Caution should be exercised when administered to a nursing woman.
- Pediatric Use: The effectiveness of OFIRMEV for the treatment of acute pain and fever has not been studied in pediatric patients less than 2 years of age. The safety and effectiveness of OFIRMEV in pediatric patients older than 2 years is supported by evidence from adequate and well controlled studies in adults with additional safety and pharmacokinetic data for this age group.
- Geriatric Use: No overall differences in safety or effectiveness were observed between geriatric and younger subjects.
- Hepatic Impairment: OFIRMEV is contraindicated in patients with severe hepatic impairment or severe active liver disease and should be used with caution in patients with hepatic impairment or active liver disease.
- Renal Impairment: In cases of severe renal impairment, longer dosing intervals and a reduced total daily dose of acetaminophen may be warranted.
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.