Drug Detail:Ofirmev (Acetaminophen (injection) [ a-seet-a-min-oh-fen ])
Generic Name: ACETAMINOPHEN 10mg in 1mL
Dosage Form: injection, solution
Drug Class: Miscellaneous analgesics
General Dosing Information
OFIRMEV may be given as a single or repeated dose for the treatment of acute pain or fever. No dose adjustment is required when converting between oral acetaminophen and OFIRMEV dosing in adults and adolescents who weigh 50 kg and above. Calculated maximum daily dose of acetaminophen is based on all routes of administration (i.e., intravenous, oral, and rectal) and all products containing acetaminophen. Exceeding the maximum mg/kg daily dose of acetaminophen as described in Tables 1-3 may result in hepatic injury, including the risk of liver failure and death. To avoid the risk of overdose, ensure that the total amount of acetaminophen from all routes and from all sources does not exceed the maximum recommended dose.
Recommended Dosage: Adults and Adolescents
Adults and adolescents weighing 50 kg and over: the recommended dosage of OFIRMEV is 1000 mg every 6 hours or 650 mg every 4 hours, with a maximum single dose of OFIRMEV of 1000 mg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 4000 mg per day (includes all routes of administration and all acetaminophen-containing products including combination products).
Adults and adolescents weighing under 50 kg: the recommended dosage of OFIRMEV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of OFIRMEV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day (includes all routes of administration and all acetaminophen-containing products including combination products).
| Age group | Dose given every 4 hours | Dose given every 6 hours | Maximum single dose | Maximum total daily dose of acetaminophen (by all routes) |
|---|---|---|---|---|
| Adults and adolescents (13 years and older) weighing ≥ 50 kg | 650 mg | 1000 mg | 1000 mg | 4000 mg in 24 hours |
| Adults and adolescents (13 years and older) weighing < 50 kg | 12.5 mg/kg | 15 mg/kg | 15 mg/kg (up to 750 mg) |
75 mg/kg in 24 hours (up to 3750 mg) |
Recommended Dosage: Children
Children 2 to 12 years of age: the recommended dosage of OFIRMEV is 15 mg/kg every 6 hours or 12.5 mg/kg every 4 hours, with a maximum single dose of OFIRMEV of 15 mg/kg, a minimum dosing interval of 4 hours, and a maximum daily dose of acetaminophen of 75 mg/kg per day.
| Age group | Dose given every 4 hours | Dose given every 6 hours | Maximum single dose | Maximum total daily dose of acetaminophen (by all routes) |
|---|---|---|---|---|
| Children 2 to 12 years of age | 12.5 mg/kg | 15 mg/kg | 15 mg/kg (up to 750 mg) |
75 mg/kg in 24 hours (up to 3750 mg) |
Recommended Dosage For Treatment of Fever in Neonates and Infants
Neonates, including premature neonates born at ≥ 32 weeks gestational age, up to 28 days chronological age: the recommended dosage of OFIRMEV is 12.5 mg/kg every 6 hours, to a maximum daily dose of acetaminophen of 50 mg/kg per day, with a minimum dosing interval of 6 hours.
Infants 29 days to 2 years of age: the recommended dosage of OFIRMEV is 15 mg/kg every 6 hours, to a maximum daily dose of acetaminophen of 60 mg/kg per day, with a minimum dosing interval of 6 hours.
| Age group | Dose given every 6 hours | Maximum total daily dose of acetaminophen (by all routes) |
|---|---|---|
| Neonates (birth to 28 days) | 12.5 mg/kg | 50 mg/kg |
| Infants (29 days to 2 years) | 15 mg/kg | 60 mg/kg |
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 or a non-vented intravenous set through the administration spike port of the 100 mL bag. OFIRMEV may be administered without further dilution. Examine the container contents before dose preparation or administering. DO NOT USE if particulate matter or discoloration is observed. Administer the contents of the container 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 container 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 container 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 container of OFIRMEV is not intended for use in patients weighing less than 50 kg. OFIRMEV is supplied in a single-dose container 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 container seal has been penetrated, or the contents transferred to another container, administer the dose of OFIRMEV within 6 hours.
For bags, refrain from applying excessive pressure causing distortion to the bag, such as wringing or twisting, since such handling could result in breakage of the bag.
Do not add other medications to the OFIRMEV solution. Diazepam and chlorpromazine hydrochloride are physically incompatible with OFIRMEV, therefore do not administer simultaneously.
