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OFIRMEV
Nonnarcotic analgesics
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Drug Name:

OFIRMEV Rx

Generic Name and Formulations:
Acetaminophen 10mg/mL; soln for IV infusion; preservative-free.

Company:
Mallinckrodt, Inc.

Therapeutic Use:

Indications for OFIRMEV:

Management of mild-to-moderate pain or moderate-to-severe pain with adjunctive opioid analgesics. Fever.

Adult:

Ensure total amount of acetaminophen from all routes and all sources does not exceed max recommended dose. Give by IV infusion over 15 mins. <50kg: 15mg/kg every 6hrs (or 12.5mg/kg every 4hrs); max single dose: 15mg/kg (up to 750mg), max daily dose: 75mg/kg/24hrs (up to 3750mg). ≥50kg: 1000mg every 6hrs (or 650mg every 4hrs); max single dose: 1000mg, max daily dose: 4000mg/24hrs. Minimum dosing interval: 4hrs.

Children:

Ensure total amount of acetaminophen from all routes and all sources does not exceed max recommended dose. Give by IV infusion over 15 mins; place small volume doses (up to 60mL) in syringe and administer using syringe pump. Fever only: (Neonates 0–28days): 12.5mg/kg every 6hrs; max daily dose: 50mg/kg/24hrs; (Infants 29days–2yrs): 15mg/kg every 6hrs; max daily dose: 60mg/kg/24hrs. Minimum dosing interval: 6hrs. Fever/pain: (<2yrs): not established (for pain); (≥2yrs): 15mg/kg every 6hrs (or 12.5mg/kg every 4hrs); max single dose: 15mg/kg (up to 750mg), max daily dose: 75mg/kg/24hrs (up to 3750mg). Minimum dosing interval: 4hrs.

Contraindications:

Severe hepatic impairment. Severe active liver disease.

Warnings/Precautions:

Ensure correct prescribing, preparing, and administering to avoid dosing errors. Risk of acute liver failure (may result in liver transplant or death) associated with the use of doses higher than recommended or involving >1 acetaminophen-containing product. Hepatic impairment. Active hepatic disease. Alcoholism. Chronic malnutrition. Severe hypovolemia. Severe renal impairment (CrCl ≤30mL/min). Pregnancy. Nursing mothers.

Interactions:

Caution with CYP2E1 inhibitors or inducers (eg, alcohol). Doses of 4000mg/day may increase INR, monitor warfarin frequently.

Pharmacological Class:

Analgesic/antipyretic.

Adverse Reactions:

Nausea, vomiting, headache, insomnia; also children: constipation, pruritus; hepatotoxicity (with high doses), hypersensitivity (discontinue if occurs); rare: serious skin reactions (eg, AGEP, Stevens-Johnson Syndrome, toxic epidermal necrolysis).

How Supplied:

Single-dose vials or bags (100mL)—24

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