Adult Dosing

Mild to moderate pain

>50 kg

• 1000 mg IV q6 hrs; alt 650 mg IV q4 hrs
• Max: 1000 mg/dose; 4000 mg/day
• Note: Minimum dosing interval is 4 hrs

<50 kg

• 15 mg/kg IV q6 hrs; alt 12.5 mg/kg IV q4 hrs
• Max: 15 mg/dose; 75 mg/kg/day
• Note: Minimum dosing interval is 4 hrs

Moderate to severe pain with adjunctive opioid analgesics

>50 kg

• 1000 mg IV q6 hrs; alt 650 mg IV q4 hrs
• Max: 1000 mg/dose; 4000 mg/day
• Note: Minimum dosing interval is 4 hrs

<50 kg

• 15 mg/kg IV q6 hrs; alt 12.5 mg/kg IV q4 hrs
• Max: 15 mg/dose; 75 mg/kg/day
• Note: Minimum dosing interval is 4 hrs

Fever

>50 kg

• 1000 mg IV q6 hrs; alt 650 mg IV q4 hrs
• Max: 1000 mg/dose; 4000 mg/day
• Note: Minimum dosing interval is 4 hrs

<50 kg

• 15 mg/kg IV q6 hrs; alt 12.5 mg/kg IV q4 hrs
• Max: 15 mg/dose; 75 mg/kg/day
• Note: Minimum dosing interval is 4 hrs

Pediatric Dosing

• Safety and effectiveness in pediatric patient <2 yrs of age have not been established

Mild to moderate pain

Children 2-12 years

• 15 mg/kg IV q6 hrs; alt 12.5 mg/kg IV q4 hrs
• Max: 15 mg/dose; 75 mg/kg/day
• Note:Minimum dosing interval is 4 hrs

Children >13 yrs, >50 kg

• 1000 mg IV q6 hrs; alt 650 mg IV q4 hrs
• Max: 1000 mg/dose; 4000 mg/day
• Note:Minimum dosing interval is 4 hrs

Children >13 yrs, <50 kg

• 15 mg/kg IV q6 hrs; alt 12.5 mg/kg IV q4 hrs
• Max: 15 mg/dose; 75 mg/kg/day
• Note:Minimum dosing interval is 4 hrs

Moderate to severe pain with adjunctive opioid analgesics

Children 2-12 yrs

• 15 mg/kg IV q6 hrs; alt 12.5 mg/kg IV q4 hrs
• Max: 15 mg/dose; 75 mg/kg/day
• Note:Minimum dosing interval is 4 hrs

Children >13 yrs, >50 kg

• 1000 mg IV q6 hrs; alt 650 mg IV q4 hrs
• Max: 1000 mg/dose; 4000 mg/day
• Note:Minimum dosing interval is 4 hrs

Children >13 yrs, <50 kg

• 15 mg/kg q6 hrs; alt 12.5 mg/kg IV q4 hrs
• Max: 15 mg/dose; 75 mg/kg/day
• Note:Minimum dosing interval is 4 hrs

Fever

Children 2-12 years

• 15 mg/kg IV q6 hrs; alt 12.5 mg/kg IV q4 hrs
• Max: 15 mg/dose; 75 mg/kg/day
• Note:Minimum dosing interval is 4 hrs

Children >13 yrs, >50 kg

• 1000 mg IV q6 hrs; alt 650 mg IV q4 hrs
• Max: 1000 mg/dose; 4000 mg/day
• Note:Minimum dosing interval is 4 hrs

Children >13 yrs, <50 kg

• 15 mg/kg q6 hrs; alt 12.5 mg/kg IV q4 hrs
• Max: 15 mg/dose; 75 mg/kg/day
• Note:Minimum dosing interval is 4 hrs

[Outline]

• Adult Dosing
• Pediatric Dosing

• Management of mild to moderate pain
• Management of moderate to severe pain with adjunctive opioid analgesics
• Pyrexia

• Hypersensitivity to any of the ingredients or class of the product
• Severe hepatic impairment or severe active liver disease

• Use therapy cautiously especially while prescribing, preparing, and administering to avoid dosing errors which could lead to accidental overdose and death. During administration be careful that the dose in milligrams (mg) and milliliters (mL) is not confused, dosing is based on weight for patients under 50 kg, infusion pumps are properly programmed and the total daily dose of acetaminophen from all sources does not exceed maximum daily limits
• Acetaminophen is associated with cases of acute liver failure, especially at the doses that exceed the maximum daily limits, resulting in liver transplant and death

Renal Dose Adjustment (Based on CrCl)

• Severe renal impairment (30 mL/min): Dose adjustments not defined, longer dosing intervals and a reduced total daily dose warranted

Hepatic Dose Adjustment

• Mild to moderate hepatic impairment: Caution advised, consider dose reduction
• Severe hepatic impairment: Contraindicated

• Acetaminophen can cause serious liver damage, including severe hepatotoxicity and death, especially when the recommended dose is exceeded
• Cases of hypersensitivity and anaphylaxis, manifesting as swelling of the face, mouth, and throat, respiratory distress, urticaria, rash, pruritus, have been reported with the use of acetaminophen. Discontinue immediately if symptoms associated with allergy or hypersensitivity occur

Cautions: Use cautiously in

• Mild to moderate hepatic impairment or active hepatic disease
• Chronic malnutrition
• Severe hypovolemia
• Severe renal impairment (creatinine clearance =< 30 mL/min)
• Chronic alcohol use

Ofirmev interacts with :

	Acenocoumarol
	Barbiturates
	Carbamazepine
	Carbatrol
	Coumadin
	Dilantin
	Dilantin Infatabs
	Dilantin-125
	Efavirenz
	Epitol
	Equetro
	INH
	Isoniazid
	Jantoven
	Mycobutin
	Mysoline
	Nevirapine
	Oxcarbazepine
	Oxtellar XR
	Phenprocoumon
	Phenytek
	Phenytoin
	Priftin
	Primidone
	Rifabutin
	Rifadin
	Rifampin
	Rifapentine
	Rimactane
	St. John's Wort
	Sustiva
	Tegretol
	Tegretol XR
	Teril
	Trileptal
	Viramune
	Viramune XR
	Warfarin

Pregnancy Category:C

Breastfeeding: Amounts of acetaminophen excreted in milk are much less than doses usually given to infants; it is considered as a good choice for analgesia and fever reduction in nursing women. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 16 February 2011). Manufacturer advises caution

• GI: Nausea, vomiting, constipation, hepatotoxicity
• CNS: Headache, insomnia
• RESP: Atelectasis
• DERM: Pruritus, rash
• HEMA: Anemia, thrombocytopenia
• GU: Acute renal tubular necrosis, chronic analgesic nephropathy
• PSYCHIATRY: Anxiety, agitation
• LOCAL: Infusion site pain, peripheral edema
• MISC: Pyrexia, fatigue, anaphylaxis, severe hypersensitivity reaction

• Analgesic and antipyretic; exact mechanism is unknown; it inhibits prostaglandin synthesis in the CNS, but lacks peripheral anti-inflammatory effects; reduces fever through direct action on hypothalamic heat-regulating center
• Metabolized in liver; CYP450: 2E1 substrate
• Excreted in urine (<5% unchanged)
• Half life: 1-4 hrs

US Trade Name(s)

• Ofirmev

US Availability

Ofirmev

• INJ: 10 mg/mL (100 mL vial)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Perfalgan

UK Availability

Perfalgan

• INJ: 10 mg/mL (50 mL vial)
• INJ: 10 mg/mL (100 mL vial)

Australian Trade Name(s)

• Perfalgan

Australian Availability

Perfalgan

• INJ: 10 mg/mL (50 mL vial)
• INJ: 10 mg/mL (100 mL vial)

[Outline]

Analgesics

Analgesics; Miscellaneous