Paracetamol

DEA Class;  OTC

Common Brand Names; Tylenol, Tylenol Arthritis Pain, Tylenol Ext, Little Fevers Children’s Fever/Pain Reliever, Little Fevers Infant Fever/Pain Reliever, PediaCare Single Dose Acetaminophen Fever Reducer/Pain Reliever

Analgesics, Other

 

Analgesic and antipyretic; no anti-inflammatory activity or effects on platelet function
Used for fever and pain of mild, moderate, or severe intensity (alone or in combination with opioids)
May be preferred over NSAIDs due to fewer hematologic, gastrointestinal, and renal effects

Indicated in Analgesia & Fever

Hypersensitivity

Severe active liver disease

Angioedema

Disorientation

Dizziness

Pruritic maculopapular rash

Rash

Hyperammonemia

Stevens-Johnson syndrome

Toxic epidermal necrolysis

Urticaria

Gastrointestinal hemorrhage

Laryngeal edema

Agranulocytosis

Leukopenia

Neutropenia

Pancytopenia

Thrombocytopenia

Thrombocytopenic purpura

Hepatotoxicity

Liver failure

Nephrotoxicity

Pneumonitis

Anaphylactoid

Hypersensitivity and anaphylactic reactions reported; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur

Acetaminophen is available in many dosage forms and products, check label carefully to avoid overdose

Use caution in patients with hepatic impairment or active liver disease

Risk of hepatotoxicity is higher in patients taking chronic high dose, or use of more than one Paracetamol-containing product

Use caution in patients with severe renal impairment; consider dosage adjustments

Consumption of 3 or more alcoholic drinks/day may increase risk of liver damage

Use with caution in patients with G6PD deficiency

Use caution in patients with chronic malnutrition

Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

Limit acetaminophen dose from all sources and routes to <4 g/day in adults

Pregnancy

Drug crosses placenta and can be detected in cord blood, newborn serum, and urine immediately after delivery

Increased risk of teratogenic effects not reported following maternal use of drug during pregnancy

Use of normal doses during pregnancy not associated with increased risk of miscarriage or still birth; however, increase in fetal death or spontaneous abortion may be seen with maternal overdose if treatment delayed

Wheezing and asthma in early childhood associated with frequent maternal use of drug during pregnancy

Lactation

Drug is excreted in milk; in general, breastfeeding is generally acceptable if relative infant dose (RID) is <10%; avoid breastfeeding when RID>25%

Adults

immediate-release

Regular strength: 325-650 mg PO/PR q4hr PRN; not to exceed 3250 mg/day; under supervision of healthcare professional, daily doses of up to 4 g/day may be used

Extra Strength: 1000 mg PO q6-8hr PRN; not to exceed 3000 mg/day; under supervision of healthcare professional, daily doses of up to 4 g/day may be used:

extended-release

2 capsules (1300 mg) PO q8hr PRN; not to exceed 3.9 g/day

maximum dose

Acetaminophen containing products: Not to exceed a cumulative dose of 3.25 g/day of acetaminophen; under supervision of healthcare professional, daily doses of up to 4 g/day may be used

Tylenol Extra-Strength (ie, 500 mg/tab or cap): Not to exceed 3 g/day (6 tabs or caps); under supervision of healthcare professional, daily doses of up to 4 g/day may be used

Pediatric

Oral solution

Neonates 28-31 weeks gestation: 10-15 mg/kg/dose PO q12hr prn; may administer an initial load of 20 mg/kg PO; not to exceed 40 mg/kg/day or 48 hr (consecutive) of maximum dose  

Neonates 32-37 weeks gestation: 10-15 mg/kg/dose PO q8hr prn; may administer an initial load of 20 mg/kg PO; not to exceed 60 mg/kg/day or 48 hr (consecutive) of maximum dose

Neonates 0-9 days: 10-15 mg/kg/dose PO q6-8hr prn; may administer an initial load of 20 mg/kg PO; not to exceed 60 mg/kg/day; or 48 hr (consecutive) of maximum dose

Neonates 10-29 days: 10-15 mg/kg/dose PO q4-8hr prn; may administer an initial load of 20 mg/kg PO; not to exceed 90 mg/kg/day; or 48 hr (consecutive) of maximum dose

Infants: 10-15 mg/kg/dose PO q4-6hr prn; not to exceed 15 mg/kg/dose or 75 mg/kg/day

Children and adolescents <60 kg: 10-15 mg/kg/dose PO q4-6hr prn; not to exceed 15 mg/kg/dose or 1,000 mg/dose, whichever is less or 75 mg/kg/day or 4,000 mg/day, whichever is less

Fixed dosing

<6 years: Ask a healthcare provider

6-12 years: 325-650 mg PO q4-6hr; not to exceed 1.625 g/day for not more than 5 days unless directed by healthcare provider

>12 years

Regular strength: 325-650 mg q4-6hr; not to exceed 3.25 g/day; under supervision of healthcare professional, doses of up to 4 g/day may be used

Extra strength: 1000 mg q6hr; not to exceed 3 g/24hr; under supervision of healthcare professional, doses of up to 4 g/day may be used

Extended release: 1.3 g q8hr; not to exceed 3.9 g/24hr

Paracetamol

tablet

  • 325mg

  • 500mg

caplet

  • 325mg

  • 500mg

  • 650mg

capsule

  • 325mg

  • 500mg

caplet, extended-release

  • 650mg

tablet, oral-disintegrating

  • 80mg

  • 160mg

tablet chewable

  • 80mg

solution or suspension, oral

  • 160mg/5mL

liquid oral

  • 160mg/5mL

  • 500mg/5mL

syrup oral

  • 160mg/5mL

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