Classes
DEA Class; OTC
Common Brand Names; Excedrin PM Headache
Analgesic and other combo
Description
Oral combination of analgesics and a sedating antihistamine
Used for the treatment of occasional headaches and minor aches and pains with accompanying sleeplessness
Not to exceed maximum recommended daily dose of acetaminophen, including acetaminophen-containing combination products, due to risk for hepatotoxicity
Uses/Indications
Indicated for temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
Contraindications
Allergy to acetaminophen, aspirin, or diphenhydramine products
Coadministration with other acetaminophen containing medications; increased risk for severe hepatic impairment
Coadministration with other diphenhydramine containing products (even topical diphenhydramine)
Adverse Effects
Acetaminophen
Angioedema, laryngeal edema
Pruritic maculopapular rash, urticaria
Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura
Hepatotoxicity
May increase uric acid, chloride, glucose
May decrease sodium, calcium, bicarbonate
Anaphylactoid reaction
Aspirin
Rash, urticaria
Dyspepsia, heartburn, nausea, stomach pain, vomiting
Tinnitus (high or chronic dose)
Diphenhydramine
Sedation
Confusion
May decrease cognitive function in geriatric patients
Anticholinergic effects
Blurred vision
Diplopia
Xerostomia
Dry nasal mucosa
Pharyngeal dryness
Thick bronchial sputum
Constipation
Warnings
Acetaminophen
Hepatic impairment or consumption of 3 or more alcoholic beverages/day may increase risk for liver damage (associated with acetaminophen)
Do not take with other products that contain acetaminophen due to risk of additive toxicity/overdose
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
Aspirin
Children and adolescents should not use aspirin for symptoms of viral infections (eg, chickenpox, influenza) due to risk for Reye syndrome
Risk for GI bleeding
Avoid with active peptic ulcer disease
Avoid in severe renal impairment (ie, CrCl <10 mL/min)
Diphenhydramine
May cause CNS depression, which can impair driving or operating heavy machinery
May potentiate effects of sedatives such as alcohol
Use caution in patients with angle-closure glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, thyroid dysfunction
Elderly patients: Considered high-risk medication for this age group because it may increase risk of falls and has high incidence of anticholinergic effects; may exacerbate existing lower urinary tract conditions or benign prostatic hyperplasia; use in special situations may be appropriate; not recommended for treatment of insomnia, because tolerance develops and risk of anticholinergic effects increases
Pregnancy and Lactation
Pregnancy
Avoid aspirin (NSAIDs) during pregnancy, particularly in third trimester because of risk for premature closure of the ductus arteriosus
Lactation: Drug enters breast milk; a decision should be made regarding whether to discontinue nursing or to discontinue drug, taking into account importance of drug to mother
Seek advice of health professional before using OTC drugs while breastfeeding
Maximum Dosage
Adults
Acetaminophen 500 mg/day PO, aspirin 500 mg/day PO, and diphenhydramine 76 mg/day PO.
Geriatric
Acetaminophen 500 mg/day PO, aspirin 500 mg/day PO, and diphenhydramine 76 mg/day PO.
Adolescents
Acetaminophen 500 mg/day PO, aspirin 500 mg/day PO, and diphenhydramine 76 mg/day PO.
Children
Children 12 years: Acetaminophen 500 mg/day PO, aspirin 500 mg/day PO, and diphenhydramine 76 mg/day PO.
Children 1 to 11 years: Safety and efficacy have not been established.
Infants
Safety and efficacy have not been established.
Neonates
Safety and efficacy have not been established.
How supplied
acetaminophen/aspirin/diphenhydramine
Caplet
250mg/250mg/38mg (as diphenhydramine citrate; equivalent to 25mg diphenhydramine)
