Paracetamol/Aspirin/Diphenhydramine

DEA Class;  OTC

Common Brand Names; Excedrin PM Headache

Analgesic and other combo

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

Indicated for temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

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)

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

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

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

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.

acetaminophen/aspirin/diphenhydramine

Caplet

250mg/250mg/38mg (as diphenhydramine citrate; equivalent to 25mg diphenhydramine)