acetaminophen/pamabrom/pyrilamine (OTC)

Frequency Not Defined

Acetaminophen

• Angioedema, laryngeal edema
• Pruritic maculopapular rash, urticaria
• Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura
• Hepatotoxicity
• Anaphylactoid reaction
• May increase uric acid, chloride, glucose
• May decrease sodium, calcium, bicarbonate

Pyrilamine

• Sedation
• Xerostomia
• Blurred vision

Pamabrom

• Discolored urine (golden tinted)

Contraindications

Hypersensitivity

Hepatitis or severe hepatic/renal impairment

Administration within 14 days of MAO inhibitors

Cautions

Risk of hepatotoxicity; higher in alcoholics, or with use of more than one acetaminophen-containing product

Acetaminophen: 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

Caution in G6PD deficiency

May cause CNS depression and impair ability to operate heavy machinery

Use caution in cardiovascular disease, diabetes mellitus, increased intraocular pressure or glaucoma, thyroid dysfunction, and prostatic hyperplasia

Patients should drink 6-8 glasses of water daily while taking the medication

Pregnancy category: C

Lactation: Excreted in breast milk

Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

Mechanism of Action

Acetaminophen: Inhibitis prostaglandin sythesis in CNS and may block peripheral pain impulse generation; acts on hypothalamus to antipyresis

Pamabrom: Weak diuretic action

Pyrilamine: Antihistamine used for sedative properties