Dosing & Uses
Dosage Forms & Strengths
acetaminophen/pamabrom/pyrilamine
capsule
- 500mg/25mg/15mg
gelcap
- 500mg/25mg/15mg
tablet
- 500mg/25mg/15mg
Analgesia/Menstrual Cramps
1-2 capsule/tablet/gelcap PO q4-6hr PRN
Safety & efficacy not established
Adverse Effects
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)
Warnings
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 & Lactation
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.Pharmacology
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