acetaminophen/pamabrom/pyrilamine (Midol Maximum Strength PMS, Pamprin Multi-Symptom Maximum Strength, Premsyn PMS)

Dosing and uses of Midol Maximum Strength PMS, Pamprin Multi-Symptom Maximum Strength (acetaminophen/pamabrom/pyrilamine)

• Adult
• Pediatric

 

Adult dosage forms and 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

 

Pediatric dosage forms and strengths

Safety & efficacy not established

 

Midol Maximum Strength PMS, Pamprin Multi-Symptom Maximum Strength (acetaminophen/pamabrom/pyrilamine) adverse (side) 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 and 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 of Midol Maximum Strength PMS, Pamprin Multi-Symptom Maximum Strength (acetaminophen/pamabrom/pyrilamine)

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