acetaminophen/pamabrom (Midol Teen, Painaid PMF Premenstrual Formula, Women's Tylenol Multi-Symptom Menstrual Relief, BackAid Max)

Dosing and uses of Midol Teen, Painaid PMF Premenstrual Formula (acetaminophen/pamabrom)

• Adult
• Pediatric

 

Adult dosage forms and strengths

acetaminophen/pamabrom

caplet

• 500mg/25mg

tablet

• 325mg/25mg

 

Analgesia/Menstrual Cramps

1-2 caplets or tablets PO q4-6hr PRN; not to exceed 8 caplets/tablets for 24 hr

 

Pediatric dosage forms and strengths

acetaminophen/pamabrom

caplet

• 500mg/25mg

tablet

• 325mg/25mg

 

Analgesia/Menstrual Cramps

<12 years: Safety and efficacy not established

≥12 years: 1-2 caplets or tablets PO q4-6hr PRN; not to exceed 8 caplets/tablets per 24 hr

 

Midol Teen, Painaid PMF Premenstrual Formula (acetaminophen/pamabrom) adverse (side) effects

Frequency not defined

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

 

Warnings

Contraindications

Hypersensitivity

Hepatitis or severe hepatic/renal impairment

 

Cautions

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

Caution in G6PD deficiency

Hepatic impairment or consumption of 3 or more alcoholic beverages/day may increase risk for liver damage (associated with acetaminophen)

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

 

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 Teen, Painaid PMF Premenstrual Formula (acetaminophen/pamabrom)

Mechanism of action

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

Pamabrom: Weak diuretic action