MEDICATION SAFETY ISSUES
Duplicate therapy issues: This product contains acetaminophen, which may be a component of other combination products. Do not exceed the maximum recommended daily dose of acetaminophen.
U.S. BRAND NAMES — Cramp Tabs [OTC]; Midol® Teen Formula [OTC]; Tylenol® Women's Menstrual Relief [OTC]
PHARMACOLOGIC CATEGORY
Analgesic, Miscellaneous
Diuretic, Combination
DOSING: ADULTS — Menstrual symptoms: Oral: Acetaminophen 650-1000 mg and pamabrom 50 mg every 4-6 hours as needed (maximum: 8 caplets/tablets/24 hours)
DOSING: PEDIATRIC — Children ≥ 12 years: Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Caplet:
Midol® Teen Formula: Acetaminophen 500 mg and pamabrom 25 mg
Tylenol® Women's Menstrual Relief: Acetaminophen 500 mg and pamabrom 25 mg
Tablet:
Cramp Tabs: Acetaminophen 325 mg and pamabrom 25 mg
DOSAGE FORMS: CONCISE
Caplet:
Midol® Teen Formula: Acetaminophen 500 mg and pamabrom 25 mg
Tylenol® Women's Menstrual Relief: Acetaminophen 500 mg and pamabrom 25 mg
Tablet:
Cramp Tabs: Acetaminophen 325 mg and pamabrom 25 mg
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Temporary relief of symptoms associated with premenstrual and menstrual symptoms (eg, cramps, bloating, water-weight gain, headache, backache, muscle aches)
ADVERSE REACTIONS SIGNIFICANT — See Acetaminophen monograph.
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Hepatotoxicity: Acetaminophen may cause hepatic toxicity with acute overdose; in addition chronic daily dosing has resulted in liver damage in some adults. Hypersensitivity: Discontinue use if hypersensitivity occurs.
Disease-related concerns: Ethanol use: Use with caution in patients with alcoholic liver disease; consuming ≥ 3 alcoholic drinks/day may increase the risk of liver damage.
Special populations: Pediatrics: Not for use in children <12 years of age.
Other warnings/precautions: Dosage limit: Limit acetaminophen dose to <4>10 days.
DRUG INTERACTIONS
Anticonvulsants (Hydantoin): May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Barbiturates: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
CarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapy
Cholestyramine Resin: May decrease the absorption of Acetaminophen. Effect is minimal if cholestyramine is administered 1 hour after acetaminophen. Risk D: Consider therapy modification
Imatinib: May increase the serum concentration of Acetaminophen. Risk D: Consider therapy modification
Isoniazid: May enhance the adverse/toxic effect of Acetaminophen. Risk C: Monitor therapy
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Risk C: Monitor therapy
Vitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. Most likely with daily acetaminophen doses >1.3 g for >1 week. Risk C: Monitor therapy
ETHANOL / NUTRITION / HERB INTERACTIONS — Ethanol: Excessive intake of ethanol may increase the risk of acetaminophen-induced hepatotoxicity. Avoid ethanol or limit to <3 drinks/day.
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