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acetaminophen/aspirin/caffeine (Excedrin Extra Strength, Vanquish, Bayer Migraine Formula, Excedrin Migraine, Excedrin Menstrual Complete, Goody's Extra Strength Fast Pain Relief Powders, Goody's Extra Strength, Goody's Extra Strength Headache Powders, Goody's Migraine Relief, Anacin Advanced Headache, Arthriten, Pamprin Max)

 

Classes: Analgesics, Other Combos

Dosing and uses of Excedrin Extra Strength, Vanquish (acetaminophen-aspirin-caffeine)

 

Adult dosage forms and strengths

acetaminophen/aspirin/caffeine

tablet/capsule

  • 194mg/227mg/33mg
  • 250mg/250mg/65mg
  • 260mg/520mg/32.5mg
  • 325mg/500mg/65mg

 

Pain, Migraine

1-2 capsules or tablets PO q4-6hr PRn

Products vary; check specific labeling for each

 

Dosing Modifications

Severe renal impairment (CrCl <10 mL/min): Avoid use

Severe hepatic impairment: Avoid use

 

Pediatric dosage forms and strengths

Safety and efficacy not established

 

Excedrin Extra Strength, Vanquish (acetaminophen-aspirin-caffeine) adverse (side) effects

Frequency not defined

Acetaminophen

  • Angioedema, laryngeal edema
  • Pruritic maculopapular rash, urticaria
  • Agranulocytosis, leukopenia, neutropenia, pancytopenia, thrombocytopenia, thrombocytopenic purpura
  • Hepatotoxicity
  • Anaphylactoid reaction

Aspirin

  • Rash, urticaria
  • Dyspepsia, heartburn, nausea, stomach pain, vomiting
  • Tinnitus (high dose or long-term use)

Caffeine

  • Palpitations (dose dependent), tachycardia
  • Insomnia, restlessness, nervousness, tremor, irritability
  • Diarrhea, nausea, vomiting
  • Diuresis
  • Tinnitus

 

Warnings

Contraindications

Hypersensitivity

Hepatitis or severe hepatic or renal impairment

Repeated administration in patients with anemia or with cardiac, pulmonary, or renal disease

 

Cautions

Risk of hepatotoxicity (higher in alcoholics and with use of >1 acetaminophen-containing product)

Glucose-6-phosphate dehydrogenase (G6PD) deficiency

Gastrointestinal (GI) bleeding; exercise particular caution in patients with history of GI bleeding, alcoholism, or bleeding disorders

Avoid with active peptic ulcer disease

Avoid with severe renal impairment (ie, CrCl <10 mL/min)

Avoid with severe hepatic impairment

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: D; avoid during pregnancy, particularly in third trimester because of risk of premature closure of ductus arteriosus

Lactation: Drug is excreted in breast milk; do not nurse

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 Excedrin Extra Strength, Vanquish (acetaminophen-aspirin-caffeine)

Mechanism of action

Acetaminophen: Acts on hypothalamus to produce antipyresis

Aspirin: Acts on hypothalamus to produce antipyresis; anti-inflammatory properties are attributed to inhibition of prostaglandin synthetase, resulting in decreased formation of thromboxane A2

Caffeine: Vasoconstrictive properties may be helpful in treatment of vascular headaches