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acetaminophen/caffeine (Excedrin Tension Headache, Excedrin Aspirin Free, APAP-Plus)

 

Classes: Analgesics, Other Combos

Dosing and uses of Excedrin Tension Headache, Excedrin Aspirin Free (acetaminophen/caffeine)

 

Adult dosage forms and strengths

acetaminophen/caffeine

gel taB

  • 500mg/65mg

tablet

  • 500mg/65mg

caplet

  • 500mg/65mg

 

Analgesia

1 capsule/tablet/geltab PO q4-6hr PRn

 

Pediatric dosage forms and strengths

Safety & efficacy not established

 

Excedrin Tension Headache, Excedrin Aspirin Free (acetaminophen/caffeine) adverse (side) effects

Acetaminophen

Pruritic maculopapular rash

Urticaria

Laryngeal edema

Angioedema

Anaphylactoid reaction

Thrombocytopenia

Leukopenia

Pancytopenia

Neutropenia

Thrombocytopenic purpura

Agranulocytosis

Hepatotoxicity

May increase uric acid, chloride, glucose

May decrease sodium, calcium, bicarbonate  

 

Caffeine

Insomnia

Restlessness

Nervousness

Tremor

Tinnitus

Irritability

Nausea

Vomiting

Diarrhea

Tachycardia

Diuresis

Palpitations (dose dependent)

 

Warnings

Contraindications

Hypersensitivity

Hepatitis or severe hepatic/renal impairment

 

Cautions

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

Do not take with other products that contain acetaminophen due to risk of additive toxicity/overdose

Caution in G6PD deficiency

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 Excedrin Tension Headache, Excedrin Aspirin Free (acetaminophen/caffeine)

Mechanism of action

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

Caffeine: Vasoconstrictive properties may be helpful when treating vascular headaches