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acetaminophen rectal (Acephen, FeverAll, FeverAll Infants, FeverAll Junior Strength, Adults' FeverAll)

 

Classes: Analgesics, Other

Dosing and uses of Acephen, FeverAll (acetaminophen rectal)

 

Adult dosage forms and strengths

suppository

  • 80mg
  • 120mg
  • 325mg
  • 650mg

 

Antipyretic/Analgesic

325-650 mg PR q4-6hr PRn

Not to exceed 4 g/day

 

Administration

Patient should lie on left side with knees bent

Remove protective wrap before inserting

Gently insert tip into rectum with slight side-to-side movement (tip of suppository pointing toward navel)

 

Pediatric dosage forms and strengths

suppository

  • 80mg
  • 120mg
  • 325mg
  • 650mg

 

Antipyretic/Analgesic

3 months to 1 year: 80 mg PR q6hr PRn

1-3 years: 80 mg PR q4hr PRn

3-6 years: 120 mg PR q4-6hrPRn

6-12 years: 325 mg PR q4-6hr PRn

>12 years: As adults; 325-650 mg PR q4-6hr PRn

Maximum daily dose

  • <12 years: Not to exceed 5 doses/24 hr
  • ≥12 years: Not to exceed 4 g/day

 

Administration

Patient should lie on left side with knees bent

Remove protective wrap before inserting

Gently insert tip into rectum with slight side-to-side movement (tip of suppository pointing toward navel)

 

Acephen, FeverAll (acetaminophen rectal) adverse (side) effects

Frequency not defined

Pruritic maculopapular rash

Urticaria

Rectal discomfort

Angioedema

Increase in bilirubin, alkaline phosphatase

Nephrotoxicity (chronic overdose)

Analgesic nephropathy

Decrease in chloride, glucose, uric acid

Laryngeal edema

Agranulocytosis

Decrease in bicarbonate, sodium, calcium

Leukopenia

Neutropenia

Pancytopenia

Thrombocytopenia

Thrombocytopenic purpura

Anaphylactoid reaction

 

Warnings

Contraindications

Hypersensitivity

 

Cautions

Acetaminophen is available in many dosage forms and products, check label carefully to avoid overdose

Risk of hepatotoxicity is higher in alcoholics, chronic high dose, or use of more than one acetaminophen-containing product

G6PD deficiency

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: B; Crosses placenta, safe to use in all stages of pregnancy short term

Lactation: Excreted in breast milk; compatible w/ breastfeeding

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 Acephen, FeverAll (acetaminophen rectal)

Mechanism of action

Inhibits prostaglandin synthesis in the CNS and works peripherally to block pain impulse generation; acts on hypothalamus to produce antipyresis

 

Pharmacokinetics

Onset: 1 hr

Duration: 4-6 hr (analgesia)

Half-life: 2.4 hr (adolescents); 2-3 hr (adults); 2-5 hr (children); 4-10 hr (neonates)

Plasma Time: 107-288 min

Peak Plasma Concentration: dose-dependent; (10 mg/kg) 5.5 mcg/mL, (20 mg/kg) 8.8 mcg/mL, (30 mg/kg) 14.2 mcg/mL

Protein Bound: 10-25% (therapeutic concentrations); 43% (toxic concentrations) 

Distribution: 1 L/kg

Metabolism: Liver (microsomal enzyme systems); conjugation (glucuronic/sulfuric acid)  

Metabolites: N-acetyl-p-benzoquinoneimine, N-acetylimidoquinone, NAPQI; further metabolized via conjugation with glutathione  

Excretion: <5% is excreted in the urine as unconjugated (free) acetaminophen and 60-80% as glucuronide metabolites

Hemodialysis: Yes