Classes
DEA Class; OTC
Common Brand Names; Alka-Seltzer PM, Bayer PM
Antitussives, Non-narcotic Combos
Description
Aspirin irreversibly blocks the COX pathway; Diphenhydramine: May cause significant confusional symptoms; not for administration to premature or full-term neonates.
Is used for the temporary Relief of Headache & Aches with Accompanying Sleeplessness
Uses/Indications
Indicated for temporary Relief of Headache & Aches with Accompanying Sleeplessness
Contraindications
Hypersensitivity
Liver damage
Hypoprothrombinemia
Vitamin K deficiency
Bleeding disorders
Asthma
Due to association of aspirin w/ Reye syndrome, do not use in children (<16 y) with viral infections
Use within 14 days of MAO inhibitor therapy
Narrow-angle glaucoma
Symptomatic prostate hypertrophy
Bladder-neck obstruction
Adverse Effects
Hypotension
Tachycardia
Agitation
Cerebral edema
Coma
Confusion
Dizziness
Headache
Subdural or intracranial hemorrhage
Lethargy
Hives
Rash May potential peptic ulcer & cause stomach distress or heartburn
Dyspepsia
GI bleeding
Ulceration & perforation
Nausea
Vomiting
Warnings
Aspirin: May cause transient decrease in renal function and aggravate chronic kidney disease; avoid use in patients with severe anemia, history of blood coagulation defects, or taking anticoagulants
Diphenhydramine: May cause significant confusional symptoms; not for administration to premature or full-term neonates
Pregnancy and Lactation
Pregnancy category: D, avoid aspirin during pregnancy, especially during third trimester (risk for premature closure of ductus arteriosus)
Lactation: excreted in breast milk; do not breast feed
Pregnant or breastfeeding patients should seek advice of health professional before using OTC drugs
Maximum Dosage
Adults
2 caplets PO qHS with water PRN
Pediatric
<12 years
Not recommended
>12 years
2 tablets PO qHS with water PRN
How supplied
Caplet
500mg/38.3mg