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Pain-associated insomnia: Oral: Two caplets (1000 mg aspirin/77 mg diphenhydramine citrate) at bedtime if needed or as directed by physician; do not exceed recommended dosage Dosing: Pediatric Children ≥12 years: Refer to adult dosing. Dosing: Geriatric Refer to adult dosing. Dosage Forms: U.S. Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Caplet, oral: Bayer® PM: Aspirin 500 mg and diphenhydramine citrate 38.3 mg Generic Equivalent Available: U.S. No Administration Administer each dose with a full glass of water. Use Aid in the relief of insomnia accompanied by minor pain or headache Adverse Reactions Significant See individual agents. Contraindications Hypersensitivity to aspirin, other pain relievers or fever reducers; concurrent use of other products containing diphenhydramine (including topical); use in children <12 years of age; pregnancy (third trimester) Warnings/Precautions

Special populations: • Pediatrics: When used for self-medication (OTC labeling): Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use this product. Changes in behavior (along with nausea and vomiting) may be an early sign of Reye's syndrome; patients should be instructed to contact their healthcare provider if these occur.

Other warnings/precautions: • Self-medication (OTC use): Prior to self-medication, patients should contact healthcare provider if they have had recurring stomach pain or upset, ulcers, bleeding problems, asthma, emphysema, chronic bronchitis, glaucoma, enlarged prostate, other serious medical problems, on a sodium-restricted diet, are currently taking an anticoagulant, steroid, sedative, other nonsteroidal anti-inflammatory medications, or medicine for arthritis, diabetes, or gout. Recommended dosages should not be exceeded, due to an increased risk of GI bleeding. Stop use and consult a healthcare provider if symptoms get worse or new symptoms occur; if an allergic reaction occurs; if feeling faint, vomiting blood, having bloody or black stools, or having stomach pain which does not get better; if ringing in the ears or hearing loss occurs; if sleeplessness lasts for >2 weeks or if pain lasts >10 days. Consuming ≥3 alcoholic beverages/day or taking longer than recommended may increase the risk of GI bleeding. Metabolism/Transport Effects Refer to individual components. Drug Interactions (For additional information: Launch Lexi-Interact™ Drug Interactions Program ) Acetylcholinesterase Inhibitors (Central): Anticholinergics may diminish the therapeutic effect of Acetylcholinesterase Inhibitors (Central). Acetylcholinesterase Inhibitors (Central) may diminish the therapeutic effect of Anticholinergics. If the anticholinergic action is a side effect of the agent, the result may be beneficial. Risk C: Monitor therapy Aclidinium: May enhance the anticholinergic effect of Anticholinergics. Risk X: Avoid combination Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy Amphetamines: May diminish the sedative effect of Antihistamines. Risk C: Monitor therapy Anticholinergics: May enhance the adverse/toxic effect of other Anticholinergics.

Pramlintide: May enhance the anticholinergic effect of Anticholinergics. These effects are specific to the GI tract. Risk D: Consider therapy modification Propafenone: May increase the serum concentration of CYP2D6 Inhibitors (Moderate). Risk C: Monitor therapy ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Risk D: Consider therapy modification Tamoxifen: CYP2D6 Inhibitors (Moderate) may decrease serum concentrations of the active metabolite(s) of Tamoxifen. Specifically, CYP2D6 inhibitors may decrease the metabolic formation of highly potent active metabolites. Management: Consider alternatives with less of an inhibitory effect on CYP2D6 activity when possible. Risk D: Consider therapy modification Thioridazine: CYP2D6 Inhibitors may decrease the metabolism of Thioridazine. Risk X: Avoid combination Tiotropium: Anticholinergics may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination TraMADol: CYP2D6 Inhibitors (Moderate) may diminish the therapeutic effect of TraMADol. These CYP2D6 inhibitors may prevent the metabolic conversion of tramadol to its active metabolite that accounts for much of its opioid-like effects. Risk C: Monitor therapy Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification Ethanol/Nutrition/Herb Interactions Ethanol Avoid ethanol (may enhance gastric mucosal damage). Pregnancy Implications See individual agents. Lactation See individual agents. Breast-Feeding Considerations See individual agents.

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification Ethanol/Nutrition/Herb Interactions Ethanol Avoid ethanol (may enhance gastric mucosal damage). Pregnancy Implications See individual agents. Lactation See individual agents. Breast-Feeding Considerations See individual agents. Pharmacodynamics/Kinetics See individual agents. Use of UpToDate is subject to the Subscription and License Agreement . Topic 9016 Version 37.0 © 2013 UpToDate, Inc. All rights reserved. | Subscription and License Agreement | Release: 21.4 - C21.36 Licensed to: Southeast Alabama Med Ctr | Support Tag: [0603-61.234.146.186-B987512CC0-S244013.14]