diphenhydramine/ibuprofen (OTC)

Brand and Other Names:Advil PM
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

diphenhydramine/ibuprofen

caplet

  • 25mg/200mg
  • 38mg/200mg
more...

Pain

Indicated for occasional sleeplessness when associated with mild-to-moderate pain; includes mild sedative ingredient (diphenhydramine)

2 caplets PO at bedtime; not to exceed 2 caplets/24 hr

Dosage Forms & Strengths

diphenhydramine/ibuprofen

caplet

  • 25mg/200mg
  • 38mg/200mg
more...

Pain

Indicated for occasional sleeplessness when associated with mild-to-moderate pain; includes mild sedative ingredient (diphenhydramine)

<12 years: Safety and efficacy not established

>12 years: 2 caplets PO at bedtime; not to exceed 2 caplets/24 hr

Diphenhydramine considered a high risk medication for the elderly as it may increase the risk of falls

Not recommended as sleep aid for elderly individuals

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Interactions

Interaction Checker

and diphenhydramine/ibuprofen

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            Adverse Effects

            Frequency Not Defined

            Diphenhydramine

            • Sedation
            • Confusion
            • Anticholinergic effects
            • May decrease cognitive function in geriatric patients
            • Xerostomia
            • Pharyngeal and nasal mucosa dryness
            • Thick sputum

            Ibuprofen

            • Nausea
            • Vomiting
            • Epigastric pain
            • Rash
            • Edema
            • Tinnitus
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            Warnings

            Contraindications

            Hypersensitivity to NSAIDs or aspirin

            Active GI bleeding disorder

            Breastfeeding

            Cautions

            Asthma (bronchial), cardiac disease, CHF, hepatic/renal impairment, hypertension

            Avoid driving or operating machinery

            Coadministration with alcohol will increase sedation

            Diphenhydramine: Caution in narrow angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction

            Cardiovascular risk

            • NSAIDs may increase risk of serious cardiovascular thrombotic events, myocardial infarction (MI), & stroke, which can be fatal
            • Risk may increase with duration of use
            • Patients with risk factors for or existing cardiovascular disease may be at greater risk
            • NSAIDs are contraindicated for perioperative pain in the setting of coronary artery bypass graft (CABG) surgery (increased risk of MI & stroke)

            Gastrointestinal risk

            • NSAIDs increase risk of serious GI adverse events including bleeding, ulceration, & perforation of the stomach or intestines, which can be fatal
            • GI adverse events may occur at any time during use & without warning symptoms
            • Elderly patients are at greater risk for serious GI events
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            Pregnancy & Lactation

            Pregnancy Category

            Diphenhydramine: B

            Ibuprofen: C; D from 30 weeks of gestation onward (may cause premature closure of the ductus arteriosus)

            The Quebec Pregnancy Registry identified 4705 women who had spontaneous abortions by 20 weeks' gestation; each case was matched to 10 control subjects (n=47,050) who had not had spontaneous abortions; exposure to nonaspirin NSAIDs during pregnancy was documented in approximately 7.5% of cases of spontaneous abortions and in approximately 2.6% of controls. (CMAJ, September 6, 2011; DOI:10.1503/cmaj.110454)

            Lactation

            Diphenhydramine: Enters breast milk; may decrease breast milk production; contraindicated with breast feeding

            Ibuprofen: Excreted into breast milk; not recommended (AAP Committee states "compatible with nursing")

            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.

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            Pharmacology

            Mechanism of Action

            Diphenhydramine: Histamine H1-receptor antagonist with low-to-moderate antihistamine properties and moderate-to-high anticholinergic/antiemetic properties

            Ibuprofen: Inhibits synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase; at least 2 isoenzymes, cyclooxygenase-1 (COX-1) & -2 (COX-2)

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