ibuprofen/pseudoephedrine (OTC)

Brand and Other Names:Advil Cold and Sinus
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ibuprofen/pseudoephedrine

caplet

  • 200mg/30mg

liquid gel capsule

  • 200mg/30mg
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Cold Symptoms

1 caplet/capsule PO q4-6hr PRN; may increase to 2 caplets/capsules q4-6hr if necessary while symptoms persist

Not to exceed 6 doses/24 hr

Administration

Take with food or milk if stomach upset occurs

Dosage Forms & Strengths

ibuprofen/pseudoephedrine

caplet

  • 200mg/30mg

liquid gel capsule

  • 200mg/30mg
more...

Cold Symptoms

<12 years: Safety and efficacy not established

>12 years: 1 caplet/capsule PO q4-6hr PRN; may increase to 2 caplets/capsules q4-6hr if necessary while symptoms persist Not to exceed 6 doses/24 hr

Administration

Take with food or milk if stomach upset occurs

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Interactions

Interaction Checker

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            Adverse Effects

            Frequency Not Defined

            GI upset

            Insomnia

            Arrhythmia

            Palpitations

            Convulsion

            Dizziness

            Drowsiness

            Excitability

            Headache

            Tremor

            Weakness

            NauseaVomiting

            Hemolytic anemia

            Aplastic anemia

            Arrhythmia

            Bronchospasm

            CHF

            Efoliative dermatitis

            Constipation

            Hypertension

            Neutropenia

            Thromboembolism

            Abdominal pain

            Anxiety

            CNS stimulation

            Hepatotoxicity

            Dizziness

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            Warnings

            Contraindications

            Hypersensitivity

            Immediately before or after heart surgery

            History of induce asthma or urticaria with NSAIDs

            Do not use with MAO inhibitors or for 2 weeks after discontinuing MAO inhibitors because of risk for hypertensive crisis

            Cautions

            Caution with hypertension, heart disease, hepatic or renal impairment, asthma, thyroid disease, diabetes, BPH, peptic ulcer disease

            NSAID content

            • May increase risk for GI ulceration, increased risk if age >60 yr or history of PUD
            • Coadministration with antiplatelets/anticoagulants
            • May decrease benefit of cardioprotective low-dose aspirin

            Pseudoephedrine

            • May exacerbate poorly controlled hypertension
            • Caution if underlying cardiovascular risks present
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            Pregnancy & Lactation

            Pregnancy Category: C; D

            Do not take NSAIDs within 3 months before delivery because of risk for 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: NSAIDs and pseudoephedrine excreted in breast milk, AAP states compatible with breastfeeding

            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

            Ibuprofen: Inhibits synthesis of prostaglandins by inhibiting cyclooxygenase (COX-1, COX-2); may inhibit chemotaxis, alter lymphocyte activity, decrease proinflammatory cytoking activity, and inhibit neutrophil aggregation, which in turn may result in anti-inflammatory activity

            Pseudoephedrine stimulates the alpha-adrenergic receptors causing bronchodilation and vasoconstriction

            Pharmacokinetics

            Ibuprofen

            • Absoroption: Rapid (85%)
            • Bioavailability: 80-100%
            • Onset: 30-60 min
            • Duration: 4-6 hr
            • Peak plasma concentration: 20 mcg/mL (tab)
            • Protein bound: 90-99%
            • Vd: 0.12 L/kg (adults); 0.2 L/kg (children)
            • Peak plasma time: 120 min (tab)
            • Metabolism: Rapid hepatic oxidation to inactivate metabolites; CYP2C9; CYP2C19 substrate
            • Half-life: 2-4hr
            • Excretion: Urine (50-60%); feces (50-40%)

            Pseudoephedrine

            • Half-Life: 3 hr (children); 9-16 hr (adults)
            • Onset: 30 min (decongestant)
            • Duration: 3-8 hr  
            • Peak Plasma Time: 1.97 hr
            • Concentration: 422 ng/mL
            • Metabolism: Liver, by N-demethylation
            • Metabolites: Inactive
            • Clearance: 7.3-7.6 mL/min/kg
            • Excretion: Urine (43-96%)
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