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ibuprofen/phenylephrine (OTC)Brand and Other Names:Advil Congestion Relief

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

ibuprofen/phenylephrine

tablet

  • 200mg/10mg
more...

Allergy & Cold Symptoms

1 tab PO q4hr PRN while symptoms persist

Not to exceed 6 tablets/24 hr

Administration

Take with food or milk if stomach upset occurs

Dosage Forms & Strengths

ibuprofen/phenylephrine

tablet

  • 200mg/10mg
more...

Allergy & Cold Symptoms

<12 years: Safety and efficacy not established

>12 years: 1 tab PO q4hr PRN while symptoms persist; not to exceed 6 tablets/24 hr

Other information

Take with food or milk if stomach upset occurs

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Interactions

Interaction Checker

ibuprofen/phenylephrine and

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    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Adverse Effects

            Frequency Not Defined

            GI upset

            Insomnia

            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

            History of induce asthma or urticaria with NSAIDs

            Immediately before or after heart surgery

            Within 2 weeks of MAO inhibitor therapy

            Cautions

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

            Ibuprofen

            • May increase risk for GI ulceration
            • Caution in coadministration with antiplatelets/anticoagulants
            • May decrease benefit of cardioprotective low-dose aspirin

            Phenylephrine

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

            Pregnancy Category: C; D during third trimester

            Do not take NSAIDs within 3 months before delivery because of risk of 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 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

            Phenylephrine is a vasoconstrictor and decongestant that relieves symptoms resulting from irritation of upper respiratory tract tissue; shrinks swollen mucous membranes, reduces nasal congestion and tissue hyperemia

            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%)

            Phenylephrine

            • Half-life: 2-3 hr
            • Onset: 10-15 min
            • Duration: 15 min (IV); 1-2 hr (IM); 50 min (SC)
            • Bioavailability: < 38%
            • Excretion: Urine (80-90%)
            • Peak plasma time: 0.75-2 hr
            • Vd: 26-61 L
            • Vdss: 340 L
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