Navigation

ibuprofen/phenylephrine (Advil Congestion Relief)

 

Classes: Cough/Cold, Other Combos; Analgesic/Decongestant Combos

Dosing and uses of Advil Congestion Relief (ibuprofen/phenylephrine)

 

Adult dosage forms and strengths

ibuprofen/phenylephrine

tablet

  • 200mg/10mg

 

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

 

Pediatric dosage forms and strengths

ibuprofen/phenylephrine

tablet

  • 200mg/10mg

 

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

 

Advil Congestion Relief (ibuprofen/phenylephrine) adverse (side) 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

 

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

 

Pregnancy and 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.

 

Pharmacology of Advil Congestion Relief (ibuprofen/phenylephrine)

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