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