ibuprofen/pseudoephedrine (Advil Cold and Sinus)
Classes: Cough/Cold, Other Combos; Analgesic/Decongestant Combos
Dosing and uses of Advil Cold and Sinus (ibuprofen/pseudoephedrine)
Adult dosage forms and strengths
ibuprofen/pseudoephedrine
caplet
- 200mg/30mg
liquid gel capsule
- 200mg/30mg
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
Pediatric dosage forms and strengths
ibuprofen/pseudoephedrine
caplet
- 200mg/30mg
liquid gel capsule
- 200mg/30mg
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
Advil Cold and Sinus (ibuprofen/pseudoephedrine) adverse (side) 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
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
Pregnancy and 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.
Pharmacology of Advil Cold and Sinus (ibuprofen/pseudoephedrine)
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%)