Dosing and uses of Sudafed PE Non-Drying Sinus Caplets (phenylephrine/guaifenesin)
Adult dosage forms and strengths
phenylephrine/guaifenesin
caplet
- 5mg/200mg
Congestion with Mucus
12 years and older: 10 mg/400 mg (2 caplets) PO q4h, up to 60 mg/2400 mg (12 caplets) in 24h
Other Information
Temporary relief of symptoms of upper respiratory tract disorders such as sinusitis, vasomotor rhinitis, and hay fever
Temporary relief of coughs associated with respiratory tract infections and related conditions such as sinusitis, pharyngitis, bronchitis, and asthma when tenacious mucus and/or mucus plugs and congestion complicate these conditions
Give with food if GI upset occurs
Pediatric dosage forms and strengths
<12 years: safety and efficacy not established
Sudafed PE Non-Drying Sinus Caplets (phenylephrine/guaifenesin) adverse (side) effects
Frequency not defined
Headache
Dizziness
Anxiety
Nervousness
Restlessness
Tremor
Weakness
Insomnia
Hallucinations
Convulsions
CNS depression
Tachycardia
Palpitations
Arrhythmias
Cardiovascular collapse with hypotension
Respiratory difficulty
Nausea
Dysuria
Pallor
Guaifenesin
- Headache
- Nausea
- Vomiting
- Rash
Warnings
Contraindications
Hypersensitivity to either component
Severe hypertension
Closed angle glaucoma
Cautions
Do not use as self-medication in chronic or persistent coughs
Pregnancy and lactation
Pregnancy category: C
Lactation: small amounts of phenylephrine excreted in breast milk, caution advised
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 Sudafed PE Non-Drying Sinus Caplets (phenylephrine/guaifenesin)
Half-Life
Phenylephrine: 2-3 hr
Guaifenesin: 1 hr
Onset
Phenylephrine: 10-15 min
Guaifenesin: 30 min
Duration
Guaifenesin: 4-6 hr
Metabolism
Phenylephrine: extensively in intestinal wall, moderately in liver
Guaifenesin: liver
Metabolites
Penylephrine: M-hydroxymandelic acid (inactive)
Guaifenesin: b-(2-methoxyphenoxy) lactic acid
Excretion
Phenylephrine: urine (80-90%)
Guaifenesin: urine
Mechanism of action
Phenylephrine: strong alpha effects resulting in increased PVR and BP and decreased COand renal perfusion
Guaifenesin: reduces viscosity of secretions by increasing amount of respiratory tract fluid
