Dosing and uses of Semprex-D (acrivastine/pseudoephedrine)
Adult dosage forms and strengths
acrivastine/pseudoephedrine
capsule
- 8mg/60mg
Seasonal Allergic Rhinitis
>12 years: 8 mg/60 mg (1 capsule) PO q4-6h QId
Efficacy for >14 days continuous treatment not adequately investigated
Renal Impairment
CrCl <48mL/min: not recommended
Other Indications & Uses
Not adequately studied for relieving common cold symptoms
Pediatric dosage forms and strengths
<12 years: Safety and efficacy not established
Semprex-D (acrivastine/pseudoephedrine) adverse (side) effects
1-10%
Somnolence
Nervousness
Insomnia
Dry mouth
<1%
Headache
Dizziness
Asthenia
Nausea
Dyspepsia
Pharyngitis
Cough increase
Dysmenorrhea
Postmarketing Reports
Rare serious hypersensitivity reactions manifested by anaphylaxis, angioedema, bronchospasm, and erythema multiforme
Pseudoephedrine
- Tachycardia
- Palpitations
Warnings
Contraindications
Hypersensitivity to acrivastine or other alkylamine antihistamines
Hypersensitivity to pseudoephedrine or other sympathomimetic amines
Severe hypertension
Severe coronary artery disease
Patients taking monoamine oxidase (MAO) inhibitors and for 14 days after stopping use of an MAO inhibitor
Cautions
Due to potential for sedation, assess individual responses before engaging in any activity requiring mental alertness, such as driving a motor vehicle or operating machinery
Concurrent use with alcohol or other CNS depressants may cause additional reductions in alertness and impairment of CNS performance and should be avoided
Pregnancy and lactation
Pregnancy category: B
Lactation: Unknown whether acrivastine is distributed in breast milk, caution advised ; pseudoephedrine is excreted in human 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 Semprex-D (acrivastine/pseudoephedrine)
Half-Life
acrivastine 1.9-3.5 hr; propionic acid metabolite 3.8 hrs
pseudoephedrine 5-8 hr
Absorption
Rapid and complete
Vd
acrivastine 0.46 L/kg
pseudoephedrine 3 L/kg
Peak Plasma Time
acrivastine 1.1 hr
pseudoephedrine 1.97 hr
Peak Plasma Concentration
acrivastine 227 ng/mL
pseudoephedrine 422 ng/mL
Protein Bound
acrivastine 50%
pseudoephedrine minimaL
Metabolism
acrivastine 11% to propionic acid metabolite
Clearance
acrivastine 2.9 mL/min/kg
pseudoephedrine 5.9 mL/min/kg
Excretion
acrivastine: feces (13%) urine (84%)
pseudoephedrine: 55-75% renal (dependent on urine pH)
Mechanism of action
Acrivastine exhibits H1-antihistaminic activity
Pseudoephedrine: indirect sympathomimetic agent, releases norepinephrine from adrenergic nerves
