Acrivastine and Pseudoephedrine
Pronunciation
(AK ri vas teen & soo doe e FED rin)
U.S. Brand Names
Semprex®-D
Synonyms
Pseudoephedrine and Acrivastine
Generic Available
No
Use
Temporary relief of nasal congestion, decongest sinus openings, running nose, itching of nose or throat, and itchy, watery eyes due to hay fever or other upper respiratory allergies
Pregnancy Risk Factor
B
Lactation
Enters breast milk/contraindicated
Contraindications
Hypersensitivity to pseudoephedrine, acrivastine (or other alkylamine antihistamines), or any component of the formulation; MAO inhibitor therapy within 14 days of initiating therapy; severe hypertension, severe coronary artery disease; renal impairment (Clcr
48 mL/minute)
Warnings/Precautions
Use with caution in patients >60 years of age; use with caution in patients with high blood pressure, ischemic heart disease, diabetes, increased intraocular pressure, GI or GU obstruction, asthma, thyroid disease, or prostatic hyperplasia; not recommended for use in children
Adverse Reactions
>10%: Central nervous system: Drowsiness, headache
1% to 10%:
Cardiovascular: Tachycardia, palpitation
Central nervous system: Nervousness, dizziness, insomnia, vertigo, lightheadedness, fatigue
Gastrointestinal: Nausea, vomiting, xerostomia, diarrhea
Genitourinary: Dysuria
Neuromuscular & skeletal: Weakness
Respiratory: Pharyngitis, cough increase
Miscellaneous: Diaphoresis
<1%: Dysmenorrhea, dyspepsia
Overdosage/Toxicology
Symptoms of overdose include trembling, tachycardia, stridor, loss of consciousness, and possible convulsions. There is no specific antidote for pseudoephedrine intoxication, and treatment is primarily supportive.
Drug Interactions
Decreased effect of guanethidine, reserpine, methyldopa, and beta-blockers
Increased toxicity with MAO inhibitors (hypertensive crisis), sympathomimetics, CNS depressants, ethanol (sedation)
Ethanol/Nutrition/Herb Interactions
Ethanol: Avoid ethanol (may increase sedation)
Mechanism of Action
Refer to Pseudoephedrine monograph; acrivastine is an analogue of triprolidine and it is considered to be relatively less sedating than traditional antihistamines; believed to involve competitive blockade of H1-receptor sites resulting in the inability of histamine to combine with its receptor sites and exert its usual effects on target cells
Pharmacodynamics/Kinetics
Pseudoephedrine:
See Pseudoephedrine monograph.
Acrivastine:
Metabolism: Minimally hepatic
Time to peak: ~1.1 hours
Excretion: Urine (84%); feces (13%)
Dosage
Oral: Adults: 1 capsule 3-4 times/day
Dosing comments in renal impairment:
Do not use
Patient Education
Take as directed; do not exceed recommended dose. Avoid use of other depressants, alcohol, or sleep-inducing medications unless approved by prescriber. You may experience drowsiness or dizziness (use caution when driving or engaging in hazardous activity until response to drug is known); or dry mouth, nausea, or vomiting (small, frequent meals, frequent mouth care, chewing gum, or sucking lozenges may help). Report persistent dizziness, sedation, or agitation; chest pain, rapid heartbeat, or palpitations; respiratory difficulty or increased cough; changes in urinary pattern; muscle weakness; or lack of improvement or worsening or condition.
Breast-feeding precaution:
Do not breast-feed.
Dental Health: Effects on Dental Treatment
Key adverse event(s) related to dental treatment: Pseudoephedrine: Xerostomia (normal salivary flow resumes upon discontinuation).
Dental Health: Vasoconstrictor/Local Anesthetic Precautions
Use with caution since pseudoephedrine is a sympathomimetic amine which could interact with epinephrine to cause a pressor response
Mental Health: Effects on Mental Status
Drowsiness is common; may produce anxiety and insomnia
Mental Health: Effects on Psychiatric Treatment
Hypertensive crisis may result with MAO inhibitor; effects of CNS depressants may be lessened
Dosage Forms
Capsule: Acrivastine 8 mg and pseudoephedrine hydrochloride 60 mg
References
Brogden RN and McTavish D, "Acrivastine: A Review of Its Pharmacological Properties and Therapeutic Efficacy in Allergic Rhinitis, Urticaria, and Related Disorders,"
Drugs
, 1991, 41(6):927-40.
Levien TL and Baker DE, "Reviews of Acrivastine and Midotrine,"
Hosp Pharm
, 1995, 30(3):229-35.
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