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

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

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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