Acrivastine / Pseudoephedrine Hydrochloride

Pronunciation: (ACK-rih-VASS-teen/SUE-doe-eh-FED-rin HIGH-droe-KLOR-ide)Class: Antihistamine, Decongestant

Trade Names:Semprex-D- Capsules 8 mg acrivastine/60 mg pseudoephedrine

Pharmacology

Acrivastine: Competitively blocks histamine at H ₂ receptor sites; pseudoephedrine: causes vasoconstriction and subsequent shrinkage of nasal mucous membranes by alpha-adrenergic stimulation, promoting nasal drainage.

Indications and Usage

Relief of symptoms associated with seasonal allergic rhinitis.

Contraindications

Hypersensitivity to any ingredient of product; known sensitivity to other alkylamine antihistamines (eg, triprolidine); patients with severe hypertension or coronary artery disease; MAOI therapy or within 14 days of stopping MAOI therapy.

Dosage and Administration

Adults and Children (12 yr of age or older)

PO 1 capsule (8 mg acrivastine/60 mg pseudoephedrine) every 4 to 6 h (up to 4 times daily).

Storage/Stability

Store capsules at controlled room temperature (59° to 86°F). Protect from light and moisture.

Drug Interactions

Acrivastine Alcohol; other CNS depressants

Additional decrease in alertness and impairment of CNS performance may occur.

Pseudoephedrine Antihypertensive agents that interfere with sympathetic activity (eg, mecamylamine, methyldopa, reserpine, veratrum alkaloids)

Antihypertensive effects of these agents may be reduced.

Digitalis

Increased ectopic pacemaker activity may occur.

MAOIs

Contraindicated in patients taking MAOIs and for 14 days after stopping use of an MAOI.

Laboratory Test Interactions

May diminish or prevent positive reactions to skin tests.

Adverse Reactions

Cardiovascular

Palpitations, tachycardia, pressor activity, cardiac arrhythmias, cardiovascular collapse (pseudoephedrine).

CNS

Somnolence; headache; dizziness; nervousness; insomnia.

EENT

Pharyngitis; increased cough.

GI

Nausea; dyspepsia.

Genitourinary

Dysmenorrhea.

Miscellaneous

Asthenia; hypersensitivity (anaphylaxis, angioedema, bronchospasm, erythema multiforme).

Precautions

Pregnancy

Category B .

Lactation

Acrivastine

Undetermined.

Pseudoephedrine

Excreted in breast milk.

Children

Safety and efficacy not established in children less than 12 yr of age.

Elderly

More likely to cause dizziness, sedation, bladder-neck obstruction, and hypertension.

Renal Function

Use is not recommended.

Special Risk Patients

Use with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, psoriatic hypertrophy, stenosing peptic ulcer, or pyloroduodenal obstruction.

Overdosage

Symptoms

Convulsions, CNS stimulation or depression, cardiovascular collapse with hypotension, fear, anxiety, tenseness, restlessness, tremor, weakness, pallor, respiratory difficulty, dysuria, insomnia, hallucinations, convulsions, arrhythmia.

Patient Information

• Advise patient to take every 4 to 6 h, up to 4 times daily, with a full glass of water.
• Advise patient to take last dose late in the afternoon or early in the evening to reduce chance of drug causing sleeplessness.
• Advise patient that if allergy symptoms are not controlled not to increase the dose of medication but to inform a health care provider.
• Caution patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
• Advise patient to avoid alcohol and other CNS depressants because of the risk of excessive sedation.
• Caution patient not to take any OTC antihistamines or decongestants while taking this medication unless advised by a health care provider.
• If patient is to have allergy skin testing, advise to not take the medication for at least 2 days before the skin testing.
• Instruct patient to stop taking drug and immediately report any of these symptoms to health care provider: nervousness, dizziness, sleeplessness.

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