Acrivastine and pseudoephedrine

U.S. BRAND NAMES — Semprex®-D
PHARMACOLOGIC CATEGORY Antihistamine
DOSING: ADULTS — Rhinitis, nasal congestion, allergic symptoms: Oral: 1 capsule 3-4 times/day
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT — Do not use.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule: Acrivastine 8 mg and pseudoephedrine hydrochloride 60 mg
DOSAGE FORMS: CONCISE Capsule: Semprex®-D: Acrivastine 8 mg and pseudoephedrine 60 mg
GENERIC EQUIVALENT 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
ADVERSE REACTIONS SIGNIFICANT >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 increased Miscellaneous: Diaphoresis
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 Disease-related concerns: Asthma: Use with caution in patients with asthma. Cardiovascular disease: Use with caution in patients with high blood pressure and/or ischemic heart disease. Diabetes: Use with caution in patients with diabetes mellitus. GI obstruction: Use with caution in patients with GI obstruction. Increased intraocular pressure: Use with caution in patients with increased intraocular pressure. Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction. Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.
Special populations: Elderly: Use with caution in patients >60 years of age. Pediatrics: Not recommended for use in children.
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)
PREGNANCY RISK FACTOR — B (show table)
LACTATION — Enters breast milk/contraindicated
PRICING — (data from drugstore.com)Capsules (Semprex-D) 8-60 mg (30): $37.47
MECHANISM OF ACTION — Refer to Pseudoephedrine; 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.
Acrivastine: Metabolism: Minimally hepatic Time to peak: ~1.1 hours Excretion: Urine (84%); feces (13%)