Adult Dosing

Seasonal allergic rhinitis

• Usual dose: 1 capsule (acrivastine 8 mg/pseudoephedrine 60 mg) PO q4-6 hrs up to 4 times daily
• Max: 4 caps/day (acrivastine 32 mg/pseudoephedrine 240 mg)

Pediatric Dosing

Seasonal allergic rhinitis

Children >12 yrs

• Usual dose: 1 capsule (acrivastine 8 mg/pseudoephedrine 60 mg) PO q4-6 hrs up to 4 times daily
• Max: 4 caps/day (acrivastine 32 mg/pseudoephedrine 240 mg)

Note:

• Safety and effectiveness in pediatric patients <12 yrs of age have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relief of symptoms associated with seasonal allergic rhinitis such as sneezing, pruritus, rhinorrhea, lacrimation, and nasal congestion

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to other alkylamine antihistamines or other sympathomimetic amines
• Severe hypertension
• Severe coronary artery disease
• Concomitant use of monoamine oxidase (MAO) inhibitors or within 14 days of its use
• Urinary retention
• Angle-closure glaucoma
• PUD
• Acute asthma

• N/A

Renal Dose Adjustment (Based on CrCl)

• 48 mL/min: Not recommended

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

See Supplemental Patient Information

• Central nervous system stimulation with convulsions or cardiovascular collapse with accompanying hypotension may occur with overdose of sympathomimetic amines
• Patients should be warned against driving a vehicle or operating potentially dangerous machinery after taking acrivastine/pseudoephedrine as it can cause somnolence in some patients
• Acrivastine/pseudoephedrine should not be used concomitantly with alcohol or other CNS depressants, as it may cause additional reductions in alertness and impairment of CNS performance

Cautions: Use cautiously in

• Renal impairment
• Hepatic impairment
• Hypertension
• Diabetes mellitus
• Ischemic heart disease
• Increased intraocular pressure
• Hyperthyroidism
• Prostatic hypertrophy
• Stenosing peptic ulcer
• Pyloroduodenal obstruction
• Asthma
• High environmental temperature
• Elderly patients

Supplemental Patient Information

• Advise patients to avoid concurrent use of alcohol and other CNS depressants during treatment with acrivastine/pseudoephedrine, as it may lead to impairment of CNS performance
• Warn patients against driving a car or operating potentially dangerous machinery after taking acrivastine/pseudoephedrine

Pregnancy Category:B

Breastfeeding: Prolonged use or high doses of acrivastine may cause drowsiness and other effects in the infant or decrease the milk supply if used before lactation is well established or in combination with a sympathomimetic such as pseudoephedrine. Alternate nonsedating antihistamines are preferred. Small amounts of pseudoephedrine in breastmilk are unlikely to harm the nursing infant; however, it may cause irritability occasionally. A single dose of pseudoephedrine decreases milk production acutely and repeated use interferes with lactation. Mothers with newborns whose lactation is not well established or mothers who are having difficulties producing sufficient milk should not receive pseudoephedrine. This information is based upon Lactmed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 20 June 2011). Manufacturer recommends use in nursing mothers only when the potential benefit justifies the potential risks to the nursing infant.

• CNS: Somnolence, headache, dizziness, nervousness, insomnia
• CV: Severe hypertension, arrhythmias, palpitations, tachycardia
• GI: Dry mouth, dyspepsia, nausea
• RESP: Pharyngitis, increased cough
• GU: Dysmenorrhea

Acrivastine

• Antihistamine; non-selectively blocks histamines at central and peripheral H1 receptors
• Metabolized by liver
• Renally excreted 84% (67% unchanged); feces 13%
• Half-life:
• acrivastine: 3.5 +/- 1.9 hrs
• propionic acid metabolite: 3.8 +/- 1.4 hrs

Pseudoephedrine

• Nasal decongestant; acts on alpha-adrenergic receptors in the mucosa of the respiratory tract, producing vasoconstriction and reducing nasal congestion. Also, relaxes bronchial smooth muscle by stimulating beta2-adrenergic receptors
• Metabolized by liver
• Renally excreted (55-75% unchanged)
• Half-life: 9-16 hrs (depends on urine pH)

US Trade Name(s)

• Semprex-D

US Availability

Semprex-D (acrivastine/pseudoephedrine)

• CAPS: 8 mg/60 mg

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Benadryl Plus Capsules

UK Availability

Benadryl Plus Capsules (acrivastine/pseudoephedrine)

• CAPS: 8 mg/60 mg

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

ENT

Nasal Preparations

Antihistamines & Decongestants

Allergy & Immunology

Nasal Preparations

Antihistamines & Decongestants

Pricing data from www.DrugStore.com in U.S.A.

• Semprex-D 8-60 MG CAPS [Bottle] (ACTIENT PHARMACEUTICALS)
  30 mg = $76.27
  90 mg = $202.65

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Drug Name: Semprex-D (acrivastine 8 MG / pseudophedrine 60 MG) Oral Capsule

Ingredient(s): Acrivastine mixture with Pseudoephedrine

Imprint: 404;SEMPREX-D

Color(s): Green, White

Shape: Capsule

Size (mm): 16.00

Score: 1

Inactive Ingredient(s): lactose / magnesium stearate / sodium starch glycolate / gelatin / d&c yellow no. 10 / fd&c green no. 3 / titanium dioxide

Drug Label Author:
UCB, Inc.

DEA Schedule:
Non-Scheduled