Adult Dosing

Allergic rhinitis

• 1 tab (fexofenadine 60 mg/pseudoephedrine 120 mg) PO bid or 1 tab (fexofenadine 180 mg/pseudoephedrine 240 mg) PO daily
• Note: Do not crush or chew the tablet

Pediatric Dosing

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

Allergic rhinitis (>12 yrs)

• 1 tab (fexofenadine 60 mg/pseudoephedrine 120 mg) PO bid or 1 tab (fexofenadine 180 mg/pseudoephedrine 240) mg PO daily
• Note: Do not crush or chew the tablet

[Outline]

• Adult Dosing
• Pediatric Dosing

• Relief of symptoms associated with seasonal allergic rhinitis

• Hypersensitivity to any of the ingredients of the product
• Narrow-angle glaucoma
• Urinary retention
• Monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment
• Severe hypertension
• Severe coronary artery disease

• N/A

Renal Dose Adjustment

• Fexofenadine 60 mg/pseudoephedrine 120 mg
• Renal impairment: Start with 1 tab PO daily

• Fexofenadine 180 mg/pseudoephedrine 240 mg
• Renal impairment: Avoid use

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 can occur with sympathomimetic amines
• Administer lower initial dose of patients with decreased renal function because they have reduced elimination of fexofenadine and pseudoephedrine
• Fexofenadine/pseudoephedrine can cause nervousness, dizziness, or sleeplessness, discontinue the treatment if such symptoms occurs

Cautions: Use cautiously in

• Renal impairment
• Hypertension
• Diabetes mellitus
• Ischemic heart disease
• Increased intraocular pressure
• Hyperthyroidism
• Prostatic hypertrophy

Supplemental Patient Information

• Patients should be instructed not to use other over-the-counter antihistamines and decongestants along with fexofenadine/pseudoephedrine

Pregnancy Category:C

Breastfeeding: Fexofenadine is not expected to cause any adverse effects in breastfed infants due to its lack of sedation and low milk levels; however causes negative effect on lactation especially in combination with a sympathomimetic agent such as pseudoephedrine. Small amounts of pseudoephedrine in breastmilk are unlikely to harm the nursing infant, however may cause irritability occasionally. Acute decrease in milk production can occur with a single dose of pseudoephedrine and repeated doses may interfere with lactation. Therefore mothers of newborns whose lactation is not yet well established or 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 16 February 2011). Manufacturer advises caution.

• CNS: Headache, CNS stimulation, nervousness, excitability, restlessness, dizziness, weakness, or insomnia, drowsiness, pressor activity, fear, anxiety, tenseness, tremor, hallucinations, seizures
• CV: Tachycardia, palpitation, cardiac arrhythmias, cardiovascular collapse. hypertension
• RESP: URTI, respiratory difficulty
• MUSC: Back pain
• GI: Ischemic colitis
• GU: Dysuria
• MISC: Pallor

Fexofenadine

• Antihistamine; blocks the action of endogenous histamine by binding at H1-receptors in the GI tract, large blood vessels, and bronchial smooth muscle thereby leading to temporary relief of the negative symptoms
• 5% of the total dose is metabolized by liver, CYP450: 3A4 substrate
• Excreted in feces 80%, urine 11%
• Half-life: 14.4 hrs

Pseudoephedrine

• Sympathomimetic amine; acts as nasal decongestant, acts on both alpha- and beta-adrenergic receptors thereby producing vasoconstriction and relaxation of bronchial smooth muscles
• Readily and almost completely absorbed from the GI tract
• Metabolized by liver
• Renally excreted (55-75% unchanged)
• Half-life: 4-6 hrs

US Trade Name(s)

• Allegra-D 12 hour
• Allegra-D 24 hour

US Availability

fexofenadine/pseudoephedrine (generic)

• ETABS
• 60 mg/120 mg
• 180 mg/240 mg

Allegra-D 12 hour (fexofenadine/pseudoephedrine)

• ETABS: 60 mg/120 mg

Allegra-D 24 hour (fexofenadine/pseudoephedrine)

• OTC ETABS: 180 mg/240 mg

Canadian Trade Name(s)

• Allegra D

Canadian Availability

Allegra-D (fexofenadine/pseudoephedrine)

• ETABS: 60 mg/120 mg

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• Telfast Decongestant

Australian Availability

Telfast Decongestant (fexofenadine/pseudoephedrine)

• TABS: 60 mg/120 mg

[Outline]

ENT

Upper Respiratory Combinations

Pulmonary

Upper Respiratory Combinations

Allergy/Cold

Antihistamine/Decongestant Combinations

ENT

Antihistamine/Decongestant Combinations

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

• Fexofenadine-Pseudoephedrine 180-240 MG TB24 [Bottle] (DR.REDDY'S LABORATORIES)
  INC. mg = $30
  mg = $90
• Allegra-D 12 Hour 60-120 MG TB12 [Bottle] (SANOFI-AVENTIS U.S.)
  30 mg = $81.57
  60 mg = $150.18

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.

• Allegra-D (fexofenadine 60 MG / pseudoephedrine 120 MG) 12 HR Extended Release Tablet (Caremark L.L.C.)
• Allegra-D (fexofenadine 60 MG / pseudoephedrine 120 MG) 12 HR Extended Release Tablet (sanofi-aventis U.S. LLC)
• Allegra-D 24 Hour (fexofenadine 180 MG / pseudoephedrine 240 MG) Extended Release Tablet (sanofi-aventis U.S. LLC)
• Fexofenadine 60 MG / pseudoephedrine 120 MG 12 HR Extended Release Tablet (Caremark L.L.C.)
• Fexofenadine 60 MG / pseudoephedrine 120 MG 12 HR Extended Release Tablet (TEVA PHARMACEUTICALS USA INC)
• Fexofenadine 60 MG / pseudoephedrine 120 MG 12 HR Extended Release Tablet (Winthrop U.S.)