pseudoephedrine/fexofenadine (Allegra D, Allegra-D 12 Hour Allergy and Congestion, Allegra-D 24 Hour Allergy and Congestion)
Classes: Antihistamine/Decongestant Combos
Dosing and uses of Allegra D (pseudoephedrine-fexofenadine)
Adult dosage forms and strengths
pseudoephedrine/fexofenadine
tablet, extended-release 12 hr
- 120mg/60mg
tablet, extented-release 24 hr
- 240mg/180mg
Seasonal Allergic Rhinitis with Nasal Congestion
12-Hour tab: 1 tab 60 mg fexofenadine/120 mg pseudoephedrine PO BId
24-Hour tab: 1 tab 180 mg fexofenadine/240 mg pseudoephedrine PO qDay
Renal Impairment
Avoid
Other Information
Take on empty stomach with water only
Swallow whole; do not chew, crush, or split tablet
Pediatric dosage forms and strengths
pseudoephedrine/fexofenadine
tablet, extended-release 12 hr
- 120mg/60mg
tablet, extended-release 24 hr
- 240mg/180mg
Seasonal Allergic Rhinitis with Nasal Congestion
<12 years: Safety and efficacy not established
12 years or older: As adults
12-Hour tab: 1 tab 60 mg fexofenadine/120 mg pseudoephedrine PO BId
24-Hour tab: 1 tab 180 mg fexofenadine/240 mg pseudoephedrine PO qDay
Renal Impairment
Avoid
Other Information
Take on empty stomach with water only
Swallow whole; do not chew, crush, or split tablet
Allegra D (pseudoephedrine-fexofenadine) adverse (side) effects
Varies in incidence & severity with the individual drug; also individual patients vary in susceptibility
1-10%
Headache (7.2%)
Drowsiness (1.3%)
Fatigue (1.3%)
Frequency not defined
CNS depression
Sedation ranging from mild drowsiness to deep sleep (most frequent)
Dizziness
Lassitude
Disturbed coordination
Muscular weakness
Restlessness, insomnia, tremors, euphoria, nervousness, delirium, palpitation, seizures is less common
Epigastric distress
Anorexia
Nausea
Vomiting
Diarrhea
Constipation
Cholestasis, hepatitis, hepatic failure, hepatic function abnormality, jaundice is rare
Tachycardia, palpitation ECG changes (eg, widened QRS)
Arrhythmias (eg, extrasystole, heart block)
Hypotension
Hypertension
Dizziness, sedation, and hypotension may occur in geriatric patients
Dryness of mouth, nose, and throat
Dysuria
Urinary retention
Impotence
Vertigo
Visual disturbances
Blurred vision
Diplopia; tinnitus
Acute labyrinthitis
Insomnia
Tremors
Nervousness
Irritability
Facial dyskinesia
Tightness of the chest
Thickening of bronchial secretions
Wheezing
Nasal stuffiness
Sweating
Chills
Early menses
Toxic psychosis
Faintness
Paresthesia
Agranulocytosis
Hemolytic anemia
Leukopenia
Thrombocytopenia
Pancytopenia
Dysmenorrhea
Dyspepsia
Fatigue
Ischemic colitis (pseudoephedrine)
Warnings
Contraindications
Documented hypersensitivity to drug or ingredients
Premature newborns and neonates
Nursing women
Cautions
Wax from external release pseudoephedrine may appear in stooL
Caution in narrow angle glaucoma, prostatic hypertrophy, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder neck obstruction
Severe renal impairment
Giving with fruit juice may decrease efficacy
Pregnancy and lactation
Pregnancy category: C
Lactation: avoid, not known if enters breast milk
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Allegra D (pseudoephedrine-fexofenadine)
Mechanism of action
Fexofenadine: H1 histamine receptor antagonist; metabolite of terfenadine
Pseudoephedrine: Alpha adrenergic agonist
