Classes
DEA Class; OTC
Common Brand Names; Allegra D, Allegra-D 12 Hour Allergy & Congestion, Allegra-D 24 Hour Allergy & Congestion
- Antihistamine/Decongestant Combos
Description
Oral non-sedating antihistamine and sympathomimetic decongestant combination
Used to relieve symptoms of allergic rhinitis in adults and children 12 years of age and older
Available without a prescription
Indications
Indicated for the temporary relief of symptoms due to seasonal allergic rhinitis or the common cold, including sneezing, rhinorrhea, itching of the nose or throat, nasal congestion, and itchy, watery eyes.
Contraindications
Documented hypersensitivity to drug or ingredients
Premature newborns and neonates
Narrow-angle glaucoma
Urinary retention
Within fourteen (14) days of taking monoamine oxidase inhibitor
Severe hypertension or severe coronary artery disease
Adverse Effects
- Headache (7.2%)
- Vomiting (8%)
- Drowsiness (1.3%)
- Fatigue (1.3%)
- Somnolence (1.5%)
- Dizziness (2%)
- Diarrhea (3%)
- Otitis media (2.5%)
- Dyspepsia (1.2%)
- Myalgia (3%)
- CNS depression
- Sedation ranging from mild drowsiness to deep sleep (most frequent)
- Lassitude
- Disturbed coordination
- Muscular weakness
- Restlessness, euphoria, nervousness, delirium, palpitation, seizures is less common
- Epigastric distress
- Anorexia
- Nausea
- Vomiting
- Diarrhea
- Constipation
Warnings
Administer lower initial dose (one tablet per day) to patients with decreased renal function; they have reduced elimination of fexofenadine and pseudoephedrine
Patients should be instructed to take medication only as prescribed; do not exceed recommended dose; if nervousness, dizziness, or sleeplessness occur, discontinue use and consult doctor
Patients should be advised against concurrent use of this drug with over-the-counter antihistamines and decongestants
Patients should also be instructed to store the medication in a tightly closed container in a cool, dry place, away from children
Patients should be told that the inactive ingredients may occasionally be eliminated in the feces in a form that may resemble the original tablet
Giving with fruit juice may decrease efficacy
Pregnancy and Lactation
There are no adequate and well-controlled studies on pregnant women; the drug combination should be used during pregnancy only if potential benefit justifies potential risk to fetus
Not known if fexofenadine is excreted in human milk; because many drugs are excreted in human milk, use caution when fexofenadine hydrochloride is administered to a nursing woman; pseudoephedrine hydrochloride administered alone distributes into breast milk of lactating human females
Maximum Dosage
180 mg/day PO fexofenadine; 240 mg/day PO pseudoephedrine.
180 mg/day PO fexofenadine; 240 mg/day PO pseudoephedrine.
180 mg/day PO fexofenadine; 240 mg/day PO pseudoephedrine.
12 years: 180 mg/day PO fexofenadine; 240 mg/day PO pseudoephedrine.
Less than 12 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Pseudoephedrine/fexofenadine
tablet, extended-release 12 hr
- 120mg/60mg
tablet, extented-release 24 hr
- 240mg/180mg
