(feks oh FEN a deen)
Upper respiratory allergies: Temporary relief of runny nose, sneezing, itching of the nose or throat, and/or itchy, watery eyes due to hay fever or other upper respiratory allergies.
Canadian labeling: Additional use (not in US labeling): Treatment of chronic idiopathic urticaria.
OTC labeling: When used for self-medication do not use if you ever had an allergic reaction to fexofenadine or any component of the formulation.
Documentation of allergenic cross-reactivity for drugs antihistamines is limited. However, because of similarities in chemical structure and/or pharmacologic actions, the possibility of cross-sensitivity can not be ruled out with certainty.
Chronic idiopathic urticaria:Canadian labeling: Oral: 60 mg every 12 hours; maximum: 120 mg/day
Upper respiratory allergies (OTC labeling): Oral:
US labeling:
Twice daily formulations: 60 mg every 12 hours (maximum: 120 mg/day)
Once daily formulations: 180 mg once daily (maximum: 180 mg/day)
Canadian labeling:
Perennial allergic rhinitis: 60 mg every 12 hours; maximum: 120 mg/day
Seasonal allergic rhinitis: 60 mg every 12 hours or 120 mg once daily; maximum: 120 mg/day
Refer to adult dosing.
Chronic idiopathic urticaria:Canadian labeling: Children ≥12 years and Adolescents: Oral: Refer to adult dosing.
Upper respiratory allergies (OTC labeling): Oral:
US labeling:
Suspension:
Children 2 to 11 years: 30 mg (5 mL) every 12 hours; maximum: 60 mg/day
Children ≥12 years and Adolescents: 60 mg (10 mL) every 12 hours; maximum: 120 mg/day
Tablets:
Children 6 to 11 years: 30 mg every 12 hours; maximum: 60 mg/day
Children ≥12 years and Adolescents: Refer to adult dosing.
Canadian labeling: Children ≥12 years and Adolescents: Seasonal and perennial allergic rhinitis: Refer to adult dosing.
There are no dosage adjustment provided in manufacturer 's labeling; however, the following adjustments have been recommended (Aronoff 2007):
Adults:
GFR >50 mL/minute: No dosage adjustment necessary for twice daily dosing (ie, 60 mg every 12 hours).
GFR 10 to 50 mL/minute: Recommended dose every 12 to 24 hours.
GFR <10 mL/minute: Recommended dose every 24 hours.
Intermittent hemodialysis or peritoneal dialysis: Recommended dose every 24 hours.
Continuous renal replacement therapy (CRRT): 60 mg every 24 hours.
Infants, Children, and Adolescents:
GFR >50 mL/minute/1.73 m2: No dosage adjustment necessary.
GFR 10 to 50 mL/minute/1.73 m2: 60 mg every 24 hours.
GFR <10 mL/minute/1.73 m2: 30 mg every 24 hours.
Intermittent hemodialysis or peritoneal dialysis: 30 mg every 24 hours.
Canadian labeling:
CrCl ≤80 mL/minute: Initial: 60 mg once daily.
Hemodialysis: Not effectively removed by hemodialysis.
There are no dosage adjustments provided in the manufacturer 's labeling; however, dosage adjustment may not be necessary as moderate to severe impairment does not substantially affect fexofenadine pharmacokinetics.
Orally disintegrating tablet: Administer on an empty stomach. Remove tablet from individual blister and place immediately on tongue; tablet will disintegrate with or without water (do administer with fruit juices).
Oral suspension, tablet: Administer with water only; do not administer with fruit juices. Shake suspension well before use. Use suspension only with enclosed dosing cup.
Some products may contain phenylalanine and/or sodium. Take suspension and tablets with water only; do not administer with fruit juices.
US labeling: Store at 20 ‚ °C to 25 ‚ °C (68 ‚ °F to 77 ‚ °F). Use tablet immediately after opening individual blister.
Canadian labeling: Store at 15 ‚ °C to 30 ‚ °C (59 ‚ °F to 86 ‚ °F). Protect from moisture.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Oral, as hydrochloride:
Allegra Allergy Childrens: 30 mg/5 mL (240 mL) [alcohol free, dye free; contains butylparaben, edetate disodium, propylene glycol, propylparaben; berry flavor]
Allegra Allergy Childrens: 30 mg/5 mL (120 mL) [alcohol free, dye free; contains butylparaben, edetate disodium, propylene glycol, propylparaben; raspberry creme flavor]
Fexofenadine HCl Childrens: 30 mg/5 mL (118 mL) [alcohol free, dye free; contains butylparaben, edetate disodium, propylene glycol, propylparaben; berry flavor]
Tablet, Oral:
Allegra Allergy: 60 mg
Allegra Allergy: 180 mg [contains brilliant blue fcf (fd&c blue #1)]
Tablet, Oral, as hydrochloride:
Allegra Allergy: 60 mg, 180 mg
Allegra Allergy Childrens: 30 mg
Allergy 24-HR: 180 mg
Mucinex Allergy: 180 mg [contains fd&c red #40]
Generic: 60 mg, 180 mg
Tablet Dispersible, Oral, as hydrochloride:
Allegra Allergy Childrens: 30 mg [contains aspartame; orange cream flavor]
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy
Amphetamines: May diminish the sedative effect of Antihistamines. Monitor therapy
Analgesics (Opioid): Anticholinergic Agents may enhance the adverse/toxic effect of Analgesics (Opioid). Specifically, the risk for constipation and urinary retention may be increased with this combination. Monitor therapy
Antacids: May decrease the serum concentration of Fexofenadine. Management: No specific recommendations concerning the time required between their administration are provided. Separate administration of each agent by as much time as possible to decrease the risk of an interaction. Exceptions: Calcium Carbonate; Magaldrate; Sodium Bicarbonate. Consider therapy modification
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy
Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Avoid combination
Benzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Consider therapy modification
Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Monitor therapy
Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification
Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants. Consider therapy modification
Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Monitor therapy
Dimethindene: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Monitor therapy
Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification
Eltrombopag: May increase the serum concentration of OATP1B1/SLCO1B1 Substrates. Monitor therapy
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Erythromycin (Systemic): May increase the serum concentration of Fexofenadine. Monitor therapy
Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Gemfibrozil: May increase the serum concentration of OATP1B1/SLCO1B1 Substrates. See separate drug interaction monographs for agents listed as exceptions. Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
Grapefruit Juice: May decrease the serum concentration of Fexofenadine. Monitor therapy
Hyaluronidase: Antihistamines may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving antihistamines (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification
HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Consider starting with a 20% to 30% lower hydrocodone dose when using together with any other CNS depressant. Dose reductions in the other CNS depressant may also be warranted. Consider therapy modification
HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy
Itraconazole: May increase the serum concentration of Fexofenadine. Monitor therapy
Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy
Ketoconazole (Systemic): May increase the serum concentration of Fexofenadine. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
Lumacaftor: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. Lumacaftor may increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy
Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Consider therapy modification
MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy
Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Monitor therapy
Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: When oxycodone is combined with another CNS depressant, a dose reduction of one or both agents should be considered. The extended release oxycodone starting dose should be reduced 50% to 67% when initiated in patients already receiving CNS depressants. Consider therapy modification
Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Avoid combination
Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Consider therapy modification
P-glycoprotein/ABCB1 Inducers: May decrease the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inducers may also further limit the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy
P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. P-glycoprotein inhibitors may also enhance the distribution of p-glycoprotein substrates to specific cells/tissues/organs where p-glycoprotein is present in large amounts (e.g., brain, T-lymphocytes, testes, etc.). Monitor therapy
Piribedil [INT]: CNS Depressants may enhance the CNS depressant effect of Piribedil [INT]. Monitor therapy
Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Avoid combination
Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
Ranolazine: May increase the serum concentration of P-glycoprotein/ABCB1 Substrates. Monitor therapy
RifAMPin: May decrease the serum concentration of Fexofenadine. RifAMPin may increase the serum concentration of Fexofenadine. Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy
ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy
Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy
Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. Consider therapy modification
Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Monitor therapy
Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Consider therapy modification
Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Consider therapy modification
Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Start tapentadol at a dose of one-third to one-half of the normal dose if being initiated in a patient who is taking another drug with CNS depressant effects. Monitor closely for evidence of excessive CNS depression. Consider therapy modification
Teriflunomide: May increase the serum concentration of OATP1B1/SLCO1B1 Substrates. Monitor therapy
Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy
Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Verapamil: May increase the bioavailability of Fexofenadine. Monitor therapy
Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Consider therapy modification
Relief of symptoms
May suppress the wheal and flare reactions to skin test antigens.
>10%:
Central nervous system: Headache (5% to 11%)
Gastrointestinal: Vomiting (children 6 months to 5 years: 4% to 12%)
1% to 10%:
Central nervous system: Drowsiness (1% to 3%), fatigue (1% to 3%), dizziness (2%), pain (2%)
Gastrointestinal: Diarrhea (3% to 4%), nausea (2%), dyspepsia (1% to 2%)
Genitourinary: Dysmenorrhea (2%)
Infection: Viral infection (3%)
Neuromuscular & skeletal: Myalgia (3%), back pain (2% to 3%), limb pain (2%)
Otic: Otitis media (2% to 4%)
Respiratory: Upper respiratory tract infection (3% to 4%), cough (2% to 4%), rhinorrhea (1% to 2%)
Miscellaneous: Fever (2%)
<1% (Limited to important or life-threatening): Hypersensitivity reaction (including anaphylaxis, angioedema, chest tightness, dyspnea, flushing, pruritus, skin rash, urticaria), insomnia, nervousness, nightmares, sleep disorder
Mild to moderate impairment with CrCl 41 to 80 mL/minute has an 87% increase in Cmax . Severe impairment with CrCl 11 to 40 mL/minute has a 111% increase in Cmax .
Cmax is increased 99%.
Disease-related concerns:
- Renal impairment: Use with caution in patients with renal impairment; dosage adjustment may be recommended.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Dosage form specific issues:
- Orally disintegrating tablet: Some products may contain phenylalanine.
Other warnings/precautions:
- Appropriate use: Do not exceed recommended dosage; or administer at the same time with aluminum or magnesium antacids or with fruit juices.
Information related to the use of fexofenadine during pregnancy is limited.
Fexofenadine is an active metabolite of terfenadine and like terfenadine it competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels and respiratory tract; it appears that fexofenadine does not cross the blood-brain barrier to any appreciable degree, resulting in a reduced potential for sedation
Rapid
Minimal (Hepatic ~5%); 3.6% transformed into methylester metabolite found only in feces
Feces (80%) and urine (12%) as unchanged drug (Simons 2004)
2 hours (Simons 2004)
Serum: ODT: 2 hours (4 hours with high-fat meal); Tablet: ~2.6 hours (Simons 2004); Suspension: ~1 hour
24 hours (Simons 2004)
14.4 hours (59% longer in patients with mild to moderate renal impairment [CrCl 41 to 80 mL/minute]; 72% longer in patients with severe renal impairment [CrCl 11 to 40 mL/minute]) (Markham 1998; Simons 2004)
60% to 70% (Markham 1998); primarily albumin and alpha1-acid glycoprotein
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience headache (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.