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Fexofenadine

Pronunciation

Pronunciation

(feks oh FEN a deen)

Index Terms

  • Fexofenadine Hydrochloride

Dosage Forms

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]

Brand Names: U.S.

  • Allegra Allergy Childrens [OTC]
  • Allegra Allergy [OTC]
  • Allergy 24-HR [OTC]
  • Fexofenadine HCl Childrens [OTC]
  • Mucinex Allergy [OTC]

Pharmacologic Category

  • Histamine H1 Antagonist
  • Histamine H1 Antagonist, Second Generation
  • Piperidine Derivative

Pharmacology

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

Absorption

Rapid

Metabolism

Minimal (Hepatic ~5%); 3.6% transformed into methylester metabolite found only in feces

Excretion

Feces (80%) and urine (12%) as unchanged drug (Simons 2004)

Onset of Action

2 hours (Simons 2004)

Time to Peak

Serum: ODT: 2 hours (4 hours with high-fat meal); Tablet: ~2.6 hours (Simons 2004); Suspension: ~1 hour

Duration of Action

24 hours (Simons 2004)

Half-Life Elimination

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)

Protein Binding

60% to 70% (Markham 1998); primarily albumin and alpha1-acid glycoprotein

Special Populations: Renal Function Impairment

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 .

Special Populations: Elderly

Cmax is increased 99%.

Use: Labeled Indications

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.

Contraindications

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.

Dosing: Adult

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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.

Dosing: Renal Impairment

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.

Dosing: Hepatic Impairment

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.

Administration

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.

Dietary Considerations

Some products may contain phenylalanine and/or sodium. Take suspension and tablets with water only; do not administer with fruit juices.

Storage

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.

Drug Interactions

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

Test Interactions

May suppress the wheal and flare reactions to skin test antigens.

Adverse Reactions

>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

Warnings/Precautions

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.

Monitoring Parameters

Relief of symptoms

Pregnancy Considerations

Information related to the use of fexofenadine during pregnancy is limited.

Patient Education

• 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.

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