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Fexofenadine and pseudoephedrine: Drug information

Fexofenadine and pseudoephedrine: Drug information
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For additional information see "Fexofenadine and pseudoephedrine: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Allegra-D Allergy & Congestion [OTC];
  • Antihistamine & Nasal Deconges [OTC] [DSC];
  • FT Allergy & Congestion-D 12HR [OTC]
Pharmacologic Category
  • Alpha-/Beta- Agonist;
  • Decongestant;
  • Histamine H1 Antagonist;
  • Histamine H1 Antagonist, Second Generation;
  • Piperidine Derivative
Dosing: Adult
Allergic rhinitis, seasonal

Allergic rhinitis, seasonal: Oral:

Fexofenadine 60 mg/pseudoephedrine 120 mg 12 Hour: One tablet twice daily.

Fexofenadine 180 mg/pseudoephedrine 240 mg 24 Hour: One tablet once daily.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Fexofenadine 60 mg/pseudoephedrine 120 mg 12 Hour:

CrCl ≥80 mL/minute: No dosage adjustment necessary.

CrCl <80 mL/minute: Initial: One tablet once daily.

Fexofenadine 180 mg/pseudoephedrine 240 mg 24 Hour: Avoid use.

Dosing: Liver Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric
Allergic rhinitis, seasonal

Allergic rhinitis, seasonal: Oral: Children ≥12 years and Adolescents: Refer to adult dosing.

Dosing: Kidney Impairment: Pediatric

Children ≥ 12 years and Adolescents:

Fexofenadine 60 mg/pseudoephedrine 120 mg 12 Hour:

CrCl ≥80 mL/minute: No dosage adjustment necessary.

CrCl <80 mL/minute: Initial: One tablet once daily.

Fexofenadine 180 mg/pseudoephedrine 240 mg 24 Hour: Avoid use.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling.

Adverse Reactions

See individual agents.

Contraindications

Hypersensitivity to fexofenadine, pseudoephedrine, adrenergic agents or other drugs of similar structure, or any component of the formulation; narrow-angle glaucoma; urinary retention; during or within 14 days of MAO inhibitor therapy; severe hypertension or coronary heart disease.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease); contraindicated in severe hypertension or coronary heart disease.

• Diabetes: Use with caution in patients with diabetes mellitus.

• Increased intraocular pressure: Use with caution in patients with increased intraocular pressure.

• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.

• Renal impairment: Use with caution in patients with renal impairment.

• Seizure disorder: Use with caution in patients with seizure disorder; may produce CNS stimulation.

• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Tablet Extended Release 12 Hour, Oral:

Allegra-D Allergy & Congestion: fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg

Antihistamine & Nasal Deconges: fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg [DSC] [contains corn starch]

FT Allergy & Congestion-D 12HR: fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg

Generic: fexofenadine hydrochloride 60 mg and pseudoephedrine hydrochloride 120 mg

Tablet Extended Release 24 Hour, Oral:

Allegra-D Allergy & Congestion: fexofenadine hydrochloride 180 mg and pseudoephedrine hydrochloride 240 mg [contains fd&c blue #1 (brill blue) aluminum lake]

Generic: fexofenadine hydrochloride 180 mg and pseudoephedrine hydrochloride 240 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablet, 12-hour (Allegra-D Allergy & Congestion Oral)

60-120 mg (per each): $1.38

Tablet, 12-hour (Fexofenadine-Pseudoephed ER Oral)

60-120 mg (per each): $0.72 - $0.87

Tablet, 24-hour (Allegra-D Allergy & Congestion Oral)

180-240 mg (per each): $2.12

Tablet, 24-hour (Fexofenadine-Pseudoephed ER Oral)

180-240 mg (per each): $0.88 - $1.13

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Administration: Adult

Tablets should be swallowed whole; do not crush or chew. Administer on an empty stomach with water; avoid administration with food. The inactive ingredients may be eliminated in the feces in a form resembling the original tablet.

Bariatric surgery: Tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Switch to separate IR components.

Administration: Pediatric

Oral: Tablets should be swallowed whole; do not crush or chew. Administer on an empty stomach with water; avoid administration with food. The inactive ingredients may be eliminated in the feces in a form resembling the original tablet.

Use: Labeled Indications

Seasonal allergic rhinitis: Relief of symptoms (eg, sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes, nasal congestion) associated with seasonal allergic rhinitis in patients ≥12 years.

Medication Safety Issues
Sound-alike/look-alike issues:

Allegra-D® may be confused with Viagra®

International issues:

Allegra-D [U.S, Canada, and multiple international markets] may be confused with Allegro brand name for fluticasone [Israel] and frovatriptan [Germany]

Metabolism/Transport Effects

Refer to individual components.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Alpha1-Blockers: May decrease therapeutic effects of Alpha-/Beta-Agonists. Risk C: Monitor

Amezinium: Antihistamines may increase stimulatory effects of Amezinium. Risk C: Monitor

Antacids: May decrease serum concentration of Fexofenadine. Management: Separate the administration of fexofenadine and aluminum- or magnesium-containing antacids. Risk D: Consider Therapy Modification

Atomoxetine: May increase hypertensive effects of Sympathomimetics. Atomoxetine may increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Benzylpenicilloyl Polylysine: Coadministration of Alpha-/Beta-Agonists and Benzylpenicilloyl Polylysine may alter diagnostic results. Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Risk D: Consider Therapy Modification

Benzylpenicilloyl Polylysine: Coadministration of Antihistamines and Benzylpenicilloyl Polylysine may alter diagnostic results. 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. Risk D: Consider Therapy Modification

Betahistine: Antihistamines may decrease therapeutic effects of Betahistine. Betahistine may decrease therapeutic effects of Antihistamines. Risk C: Monitor

Bornaprine: Sympathomimetics may increase anticholinergic effects of Bornaprine. Risk C: Monitor

Bromocriptine: May increase hypertensive effects of Alpha-/Beta-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider Therapy Modification

Cannabinoid-Containing Products: May increase tachycardic effects of Sympathomimetics. Risk C: Monitor

Certoparin: Antihistamines may increase therapeutic effects of Certoparin. Risk C: Monitor

Chloroprocaine (Systemic): May increase hypertensive effects of Alpha-/Beta-Agonists. Risk C: Monitor

Cocaine (Topical): May increase hypertensive effects of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider Therapy Modification

Dihydralazine: Sympathomimetics may decrease therapeutic effects of Dihydralazine. Risk C: Monitor

Doxofylline: Sympathomimetics may increase adverse/toxic effects of Doxofylline. Risk C: Monitor

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): May increase vasoconstricting effects of Alpha-/Beta-Agonists. Risk X: Avoid

Esketamine (Injection): May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for elevated heart rate, hypertension, and arrhythmias may be increased. Risk C: Monitor

FentaNYL: Decongestants may decrease serum concentration of FentaNYL. Risk C: Monitor

Grapefruit Juice: May decrease serum concentration of Fexofenadine. Risk C: Monitor

Guanethidine: May increase hypertensive effects of Sympathomimetics. Guanethidine may increase arrhythmogenic effects of Sympathomimetics. Risk C: Monitor

Hexoprenaline: May increase adverse/toxic effects of Alpha-/Beta-Agonists. Risk X: Avoid

Hyaluronidase: Antihistamines may decrease therapeutic effects of Hyaluronidase. Risk C: Monitor

Iobenguane Radiopharmaceutical Products: Alpha-/Beta-Agonists (Indirect-Acting) may decrease therapeutic effects of Iobenguane Radiopharmaceutical Products. Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid

Kratom: May increase adverse/toxic effects of Sympathomimetics. Risk X: Avoid

Landiolol: Sympathomimetics may decrease therapeutic effects of Landiolol. Risk C: Monitor

Levothyroxine: May increase therapeutic effects of Sympathomimetics. Sympathomimetics may increase therapeutic effects of Levothyroxine. Levothyroxine may increase adverse/toxic effects of Sympathomimetics. Specifically, the risk of coronary insufficiency may be increased in patients with coronary artery disease. Risk C: Monitor

Linezolid: May increase hypertensive effects of Sympathomimetics. Management: Consider initial dose reductions of sympathomimetic agents, and closely monitor for enhanced blood pressure elevations, in patients receiving linezolid. Risk D: Consider Therapy Modification

Lisuride: May increase hypertensive effects of Alpha-/Beta-Agonists. Risk X: Avoid

Metergoline: May increase adverse/toxic effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor

Monoamine Oxidase Inhibitors: May increase hypertensive effects of Alpha-/Beta-Agonists (Indirect-Acting). While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors. Refer to linezolid specific monographs for details. Risk X: Avoid

P-glycoprotein/ABCB1 Inducers: May decrease serum concentration of Fexofenadine. Risk C: Monitor

Pergolide: May increase hypertensive effects of Alpha-/Beta-Agonists. Risk C: Monitor

Pitolisant: Antihistamines may decrease therapeutic effects of Pitolisant. Risk X: Avoid

Reserpine: May decrease therapeutic effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor

RifAMPin: May decrease serum concentration of Fexofenadine. RifAMPin may increase serum concentration of Fexofenadine. Risk C: Monitor

Serotonin/Norepinephrine Reuptake Inhibitor: May increase tachycardic effects of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitor may increase vasopressor effects of Alpha-/Beta-Agonists. Management: If possible, avoid coadministration of direct-acting alpha-/beta-agonists and serotonin/norepinephrine reuptake inhibitors. If coadministered, monitor for increased sympathomimetic effects (eg, increased blood pressure, chest pain, headache). Risk D: Consider Therapy Modification

Solriamfetol: Sympathomimetics may increase hypertensive effects of Solriamfetol. Sympathomimetics may increase tachycardic effects of Solriamfetol. Risk C: Monitor

Spironolactone: May decrease vasoconstricting effects of Alpha-/Beta-Agonists. Risk C: Monitor

Sympathomimetics: May increase adverse/toxic effects of Sympathomimetics. Risk C: Monitor

Tedizolid: May increase adverse/toxic effects of Sympathomimetics. Specifically, the risk for increased blood pressure and heart rate may be increased. Risk C: Monitor

Tranylcypromine: May increase hypertensive effects of Alpha-/Beta-Agonists (Indirect-Acting). Risk X: Avoid

Tricyclic Antidepressants: May increase vasopressor effects of Alpha-/Beta-Agonists. Management: Avoid, if possible, the use of alpha-/beta-agonists in patients receiving tricyclic antidepressants. If combined, monitor for evidence of increased pressor effects and consider reductions in initial dosages of the alpha-/beta-agonist. Risk D: Consider Therapy Modification

Food Interactions

See individual agents.

Pregnancy Considerations

Adverse events have been observed in animal reproduction studies using this combination. Refer to individual monographs.

Breastfeeding Considerations

Pseudoephedrine is present in breast milk; it is not known if fexofenadine is present in breast milk. The manufacturer recommends that caution be exercised when administering fexofenadine/pseudoephedrine to breastfeeding women. Refer to individual monographs.

Dietary Considerations

Doses should be administered on an empty stomach with water.

Mechanism of Action

Fexofenadine: Competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract.

Pseudoephedrine: Directly stimulates alpha-adrenergic receptors of respiratory mucosa causing vasoconstriction; directly stimulates beta-adrenergic receptors causing bronchial relaxation.

Pharmacokinetics (Adult Data Unless Noted)

See individual agents.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AR) Argentina: Allegra d;
  • (BD) Bangladesh: Fixal plus;
  • (BR) Brazil: Allegra d | Allexofedrin d;
  • (DO) Dominican Republic: Allegra d;
  • (EC) Ecuador: Allegra d;
  • (HK) Hong Kong: Telfast d;
  • (ID) Indonesia: Telfast plus;
  • (JP) Japan: Dellegra;
  • (KE) Kenya: Fexet d;
  • (KR) Korea, Republic of: Allegra d;
  • (MX) Mexico: Allegra d;
  • (MY) Malaysia: Altiva d | Telfast d;
  • (PE) Peru: Allegra d;
  • (PK) Pakistan: Fendina d | Fexet d | Fexo-D | Sizzle d | Telfast d | Telfex D | Xadine plus;
  • (PR) Puerto Rico: Allegra D 12hr | Allegra D 24 Hour | Allegra-D 12 Hour | Fexofenadine Hcl and Pseudoephedrine Hbr | Fexofenadine Hcl and Pseudoephedrine Hcl;
  • (PY) Paraguay: Alermid plus | Allegra d | Restaler d;
  • (QA) Qatar: Telfast-D;
  • (SG) Singapore: Telfast d;
  • (TW) Taiwan: Vantydin 12 hour SR;
  • (UY) Uruguay: Allegra d;
  • (VE) Venezuela, Bolivarian Republic of: Allegra d | Rinolast d
  1. Allegra-D (fexofenadine/pseudoephedrine HCl) [product monograph]. Laval, Quebec, Canada: Sanofi-Aventis Canada Inc; January 2017.
  2. Allegra-D 12 Hour (fexofenadine/pseudoephedrine HCl) [prescribing information]. Chattanooga, TN: Chattem, Inc; received April 2020.
  3. Allegra-D 24 Hour (fexofenadine/pseudoephedrine HCl) [prescribing information]. Chattanooga, TN: Chattem, Inc; received April 2020.
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