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تعداد آیتم قابل مشاهده باقیمانده : 3 مورد

Fexofenadine: Pediatric drug information

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

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Allegra Allergy Childrens [OTC];
  • Allegra Allergy [OTC];
  • Allegra Hives 24HR [OTC];
  • Allergy 24-HR [OTC];
  • Allergy Childrens [OTC];
  • Allergy Relief [OTC];
  • Allergy Relief/Indoor/Outdoor [OTC];
  • FT Allergy Relief 12 Hour [OTC];
  • FT Allergy Relief 24 Hour [OTC];
  • FT Allergy Relief [OTC]
Therapeutic Category
  • Antihistamine
Dosing: Pediatric
Allergic symptoms/rhinitis

Allergic symptoms/rhinitis: Product-specific dosing:

Twice-daily formulations (eg, oral suspension, oral disintegrating tablet, regular tablet):

Oral suspension:

Infants ≥6 months and Children <2 years: Limited data available (Ref):

<10.5 kg: Oral: 15 mg every 12 hours.

≥10.5 kg: Oral: 30 mg every 12 hours.

Dosing based on a safety and tolerability study on patients with allergic rhinitis receiving fexofenadine 15 mg twice daily (weight <10.5 kg, n=85) and fexofenadine 30 mg twice daily (weight ≥10.5 kg, n=108) compared to placebo (n=199); adverse events were similar between fexofenadine and placebo (Ref).

Children ≥2 to <12 years: Oral: 30 mg every 12 hours; maximum daily dose: 60 mg/day.

Children ≥12 years and Adolescents: Oral: 60 mg every 12 hours; maximum daily dose: 120 mg/day.

Orally-disintegrating tablet (ODT):

Children ≥6 years to <12 years: Oral: 30 mg every 12 hours; maximum daily dose: 60 mg/day.

Children ≥12 years and Adolescents: Oral: 60 mg every 12 hours; maximum daily dose: 120 mg/day.

12-hour tablet: Children ≥12 years and Adolescents: Oral: 60 mg every 12 hours; maximum daily dose: 120 mg/day.

Once-daily formulation:

Children ≥12 years and Adolescents: Oral: 180 mg once daily.

Urticaria, acute

Urticaria, acute: Limited data available (Ref):

Children ≥6 to 11 years: Twice-daily formulations (eg, oral suspension, oral disintegrating tablet, regular tablet): Oral: 30 mg every 12 hours.

Children ≥12 years and Adolescents: Twice-daily formulations (eg, oral suspension, oral disintegrating tablet, regular tablet): Oral: 60 mg every 12 hours.

Urticaria, chronic spontaneous

Urticaria, chronic spontaneous: Limited data available: Note: Considered first-line therapy for management of chronic urticaria; if response inadequate after 2 to 4 weeks of therapy or symptoms intolerable, consider increasing the dose of fexofenadine (as age and weight permits) as second-line treatment rather than changing therapy (Ref).

Infants ≥6 months to Children <2 years: Twice-daily formulations (eg, oral suspension): Oral: 15 mg every 12 hours (Ref).

Children ≥2 to <12 years: Twice-daily formulations (eg, oral suspension, orally-disintegrating tablet, regular tablet): Oral: 30 mg twice daily (Ref).

Children ≥12 years and Adolescents:

Twice-daily formulations (eg, oral suspension, orally-disintegrating tablet, regular tablet): Oral: 60 mg every 12 hours (Ref).

Once-daily formulation: Oral: 180 mg once daily (Ref).

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: Pediatric

Twice-daily formulations (eg, oral suspension, oral disintegrating tablet, regular tablet):

There are no dosage adjustments provided in the OTC manufacturer's labeling; previous prescribing information (Ref) suggested the following

Infants ≥6 months to Children <2 years: Any degree of kidney impairment: Initial: 15 mg once daily.

Children 2 to 11 years: Any degree of kidney impairment: 30 mg once daily.

Children ≥12 years and Adolescents: Any degree of kidney impairment: 60 mg once daily.

Others have suggested the following: Children ≥12 years and Adolescents (Ref):

CrCl 10 to 50 mL/minute: 60 mg once daily.

CrCl <10 mL/minute: 30 mg once daily.

Hemodialysis: Not effectively removed by hemodialysis: 30 mg once daily.

Peritoneal dialysis: 30 mg once daily.

Once-daily formulation: There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Liver Impairment: Pediatric

There are no dosage adjustments provided in manufacturer's labeling.

Dosing: Adult

(For additional information see "Fexofenadine: Drug information")

Upper respiratory allergies

Upper respiratory allergies:

Twice-daily formulations: Oral: 60 mg every 12 hours (maximum: 120 mg/day).

Once-daily formulations: Oral: 180 mg once daily (maximum: 180 mg/day).

Urticaria, new onset and chronic spontaneous

Urticaria, new onset and chronic spontaneous (off-label use):

New onset: Oral: Initial: 180 mg once daily. If symptom control is inadequate, may immediately increase to 180 mg twice daily (Ref).

Chronic spontaneous: Oral: 180 mg once daily (Ref). If symptom control is inadequate, add a different second-generation antihistamine; higher doses of fexofenadine have not been shown to be more effective in controlling urticaria symptoms in most patients (Ref).

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

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Use of the once-daily formulation is not recommended in patients with eGFR <50 mL/minute/1.73 m2 or on renal replacement therapies (Ref).

Altered kidney function (Ref):

eGFR ≥50 mL/minute/1.73 m2: Oral: No dosage adjustment necessary.

eGFR 10 to <50 mL/minute/1.73 m2: Oral: 60 mg every 12 to 24 hours.

eGFR <10 mL/minute/1.73 m2: Oral: 60 mg every 24 hours. Note: Results of a pharmacokinetic study suggest that nonrenal clearance of fexofenadine is impaired in patients with end-stage kidney disease (ESKD) (Ref); monitor patients for signs and symptoms of drug accumulation and toxicity.

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2):

Note: Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Younger patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).

Oral: No dosage adjustment necessary (Ref).

Hemodialysis, intermittent (thrice weekly): Not dialyzable (Ref):

Oral: 60 mg every 24 hours (Ref).

Note: Results of a pharmacokinetic study suggest that nonrenal clearance of fexofenadine is impaired in patients with ESKD (Ref); monitor patients for signs and symptoms of drug accumulation and toxicity.

Peritoneal dialysis: Significant removal unlikely (large Vd) (Ref):

Oral: 60 mg every 24 hours (Ref).

Note: Results of a pharmacokinetic study suggest that nonrenal clearance of fexofenadine is impaired in patients with ESKD (Ref); monitor patients for signs and symptoms of drug accumulation and toxicity.

CRRT:

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) and minimal residual kidney function unless otherwise noted. Close monitoring of response and adverse reactions (eg, excess sedation) due to drug accumulation is important.

Oral: 60 mg every 24 hours (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration):

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Close monitoring of response and adverse reactions (eg, excess sedation) due to drug accumulation is important.

Oral: 60 mg every 24 hours (Ref).

Dosing: Liver Impairment: Adult

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

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%: Gastrointestinal: Vomiting (infants and children: 12%)

1% to 10%:

Gastrointestinal: Diarrhea (infants and children: 4%), stomach discomfort (adolescents and adults: 2%)

Genitourinary: Dysmenorrhea (adolescents and adults: 2%)

Nervous system: Dizziness (adolescents and adults: 2%), drowsiness (infants and children: ≤3%), fatigue (infants and children: ≤3%), headache (adolescents and adults: 5% to 10%)

Neuromuscular & skeletal: Back pain (adolescents and adults: 2% to 3%), limb pain (adolescents and adults: 2%)

Respiratory: Cough (children: 4%), rhinorrhea (infants and children: 2%), upper respiratory tract infection (children: 3%)

Miscellaneous: Fever (children: 2%)

Postmarketing (any population):

Dermatologic: Skin rash (Wahn 2003), Stevens-Johnson syndrome (Teo 2017), toxic epidermal necrolysis (Teo 2017)

Gastrointestinal: Dyspepsia (Meltzer 2004), nausea (Wahn 2003)

Hypersensitivity reaction: Anaphylaxis, angioedema, hypersensitivity reaction

Nervous system: Insomnia, nervousness, nightmares, sleep disorder

Respiratory: Epistaxis (Wahn 2003)

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.

Warnings/Precautions

Disease-related concerns:

• Renal impairment: Use with caution in patients with renal impairment; dosage adjustment may be recommended.

Dosage form specific issues:

• Orally disintegrating tablet: Some products may contain phenylalanine.

Other warnings/precautions:

• OTC labeling: When used for self-medication (OTC), do not exceed recommended dosage or administer at the same time with aluminum or magnesium antacids or with fruit juices.

Warnings: Additional Pediatric Considerations

Safety and efficacy for the use of cough and cold products in pediatric patients <4 years of age is limited; the AAP warns against the use of these products for respiratory illnesses in young children. Serious adverse effects including death have been reported. Many of these products contain multiple active ingredients, increasing the risk of accidental overdose when used with other products. The FDA does not recommend OTC uses for these products in pediatric patients <2 years of age and recommends to use with caution in pediatric patients ≥2 years of age. Health care providers are reminded to ask caregivers about the use of OTC cough and cold products in order to avoid exposure to multiple medications containing the same ingredient (AAP 2018; CDC 2007; FDA 2017; FDA 2018).

Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).

Dosage Forms: US

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

Suspension, Oral, as hydrochloride:

Allegra Allergy Childrens: 30 mg/5 mL (240 mL) [alcohol free, dye free; contains butylparaben, edetate (edta) disodium, propylene glycol, propylparaben; berry flavor]

Allegra Allergy Childrens: 30 mg/5 mL (120 mL) [alcohol free, dye free; contains butylparaben, edetate (edta) disodium, propylene glycol, propylparaben; raspberry creme flavor]

Allergy Childrens: 30 mg/5 mL (118 mL, 237 mL [DSC]) [alcohol free, dye free; contains butylparaben, edetate (edta) disodium, propylene glycol, propylparaben; berry flavor]

Tablet, Oral, as hydrochloride:

Allegra Allergy: 60 mg, 180 mg

Allegra Allergy: 180 mg [contains fd&c blue #1 (brilliant blue)]

Allegra Hives 24HR: 180 mg

Allergy 24-HR: 180 mg

Allergy Relief: 60 mg [contains corn starch]

Allergy Relief: 180 mg

Allergy Relief: 180 mg [contains corn starch]

Allergy Relief/Indoor/Outdoor: 180 mg [contains corn starch]

FT Allergy Relief: 180 mg

FT Allergy Relief 12 Hour: 60 mg [contains corn starch, fd&c red #40 (allura red ac dye)]

FT Allergy Relief 24 Hour: 180 mg

FT Allergy Relief 24 Hour: 180 mg [contains corn starch, fd&c red #40 (allura red ac dye)]

Generic: 60 mg, 180 mg

Tablet Disintegrating, Oral, as hydrochloride:

Allegra Allergy Childrens: 30 mg [dye free; contains aspartame; orange cream flavor]

Generic Equivalent Available: US

May be product dependent

Pricing: US

Suspension (Allegra Allergy Childrens Oral)

30 mg/5 mL (per mL): $0.13

Tablet, orally-disintegrating (Allegra Allergy Childrens Oral)

30 mg (per each): $1.26

Tablets (Allegra Allergy Oral)

60 mg (per each): $1.17

180 mg (per each): $0.95

Tablets (Allegra Hives 24HR Oral)

180 mg (per each): $1.88

Tablets (Fexofenadine HCl Oral)

60 mg (per each): $0.12 - $0.22

180 mg (per each): $0.27 - $0.59

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: Pediatric

Oral:

Twice-daily formulations:

Suspension, regular tablet: May administer without respect to food. Take with water; avoid administration with fruit juices; shake suspension well before use. Administer suspension with an accurate measuring device; do not use a household teaspoon.

Orally-disintegrating tablet: Administer on an empty stomach. Do not remove from blister pack until ready to administer. Using dry hands, place immediately on tongue. Tablet will dissolve within seconds and may be swallowed with or without liquid; avoid administering with fruit juices.

Once-daily formulation: Swallow whole with water; do not take with fruit juices.

Administration: Adult

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 not 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.

Storage/Stability

Store at 20°C to 25°C (68°F to 77°F). Use orally disintegrating tablet immediately after opening individual blister.

Use

Relief of symptoms due to hayfever or upper respiratory allergies (OTC products: Oral suspension: FDA approved in ages ≥2 years and adults; Meltable tablets: FDA approved in ages ≥6 years and adults; Tablets [12 or 24 hours]: FDA approved in ages ≥12 years and adults); has also been used to treat uncomplicated skin manifestations of urticaria. Note: Approved ages and uses for generic products may vary; consult labeling for specific information.

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

Allegra may be confused with Allegra Anti-Itch Cream (diphenhydramine/allantoin), Viagra

Fexofenadine may be confused with fesoterodine

Mucinex Allergy may be confused with Mucinex

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (pediatric liquid medications requiring measurement) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).

International issues:

Allegra [US, Canada, and multiple international markets] may be confused with Allegro brand name for fluticasone [Israel] and frovatriptan [Germany]

Metabolism/Transport Effects

Substrate of CYP3A4 (Minor), MATE1/2-K, OAT1/3, OATP1B1/1B3, P-glycoprotein (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

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.

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

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

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

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

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

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

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

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

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

Food Interactions

High-fat meals decrease the bioavailability of fexofenadine by ~50%. Fruit juice (apple, grapefruit, orange) may decrease bioavailability of fexofenadine by ~36%. Management: Separating fexofenadine administration and fruit juice consumption by at least 4 hours may decrease the significance of this possible interaction.

Dietary Considerations

Some products may contain phenylalanine and/or sodium. Take suspension and tablets preferably with water; separate administration with grapefruit or other fruit juices by at least 4 hours.

Pregnancy Considerations

Fexofenadine crosses the placenta (Pinto 2020).

Outcome data following maternal use of fexofenadine during pregnancy are available (Andersson 2020, Craig-McFeely 2001, Gilboa 2009, Hansen 2020, Kocatürk 2022). Based on the limitations of available data, second-generation antihistamines are considered acceptable for use during pregnancy, with preference given to agents with more study (EAACI [Zuberbier 2022]).

Algorithms are available for the treatment of acute rhinitis and urticaria. When treatment with a second-generation oral antihistamine is recommended, agents other than fexofenadine may be preferred for use during pregnancy (AAAAI/ACAAI [Dykewicz 2020], Andersson 2020, EAACI [Zuberbier 2022]).

Monitoring Parameters

Improvement in signs and symptoms of allergic rhinitis and chronic idiopathic urticaria

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: 2 hours (Simons 2004)

Duration of action: 24 hours (Simons 2004)

Absorption: Rapid

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

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

Bioavailability: ~33%

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)

Time to peak, serum: ODT: 2 hours (4 hours with high-fat meal); Tablet: ~2.6 hours (Simons 2004); Suspension: ~1 hour

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

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: 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.

Older adult: Cmax is increased 99%.

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

  • (AE) United Arab Emirates: Celera | Fenadex | Fexigra | Fexodine | Fexogen | Fexon | Fexotel | Sarfast | Telfast | Telife | Zyhist;
  • (AR) Argentina: Alercas | Alerfedine | Allegra | Allegra pediatrico | Mudantil | Mudantil f | Vagran 120 | Vagran 180;
  • (AT) Austria: Telfast;
  • (AU) Australia: Allerfexo | Amcal Fexo | Apohealth fexofenadine hayfever & allergy relief | Blooms the chemist fexofenadine | Chemists Own Fexo | Chemists' Own Fexo | Chemmart fexofenadine | Chemplus fexofenadine | Discount drug stores fexofenadine | Fexal | Fexo | Fexofenadine | Fexofenadine hayfever & allergy relief | Fexorelief | Fexotabs | Guardian Fexo | Hayfexo | Pharmacist fexofenadine | Pharmacists own fexofenadine | Pharmacy care fexo | Pharmacy health fexofenadine | Priceline pharmacy fexofenadine hayfever & allergy relief | Tefodine | Telfast | Terry white chemists fexofenadine | Trust fex | Xergic | Your pharmacy fexofenadine;
  • (BD) Bangladesh: Afexa | Alafree | Alagra | Alanil | Alerfast | Alerfex | Alfex | Axodin | Axofen | Delfex | Dinafex | Elfexo | Fastel | Fegra | Fenadin | Fenofex | Fexo | Fexobest | Fexocold | Fexocon | Fexodin | Fexofast | Fexofen | Fexomin | Fexon | Fexona | Fexonaaf | Fexoral | Fexotab | Fexten | Fixal | Fixen | Furia | Nolargy | Odafen | Perfex | Rafex | Rinofen | Ritch | Rynofex | Sardin | SB fexec | Sifena | Telfadin | Telfast | Telfex | Vifas | X din | Xofast | Xofena;
  • (BE) Belgium: Allegratab | Allergo Rhinathiol | Fexofenadine Sandoz | Telfast;
  • (BF) Burkina Faso: Telfast | Xafen;
  • (BG) Bulgaria: Allegra | Ewofex | Telfast;
  • (BR) Brazil: Allegra | Allexofedrin | Allexofedrin pediatrico | Altiva | Cloridato fexofenadina | Cloridrato de fexofenadina | Desrinite | Fexodane | Fexolerg | Fexoliv | Fexx | Lexler | Praalergia | Rafex;
  • (CH) Switzerland: Fexo mepha allergie | Fexo pollen sandoz | Fexofenadin mepha | Fexofenadin sandoz | Fexofenadin spirig | Fexofenadine Zentiva | Telfast | Telfastin | Telfastin allergo;
  • (CI) Côte d'Ivoire: Rifex | Xafen | Xonadine;
  • (CL) Chile: Alexia | Allegra;
  • (CN) China: A te la | Lai duo fei | Min jie | Raltiva | Rui fei | Sai le xi;
  • (CO) Colombia: Aleraliv | Alerfast | Alermed | Allegra | Fentradol | Fexodina | Fexofem | Fexofenadina | Fexofenadina hcl | Fexu | Fexuped | Fexy | Garmisch fentradol | Gyets | Hismanal | Pedialab | Rinolast;
  • (CZ) Czech Republic: Ewofex | Fexigra;
  • (DE) Germany: Fexofenaderm | Fexofenadin hexal | Fexofenadin Winthrop | Fexofenadine cipla | Telfast;
  • (DK) Denmark: Alnodine | Nefoxef;
  • (DO) Dominican Republic: Alercas | Allegra pediatrico | Fexofast | Fexofran | Ronoprin;
  • (EC) Ecuador: Alerfast | Alerfedine | Alexia | Allegra | Fexofen | Fexofenadina | Fexofenadina mk | Rinolast;
  • (EG) Egypt: Alertam | Allerfen | Allergyna | Elballerge | Fastel | Fexodine | Fexolerg | Fexon | Histafree | Histamedizen | Linofenadine | Sanzalera | Telfast;
  • (ES) Spain: Fexofenadina cipla | Fexofenadina Tevagen;
  • (FI) Finland: Fexofenadine Bmm Pharma | Fexofenadine ratiopharm | Fexorin | Telfast;
  • (FR) France: Allervi | Fexofenadine Biogaran | Fexofenadine mylan | Telfast;
  • (GB) United Kingdom: Fexofenadine | Fexofenadine cipla | Fexofenadine Teva | Histallay | Telfast | Treathay;
  • (GR) Greece: Allegra;
  • (HK) Hong Kong: Allegix | Allerfast | Axodin | Bosnum | Fenadin | Fexet | Fexodine | Fexofenadine HCL | Fexostad | Fixdep | Neo fas | Telfast | Zafil;
  • (HR) Croatia: Allegra | Feksofenadinklorid cipla | Telfast;
  • (HU) Hungary: Allegra | Ewofex | Fexgen | Fexofep | Telfast;
  • (ID) Indonesia: Fexomin | Fexoven | Sanolergic | Telfast | Telfast bd | Telfast hd;
  • (IE) Ireland: Fexofast | Fexofenadine | Telfast | Telfast allergy;
  • (IL) Israel: Fexofenadine Teva | Fexofenadine trima | Telfast;
  • (IN) India: Afexdine | Air | Alafex | Alarrest | Alecloz | Alerfex | Alernex | Alert | Alexo | Alfexo | Alifex | Allegix | Allegra | Allerfast | Allerfex | Allergix | Allergo | Allofex | Altiva | Belfexin | Cnf plus | Curifex | Delpodine | Effectin | Ethifex | Etofex | F din | Fax | Faxodas | Fegra | Fenagra | Fenixa | Fenq | Fex | Fexair | Fexeit | Fexidine | Fexigra | Fexo | Fexobit | Fexocet | Fexoday | Fexodin | Fexodine | Fexofast | Fexofen | Fexoleb | Fexolife | Fexona | Fexopride | Fexotrol | Fexova | Fexovib | Fext | Fextim | Fextral | Fextro | Fexy | Finide | Finista | Fx 24 | Fxla | Hhfexo | Histafree | Histagra | Histakind | Histaloc | Histeas | Histos | Klm fx | Lcfex | Luracise | Nexofex | Odifex | Ofena | Ofine | Radifex | Rhinofex | Sinarest fx | Tadil | Ultigra | Verifine | Wexodine | X dine | Xaria Kidz | Zietex;
  • (IS) Iceland: Nefoxef;
  • (IT) Italy: Fexallegra | Fexofenadina dr reddy's | Fexofenadina MG | Fexofenadina sanofi | Fexofenadina sanofi aventis | Fixodin | Kalicet | Telfast;
  • (JO) Jordan: Exofen | Feksine | Fexadine | Fexodex | Fexofast | Telfast;
  • (JP) Japan: Allegra | Allegra fx | Allerbi | Fexofenadine alpha | Fexofenadine hydrochloride dk | Fexofenadine hydrochloride ffp | Fexofenadine hydrocloride bmd | Nospole rhinitis fx | Nosupol bien jyou fx | Skyblon HI;
  • (KE) Kenya: Allegix | Allerfast | Allerfex | Allergo | Allerstat | Arest | Axodin | Bosnum | Fexet | Fexidine | Fexipas 120 | Fexo | Fexofen | Telfast | Ultigra | Xonadine;
  • (KR) Korea, Republic of: Alfenadine | Allecot | Allegra | Allerdin | Alletoc | Fexigra | Fexofen | Fexomin | Fexon | Fexonadine | Nosejin;
  • (KW) Kuwait: Fexodine | Telfast;
  • (LB) Lebanon: Exofen | Fenadex | Fexofen | Telfast;
  • (LT) Lithuania: Altiva | Telfast;
  • (LU) Luxembourg: Allegratab | Telfast;
  • (LV) Latvia: Allegra | Altiva;
  • (MA) Morocco: Telfast;
  • (MX) Mexico: Afernidin | Aldifex | Allegra | Apertum OX | Biostafex | Clareve | Desrotan | Fexofenadin | Fexofenadin Landsteiner | Fexofenadina | Fexofenadina rayere | Fexoff R | Pirquet | Ranfast;
  • (MY) Malaysia: Altiva | Fexofenadin Stada | Fexofin | Fexovid | Telfast;
  • (NG) Nigeria: Allerstat | Fexet | Fexidine | Fexofenadine;
  • (NL) Netherlands: Allegra Fexotabs | Fexofenadine HCL | Fexofenadine hcl amarox | Fexofenadine hcl mylan | Fexofenadine HCl Sandoz | Telfast;
  • (NO) Norway: Allegra | Altifex | Feksofenadin cipla | Telfast;
  • (NZ) New Zealand: Fexaclear | Fexofast | Hayfexo | Pharmacy health fexofenadine hayfever & allergy relief | Telfast;
  • (PE) Peru: Allegra | Allegra pediatrico | Allemax | Fenamax | Fenax | Fexaller | Fexofast | Fexofenadina | Libberafex | Xendixtal | Zetafex;
  • (PH) Philippines: Eofen | Fenafex | Fexet | Fexoral | Fexotab | Rhinogan | Sensitin | Telfast;
  • (PK) Pakistan: Adine | Afex | Allergia | Alofex | Alrin | Altiva | Callfast | Demxet | Enadin | Faasfodine | Fanamed | Fanasel | Faxid | Faxodine | Fegix | Fenacare | Fenadex | Fendina-f | Fenix | Fenoxy | Fescot | Fexamed | Fexera | Fexet | Fexheal | Fexidine | Feximor | Fexine | Fexinol | Fexmit | Fexo | Fexofast | Fexofin | Fexokure | Fexolis | Fexolyd | Fexoprime | Fexosure | Fexsel | Fidaxo | Fifex | Fiofen | Fix it | Fixfast | Fluzip | Font | Genfix | Geridin | Hifast | Infex | Lenodine | Lixifil | Mafodin | Mb fex | Meadow | Megafast | Neofexa | Nifty | Novahist | Obfex | Odifex | Plexid | Plifast | Raltiva | Ramfex | Remast | Revofex | Saifex | Sb Din | Simfexo | Sizzle | Sneez | Softin f | Tansidin | Tefend | Telfast | Telfex | Telwin | Tilast | Vasofax | Welfast | Xadine | Xfr | Xyfex;
  • (PL) Poland: Allegra | Allegra telfast | Allertec fexo | Fexogen | Telfast | Telfexo;
  • (PR) Puerto Rico: Allegra | Allegra allergy non drowsy | Allegra hives | Allergy relief | Children's allegra allergy | Fexofenadine | Fexofenadine HCL | Mucinex allergy;
  • (PT) Portugal: Fexofenadina Generis | Fexofenadina Mylan | Nalerge;
  • (PY) Paraguay: Alercas | Alermid | Allegra | Allegra pediatrico | Congex | Novo alergiol | Restaler nf | Tolston nf;
  • (QA) Qatar: Exofen | Fenadex | Fexa | Fexodine | Qfexine | Telfadin | Telfast;
  • (RO) Romania: Altiva | Ewofex | Telfast;
  • (RU) Russian Federation: Allegra | Bexist sanovel | Dinox | Fexadin | Fexo | Fexofenadine akrikhin | Telfast;
  • (SA) Saudi Arabia: Fenadex | Fexodine | Fexofin | Fexotel | Sarfex | Telfast;
  • (SE) Sweden: Allegra | Fexofenadin | Fexofenadin abacus medicine | Fexofenadin ABECE | Fexofenadin apofri | Fexofenadin Cipla | Fexofenadin Ebb | Fexofenadin orifarm | Nefoxef | Telfast;
  • (SG) Singapore: Exodin | Fexofen | Telfast;
  • (SI) Slovenia: Allegra | Feksofenadin Mylan | Telfast;
  • (SK) Slovakia: Allegra | Ewofex | Fixit | Telfast;
  • (TH) Thailand: Avafast | Bosnum | Fenafex | Fexofast | Medifast | Sanik | Telfast | Tofexo | Vifas;
  • (TN) Tunisia: Fenadex | Telfast;
  • (TR) Turkey: Feksine | Fexadyne | Fexofen | Mayfex | Telfast;
  • (TW) Taiwan: Alledine | Fe Min | Fenadin | Fexodine | Fexofenadine | Fynadin | Jfs fct root | Nasaga | Naxodine | Su Min;
  • (UA) Ukraine: Alexofast | Alfast | Allegra | Allergo | Altiva | Fexofen | Telfast | Tigofast;
  • (UG) Uganda: Exofen | Fexofen | Fixdep | Xonadine;
  • (UY) Uruguay: Alergistin nf | Allegra | Fexofen | Norinal | Novo Alerfedine | Tolston;
  • (VE) Venezuela, Bolivarian Republic of: Alermid | Allegra | Fenax | Fentradol | Fexofenadina | Fexoril | Rinofen | Rinolast;
  • (VN) Viet Nam: Agimfast | Alerday | Allerphast | Apifexo | Cadifast | Fedimtast | Fefasdin | Fexfed | Fexnad | Fexodinefast | Fexophar | Gimfastnew | Hasalfast | Imexofen | Inflex | Lerphat | Loxcip | Malag | Telanhis | Telfadin | Telfor | Telgate | Ternafast | Tinfoten | Tinifast | Tiphafast | Tocimat | Usaallerz | Xonatrix | Xonatrix forte;
  • (ZA) South Africa: Afex | Fenofex | Fexaway | Fexo | Fexofenadine biotech | Telfast | Tellerge;
  • (ZM) Zambia: Allerfast | Allerstat | Fixdep | Ultigra;
  • (ZW) Zimbabwe: Telfast
  1. Allegra (fexofenadine) [prescribing information]. Bridgewater, NJ: sanofi-aventis U.S. LLC; July 2007.
  2. Allegra (fexofenadine) [product monograph]. Laval, Quebec, Canada: sanofi-aventis Canada; September 2006.
  3. Allegra Allergy 12 Hour (fexofenadine) [prescribing information]. Chatanooga, TN: Chattam; received April 2020.
  4. Allegra Allergy 24 Hour (fexofenadine) [prescribing information]. Chatanooga, TN: Chattam; received April 2020.
  5. Allegra Allergy Childrens (fexofenadine oral suspension) [prescribing information]. Chatanooga, TN: Chattam; received December 2022.
  6. Allegra Allergy Childrens (fexofenadine orally disintegrating tablets) [prescribing information]. Chatanooga, TN: Chattam; received February 2021.
  7. American Academy of Pediatrics (AAP). Cough and cold medicines should not be prescribed, recommended or used for respiratory illnesses in young children. Updated June 12, 2018. Available at http://www.choosingwisely.org/clinician-lists/american-academy-pediatrics-cough-and-cold-medicines-for-children-under-four/
  8. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  9. Andersson NW, Torp-Pedersen C, Andersen JT. Association between fexofenadine use during pregnancy and fetal outcomes. JAMA Pediatr. 2020;174(8):e201316. doi:10.1001/jamapediatrics.2020.1316 [PubMed 32478810]
  10. Aronoff GR, Bennett WM, Berns JS, et al. Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children. 5th ed. Philadelphia, PA: American College of Physicians; 2007, p 94.
  11. Asero R. New-onset urticaria. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. https://www.uptodate.com. Accessed March 14, 2023.
  12. Bernstein JA, Lang DM, Khan DA, et al; American Academy of Allergy, Asthma & Immunology (AAAAI); the American College of Allergy, Asthma & Immunology (ACAAI); Joint Council of Allergy, Asthma & Immunology. The diagnosis and management of acute and chronic urticaria: 2014 update. J Allergy Clin Immunol. 2014;133(5):1270-1277. doi:10.1016/j.jaci.2014.02.036 [PubMed 24766875]
  13. Bilbao-Meseguer I, Rodríguez-Gascón A, Barrasa H, Isla A, Solinís MÁ. Augmented renal clearance in critically ill patients: a systematic review. Clin Pharmacokinet. 2018;57(9):1107-1121. doi:10.1007/s40262-018-0636-7 [PubMed 29441476]
  14. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014;70(3):417. [PubMed 24528912]
  15. Centers for Disease Control and Prevention (CDC). Infant deaths associated with cough and cold medications--two states, 2005. MMWR Morb Mortal Wkly Rep. 2007;56(1):1-4. [PubMed 17218934]
  16. Craig-McFeely PM, Acharya NV, Shakir SA. Evaluation of the safety of fexofenadine from experience gained in general practice use in England in 1997. Eur J Clin Pharmacol. 2001;57(4):313-320. doi:10.1007/s002280100292 [PubMed 11549210]
  17. Dykewicz MS, Wallace DV, Amrol DJ, et al. Rhinitis 2020: a practice parameter update. J Allergy Clin Immunol. 2020;146(4):721-767. doi:10.1016/j.jaci.2020.07.007 [PubMed 32707227]
  18. Expert opinion. Senior Renal Editorial Team:Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc,FSHP, FISAC; Michael Heung, MD, MS.
  19. Finn AF Jr, Kaplan AP, Fretwell R, Qu R, Long J. A double-blind, placebo-controlled trial of fexofenadine HCl in the treatment of chronic idiopathic urticaria. J Allergy Clin Immunol. 1999;104(5):1071-1078. [PubMed 10550755]
  20. Food and Drug Administration (FDA). Most young children with a cough or cold don't need medicines. July 18, 2017. Available at https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm422465.htm. Last accessed November 2, 2018.
  21. Food and Drug Administration (FDA). Use caution when giving cough and cold products to kids. Updated February 8, 2018. Available at https://www.fda.gov/drugs/resourcesforyou/specialfeatures/ucm263948.htm. Last accessed November 2, 2018.
  22. Gilboa SM, Strickland MJ, Olshan AF, Werler MM, Correa A; National Birth Defects Prevention Study. Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Mol Teratol. 2009;85(2):137-150. doi:10.1002/bdra.20513 [PubMed 19161158]
  23. Hampel FC, Kittner B, van Bavel JH. Safety and tolerability of fexofenadine hydrochloride, 15 and 30 mg, twice daily in children aged 6 months to 2 years with allergic rhinitis. Ann Allergy Asthma Immunol. 2007;99(6):549-554. [PubMed 18219837]
  24. Hansen C, Desrosiers TA, Wisniewski K, et al. Use of antihistamine medications during early pregnancy and selected birth defects: The National Birth Defects Prevention Study, 1997-2011. Birth Defects Res. 2020;112(16):1234-1252. doi:10.1002/bdr2.1749 [PubMed 32657014]
  25. Ito S, Blajchman A, Stephenson M, et al. Prospective follow-up of adverse reactions in breast-fed infants exposed to maternal medication. Am J Obstet Gynecol. 1993;168(5):1393-1399. [PubMed 8498418]
  26. Kaplan AP, Spector SL, Meeves S, Liao Y, Varghese ST, Georges G. Once-daily fexofenadine treatment for chronic idiopathic urticaria: a multicenter, randomized, double-blind, placebo-controlled study. Ann Allergy Asthma Immunol. 2005;94(6):662-669. [PubMed 15984599]
  27. Khan DA. Chronic spontaneous urticaria: standard management and patient education. Post TW, ed. UpToDate. Waltham, MA: UpToDate Inc. http://www.uptodate.com. Accessed March 14, 2023.
  28. Kliegman RM and St. Geme J, eds. Nelson Textbook of Pediatrics. 21st ed. Philadelphia, PA: Saunders Elsevier; 2020.
  29. Kocatürk E, Podder I, Zenclussen AC, et al. Urticaria in pregnancy and lactation. Front Allergy. 2022;3:892673. doi:10.3389/falgy.2022.892673 [PubMed 35873599]
  30. Lee XH, Ong LX, Cheong JY, et al. A stepwise approach in the management of chronic spontaneous urticaria in children. Asia Pac Allergy. 2016;6(1):16-28. [PubMed 26844216]
  31. Lucas BD Jr, Purdy CY, Scarim SK, et al. Terfenadine pharmacokinetics in breast milk in lactating women. Clin Pharmacol Ther. 1995;57(4):398-402. [PubMed 7712667]
  32. Markham A, Wagstaff AJ. Fexofenadine. Drugs. 1998;55(2):269-274; discussion 275-276. [PubMed 9506246]
  33. Meltzer EO, Scheinmann P, Rosado Pinto JE, et al. Safety and efficacy of oral fexofenadine in children with seasonal allergic rhinitis--a pooled analysis of three studies. Pediatr Allergy Immunol. 2004;15(3):253-260. doi:10.1111/j.1399-3038.2004.00167.x [PubMed 15209959]
  34. Nelson HS, Reynolds R, Mason J. Fexofenadine HCl is safe and effective for treatment of chronic idiopathic urticaria. Ann Allergy Asthma Immunol. 2000;84(5):517-522. doi:10.1016/S1081-1206(10)62515-X [PubMed 10831005]
  35. Pinto LSR, Vale GTD, Moreira FL, et al. Direct chiral LC-MS/MS analysis of fexofenadine enantiomers in plasma and urine with application in a maternal-fetal pharmacokinetic study. J Chromatogr B Analyt Technol Biomed Life Sci. 2020;1145:122094. doi:10.1016/j.jchromb.2020.122094 [PubMed 32311673]
  36. Powell RJ, Leech SC, Till S, et al; British Society for Allergy and Clinical Immunology. BSACI guideline for the management of chronic urticaria and angioedema.Clin Exp Allergy. 2015;45(3):547-565. [PubMed 25711134]
  37. Pozzo-Magaña BR. Chronic urticaria in children: a review. EMJ Dermatol. 2017;5(1):74-82.
  38. Refer to manufacturer's labeling.
  39. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
  40. Simons FE. Advances in H1-antihistamines. N Engl J Med. 2004;351(21):2203-2217. [PubMed 15548781]
  41. Simons FE, Bergman JN, Watson WT, Simons KJ. The clinical pharmacology of fexofenadine in children. J Allergy Clin Immunol. 1996;98(6, pt 1):1062-1064. [PubMed 8977506]
  42. Teo SL, Santosa A, Bigliardi PL. Stevens-Johnson syndrome/toxic epidermal necrolysis overlap induced by fexofenadine. J Investig Allergol Clin Immunol. 2017;27(3):191-193. doi:10.18176/jiaci.0158 [PubMed 28570227]
  43. Thomson BK, Nolin TD, Velenosi TJ, et al. Effect of CKD and dialysis modality on exposure to drugs cleared by nonrenal mechanisms. Am J Kidney Dis. 2015;65(4):574-582. doi:10.1053/j.ajkd.2014.09.015 [PubMed 25453994]
  44. Udy AA, Roberts JA, Boots RJ, Paterson DL, Lipman J. Augmented renal clearance: implications for antibacterial dosing in the critically ill. Clin Pharmacokinet. 2010;49(1):1-16. doi:10.2165/11318140-000000000-00000 [PubMed 20000886]
  45. Wahn U, Meltzer EO, Finn AF Jr, et al. Fexofenadine is efficacious and safe in children (aged 6-11 years) with seasonal allergic rhinitis. J Allergy Clin Immunol. 2003;111(4):763-769. doi:10.1067/mai.2003.1384 [PubMed 12704355]
  46. Zuberbier T, Abdul Latiff AH, et al. The international EAACI/GA²LEN/EuroGuiDerm/APAAACI guideline for the definition, classification, diagnosis, and management of urticaria. Allergy. 2022;77(3):734-766. doi:10.1111/all.15090 [PubMed 29336054]
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