Allegra Children's Allergy

Second Generation Antihistamines

Avoid grapefruit, orange, and apple juice before or after drug administration to avoid potential reduction bioavailability.

Tablets or capsules: Administer orally with water. May be administered without regard to meals.
Orally disintegrating tablets: Dissolve tablets on the tongue then swallow with or without water; do not chew. Administer on an empty stomach. Do not remove from original blister package until the time of administration.

Oral suspension: Shake well prior to each use. Measure dosage using a calibrated measuring device. Keep in a tightly closed container away from children.

anaphylactoid reactions / Rapid / Incidence not known
angioedema / Rapid / Incidence not known

chest pain (unspecified) / Early / Incidence not known
dyspnea / Early / Incidence not known

vomiting / Early / 4.2-12.0
headache / Early / 4.8-10.3
dyspepsia / Early / 4.7-4.7
fever / Early / 1.9-4.5
infection / Delayed / 0.9-4.3
cough / Delayed / 1.9-4.0
diarrhea / Early / 2.8-3.7
fatigue / Early / 0.7-2.8
myalgia / Early / 2.6-2.6
back pain / Delayed / 2.1-2.5
pharyngitis / Delayed / 2.4-2.4
rhinorrhea / Early / 0.9-2.1
dizziness / Early / 2.1-2.1
dysmenorrhea / Delayed / 1.5-1.5
paranoia / Early / 0-1.0
insomnia / Early / 0-1.0
restlessness / Early / 0-1.0
rash / Early / Incidence not known
urticaria / Rapid / Incidence not known
pruritus / Rapid / Incidence not known
flushing / Rapid / Incidence not known

Allegra, Allegra Allergy 12 Hour, Allegra Allergy 24 Hour, Allegra Children's Allergy, Allegra Children's Allergy ODT, Allegra Hives, Allegra ODT, Allergy Relief, Children's Allergy, Children's Allergy Fexofenadine

OTC, Rx

Non-sedating antihistamine (H1-receptor antagonist)
Used for seasonal allergic rhinitis and chronic idiopathic urticaria
Active metabolite of terfenadine; fexofenadine does not typically prolong the QT interval

60 mg PO twice daily. Alternatively, 180 mg PO once daily.

30 mg PO twice daily. During controlled trials of patients 6 to 11 years of age, 60 mg twice daily was not more beneficial than 30 mg twice daily.

60 mg PO twice daily; place on the tongue and allow to disintegrate.[42362] [43588]

30 mg PO twice daily; place on the tongue and allow to disintegrate.

60 mg PO twice daily.

30 mg PO twice daily.

60 mg PO twice daily. Alternatively, 180 mg PO once daily.

30 mg PO twice daily.

30 mg PO twice daily; place on tongue and allow to disintegrate.[42362]

30 mg PO twice daily.

15 mg PO twice daily.

No dosage adjustment is recommended. The pharmacokinetics of fexofenadine are not substantially different in patients with hepatic disease.

CrCl 80 mL/minute/1.73 m2 or more: No adjustment necessary.
CrCl 11 to 80 mL/minute/1.73 m2: Reduce the starting dose to once daily administration as follows based on age:
-Adults, Adolescents, and Children 12 years and older: 60 mg PO once daily.
-Children 2 to 11 years: 30 mg PO once daily.
-Infants and Children 6 months to less than 2 years: 15 mg PO once daily.
CrCl  10 mL/minute/1.73 m2 or less:
-Adults, Adolescents, and Children 12 years and older: Not included in the FDA-approved label, some experts recommend 30 mg PO once daily.
-Infants and Children less than 12 years: Dosage recommendations are not available.
 
Intermittent hemodialysis
Dosing not included in the FDA-approved label, some experts recommend 30 mg PO once daily for patients older than 12 years; dosing for other age groups is not available. The effect of hemodialysis on the removal of fexofenadine is unknown. After terfenadine oral administration, hemodialysis did not effectively remove fexofenadine (the major active metabolite of terfenadine) from blood (up to 1.7% was removed).

Alogliptin; Pioglitazone: (Minor) Concentrations of fexofenadine may be increased with concomitant use of pioglitazone. The effect of pioglitazone capistration on the systemic exposure of fexofenadine was determined in a drug-drug interaction study. Coadministration of pioglitazone 45 mg once daily with fexofenadine 60 mg twice daily for 7 days resulted in a 30% and 37% increase in fexofenadine AUC and Cmax, respectively. Patients should be monitored for increased side effects from fexofenadine.
Aluminum Hydroxide: (Moderate) Coadministration with antacids (containing aluminum or magnesium) within 15 minutes decreases the AUC and Cmax of fexofenadine by 41% and 43%, respectively. Separate administration is recommended.
Aluminum Hydroxide; Magnesium Carbonate: (Moderate) Coadministration with antacids (containing aluminum or magnesium) within 15 minutes decreases the AUC and Cmax of fexofenadine by 41% and 43%, respectively. Separate administration is recommended.
Aluminum Hydroxide; Magnesium Hydroxide: (Moderate) Coadministration with antacids (containing aluminum or magnesium) within 15 minutes decreases the AUC and Cmax of fexofenadine by 41% and 43%, respectively. Separate administration is recommended.
Aluminum Hydroxide; Magnesium Hydroxide; Simethicone: (Moderate) Coadministration with antacids (containing aluminum or magnesium) within 15 minutes decreases the AUC and Cmax of fexofenadine by 41% and 43%, respectively. Separate administration is recommended.
Aluminum Hydroxide; Magnesium Trisilicate: (Moderate) Coadministration with antacids (containing aluminum or magnesium) within 15 minutes decreases the AUC and Cmax of fexofenadine by 41% and 43%, respectively. Separate administration is recommended.
Antacids: (Moderate) Coadministration with antacids (containing aluminum or magnesium) within 15 minutes decreases the AUC and Cmax of fexofenadine by 41% and 43%, respectively. Separate administration is recommended.
Aspirin, ASA; Citric Acid; Sodium Bicarbonate: (Major) Co-administration with antacids within 15 minutes decreases the AUC and Cmax of fexofenadine. Separate administration is recommended.
Calcium Carbonate: (Moderate) Co-administration with antacids within 15 minutes decreases the AUC and Cmax of fexofenadine. Separate administration is recommended.
Calcium Carbonate; Famotidine; Magnesium Hydroxide: (Moderate) Co-administration with antacids within 15 minutes decreases the AUC and Cmax of fexofenadine. Separate administration is recommended.
Calcium Carbonate; Magnesium Hydroxide: (Moderate) Co-administration with antacids within 15 minutes decreases the AUC and Cmax of fexofenadine. Separate administration is recommended.
Calcium Carbonate; Magnesium Hydroxide; Simethicone: (Moderate) Co-administration with antacids within 15 minutes decreases the AUC and Cmax of fexofenadine. Separate administration is recommended.
Calcium Carbonate; Simethicone: (Moderate) Co-administration with antacids within 15 minutes decreases the AUC and Cmax of fexofenadine. Separate administration is recommended.
Calcium; Vitamin D: (Moderate) Co-administration with antacids within 15 minutes decreases the AUC and Cmax of fexofenadine. Separate administration is recommended.
Desloratadine: (Minor) Although desloratadine is considered a 'non-sedating' antihistamine, dose-related sedation has been noted. For this reason, it would be prudent to monitor for drowsiness during concurrent use of desloratadine with CNS depressants such as other H1-blockers.
Desloratadine; Pseudoephedrine: (Minor) Although desloratadine is considered a 'non-sedating' antihistamine, dose-related sedation has been noted. For this reason, it would be prudent to monitor for drowsiness during concurrent use of desloratadine with CNS depressants such as other H1-blockers.
Elexacaftor; tezacaftor; ivacaftor: (Moderate) Monitor for fexofenadine-related adverse reactions during coadministration of elexacaftor; tezacaftor; ivacaftor as concurrent use may increase exposure of fexofenadine. Fexofenadine is a substrate for the transporters OATP1B1 and OATP1B3; elexacaftor; tezacaftor; ivacaftor may inhibit uptake of OATP1B1 and OATP1B3.
Eltrombopag: (Moderate) Monitor patients for fexofenadine adverse reactions if coadministered with eltrombopag. Eltrombopag is an inhibitor of the transporter OATP1B1. Drugs that are substrates for this transporter, such as fexofenadine, may exhibit an increase in systemic exposure if coadministered with eltrombopag.
Etravirine: (Moderate) Etravirine is an inhibitor of the efflux transporter P-glycoprotein (PGP). Fexofenadine is a P-glycoprotein substrate. Increased concentrations of fexofenadine may occur if it is coadministered with etravirine; exercise caution.
Grapefruit juice: (Major) Fruit juices such as grapefruit juice, orange juice, and apple juice may reduce the bioavailability, systemic exposure, and clinical efficacy of fexofenadine. Patients should avoid drinking fruit juice within 4 hours before and 1 to 2 hours after taking fexofenadine; tablets and capsules should be consumed with water, not juice. Many fruit juices are organic anion transporting peptide (OATP) 1A2 and/or OATP2B1 inhibitors. OATP-mediated transport facilitates the intestinal absorption of fexofenadine. It is estimated that the bioavailability of fexofenadine is decreased by 36% when coadministered with grapefruit or orange juice. Apple juice, orange juice, and grapefruit juice have been reported to decrease the AUC and Cmax of fexofenadine by up to 70%.
Heparin: (Minor) Antihistamines may partially counteract the anticoagulant actions of heparin, according to the product labels. However, this interaction is not likely of clinical significance since heparin therapy is adjusted to the partial thromboplastin time (aPTT) and other clinical parameters of the patient.
Isoniazid, INH; Pyrazinamide, PZA; Rifampin: (Minor) Rifampin may decrease plasma concentrations of fexofenadine and potentially reduce its antihistaminic effects. Although the therapeutic range of fexofenadine is broad, monitor for potential decreased therapeutic effects of fexofenadine if rifampin is initiated.
Isoniazid, INH; Rifampin: (Minor) Rifampin may decrease plasma concentrations of fexofenadine and potentially reduce its antihistaminic effects. Although the therapeutic range of fexofenadine is broad, monitor for potential decreased therapeutic effects of fexofenadine if rifampin is initiated.
Ketoconazole: (Minor) Ketoconazole may inhibit the metabolism of fexofenadine via its effects on the CYP3A4 isozyme of the cytochrome P-450 microsomal enzyme system.
Levoketoconazole: (Minor) Ketoconazole may inhibit the metabolism of fexofenadine via its effects on the CYP3A4 isozyme of the cytochrome P-450 microsomal enzyme system.
Lopinavir; Ritonavir: (Moderate) Monitor for fexofenadine-related adverse reactions during concurrent administration with lopinavir as use of these drugs together may increase exposure of fexofenadine. Fexofenadine is a substrate of the organic anion transporting peptide (OATP1B1); lopinavir inhibits OATP1B1.
Loratadine: (Minor) Although loratadine is considered a 'non-sedating' antihistamine, dose-related sedation has been noted. For this reason, it would be prudent to monitor for drowsiness during concurrent use of loratadine with CNS depressants such as other H1-blockers.
Loratadine; Pseudoephedrine: (Minor) Although loratadine is considered a 'non-sedating' antihistamine, dose-related sedation has been noted. For this reason, it would be prudent to monitor for drowsiness during concurrent use of loratadine with CNS depressants such as other H1-blockers.
Magnesium Hydroxide: (Moderate) Coadministration with antacids (containing aluminum or magnesium) within 15 minutes decreases the AUC and Cmax of fexofenadine by 41% and 43%, respectively. Separate administration is recommended.
Omeprazole; Sodium Bicarbonate: (Major) Co-administration with antacids within 15 minutes decreases the AUC and Cmax of fexofenadine. Separate administration is recommended.
Pioglitazone: (Minor) Concentrations of fexofenadine may be increased with concomitant use of pioglitazone. The effect of pioglitazone capistration on the systemic exposure of fexofenadine was determined in a drug-drug interaction study. Coadministration of pioglitazone 45 mg once daily with fexofenadine 60 mg twice daily for 7 days resulted in a 30% and 37% increase in fexofenadine AUC and Cmax, respectively. Patients should be monitored for increased side effects from fexofenadine.
Pioglitazone; Glimepiride: (Minor) Concentrations of fexofenadine may be increased with concomitant use of pioglitazone. The effect of pioglitazone capistration on the systemic exposure of fexofenadine was determined in a drug-drug interaction study. Coadministration of pioglitazone 45 mg once daily with fexofenadine 60 mg twice daily for 7 days resulted in a 30% and 37% increase in fexofenadine AUC and Cmax, respectively. Patients should be monitored for increased side effects from fexofenadine.
Pioglitazone; Metformin: (Minor) Concentrations of fexofenadine may be increased with concomitant use of pioglitazone. The effect of pioglitazone capistration on the systemic exposure of fexofenadine was determined in a drug-drug interaction study. Coadministration of pioglitazone 45 mg once daily with fexofenadine 60 mg twice daily for 7 days resulted in a 30% and 37% increase in fexofenadine AUC and Cmax, respectively. Patients should be monitored for increased side effects from fexofenadine.
Posaconazole: (Moderate) Posaconazole and fexofenadine should be coadministered with caution due to a potential for altered plasma concentrations of both drugs. Both fexofenadine and posaconazole are substrates of the drug efflux protein, P-glycoprotein, which when administered together may increase the absorption or decrease the clearance of the other drug. This interaction may cause alterations in the plasma concentrations of both posaconazole and fexofenadine, ultimately resulting in an increased risk of adverse events.
Rifampin: (Minor) Rifampin may decrease plasma concentrations of fexofenadine and potentially reduce its antihistaminic effects. Although the therapeutic range of fexofenadine is broad, monitor for potential decreased therapeutic effects of fexofenadine if rifampin is initiated.
Sincalide: (Moderate) Sincalide-induced gallbladder ejection fraction may be affected by concurrent medications, including H1-blockers. False study results are possible; thorough patient history is important in the interpretation of procedure results.
Sodium Bicarbonate: (Major) Co-administration with antacids within 15 minutes decreases the AUC and Cmax of fexofenadine. Separate administration is recommended.
St. John's Wort, Hypericum perforatum: (Minor) St. John's Wort may increase, decrease, or not change the plasma concentrations and AUC of fexofenadine. The mechanisms proposed have included CYP3A4 induction and/or altered P-glycoprotein efflux transport of fexofenadine. The clinical importance of this theoretical interaction has not been established; further study is needed.

Allegra Children's Allergy ODT/Allegra ODT Oral Tab Orally Dis: 30mg
Allegra/Allegra Allergy 12 Hour/Allegra Allergy 24 Hour/Allegra Children's Allergy/Allegra Hives/Allergy Relief/Fexofenadine/Fexofenadine Hydrochloride Oral Tab: 30mg, 60mg, 180mg
Allegra/Allegra Children's Allergy/Children's Allergy/Children's Allergy Fexofenadine/Fexofenadine/Fexofenadine Hydrochloride Oral Susp: 5mL, 30mg

180 mg/day PO if given once daily; 120 mg/day if given in 2 divided doses.

180 mg/day PO if given once daily; 120 mg/day if given in 2 divided doses.

180 mg/day PO if given once daily; 120 mg/day if given in 2 divided doses.

12 years: 180 mg/day PO if given once daily; 120 mg/day if given in 2 divided doses.
2 to 11 years: 60 mg/day PO.
Less than 2 years: 30 mg/day PO.

6 months and older: 30 mg/day PO.
Less than 6 months: Safety and efficacy have not been established.

Safety and efficacy have not been established.

Fexofenadine is an antihistamine with selective H1-receptor antagonist activity. Similar to other H1-blockers, fexofenadine does not prevent the release of histamine as do cromolyn and nedocromil, but competes with free histamine for binding at the H1-receptor. This competitive antagonism blocks the effects of histamine on H1-receptors in the GI tract, uterus, large blood vessels, and bronchial smooth muscle. Blockade of H1-receptors also suppresses the formation of edema, flare, and pruritus that result from histaminic activity. At higher concentrations, H1-receptor antagonism becomes relatively irreversible. Fexofenadine does not cross the blood-brain barrier and does not exert anticholinergic or alpha-1-antagonist effects in animal studies. In humans, CNS depression is minimal compared with first-generation H1-antagonists. Although fexofenadine is a metabolite of terfenadine which has been associated with QT prolongation and ventricular tachycardias (torsades de pointes), pre-marketing trials with fexofenadine demonstrated no significant prolongation of the QT interval; doses up to 800 mg/day have been studied.

Fexofenadine is administered orally. The onset of antihistamine effectiveness (evaluated by wheal and flare studies) is about 1 hour and persists for up to 12 hours. Protein binding ranges from 60% to 70%; fexofenadine is primarily bound to albumin and alpha-1-acid glycoprotein. Based on radiolabeled studies, approximately 80% and 11% of a dose was recovered in the feces and urine, respectively. Approximately 5% of the total administered dose is metabolized. Because the absolute bioavailability has not been determined, it is unknown if the fecal component represents unabsorbed drug or biliary excretion of the drug. Therefore, it is unknown if either renal excretion and/or metabolism plays a significant role in systemic drug elimination. The mean elimination half-life is approximately 14.4 hours in normal volunteers receiving 60 mg twice daily.
 
Affected Cytochrome P450 (CYP450) enzymes and drug transporters: P-glycoprotein (P-gp) and OATP
Fexofenadine is a substrate for P-glycoprotein (P-gp) and organic anion transporting peptide (OATP) transport.

Fexofenadine is rapidly absorbed. The absolute bioavailability of fexofenadine is unknown. The mean time to maximum plasma concentrations (Tmax) following oral administration with conventional tablets, capsule or oral solution is 2 to 3 hours and 1 hour, respectively. The Tmax of the orally disintegrating tablet (ODT) formulation is 2 hours post-dose. Administration of the ODT formulation with a high fat-meal decreases the AUC and maximum concentration (Cmax) by about 40% and 60%, respectively, and Tmax is delayed by 2 hours. When the conventional tablet or capsule is given with a high fat meal, the AUC and Cmax are decreased by approximately 20%. Mixing capsule contents with applesauce has no significant effect on the pharmacokinetic parameters. Administration of the oral suspension and a high fat meal decreases the exposure (AUC) and Cmax by approximately 30% and 47% respectively. The tablets, capsule, and oral suspension may be given with food. The fexofenadine ODT should be taken on an empty stomach, but it may be taken with water. Fexofenadine oral suspension is bioequivalent to fexofenadine tablets on a mg per mg basis.

There have been no adequate and well-controlled studies regarding the use of fexofenadine in human pregnancy. Results of animal studies have revealed an absence of mutagenicity or infertility. Teratogenicity was not observed in rats given approximately 15 times the maximum daily oral dose in humans based on an AUC comparison. Decreased pup weight gain and survival occurred in rats given 3 times the maximum daily oral dose in humans. Fexofenadine should be used during pregnancy only when the benefits of therapy outweigh the risks. One study examining the risk of adverse fetal outcomes associated with fexofenadine use during pregnancy concluded that it does not appear to be associated with an increased risk of adverse fetal outcomes. However, non-pharmacologic methods (e.g., fluids, rest) are recommended to be tried first during pregnancy and individuals should see their health care professional for a proper diagnosis and for treatment recommendations. Loratadine and oral cetirizine are acceptable antihistamine alternatives based on their excellent safety data and recommendation in multiple guidelines for use to treat allergies and urticaria during pregnancy. 

According to the manufacturer, caution should be exercised when fexofenadine is administered to a breast-feeding woman. It is unknown whether fexofenadine is excreted into human breast milk. Fexofenadine has generally been considered to be compatible with breast-feeding due to its low sedative activity; monitor the infant for irritability or for any effects of this antihistamine on lactation. Loratadine may be considered as an alternative for the treatment of allergy symptoms. Because of its lack of sedation and low milk concentrations, maternal use would not be expected to cause adverse effects in breast-fed babies and loratadine is considered usually compatible with breast-feeding. The British Society for Allergy and Clinical Immunology also recommends loratadine at the lowest dose as a preferred antihistamine in breast-feeding women. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.