INDICATIONS AND USAGE

1.1 seasonal allergic rhinitis Allegra is indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 2 years and older.
1.2 chronic idiopathic urticaria Allegra is indicated for the treatment of skin manifestations of chronic idiopathic urticaria singles in adults and children 6 months and older.
2 DOSAGE AND ADMINISTRATION
2.1 Allegra tablets Allergic Rhinitis seasonal and chronic idiopathic urticaria Adults and children 12 years and older The recommended dose pill Allegra is 60 mg twice daily or 180 mg once daily with water. A dose of 60 mg once a day is recommended that the starting dose in patients with decreased renal function [see Clinical Pharmacology (12.3)]. Children 6 to 11 years. The recommended dose pill Allegra is 30 mg twice daily with water. A dose of 30 mg once a day is recommended that the starting dose for pediatric with decreased renal function [see Clinical Pharmacology (12.3)].
2.2 Allegra ODT Allergic Rhinitis seasonal and chronic idiopathic urticaria Children 6 to 11 years: Allegra ODT is to be used only in children 6 to 11 years. The recommended dose of Allegra ODT is 30 mg twice daily. A dose of 30 mg once a day is recommended that the starting dose for pediatric with decreased renal function [see Clinical Pharmacology (12.3)]. Allegra ODT aims to disintegrate on the tongue, followed by swallowing with or without water. Allegra ODT should be taken on an empty stomach. Allegra ODT is not intended to be chewed. Allegra ODT should not be removed from the original blister package until the administration.
2.3 Allegra Oral Suspension Seasonal allergic rhinitis Children 2 to 11 years: The recommended dose of Allegra oral suspension is 30 mg twice daily. A dose of 30 mg (5 mL) once a day is recommended that the starting dose for pediatric with decreased renal function [see Clinical Pharmacology (12.3)]. Shake the bottle before each use. Urticaria chronic idiopathic Children 6 months to 11 years: The recommended dose of Allegra oral suspension is 30 mg of (5 mL) twice daily for patients 2 to 11 years and 15 mg (2.5 mL) twice daily for patients 6 months at less than 2 years. For pediatric patients with decreased renal function, the recommended starting doses of Allegra oral suspension is 30 mg (5 mL) once daily for patients 2 to 11 years and 15 mg (2.5 mL) once per day for patients 6 months unless From 2 years [see Clinical Pharmacology (12.3)]. Shake the bottle before each use. 3 dosage forms and strengths Allegra tablets are available in 30 mg, 60 mg and 180 mg strengths. Allegra tablets are coated with a film of coating color fishing. Tablets have the form and following the unique identifiers: 30 mg tablets are round, bi-convex and have 03 on one side and a scripted "e" on the other; 60 mg are oval, bi-convex and have 06 on one side A written summary and "e" on the other; And 180 mg are oblong, bi-convex and have 018 on one side and a scripted "e" on the other. Allegra ODT is available in the form of 30 mg orally disintegrating tablet and white, flat face, ½-inch round shape with bevelled edges and sunken scripted with a "e" on one side and "311AV 's other side. Allegra oral suspension is available in 30 mg d '/ 5 mL (6 mg d' / ml) d '. 4 CONTRAINDICATIONS Allegra tablets, Allegra and Allegra ODT oral suspension are contraindicated in patients with known hypersensitivity to fexofenadine and one of the ingredients of Allegra. Rare cases of hypersensitivity reactions to events such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported. 5 warnings and precautions
5.1 Phenylketonuria ODT Allegra contains phenylalanine, a component of aspartame. Each 30 mg Allegra ODT contains 5.3 mg phenylalanine. Allegra Allegra products other than ODT do not contain phenylalanine.
6 REACTIONS
6.1 clinical studies of the experience Because clinical trials are conducted under different conditions, the rate of side effects seen in clinical trials of a drug can not be directly compared with the rate in clinical trials of another drug, and may not reflect the rates in practice. The safety data described below relate to exposure to fexofenadine hydrochloride 5083 patients in trials for allergic rhinitis and chronic idiopathic urticaria. In these trials, 3010 patients 12 years and older with seasonal allergic rhinitis were exposed to fexofenadine hydrochloride in doses of 20 to 240 mg twice daily or 120 to 180 mg once daily. A total of 646 patients 6 to 11 years of age with seasonal allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 15 to 60 mg twice daily. The duration of treatment in these trials was 2 weeks. A total of 534 patients 6 months to 5 years, with allergic rhinitis have been exposed to fexofenadine hydrochloride at doses of 15 to 30 mg twice daily. The duration of treatment in these studies ranged from 1 day to 2 weeks. There were 893 patients 12 years and older with chronic idiopathic urticaria in fexofenadine hydrochloride exposed to doses of 20 to 240 mg twice daily or 180 mg once daily. The duration of treatment in these trials was 4 weeks. Seasonal allergic rhinitis Adults and teens: In placebo-controlled seasonal allergic rhinitis clinical trials on subjects 12 years and older, 2439 subjects received fexofenadine hydrochloride capsules in doses of 20 mg to 240 mg twice daily. All adverse events were reported by more than 1% of subjects who received the recommended daily dose of fexofenadine hydrochloride (60 mg twice daily) are listed in Table 1. In another placebo-controlled clinical study in the United States, 571 subjects aged 12 years and older has received fexofenadine hydrochloride tablets at doses of 120 or 180 mg once daily. Table 1 also lists the possible side effects that have been reported by more than 2% of subjects treated with fexofenadine hydrochloride tablets at a dose of 180 mg once daily. The incidence of side effects, including drowsiness and fatigue, was not dose-related and is similar across subgroups defined by age, sex and race. Table 1 Adverse events in subjects aged 12 years and older reported in placebo-controlled seasonal allergic rhinitis clinical trials in the United States twice a day with fexofenadine capsules dosing at rates of more than 1% Reaction unwanted Fexofenadine 60 mg Twice a day Placebo Twice a day (N = 680) (N = 674) Frequency Frequency Dysmenorrea 1.5% 0.3% Once-daily dosing with fexofenadine hydrochloride tablets at rates of more than 2% Reaction unwanted Fexofenadine 180 mg Once a day Placebo (N = 283) (N = 293) Frequency Frequency Headache 10.3% 7.2% Pain 2.5% 1.4% The frequency and magnitude of laboratory abnormalities were similar in fexofenadine hydrochloride, and subjects treated with placebo. Pediatrics: Table 2 lists the side effects in subjects aged 6 years to 11 years were reported by more than 2% of subjects treated with fexofenadine hydrochloride tablets at a dose of 30 mg twice daily in placebo-controlled seasonal allergic rhinitis studies in the United States and Canada. Table 2 Adverse events observed in placebo-controlled seasonal allergic rhinitis studies in pediatric subjects aged from 6 years to 11 years in the United States and Canada at rates of more than 2% Adverse reaction Fexofenadine 30 mg Twice a day (N = 209) Placebo (N = 229) Frequency Frequency Cough 3.8% 1.3% Upper Respiratory Tract Infection 2.9% 0.9% Pyrexie 2.4% 0.9% Otitis Media 2.4% 0.0% Table 3 lists the side effects in patients 6 months to 5 years who were reported by more than 2% of subjects treated with fexofenadine hydrochloride 3 open single and multiple dose pharmacokinetic studies and 3 placebo-controlled studies security with fexofenadine hydrochloride capsule contents (484 subjects) and suspension (50 subjects) at doses of 15 mg of (108 subjects) and 30 mg of (426 subjects) given twice daily. Table 3 Adverse events observed in the placebo-controlled studies in children subjects with allergic rhinitis, aged 6 months to 5 years at rates in excess of 2% Adverse reaction Fexofenadine 15 mgTwice Daily Fexofenadine 30 mgTwice Daily Fexofenadine Total A placebo twice daily (N = 108) (N = 426) (N = 534) (N = 430) Frequency Frequency Frequency Frequency Vomiting 12.0% 4.2% 5.8% 8.6% Diarrhea 3.7% 2.8% 3.0% 2.6% Drowsiness / Fatigue 2.8% 0.9% 1.3% 0.2% Rhinorrhea 0.9% 2.1% 1.9% 0.9% Urticaria chronic idiopathic Adverse events reported by the subjects 12 years and older in placebo-controlled chronic idiopathic urticaria studies were similar to those reported in placebo-controlled studies of seasonal allergic rhinitis. In placebo-controlled chronic idiopathic urticaria clinical trials, 726 subjects 12 years and older has received fexofenadine hydrochloride tablets at doses of 20 to 240 mg twice daily. Table 4 lists the side effects in subjects aged 12 years and older who were reported by more than 2% of subjects treated with fexofenadine hydrochloride 60 mg twice daily in controlled clinical studies in the USA and Canada . In a placebo-controlled clinical study in the United States, 167 subjects aged 12 years and older has received fexofenadine hydrochloride 180 mg. Table 4 also lists the possible side effects that have been reported by more than 2% of subjects treated with fexofenadine hydrochloride tablets at a dose of 180 mg once daily. Table 4 Adverse events observed in patients 12 years and older in placebo-controlled studies chronic idiopathic urticaria twice a day with fexofenadine hydrochloride dosage studies in the United States and Canada at rates of more than 2% Reaction unwanted Fexofenadine 60 mg Twice a day (N = 191) Placebo (N = 183) Frequency Frequency Dizziness 2.1% 1.1% Pain 2.1% 1.1% Troubles digestive 2.1% 0.6% Pan in end 2.1% 0.0% Once-daily dosing with fexofenadine hydrochloride a study in the United States at a rate of more than 2% Reaction unwanted Fexofenadine 180 mg Once a day (N = 167) Placebo (N = 92) Frequency Frequency Headache 4.8% 3.3% The safety of fexofenadine hydrochloride in the treatment of chronic idiopathic urticaria in pediatric patients 6 months to 11 years is based on the safety profile of fexofenadine hydrochloride in adults and in children at doses equal to or greater than the recommended dosage [see employment in the People specific (8.4)] 6.2 Postmarketing Experience In addition to the adverse events reported in clinical trials and listed above, the following undesirable effects have been identified after the approval of the use Allegra. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to exposure to drugs. The events that have rarely been reported in post-marketing courses include: insomnia, nervousness, trouble sleeping or paroniria, and hypersensitivity reactions (including anaphylaxis, urticaria, angioedema, chest tightness, dyspnea, flushing , pruritus and rash). 7 Drug Interactions 7.1 Antacids Fexofenadine hydrochloride should not be taken in time closely with aluminum and magnesium-containing antacids. In subjects healthy adults, administration of 120 mg of fexofenadine hydrochloride (2 X 60 mg of the capsule) in the 15 minutes of aluminum and magnesium-containing antacids (Maalox) fell fexofenadine AUC by 41% and Cmax 43%. 7.2 Erythromycin and Ketoconazole Fexofenadine has been shown to exhibit minimal (about 5%) metabolism. However, the administration of fexofenadine hydrochloride or with ketoconazole or erythromycin resulted in increased plasma concentrations of fexofenadine in subjects healthy adults. Fexofenadine had no effect on the pharmacokinetics of a ketoconazole or erythromycin. In 2 separate studies subjects healthy adults, fexofenadine hydrochloride 120 mg twice daily (240 mg total daily dose) was co-administered with either erythromycin 500 mg every 8 hours or ketoconazole 400 mg once day under steady-state conditions in healthy subjects adults (N = 24, each study). No differences in adverse events or QTc interval was observed when subjects were administered fexofenadine hydrochloride alone or in combination either with ketoconazole or erythromycin. The results of these studies are summarized in the following table Table 5 Effects on the state of fexofenadine pharmacokinetics after 7 days of co-administration of fexofenadine hydrochloride 120 mg every 12 hours in healthy adult subjects (n = 24) concomitant drug CmaxSS (Pic plasma concentration) AUCss (0 to 12) (Measurement of systemic exposure) Erythromycin (500 mg every 8 hours) +82% +109% Ketoconazole (400 mg once daily) +135% +164% Changes in plasma levels were within the range of plasma levels achieved in adequate and well-controlled clinical trials. The mechanism of these interactions was assessed in vitro, in situ and in vivo animal models. These studies indicate that ketoconazole or erythromycin co improves fexofenadine gastrointestinal absorption. The observed increase in the bioavailability of fexofenadine may be due to effects related to transport, such as P-glycoprotein. In vivo animal studies also suggest that in addition to improving the uptake, ketoconazole secretion decreases fexofenadine gastrointestinal, while erythromycin may also reduce the biliary excretion. 7.3 Fruit juice Fruit juices, such as grapefruit, oranges and apples can reduce the bioavailability and exposure of fexofenadine. This is based on the results of 3 clinical studies using histamine-induced papules and rashes associated with a population pharmacokinetic analysis. The size of wheal and flare were significantly larger when fexofenadine hydrochloride was administered with either grapefruit or orange juice in relation to the water. Based on the reports of the literature, the same effects can be extrapolated to other fruit juices such as apple juice. The clinical significance of these findings is unknown. In addition, based on the population pharmacokinetic analysis of the combined data of grapefruit and orange juice with research data from a bioequivalence study, the bioavailability of fexofenadine was reduced by 36%. Therefore, in order to maximize the impact of fexofenadine, it is recommended that Allegra tablets should be taken with water [see Clinical Pharmacology (12.3) and Dosage and administration (2.1)]. ODT Allegra can be taken with or without water. (See Clinical Pharmacology (12.3) and Dosage and administration (2.2)]. 8 utilization in specific populations 8.1 Pregnancy Teratogenicity: Pregnancy Category C. There was no evidence of teratogenicity in rats or rabbits at oral doses of terfenadine up to 300 mg / kg, (which led to fexofenadine exposure were about 4 and 30 hours, respectively, the exhibition The maximum recommended daily oral dose of 180 mg of fexofenadine hydrochloride based on the comparison of AUCs). In mice, no adverse effects and no teratogenic effects were observed during gestation with fexofenadine hydrochloride oral doses up to 3730 mg / kg (which led to fexofenadine exposure, which were approximately 15 After exposure to the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride based on the comparison of AUCs). There are no adequate and well-controlled studies in pregnant women. Fexofenadine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Nonteratogenic effects: Dose linked to a small decrease in weight gain and survival were observed in rats exposed to an oral dose of 150 mg / kg of terfenadine (which led to fexofenadine exhibition, which were approximately 3 times exposure to the maximum recommended daily oral dose of 180 mg human of fexofenadine hydrochloride based on the comparison of AUCs). 8.3 Breastfeeding It is not known whether fexofenadine is excreted in human milk. There are no adequate and well-controlled studies in women during lactation. Because many drugs are excreted in human milk, caution should be exercised when fexofenadine hydrochloride is administered to a nursing woman. 8.4 Pediatric Use The recommended doses of fexofenadine hydrochloride in pediatrics 6 months to 11 years are based on studies comparing the pharmacokinetics of fexofenadine in adults and children on subjects and the safety profile of fexofenadine hydrochloride in both adults and children subjects at doses equal to or higher than the recommended doses.The safety and efficacy of fexofenadine hydrochloride in pediatrics under 6 months have not been established. The safety of fexofenadine hydrochloride is based on the administration of Allegra tablets at a dose of 30 mg twice daily demonstrated in 438 pediatric subjects 6 years to 11 years in 2 placebo-controlled for 2 weeks seasonal allergic rhinitis trial. The safety of fexofenadine hydrochloride at doses of 15mg and 30 mg once and twice daily was demonstrated in 969 pediatric subjects (6 months to 5 years) with allergic rhinitis in 3 pharmacokinetic studies and 3 of Security Studies. The safety of fexofenadine hydrochloride for the treatment of chronic idiopathic urticaria in patients 6 months to 11 years is based on studies comparing the pharmacokinetics of Allegra for adults and children on subjects and the safety profile of fexofenadine in both adult and pediatric subjects in doses equal to or greater than the recommended dose. The efficacy of fexofenadine hydrochloride for the treatment of seasonal allergic rhinitis in patients 6 to 11 years old, was demonstrated in 1 trial (N = 411) in which Allegra tablets 30 mg twice daily significantly reduced the symptoms by scores compared with placebo, and the extrapolation from the demonstrated effectiveness in subjects aged 12 years and older, comparisons and pharmacokinetics in adults and children. The efficacy of fexofenadine hydrochloride 30 mg twice daily for the treatment of seasonal allergic rhinitis in patients 2 to 5 years is based on comparisons of pharmacokinetics in adults and pediatric subjects and an extrapolation of evidence from the effectiveness of fexofenadine hydrochloride adult subjects with the state and the likelihood that the disease course, pathophysiology, and the influence of drugs are substantially similar in pediatric patients than in adult patients. The efficacy of fexofenadine hydrochloride for the treatment of chronic idiopathic urticaria in patients 6 months to 11 years is based on comparisons of pharmacokinetics in adults and children and an extrapolation of the effectiveness of Allegra demonstrated in adults with this disease and the probability that the disease, the pathophysiology and the effect of drugs are substantially the same among children than adult patients. Administration of 15 mg of fexofenadine hydrochloride Pediatric topics 6 months to less than 2 years and 30 mg for pediatric subjects 2 to 11 years of exposure produced comparable to those observed with a dose of 60 mg administered to adults. 8.5 Seniors Clinical studies of tablets and capsules Allegra did not include a sufficient number of subjects aged 65 years and older to determine if the population responds differently from younger subjects. Other reported clinical experience has not identified differences in responses between geriatrics and younger subjects. The drug is known to be substantially excreted by the kidneys and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because the elderly are more likely to have decreased renal function, care should be taken in choosing the dose, and it may be useful to monitor renal function [see Clinical Pharmacology (12.3)]. 8.6 renal Based on the increase in the bioavailability and half-life, a dose of 60 mg once a day is recommended that the starting dose in adult patients with decreased renal function (mild, moderate or severe renal insufficiency) . For pediatric patients with decreased renal function (mild, moderate or severe renal insufficiency), the recommended starting dose of fexofenadine is 30 mg once daily for patients 2 to 11 years and 15 mg once daily for patients 6 months to less than 2 years of age. [See Dosage and administration (2.2 and 2.3) and Clinical Pharmacology (12.3)] 8.7 liver The pharmacokinetics of fexofenadine hydrochloride in patients with hepatic impairment does not differ substantially from that observed in healthy subjects.