ALLEGRA

ALLEGRA- fexofenadine hydrochloride tablet, orally disintegrating
ALLEGRA- fexofenadine hydrochloride tablet, film coated
ALLEGRA- fexofenadine hydrochloride suspension
sanofi-aventis U.S. LLC

1 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 of age and older.

1.2 Chronic Idiopathic Urticaria

ALLEGRA is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older.

2 DOSAGE AND ADMINISTRATION

2.1 ALLEGRA tablets

Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria

Adults and Children 12 Years and Older

The recommended dose of ALLEGRA tablets is 60 mg twice daily or 180 mg once daily with water. A dose of 60 mg once daily is recommended as the starting dose in patients with decreased renal function [see Clinical Pharmacology (12.3)].

Children 6 to 11 Years.

The recommended dose of ALLEGRA tablets is 30 mg twice daily with water. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function [see Clinical Pharmacology (12.3)].

2.2 ALLEGRA ODT

Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria

Children 6 to 11 Years:

ALLEGRA ODT is intended for use only in children 6 to 11 years of age. The recommended dose of ALLEGRA ODT is 30 mg twice daily. A dose of 30 mg once daily is recommended as the starting dose in pediatric patients with decreased renal function [see Clinical Pharmacology (12.3)].

ALLEGRA ODT is designed 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 time of 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 daily is recommended as the starting dose in pediatric patients with decreased renal function [see Clinical Pharmacology (12.3)].

Shake bottle well, before each use.

Chronic Idiopathic Urticaria

Children 6 Months to 11 Years:

The recommended dose of ALLEGRA oral suspension is 30 mg (5 mL) twice daily for patients 2 to 11 years of age and 15 mg (2.5 mL) twice daily for patients 6 months to less than 2 years of age. For pediatric patients with decreased renal function, the recommended starting doses of ALLEGRA oral suspension are 30 mg (5 mL) once daily for patients 2 to 11 years of age and 15 mg (2.5 mL) once daily for patients 6 months to less than 2 years of age [see Clinical Pharmacology (12.3)].

Shake bottle well, 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 peach colored film coating. Tablets have the following unique shape and identifiers: 30 mg tablets are round, bi-convex and have 03 on one side and a scripted “e” on the other; 60 mg tablets are oval, bi-convex and have 06 on one side and a scripted “e” on the other; and 180 mg tablets are oblong, bi-convex and have 018 on one side and a scripted “e” on the other.

ALLEGRA ODT is available as a 30 mg orally disintegrating tablet and is white, flat-faced, ½-inch round shaped with beveled edges and debossed with a scripted “e” on one side and “311AV” on the other side.

ALLEGRA oral suspension is available as 30 mg/ 5 mL (6 mg/mL).

4 CONTRAINDICATIONS

ALLEGRA tablets, ALLEGRA ODT and ALLEGRA oral suspension are contraindicated in patients with known hypersensitivity to fexofenadine and any of the ingredients of ALLEGRA. Rare cases of hypersensitivity reactions with manifestations such as angioedema, chest tightness, dyspnea, flushing and systemic anaphylaxis have been reported.

5 WARNINGS AND PRECAUTIONS

5.1 Phenylketonurics

ALLEGRA ODT contains phenylalanine, a component of aspartame. Each 30 mg ALLEGRA ODT contains 5.3 mg phenylalanine. ALLEGRA products other than ALLEGRA ODT do not contain phenylalanine.

6 ADVERSE REACTIONS

6.1 Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety data described below reflect exposure to fexofenadine hydrochloride in 5083 patients in trials for allergic rhinitis and chronic idiopathic urticaria. In these trials, 3010 patients 12 years of age and older with seasonal allergic rhinitis were exposed to fexofenadine hydrochloride at 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 of age with allergic rhinitis were exposed to fexofenadine hydrochloride at doses of 15 to 30 mg twice daily. The duration of treatment in these trials ranged from 1 day to 2 weeks. There were 893 patients 12 years of age and older with chronic idiopathic urticaria exposed to fexofenadine hydrochloride at 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 Adolescents: In placebo-controlled seasonal allergic rhinitis clinical trials in subjects 12 years of age and older, 2439 subjects received fexofenadine hydrochloride capsules at doses of 20 mg to 240 mg twice daily. All adverse reactions that were reported by greater than 1% of subjects who received the recommended daily dose of fexofenadine hydrochloride (60 mg capsules twice daily) are listed in Table 1.

In another placebo-controlled clinical study in the United States, 571 subjects aged 12 years and older received fexofenadine hydrochloride tablets at doses of 120 or 180 mg once daily. Table 1 also lists adverse reactions that were reported by greater than 2% of subjects treated with fexofenadine hydrochloride tablets at doses of 180 mg once daily.

The incidence of adverse reactions, including somnolence/fatigue, was not dose-related and was similar across subgroups defined by age, gender, and race.

Table 1 Adverse reactions in subjects aged 12 years and older reported in placebo-controlled seasonal allergic rhinitis clinical trials in the United States
Twice-daily dosing with fexofenadine capsules at rates of greater than 1%
Adverse reaction Fexofenadine 60 mg Twice Daily Placebo Twice Daily
(n=680) (n=674)
Frequency Frequency
Dysmenorrhea 1.5% 0.3%
Once-daily dosing with fexofenadine hydrochloride tablets at rates of greater than 2%
Adverse reaction Fexofenadine 180 mg Once Daily Placebo
(n=283) (n=293)
Frequency Frequency
Headache 10.3% 7.2%
Back Pain 2.5% 1.4%

The frequency and magnitude of laboratory abnormalities were similar in fexofenadine hydrochloride- and placebo-treated subjects.

Pediatrics: Table 2 lists adverse reactions in subjects aged 6 years to 11 years of age which were reported by greater 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 reactions reported in placebo-controlled seasonal allergic rhinitis studies in pediatric subjects aged 6 years to 11 years in the United States and Canada at rates of greater than 2%
Adverse reaction Fexofenadine 30 mg Twice Daily(n=209) Placebo (n=229)
Frequency Frequency
Cough 3.8% 1.3%
Upper Respiratory Tract Infection 2.9% 0.9%
Pyrexia 2.4% 0.9%
Otitis Media 2.4% 0.0%

Table 3 lists adverse reactions in subjects 6 months to 5 years of age which were reported by greater than 2% of subjects treated with fexofenadine hydrochloride in 3 open single- and multiple-dose pharmacokinetic studies and 3 placebo-controlled safety studies with fexofenadine hydrochloride capsule content (484 subjects) and suspension (50 subjects) at doses of 15 mg (108 subjects) and 30 mg (426 subjects) given twice a day.

Table 3 Adverse reactions reported in placebo-controlled studies in pediatric subjects with allergic rhinitis aged 6 months to 5 years of age at rates greater than 2%
Adverse reaction Fexofenadine 15 mg Twice Daily Fexofenadine 30 mg Twice Daily Fexofenadine Total Twice Daily Placebo
(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%
Somnolence/Fatigue 2.8% 0.9% 1.3% 0.2%
Rhinorrhea 0.9% 2.1% 1.9% 0.9%

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