Prescription drugs info

Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity. Both enantiomers of fexofenadine hydrochloride displayed approximately equipotent antihistaminic effects. Fexofenadine hydrochloride inhibited antigen-induced bronchospasm in sensitized guinea pigs and histamine release from peritoneal mast cells in rats. The clinical significance of these findings is unknown. In laboratory animals, no anticholinergic or alpha1-adrenergic blocking effects were observed. Moreover, no sedative or other central nervous system effects were observed. Radiolabeled tissue distribution studies in rats indicated that fexofenadine does not cross the blood-brain barrier.

Click here to order Allegra, U.S. orders only

All other countries click here to buy Allegra

Reports of fexofenadine hydrochloride overdose have been infrequent and contain limited information. However, dizziness, drowsiness, and dry mouth have been reported. Single doses of fexofenadine hydrochloride up to 800 mg (6 healthy subjects at this dose level), and doses up to 690 mg twice daily for 1 month (3 healthy subjects at this dose level) or 240 mg once daily for 1 year (234 healthy subjects at this dose level) were administered without the development of clinically significant adverse events as compared to placebo.

In the event of overdose, consider standard measures to remove any unabsorbed drug. Symptomatic and supportive treatment is recommended. Following administration of terfenadine, hemodialysis did not effectively remove fexofenadine, the major active metabolite of terfenadine, from blood (up to 1.7% removed).

No deaths occurred at oral doses of fexofenadine hydrochloride up to 5000 mg/kg in mice (110 times the maximum recommended daily oral dose in adults and children based on mg/m2) and up to 5000 mg/kg in rats (230 times the maximum recommended daily oral dose in adults and 210 times the maximum recommended daily oral dose in children based on mg/m2). Additionally, no clinical signs of toxicity or gross pathological findings were observed. In dogs, no evidence of toxicity was observed at oral doses up to 2000 mg/kg (300 times the maximum recommended daily oral dose in adults and 280 times the maximum recommended daily oral dose in children based on mg/m2).

Click here to order Allegra, U.S. orders only

All other countries click here to buy Allegra

Clinical studies of Allegra tablets and capsules did not include sufficient numbers of subjects aged 65 years and over to determine whether this population responds differently from younger subjects. Other reported clinical experience has not identified differences in responses between the geriatric and younger subjects. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

Click here to order Allegra, U.S. orders only

All other countries click here to buy Allegra

The recommended doses of fexofenadine hydrochloride in pediatric patients 6 months to 11 years of age are based on cross-study comparison of the pharmacokinetics of fexofenadine in adults and pediatric subjects and on the safety profile of fexofenadine hydrochloride in both adult and pediatric subjects at doses equal to or higher than the recommended doses.

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 of age in 2 placebo-controlled 2-week seasonal allergic rhinitis trials. The safety of fexofenadine hydrochloride at doses of 15mg and 30 mg given once and twice a day has been demonstrated in 969 pediatric subjects (6 months to 5 years of age) with allergic rhinitis in 3 pharmacokinetic studies and 3 safety studies. The safety of fexofenadine hydrochloride for the treatment of chronic idiopathic urticaria in subjects 6 months to 11 years of age is based on cross-study comparison of the pharmacokinetics of Allegra in adult and pediatric subjects and on the safety profile of fexofenadine in both adult and pediatric subjects at doses equal to or higher than the recommended dose.

The effectiveness of fexofenadine hydrochloride for the treatment of seasonal allergic rhinitis in subjects 6 to 11 years of age was demonstrated in 1 trial (n=411) in which Allegra Tablets 30 mg twice daily significantly reduced total symptom scores compared to placebo, along with extrapolation of demonstrated efficacy in subjects aged 12 years and above, and the pharmacokinetic comparisons in adults and children. The effectiveness of fexofenadine hydrochloride 30 mg twice daily for the treatment of seasonal allergic rhinitis in patients 2 to 5 years of age is based on the pharmacokinetic comparisons in adult and pediatric subjects and an extrapolation of the demonstrated efficacy of fexofenadine hydrochloride in adult subjects with this condition and the likelihood that the disease course, pathophysiology, and the drug’s effect are substantially similar in pediatric patients to those in adult patients. The effectiveness of fexofenadine hydrochloride for the treatment of chronic idiopathic urticaria in patients 6 months to 11 years of age is based on the pharmacokinetic comparisons in adults and children and an extrapolation of the demonstrated efficacy of Allegra in adults with this condition and the likelihood that the disease course, pathophysiology and the drug’s effect are substantially similar in children to that of adult patients. Administration of a 15 mg dose of fexofenadine hydrochloride to pediatric subjects 6 months to less than 2 years of age and a 30 mg dose to pediatric subjects 2 to 11 years of age produced exposures comparable to those seen with a dose of 60 mg administered to adults.

The safety and effectiveness of fexofenadine hydrochloride in pediatric patients under 6 months of age have not been established.

Click here to order Allegra, U.S. orders only

All other countries click here to buy Allegra

It is not known if 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.

Click here to order Allegra, U.S. orders only

All other countries click here to buy Allegra

Teratogenic Effects
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 exposures that were approximately 4 and 30 times, respectively, the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride in adults based on comparison of AUCs).

In mice, no adverse effects and no teratogenic effects during gestation were observed with fexofenadine hydrochloride at oral doses up to 3730 mg/kg (which led to fexofenadine exposures that were approximately 15 times the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride in adults based on 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-related decreases in pup weight gain and survival were observed in rats exposed to an oral dose of 150 mg/kg of terfenadine (which led to fexofenadine exposures that were approximately 3 times the exposure at the maximum recommended human daily oral dose of 180 mg of fexofenadine hydrochloride in adults based on comparison of AUCs).

Click here to order Allegra, U.S. orders only

All other countries click here to buy Allegra

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.

Click here to order Allegra, U.S. orders only

All other countries click here to buy Allegra

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.

Click here to order Allegra, U.S. orders only

All other countries click here to buy Allegra

Allegra tablets dosage and administration
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.

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.

Allegra ODT dosage and administration
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.

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.

Allegra oral suspension dosage and administration
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.

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.

Shake bottle well, before each use.

Click here to order Allegra, U.S. orders only

All other countries click here to buy Allegra

-Allegra Tablets: 30 mg, 60 mg, and 180 mg
-Allegra ODT: 30 mg
- Allegra oral suspension: 30 mg/5mL (6mg/mL)

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)

Click here to order Allegra, U.S. orders only

All other countries click here to buy Allegra