Allegra

Unless your doctor tells you otherwise, continue your normal diet.

• Allegra^®

Allegra is both an over-the-counter and a prescription medication used to relieve the allergy symptoms of seasonal allergic rhinitis. It is also used to relieve symptoms of urticaria (hives) such as red, itchy raised areas of the skin, including itching and rash . 

Allegra is in a class of medications called antihistamines. These works by blocking the effects of histamine, a substance in the body that causes allergy symptoms.

Allegra comes as a tablet, an orally disintegrating tablet, and a suspension (liquid) to take by mouth. It is usually taken with water once or twice a day.

Common side effects of Allegra include headache, back pain, cough, diarrhea, and fatigue.

Allegra can also cause dizziness. Do not drive or operate heavy machinery until you know how Allegra affects you.

• Sanofi-Aventis U.S. LLC

Allegra is part of the drug class:

• Other antihistamines for systemic use

If you take too much Allegra, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Absorption

Bioavailability

Rapidly absorbed from the GI tract following oral administration,1 2 38 77 81 with peak plasma concentrations achieved in about 2.6 hours after administration as conventional capsules 1 2 or in about 1.8–2 hours after administration as extended-release tablets in fixed combination with pseudoephedrine hydrochloride.77 88

Conventional capsules and tablets are bioequivalent when administered at equal doses.1

Onset

Antihistaminic effect occurs within 1–3 hours.1

Duration

Antihistaminic effect persists for about 12 hours following oral administration of 20- or 40-mg doses.1 41 77 79 81 88

Food

No substantial alterations in fexofenadine pharmacokinetics observed in adults when contents of the 60-mg capsules were mixed with applesauce prior to administration.1

Administration with fruit juices (e.g., apple, grapefruit, orange) may reduce fexofenadine bioavailability compared with administration with water.77 88

Decreased rate and/or extent of absorption of fexofenadine observed when the fixed-combination preparations were administered concomitantly with a high-fat meal.77 88 (See Administration under Dosage and Administration.)

Special Populations

In patients with mild to severe renal impairment (Clcr of 11–80 mL/minute) and in those on hemodialysis (Clcr ≤ 10 mL/minute), peak plasma fexofenadine concentrations were increased by 87–111 and 82%, respectively, compared with those in healthy adults.1 77 88

In geriatric patients ≥65 years of age, peak plasma fexofenadine concentrations were 99% greater than in younger adults.1 2 36 77 79 88

Distribution

Extent

Distribution into human body tissues and fluid not fully elucidated;2 distributes into the small and large intestines, stomach, pancreas, liver, and kidney in animals.2 Distributed more extensively into plasma than blood or saliva.2 Does not appear to cross the blood-brain barrier.1 2 77 79 81 88

Not known whether fexofenadine crosses the placenta or distributes into milk.2

Plasma Protein Binding

60–70% (mainly albumin and α1-acid glycoprotein).1 2 77 88

Elimination

Metabolism

About 0.5–1.5% of a dose is metabolized in the liver by CYP enzymes, while about 3.5% is metabolized by a second metabolic pathway.70

Elimination Route

Excreted in feces (80%) and urine (11–12%).1 2 77 79 81 88

Half-life

14.4–14.6 hours.1 2 77 88

Special Populations

In patients with mild to severe renal impairment (Clcr of 11–80 mL/minute) and in those on hemodialysis (Clcr ≤10 mL/minute), half-life was 59–72 and 31% longer, respectively, compared with that in healthy adults.1 77 88

• Specific, selective, histamine H1-receptor antagonist.1 2 3 18 19 20 22 80

• Lacks cardiotoxic potential of terfenadine15 16 17 36 66 67 80 since it does not block the potassium channel involved in repolarization of cardiac cells (i.e., blockade of the delayed rectifier potassium current IK).1 8 16 36 66 67 80

• No appreciable anticholinergic,1 2 77 80 88 antidopaminergic,2 or α- or β-adrenergic blocking1 77 88 effects at usual antihistaminic doses in pharmacologic studies.

• In clinical studies, incidence of CNS effects (e.g., sedation, EEG disturbances, impaired psychomotor performance) associated with fexofenadine is similar to that with placebo and less than that with first generation antihistamines (e.g., chlorpheniramine, clemastine, diphenhydramine, triprolidine).1 70

In the U.S.

• Allegra
• Allegra ODT

Available Dosage Forms:

• Tablet
• Tablet, Disintegrating
• Capsule
• Suspension

Therapeutic Class: Respiratory Agent

Pharmacologic Class: Antihistamine, Less-Sedating

Chemical Class: Butyrophenone

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fexofenadine in children below 6 months of age. Safety and efficacy have not been established .

Do not give any cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Appropriate studies performed to date have not demonstrated geriatrics-specific problems that would limit the usefulness of fexofenadine in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require an adjustment in the dose for patients receiving fexofenadine .

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Eliglustat
• Simeprevir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• St John's Wort

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Apple Juice
• Grapefruit Juice
• Orange Juice

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Kidney disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body .

• Phenylketonuria—Use with caution. The oral disintegrating tablets contain phenylalanine .

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.

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.

Dizziness, drowsiness, and dry mouth have been reported with fexofenadine hydrochloride overdose. 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).

Provide the following information to patients and parents/caregivers of pediatric patients taking Allegra tablets, Allegra ODT or Allegra oral suspension:

• Allegra tablets, Allegra ODT or Allegra oral suspension are prescribed for the relief of symptoms of seasonal allergic rhinitis or for the relief of symptoms of chronic idiopathic urticaria (hives). Instruct patients to take Allegra only as prescribed. Do not exceed the recommended dose.If any untoward effects occur while taking Allegra, discontinue use and consult a doctor.

• Patients who are hypersensitive to any of the ingredients should not use these products.

• Patients who are pregnant or nursing should use these products only if the potential benefit justifies the potential risk to the fetus or nursing infant.

• Advise patients and parents/caregivers of pediatric patients to store the medication in a tightly closed container in a cool, dry place, away from small children.

• Advise patients and parents/caregivers not to take Allegra with fruit juices.

For Allegra tablets: Advise patients to take the Allegra tablets with water.

For Allegra ODT: Advise patients to take their dose on an empty stomach. Allow Allegra ODT to disintegrate on the tongue before swallowing, with or without water. Allegra ODT is not intended to be chewed. Store Allegra ODT in its original blister package. Do not remove Allegra ODT from the original blister package until the time of administration.

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.

For Allegra oral suspension: Advise patients and parents/caregivers of pediatric patients to shake the Allegra oral suspension bottle well, before each use.

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

Allegra ODT manufactured for:

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807

©2007 sanofi-aventis U.S. LLC

PRINCIPAL DISPLAY PANEL - 10 Blister Carton

NDC 0088-1113-30

Rx ONLY

Allegra®
fexofenadine HCl

ODT Orally Disintegrating Tablets, 30 mg

Ten 6 Tablet Blisters

sanofi aventis

PRINCIPAL DISPLAY PANEL - 30 mg Bottle Label

NDC 0088-1106-47

Allegra®
fexofenadine hydrochloride
Tablets

30mg

100 Tablets

sanofi aventis

PRINCIPAL DISPLAY PANEL - 60 mg Bottle Label

NDC 0088-1107-47

Allegra®
fexofenadine hydrochloride
Tablets

60mg

100 Tablets

sanofi aventis

PRINCIPAL DISPLAY PANEL - 180 mg Bottle Label

NDC 0088-1109-47

Allegra®
fexofenadine
hydrochloride
Tablets

180mg

100 Tablets

sanofi aventis

PRINCIPAL DISPLAY PANEL - 300 mL Bottle Label

NDC 0088-1097-20

Allegra®
fexofenadine HCl
Oral Suspension, 30mg/5mL (6mg/mL)

One 300mL Bottle

sanofi aventis

SHAKE WELL BEFORE USING

Rx ONLY

Each mL of Allegra® Oral Suspension contains 6mg
of fexofenadine hydrochloride

Dosage and Administration: See package insert.

WARNING: Keep out of reach of children.

Pharmacist: Dispense in light-resistant, tight
container with child-resistant closure.

Store at controlled room temperature 20–25°C
(68–77°F). [See USP Controlled Room
Temperature].

sanofi-aventis U.S. LLC

Bridgewater, NJ 08807
©2008
50087397

Ask a doctor or pharmacist before taking Allegra if you are allergic to any drugs, or if you have kidney disease.

Do not take Allegra with fruit juice (such as apple, orange, or grapefruit).

There may be other drugs that can affect Allegra. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Stop using Allegra and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor if your symptoms do not improve, or if they get worse after you start taking Allegra. Never use more than the recommended dose.

Use Allegra exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take the regular tablet with a full glass of water. Do not use any other type of liquid. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

To take fexofenadine orally disintegrating tablets (Allegra ODT):

• Keep the tablet in its blister pack until you are ready to take the medicine. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.

• Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.

• Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

• Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

Take the Allegra disintegrating tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

Tell your doctor if your symptoms do not improve, or if they get worse after you start taking Allegra. Never use more than the recommended dose.

Store Allegra at room temperature away from moisture and heat. Keep the medicine bottle tightly closed.

Get emergency medical help if you have any of these signs of an allergic reaction to Allegra: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Allegra and call your doctor if you have fever, chills, body aches, cough, or other flu symptoms.

Less serious Allegra side effects may include:

• nausea, diarrhea, upset stomach;

• menstrual cramps;

• drowsiness, tired feeling;

• headache; or

• muscle or back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This drug is a metabolite of terfenadine; when given terfenadine, animal models expressed this drug.

Use is not recommended. Excreted into human milk: Unknown Excreted into animal milk: Unknown Comment: -The effects in the nursing infant are unknown.