About Allegra.

Fruit juices such as grapefruit, orange and apple may reduce the bioavailability and exposure of fexofenadine. This is based on the results from 3 clinical studies using histamine induced skin wheals and flares coupled with population pharmacokinetic analysis. The size of wheal and flare were significantly larger when fexofenadine hydrochloride was administered with either grapefruit or orange juices compared to water. Based on the literature reports, the same effects may be extrapolated to other fruit juices such as apple juice. The clinical significance of these observations is unknown. In addition, based on the population pharmacokinetics analysis of the combined data from grapefruit and orange juices studies with the data from a bioequivalence study, the bioavailability of fexofenadine was reduced by 36%. Therefore, to maximize the effects of fexofenadine, it is recommended that Allegra tablets should be taken with water

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).

Adults and Children 12 Years and Older

For hay fever, the usual dosage is 60 milligrams twice a day or 180 milligrams once a day. For hives, it’s 60 milligrams twice a day. If you have kidney problems, your doctor may have you take only one 60-milligram dose daily.

Children 6 through 11 years old

For hay fever or hives, the usual dosage is 30 milligrams twice a day. Children with kidney problems may be prescribed only one 30-milligram dose each day.

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.

DRUG INTERACTIONS: Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: antacids containing aluminum and magnesium, St. John’s wort. Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain additional antihistamines that could increase your risk for side effects. Ask your pharmacist about the safe use of those products. Do not start or stop any medicine without doctor or pharmacist approval.

OVERDOSE: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: unusual drowsiness.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: The manufacturer of U.S. products recommends storage at room temperature between 68-77 degrees F (20-25 degrees C). The manufacturer of Canadian products recommends storage at room temperature between 59-86 degrees F (15-30 degrees C). Store away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.

MEDICAL ALERT: Your condition can cause complications in a medical emergency.

• Individuals who are allergic to fexofenadine or any of its ingredients
• Individuals who are pregnant, think they may be pregnant, or are planning to become pregnant
• Individuals who are breastfeeding

taking fexofenadine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, heart problems (QT prolongation). Limit alcoholic beverages, as it may intensify drug side effects. (See also Side Effects.) Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

• Do not take Allegra close to a dose of an antacid that contains aluminum or magnesium such as Rolaids, Maalox, Mylanta, Milk of Magnesia, Pepcid Complete, and others. These antacids may decrease the effects of Allegra.
• Drugs other than those listed here may also interact with Allegra. Talk to your doctor and pharmacist before taking other medications, including herbal products

Seasonal Allergic Rhinitis

ALLEGRA tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older.

ALLEGRA Oral Suspension is indicated for the relief of symptoms associated with seasonal allergic rhinitis in children 2 to 11 years of age.

Symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes.

Chronic Idiopathic Urticaria

ALLEGRA tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older.

ALLEGRA Oral Suspension is indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in children 6 months to 11 years of age.

Fexofenadine hydrochloride significantly reduces pruritus and the number of wheals.

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.