About Allegra.

Fexofenadine has been shown to exhibit minimal (ca. 5%) metabolism. However, co-administration of Fexofenadine hydrochloride with either ketoconazole or erythromycin led to increased plasma concentrations of Fexofenadine. Fexofenadine had no effect on the pharmacokinetics of either erythromycin or ketoconazole. In 2 separate studies, 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 daily under steady-state conditions to healthy volunteers (n=24, each study). No differences in adverse events or QTc interval were observed when subjects were administered Fexofenadine hydrochloride alone or in combination with either erythromycin or ketoconazole.

The changes in plasma levels were within the range of plasma levels achieved in adequate and well-controlled clinical trials.

The mechanism of these interactions has been evaluated in in vitro, in situ, and in vivo animal models. These studies indicate that ketoconazole or erythromycin co-administration enhances Fexofenadine gastrointestinal absorption. This observed increase in the bioavailability of Fexofenadine may be due to transport-related effects, such as p-glycoprotein. In vivo animal studies also suggest that in addition to enhancing absorption, ketoconazole decreases Fexofenadine gastrointestinal secretion, while erythromycin may also decrease biliary excretion.

Seasonal Allergic Rhinitis

Fexofenadine Hydrochloride Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older. Symptoms treated effectively were sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes.

Chronic Idiopathic Urticaria

Fexofenadine Hydrochloride Tablets are indicated for treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age and older. It significantly reduces pruritus and the number of wheals.

Before using fexofenadine, tell your doctor if you are allergic to any drugs, or if you have kidney disease.
Fruit juices and certain antacids can make it harder for your body to absorb fexofenadine. Take the disintegrating tablet on an empty stomach, at least 1 hour before or 2 hours after a meal.

There may be other drugs that can affect fexofenadine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Stop using this medication 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.

Less serious side effects are more likely, and you may have none at all. Tell your doctor about any unusual or bothersome side effect.

Tell your doctor if your symptoms do not improve, or if they get worse after you start taking fexofenadine. Never take more of the medication than your doctor has prescribed.

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.

ALLEGRA Tablets

Seasonal Allergic Rhinitis and Chronic Idiopathic Urticaria

Adults and Children 12 Years and Older

The recommended dose of ALLEGRA 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 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

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.

Take Allegra exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Take this medicine 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 Allegra orally disintegrating tablets:

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 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 take more of the medication than your doctor has prescribed.
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: 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 side effects may include:

• nausea, diarrhea, upset stomach;
• menstrual cramps;
• drowsiness, tired feeling;
• headache; or
• muscle or back pain.

This list is not complete and other side effects may occur. Tell your doctor about any unusual or bothersome side effect.

Allegra relieves the itchy, runny nose, sneezing, and itchy, red, watery eyes that come with hay fever. It is also used to relieve the itching and welts of hives. Allegra is a type of antihistamine that rarely causes drowsiness.

In addition to the antihistamine in Allegra, Allegra-D also contains the nasal decongestant pseudoephedrine.

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