Generic Allegra

Fexofenadine hydrochloride, the active ingredient of Allegra tablets, Allegra ODT and Allegra oral suspension, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1 hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-α,α-dimethyl benzeneacetic acid hydrochloride. It has the following chemical structure

The molecular weight is 538.13 and the empirical formula is C32H39NO4•HCl.

Fexofenadine hydrochloride is a white to off-white crystalline powder. It is freely soluble in methanol and ethanol, slightly soluble in chloroform and water, and insoluble in hexane. Fexofenadine hydrochloride is a racemate and exists as a zwitterion in aqueous media at physiological pH.

Allegra is formulated as a tablet for oral administration. Each tablet contains 30, 60, or 180 mg fexofenadine hydrochloride (depending on the dosage strength) and the following excipients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. The aqueous tablet film coating is made from hypromellose, iron oxide blends, polyethylene glycol, povidone, silicone dioxide, and titanium dioxide.

Allegra ODT is formulated for disintegration in the mouth immediately following administration. Each orally disintegrating tablet contains 30 mg fexofenadine hydrochloride and the following excipients: citric acid anhydrous, crospovidone, magnesium stearate, mannitol, methacrylate copolymer, microcrystalline cellulose, povidone K-30, sodium bicarbonate, sodium starch glycolate, aspartame, natural and artificial orange flavor, artificial cream flavor, and alcohol anhydrous; the alcohol is predominantly removed during the manufacturing process.

Allegra oral suspension, a white uniform suspension, contains 6 mg fexofenadine hydrochloride per mL and the following excipients: propylene glycol, edetate disodium, propylparaben, butylparaben, xanthan gum, poloxamer 407, titanium dioxide, sodium phosphate monobasic monohydrate, sodium phosphate dibasic heptahydrate, artificial raspberry cream flavor, sucrose, xylitol and purified water.

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 timesthe 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).

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.

Before taking Allegra, tell your doctor if you are also taking ketoconazole (Nizoral), or erythromycin (E-Mycin, E.E.S., Ery-Tab, Erythrocin).

There may be other drugs that can interact with Allegra. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include dry mouth, dizziness, or drowsiness.

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.

Before using Allegra, tell your doctor if you are allergic to any drugs, or if you have kidney disease.
FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether this medication passes into breast milk or if it could harm a nursing baby. Do not use Allegra without telling your doctor if you are breast-feeding a baby. Allegra tablets and capsules may be used to treat seasonal allergy symptoms in children who are at least 6 years old. Allegra oral suspension (liquid) may be used in children ages 2 through 11. When treating chronic idiopathic urticaria, the liquid may be used in children as young as 2 months old.

• If you are buying Allegra for the first time, start with a small amount to make sure that Allegra works for you and then order more later.
• If you have been taking Allegra for a while and will continue to take it regularly, buy as much Allegra as you can at once. Most online drug stores offer discounted prices when you buy Allegra in large quantities. Plus, you won’t have to worry about refills for a while.
• Remember to consider the total cost of your Allegra order when you compare Allegra prices, including any doctor consultation fees and delivery charges.

Allegra provides the effective non-drowsy relief of symptoms associated with seasonal allergic rhinitis in adults and children 6 years of age and older: sneezing, itchy nose, throat, and watery, red eyes. Allegra is an antihistamine. Histamine is a chemical in your body that causes allergy symptoms. Allegra helps block the effect of histamine and relieves the allergic symptoms. Relief of allergy symptoms may begin in as little as 60 minutes. The Allegra family is available in a variety of dosages, but we only offer 180mg tablets taken once a day which can be taken with or without food. This dosage is for people 12 and older. Side effects with Allegra 180 mg for seasonal allergies are low and may include headache, cold, or back pain.