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(fexofenadine hydrochloride) Tablets, ODT (orally disintegrating tablets) and Oral Suspension
Fexofenadine hydrochloride, the active ingredient of ALLEGRA (fexofenadine hcl) tablets, ALLEGRA (fexofenadine hcl) ODT and ALLEGRA (fexofenadine hcl) oral suspension, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1 nylmethyl)-1-piperidinyl]-butyl]- α, α-dimethylhydroxy-4-benzeneacetic acid hydrochloride. It has the following chemical structure
The molecular weight is 538.13 and the empirical formula is C32H39NO4•HCl.
ALLEGRA (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. ALLEGRA (fexofenadine hydrochloride) is a racemate and exists as a zwitterion in aqueous media at physiological pH.
ALLEGRA (fexofenadine hcl) is formulated as a tablet for oral administration. Each tablet contains 30, 60, or 180 mg ALLEGRA (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 (fexofenadine hcl) ODT is formulated for disintegration in the mouth immediately following administration. Each orally disintegrating tablet contains 30 mg ALLEGRA (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 (fexofenadine hcl) oral suspension, a white uniform suspension, contains 6 mg ALLEGRA (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.
What are the possible side effects of fexofenadine (Allegra, Allegra ODT)?
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 fexofenadine 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 is not a complete list of side effects and others may occur. Call your doctor...
What are the precautions when taking fexofenadine hcl (Allegra)?
Before taking fexofenadine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Liquid products may contain sugar. The rapidly-dissolving tablets may contain aspartame. Caution is advised if you have diabetes, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet....
Last reviewed on RxList: 11/1/2010
This monograph has been modified to include the generic and brand name in many instances.
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