Allegra

DRUG DESCRIPTION

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]- ?, ?-dimethylhydroxy-4-benzeneacetic acid hydrochloride. It has the following chemical structure

ALLEGRA® (fexofenadine hydrochloride) Structural Formula Illustration

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...

Read All Potential Side Effects and See Pictures of Allegra »

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.

Limit alcoholic beverages, as it may intensify drug side effects. (See also Side Effects.)

The rapidly dissolving tablet may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely.

Kidney function declines as you grow older. This...

Read All Potential Precautions of Allegra »


Allegra Consumer (continued)

SIDE EFFECTS: Stomach upset, menstrual cramps, back pain, cough, fever, stuffy nose, earache or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

This medication does not usually cause drowsiness when used at recommended doses and under normal circumstances. However, this drug may make you dizzy; therefore use caution engaging in activities that require alertness such as driving or using machinery.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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.

Limit alcoholic beverages, as it may intensify drug side effects. (See also Side Effects.)

The rapidly dissolving tablet may contain aspartame. If you have phenylketonuria (PKU) or any other condition that requires you to restrict your intake of aspartame (or phenylalanine), consult your doctor or pharmacist about using this drug safely.

Kidney function declines as you grow older. This medication is removed by the kidneys. The elderly may be more sensitive to the effects of this 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.


Allegra Patient Information Including Side Effects

Brand Names: Allegra, Allegra ODT

Generic Name: fexofenadine (Pronunciation: FEX oh FEN a deen)

  • What is fexofenadine (Allegra)?
  • What are the possible side effects of fexofenadine (Allegra)?
  • What is the most important information I should know about fexofenadine (Allegra)?
  • What should I discuss with my healthcare provider before taking fexofenadine (Allegra)?
  • How should I take fexofenadine (Allegra)?
  • What happens if I miss a dose (Allegra)?
  • What happens if I overdose (Allegra)?
  • What should I avoid while taking fexofenadine (Allegra)?
  • What other drugs will affect fexofenadine (Allegra)?
  • Where can I get more information?

What is fexofenadine (Allegra)?

Fexofenadine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Fexofenadine is used to treat the symptoms of seasonal allergies (hay fever) in adults and children.

Fexofenadine is also used to treat skin itching and hives caused by a condition called chronic idiopathic urticaria in adults and children.

Fexofenadine may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of fexofenadine (Allegra)?

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 for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about fexofenadine (Allegra)?

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.

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.

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