Allegra ODT

Name: Allegra ODT

What is Allegra ODT (fexofenadine)?

Fexofenadine is an antihistamine that reduces the effects of 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 not listed in this medication guide.

How should I take Allegra ODT (fexofenadine)?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Take the regular tablet 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 fexofenadine orally disintegrating tablets (Allegra ODT):

  • 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 fexofenadine. Never use more than the recommended dose.

Store at room temperature away from moisture and heat. Keep the medicine bottle tightly closed.

Uses For Allegra ODT

Fexofenadine is an antihistamine. It is used to relieve the symptoms of hay fever (seasonal allergic rhinitis) and hives of the skin (chronic idiopathic urticaria) .

Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. Also, in some people histamine can close up the bronchial tubes (air passages of the lungs) and make breathing difficult. Histamine can also cause some people to have hives, with severe itching of the skin .

This medicine is available only with your doctor's prescription .

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Allegra ODT Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
  • Chest tightness
  • feeling of warmth, redness of the face, neck, arms and occasionally, upper chest
  • large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • shortness of breath, difficult or labored breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Vomiting
Less common
  • Back pain
  • body aches or pain
  • chills
  • coughing
  • diarrhea
  • difficulty with moving
  • dizziness
  • ear congestion
  • earache
  • fever
  • headache
  • joint pain
  • loss of voice
  • muscle aching or cramping
  • muscle pains or stiffness
  • nasal congestion
  • nausea
  • pain in arms or legs
  • pain or tenderness around eyes or cheekbones
  • painful menstrual bleeding
  • redness or swelling in ear
  • ringing or buzzing in ears
  • runny or stuffy nose
  • sleepiness or unusual drowsiness
  • sneezing
  • sore throat
  • stomach upset
  • swollen joints
  • unusual feeling of tiredness or weakness
  • viral infection (such as cold and flu)
Rare
  • Nervousness
  • rash
  • sleeplessness
  • terrifying dreams
  • trouble sleeping

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

What do I need to tell my doctor BEFORE I take Allegra ODT?

  • If you have an allergy to fexofenadine or any other part of Allegra ODT (fexofenadine orally disintegrating tablets).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Allegra ODT?

  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

For Healthcare Professionals

Applies to fexofenadine: oral capsule, oral suspension, oral tablet, oral tablet disintegrating

General

The most commonly reported side effects included headache, drowsiness, dizziness, and nausea.[Ref]

Gastrointestinal

Very common (10% or more): Vomiting (up to 12%)
Common (1% to 10%): Nausea, diarrhea, stomach discomfort[Ref]

Nervous system

Very common (10% or more): Headache (up to 10.3%)
Common (1% to 10%): Drowsiness, dizziness, somnolence[Ref]

Other

Common (1% to 10%): Otitis media, pyrexia, fatigue, extremity pain[Ref]

Respiratory

Common (1% to 10%): Cough, upper respiratory tract infection, rhinorrhea
Frequency not reported: Dyspnea[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Genitourinary

Common (1% to 10%): Dysmenorrhea[Ref]

Psychiatric

Frequency not reported: Insomnia, nervousness, nightmares, sleep disorders or paroniria/excessive dreaming[Ref]

Cardiovascular

Frequency not reported: Palpitations, tachycardia, chest tightness[Ref]

Hypersensitivity

Frequency not reported: Hypersensitivity reactions, angioedema, systemic anaphylaxis[Ref]

Dermatologic

Frequency not reported: Rash, pruritus, flushing[Ref]

Some side effects of Allegra ODT may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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