Allegra-D

DRUG DESCRIPTION

ALLEGRA-D® 12 HOUR (fexofenadine hcl and pseudoephedrine hcl) (fexofenadine hydrochloride and pseudoephedrine hydrochloride) Extended-Release Tablets for oral administration contain 60 mg fexofenadine hydrochloride for immediate release and 120 mg pseudoephedrine hydrochloride for extended release. Tablets also contain as excipients: microcrystalline cellulose, pregelatinized starch, croscarmellose sodium, magnesium stearate, carnauba wax, stearic acid, silicon dioxide, hypromellose and polyethylene glycol.

Fexofenadine hydrochloride, one of the active ingredients of ALLEGRA-D (fexofenadine hcl and pseudoephedrine hcl) 12 HOUR, is a histamine H1-receptor antagonist with the chemical name (±)-4-[1-hydroxy-4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-butyl]-?, ?-dimethyl benzeneacetic acid hydrochloride and the following chemical structure:

Fexofenadine HCl Structural Formula Illustration

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.

Pseudoephedrine hydrochloride, the other active ingredient of ALLEGRA-D (fexofenadine hcl and pseudoephedrine hcl) 12 HOUR, is an adrenergic (vasoconstrictor) agent with the chemical name [S-(R*,R*)]-?-[1-(methylamino)ethyl]-benzenemethanol hydrochloride and the following chemical structure:

The molecular weight is 201.70. The molecular formula is C10H15NO•HCl. Pseudoephedrine hydrochloride occurs as fine, white to off-white crystals or powder, having a faint characteristic odor. It is very soluble in water, freely soluble in alcohol, and sparingly soluble in chloroform.

What are the possible side effects of fexofenadine and pseudoephedrine (Allegra -D 24 Hour, Allegra-D)?

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 using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • increased blood pressure (severe...

Read All Potential Side Effects and See Pictures of Allegra-D »

What are the precautions when taking fexofenadine hcl and pseudoephedrine hcl (Allegra-D)?

Before taking fexofenadine with pseudoephedrine, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow angle type), severe difficulty urinating (urinary retention), severe high blood pressure, severe heart/blood vessel disease (coronary artery disease), experienced serious side effects with decongestants (irregular heart rhythm).

Before using this medication, tell your doctor or pharmacist your medical history, especially of:...

Read All Potential Precautions of Allegra-D »


Allegra-D Consumer (continued)

SIDE EFFECTS: Nausea, stomach upset, trouble sleeping, headache, dizziness, nervousness or dry mouth may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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.

Tell your doctor immediately if any of these serious side effects occur: fast/irregular heartbeat, uncontrolled shaking or tremor.

Tell your doctor immediately if any of these unlikely but serious side effects occur: seizures, mental/mood changes.

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.

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 with pseudoephedrine, 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.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: glaucoma (narrow angle type), severe difficulty urinating (urinary retention), severe high blood pressure, severe heart/blood vessel disease (coronary artery disease), experienced serious side effects with decongestants (irregular heart rhythm).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, problems urinating (e.g., enlarged prostate), high blood pressure, diabetes, heart problems (e.g., ischemic heart disease), thyroid problems (hyperthyroidism), glaucoma (open angle type).

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

Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Allegra-D Patient Information Including Side Effects

Brand Names: Allegra -D 24 Hour, Allegra-D

Generic Name: fexofenadine and pseudoephedrine (Pronunciation: FEX oh FEN a deen and SOO doe ee FED rin)

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

What is fexofenadine and pseudoephedrine (Allegra-D)?

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.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of fexofenadine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Fexofenadine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What are the possible side effects of fexofenadine and pseudoephedrine (Allegra-D)?

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 using this medication and call your doctor at once if you have any of these serious side effects:

  • fast, pounding, or uneven heartbeat;
  • confusion, hallucinations, unusual thoughts or behavior;
  • severe dizziness, anxiety, restless feeling, or nervousness;
  • increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);
  • confusion, hallucinations, unusual thoughts or behavior;
  • easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
  • urinating less than usual or not at all.

Less serious side effects may include:

  • blurred vision;
  • dry mouth;
  • nausea, stomach pain, constipation;
  • mild loss of appetite, stomach upset;
  • warmth, tingling, or redness under your skin;
  • sleep problems (insomnia);
  • restless or excitability (especially in children);
  • skin rash or itching;
  • dizziness, drowsiness;
  • problems with memory or concentration; or
  • ringing in your ears.

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.

What is the most important information I should know about fexofenadine and pseudoephedrine (Allegra-D)?

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Fexofenadine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Avoid drinking alcohol. It can increase some of the side effects of this medication.

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