Allegra-D 24 Hour

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. Cold or allergy medicine is usually taken only for a short time until your symptoms clear up.

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 crush, chew, or break an extended-release tablet. Swallow it whole.

Take fexofenadine and pseudoephedrine on an empty stomach, at least 1 hour before or 2 hours after a meal.

Take this medicine only with water. Avoid fruit juice; especially orange, apple, or grapefruit juice. Fruit juice can make it harder for your body to absorb fexofenadine.

Call your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need surgery or medical tests, tell the surgeon or doctor ahead of time if you have taken a cold or allergy medicine within the past few days.

Store at room temperature away from moisture and heat.

Avoid using antacids within 15 minutes before or after taking fexofenadine and pseudoephedrine. Antacids can make it harder for your body to absorb this medication.

Ask a doctor or pharmacist before using any other cold or allergy medicine. Many combination medicines contain pseudoephedrine. Taking certain products together can cause you to get too much of this medicine.

Drinking alcohol can increase certain side effects of this medication.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using fexofenadine and pseudoephedrine and call your doctor at once if you have:

• pounding heartbeats or fluttering in your chest; or

• severe dizziness, anxiety, restless feeling, tremors, or nervousness.

Common side effects may include:

• mild dizziness;

• dry mouth, nose, or throat;

• nausea; or

• sleep problems (insomnia).

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.

• Tell all of your health care providers that you take Allegra-D 24 Hour. This includes your doctors, nurses, pharmacists, and dentists.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take this medicine for longer than you were told by your doctor.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Allegra-D 24 Hour affects you.
• Avoid drinking alcohol while taking this medicine.
• Talk with your doctor before you use other drugs and natural products that slow your actions.
• Use with care in children. Talk with the doctor.
• Do not give to a child younger than 12 years of age.
• If you are 65 or older, use Allegra-D 24 Hour with care. You could have more side effects.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

ALLEGRA-D® 24 HOUR (fexofenadine hydrochloride and pseudoephedrine hydrochloride) Extended-Release Tablets for oral administration contain 180 mg fexofenadine hydrochloride for immediate release and 240 mg pseudoephedrine hydrochloride for extended release. Tablets also contain as excipients: microcrystalline cellulose, sodium chloride, cellulose acetate, polyethylene glycol, opadry white, povidone, talc, hypromellose, croscarmellose sodium, copovidone, titanium dioxide, magnesium stearate, colloidal silicon dioxide, brilliant blue aluminum lake, acetone, isopropyl alcohol, methyl alcohol, methylene chloride, water, and black ink.

Fexofenadine hydrochloride, one of the active ingredients of Allegra-D 24 Hour, 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 and 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.

Pseudoephedrine hydrochloride, the other active ingredient of Allegra-D 24 Hour, is an adrenergic (vasoconstrictor) agent with the chemical name [S-(R*,R*)]-α-[1-(methylamino)ethyl]-benzenemethanol hydrochloride and the following chemical structure:

The molecular weight is 201.70 and 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.

Allegra-D 24 Hour is contraindicated in patients with known hypersensitivity to any of its ingredients.

Due to its pseudoephedrine component, Allegra-D 24 Hour is contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment (see Drug Interactions section). It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include: insomnia, dizziness, weakness, tremor, or arrhythmias.

Most reports of fexofenadine hydrochloride overdose contain limited information. However, dizziness, drowsiness, and dry mouth have been reported. For the pseudoephedrine hydrochloride component of Allegra-D 24 Hour, information on acute overdose is limited to the marketing history of pseudoephedrine hydrochloride. Single doses of fexofenadine hydrochloride up to 800 mg (6 healthy volunteers at this dose level), and doses up to 690 mg twice daily for one month (3 healthy volunteers at this dose level), were administered without the development of clinically significant adverse events.

In large doses, sympathomimetics may give rise to giddiness, headache, nausea, vomiting, sweating, thirst, tachycardia, precordial pain, palpitations, difficulty in micturition, muscular weakness and tenseness, anxiety, restlessness, and insomnia. Many patients can present a toxic psychosis with delusions and hallucinations. Some may develop cardiac arrhythmias, circulatory collapse, convulsions, coma, and respiratory failure.

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). The effect of hemodialysis on the removal of pseudoephedrine is unknown.

No deaths occurred in mature mice and rats at oral doses of fexofenadine hydrochloride up to 5000 mg/kg (approximately 110 and 230 times, respectively, the maximum recommended human daily oral dose of Allegra-D 24 Hour on a mg/m2 basis.) The median oral lethal dose in newborn rats was 438 mg/kg (approximately 20 times the maximum recommended human daily oral dose of Allegra-D 24 Hour on a mg/m2 basis). In dogs, no evidence of toxicity was observed at oral doses up to 2000 mg/kg (approximately 300 times the maximum recommended human daily oral dose of Allegra-D 24 Hour on a mg/m2 basis). The oral median lethal dose of pseudoephedrine hydrochloride in rats was 1674 mg/kg (approximately 55 times the maximum recommended human daily oral dose of Allegra-D 24 Hour on a mg/m2 basis).

The recommended dose of Allegra-D 24 Hour Extended-Release Tablets is one tablet once daily administered on an empty stomach with water for adults and children 12 years of age and older. Allegra-D 24 Hour tablets should generally be avoided in patients with renal insufficiency. Allegra-D 24 Hour must be swallowed whole and never crushed or chewed.

Avoid using antacids within 15 minutes before or after taking Allegra-D 24 Hour. Antacids can make it harder for your body to absorb this medication.

Ask a doctor or pharmacist before using any other cold or allergy medicine. Many combination medicines contain pseudoephedrine. Taking certain products together can cause you to get too much of this medicine.

Drinking alcohol can increase certain side effects of this medication.

Taking this medicine with other drugs that make you sleepy or slow your breathing can worsen these effects. Ask your doctor before taking Allegra-D 24 Hour with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with fexofenadine and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.