Fexofenadine/pseudoephedrine

What is Fexofenadine/pseudoephedrine?

• Fexofenadine/pseudoephedrine (Allegra-D) is a combination of Fexofenadine hydrochloride, a histamine H1-receptor antagonist and Pseudoephedrine hydrochloride, an adrenergic (vasoconstrictor) agent.

Fexofenadine

Pseudoephedrine Structure

What are the uses of this medicine?

• Fexofenadine/pseudoephedrine (Allegra-D) is used for the relief of symptoms associated with seasonal allergic rhinitis in adults and children 12 years of age and older. Symptoms treated effectively include sneezing, rhinorrhea, itchy nose/palate/ and/or throat, itchy/watery/red eyes, and nasal congestion.

• Fexofenadine/pseudoephedrine (Allegra-D) should be administered when both the antihistaminic properties of fexofenadine hydrochloride and the nasal decongestant properties of pseudoephedrine hydrochloride are desired.

How does this medicine work?

• Fexofenadine hydrochloride, the major active metabolite of terfenadine, is an antihistamine with selective peripheral H1-receptor antagonist activity.
• Pseudoephedrine hydrochloride is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa.

• Pseudoephedrine hydrochloride is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. Pseudoephedrine produces peripheral effects similar to those of ephedrine and central effects similar to, but less intense than, amphetamines.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with known hypersensitivity to any of its ingredients
• with narrow-angle glaucoma or urinary retention
• receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment
• with severe hypertension, or severe coronary artery disease

What drug interactions can this medicine cause?

• Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Be sure to mention the medications listed below:

• asthma medications
• diet pills
• digoxin (Digitek, Lanoxin, Lanoxicaps)
• erythromycin (E.E.S., E-Mycin, Erythrocin)
• ketoconazole (Nizoral)
• medications for high blood pressure such as methyldopa (Aldomet) and reserpine (Serpalan, Serpasil, Serpatabs)
• over-the-counter antihistamines
• decongestants
• stimulants

Is this medicine FDA approved?

• In 2019, it was the 380th most commonly prescribed medication in the United States, with more than 500 thousand prescriptions.

How should this medicine be used?

Recommended dosage:

• The fexofenadine and pseudoephedrine 12-hour tablet is usually taken once or twice a day on an empty stomach with water.
• The fexofenadine and pseudoephedrine 24-hour tablet is usually taken once a day on an empty stomach with water.

Administration:

• The combination of fexofenadine and pseudoephedrine comes as an extended-release (long-acting) tablet to take by mouth.
• Fexofenadine and pseudoephedrine will work better if it is not taken with fruit juices such as orange, grapefruit, or apple juice.
• Take fexofenadine and pseudoephedrine at around the same time(s) every day.
• Swallow the tablets whole; do not split, chew, or crush them.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Allegra-D® 24 HOUR (fexofenadine hydrochloride and pseudoephedrine hydrochloride) Extended-Release Tablets
• Allegra-D® 12 HOUR (fexofenadine hydrochloride and pseudoephedrine hydrochloride) Extended-Release Tablets

This medicine is available in fallowing brand namesː

• Allegra-D

What side effects can this medication cause?

The most common side effects of this medicine include:

• Headache
• Upper Respiratory Tract Infection
• Back Pain
• Nervousness
• excitability
• restlessness
• dizziness
• weakness
• insomnia
• Headache
• drowsiness
• tachycardia
• palpitation
• pressor activity
• cardiac arrhythmias
• ischemic colitis
• fear
• anxiety
• tenseness
• tremor
• hallucinations
• seizures
• pallor
• respiratory difficulty
• dysuria
• cardiovascular collapse

What special precautions should I follow?

• Sympathomimetic amines should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or prostatic hypertrophy.
• Because Allegra-D 24 HOUR is a once-daily, fixed-dose combination that cannot be titrated and renal insufficiency. Allegra-D tablets should generally be avoided in patients with renal insufficiency.
• Do not exceed the recommended dose. If nervousness, dizziness, or sleeplessness occur, discontinue use and consult the doctor. Patients should also be advised against the concurrent use of Allegra-D tablets with over-the-counter antihistamines and decongestants.
• The product should not be used by patients who are hypersensitive to it or to any of its ingredients.
• Due to its pseudoephedrine component, this product should not be used by patients with narrow-angle glaucoma, urinary retention, or by patients receiving a monoamine oxidase (MAO) inhibitor or within 14 days of stopping use of MAO inhibitor.
• It also should not be used by patients with severe hypertension or severe coronary artery disease.
• Patients should be advised to take the tablet on an empty stomach with water.
• Patients should be directed to swallow the tablet whole.
• Patients should be cautioned not to break or chew the tablet.
• Patients should also be instructed to store the medication in a tightly closed container in a cool, dry place, away from children.
• It is not known if fexofenadine is excreted in human milk. Because many drugs are excreted in human milk, caution should be used when fexofenadine hydrochloride is administered to a nursing woman.

What to do in case of emergency/overdose?

Symptoms of overdose may include:

• dizziness
• drowsiness
• dry mouth
• giddiness
• headache
• nausea
• vomiting
• sweating
• thirst
• tachycardia
• precordial pain
• palpitations
• difficulty in micturition
• muscular weakness and tenseness
• anxiety
• restlessness
• insomnia
• psychosis with delusions and hallucinations
• cardiac arrhythmias
• circulatory collapse
• convulsions
• coma
• respiratory failure

Management of overdosage:

• In the event of overdose, consider standard measures to remove any unabsorbed drug.
• Symptomatic and supportive treatment is recommended.
• The effect of hemodialysis on the removal of pseudoephedrine is unknown.
• Following administration of terfenadine, hemodialysis did not effectively remove fexofenadine, the major active metabolite of terfenadine, from blood.

Can this medicine be used in pregnancy?

• Category C.
• Patients should be told that this product should be used in pregnancy or lactation only if the potential benefit justifies the potential risk to the fetus or nursing infant.

Can this medicine be used in children?

• Safety and effectiveness of Allegra-D in children below the age of 12 years have not been established.
• Allegra-D is not recommended for pediatric patients under 12 years of age.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• FEXOFENADINE HYDROCHLORIDE
• PSEUDOEPHEDRINE HYDROCHLORIDE

Inactive Ingredients:

• CELLULOSE, MICROCRYSTALLINE
• SODIUM CHLORIDE
• CELLULOSE ACETATE
• POLYETHYLENE GLYCOL
• POVIDONE
• TALC
• HYPROMELLOSE
• CROSCARMELLOSE SODIUM
• COPOVIDONE
• TITANIUM DIOXIDE
• MAGNESIUM STEARATE
• SILICON DIOXIDE
• FD&C BLUE NO. 1
• ALUMINUM OXIDE
• ACETONE
• ISOPROPYL ALCOHOL
• METHYL ALCOHOL
• METHYLENE CHLORIDE
• WATER

Who manufactures and distributes this medicine?

• sanofi-aventis U.S. LLC
• Bridgewater, NJ

What should I know about storage and disposal of this medication?

• Store Allegra-D 12 HOUR Extended-Release Tablets at 20–25°C (68–77°F).
• Store Allegra-D 24 HOUR Extended-Release Tablets at 20–25°C (68–77°F).

• Dailymed label info on Fexofenadine/pseudoephedrine
• FDA Fexofenadine/pseudoephedrine

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