Pseudoephedrine-Fexofenadine

Pseudoephedrine-Fexofenadine is an over-the-counter medicine used to treat the symptoms of Seasonal Allergic Rhinitis with Nasal Congestion.

• Pseudoephedrine-Fexofenadine is available under the following different brand names: Allegra D, Allegra-D 12 Hour Allergy & Congestion, Allegra-D 24 Hour Allergy & Congestion

Common side effects of Pseudoephedrine-Fexofenadine include:

• mild dizziness,
• dry mouth, nose, or throat,
• nausea, and
• sleep problems (insomnia)

Serious side effects of Pseudoephedrine-Fexofenadine include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• pounding heartbeats,
• fluttering in the chest,
• severe dizziness,
• anxiety,
• restless feeling,
• tremors, and
• nervousness

Rare side effects of Pseudoephedrine-Fexofenadine include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult and pediatric dosage

Tablet, Extended-release 12 hours

• 120 mg/ 60 mg

Tablet, Extended-release 24 hours

• 240 mg/ 180 mg

Seasonal Allergic Rhinitis with Nasal Congestion

Adult dosage

• 12-Hour tab: 1 tab 60 mg fexofenadine/120 mg pseudoephedrine orally every 12 hours
• 24-Hour tab: 1 tab 180 mg fexofenadine/240 mg pseudoephedrine orally once a day

Pediatric dosage

• Children below 12 years
  • Safety and efficacy not established
• Children above 12 years
  • 12-Hour tab: 1 tab 60 mg fexofenadine/120 mg pseudoephedrine orally two times a day
  • 24-Hour tab: 1 tab 180 mg fexofenadine/240 mg pseudoephedrine orally once a day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first

• Pseudoephedrine-Fexofenadine has severe interactions with the following drugs:
  • dihydroergotamine
  • dihydroergotamine inhaled
  • dihydroergotamine intranasal
  • ergoloid mesylates
  • ergonovine
  • ergotamine
  • grapefruit
  • isocarboxazid
• Pseudoephedrine-Fexofenadine has serious interactions with at least 31 other drugs.
• Pseudoephedrine-Fexofenadine has moderate interactions with at least 110 other drugs.
• Pseudoephedrine-Fexofenadine has minor interactions with the following drugs:
  • amiodarone
  • atorvastatin
  • clarithromycin
  • clotrimazole
  • cyclosporine
  • desmopressin
  • dronedarone

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Documented hypersensitivity to drugs or ingredients
• Premature newborns and neonates
• Narrow-angle glaucoma
• Urinary retention
• Within fourteen (14) days of taking monoamine oxidase inhibitor
• Severe hypertension or severe coronary artery disease

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pseudoephedrine-Fexofenadine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pseudoephedrine-Fexofenadine?”

Cautions

• Administer lower initial dose (one tablet per day) to patients with decreased renal function; they have reduced elimination of fexofenadine and pseudoephedrine
• Patients should be instructed to take medication only as prescribed; do not exceed recommended dose; if nervousness, dizziness, or sleeplessness occur, discontinue use, and consult a doctor
• Patients should be advised against concurrent use of this drug with over-the-counter antihistamines and decongestants
• Patients should also be instructed to store the medication in a tightly closed container in a cool, dry place, away from children
• Patients should be told that the inactive ingredients may occasionally be eliminated in the feces in a form that may resemble the original tablet
• Giving fruit juice may decrease the efficacy

Pregnancy and Lactation

• There are no adequate and well-controlled studies on pregnant women; the drug combination should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus
• In mice, no adverse effects and no teratogenic effects during gestation were observed with fexofenadine at dietary doses up to 3730 mg/kg (approximately 15 times the maximum recommended human daily oral dose of this drug based on a comparison of the AUCs)
• Dose-related decreases in pup weight gain and survival were observed in rats exposed to an oral dose of 150 mg/kg of terfenadine; this dose produced an AUC of fexofenadine that was approximately 4 times the AUC at the maximum recommended human daily oral dose
• In mice, fexofenadine produced no effect on male or female fertility at average dietary doses up to 4438 mg/kg (approximately 15 times the maximum recommended human daily oral dose of this drug combination based on a comparison of the AUCs)
• Lactation
  • Not known if fexofenadine is excreted in human milk; because many drugs are excreted in human milk, use caution when fexofenadine hydrochloride is administered to a nursing woman; pseudoephedrine hydrochloride is administered alone or distributed into the breast milk of lactating human females
  • Pseudoephedrine concentrations in milk are consistently higher than those in plasma; the total amount of drug in milk as judged by AUC is 2 to 3 times greater than the plasma AUC; the fraction of a pseudoephedrine dose excreted in milk is estimated to be 0.4 % to 0.7 %
  • A decision should be made whether to discontinue nursing or to discontinue the drug, considering the importance of therapy to the mother; exercise caution when the drug combination is administered to nursing women