Fexofenadine D 12hr 60-120mg ER Tb
It is used to treat nose stuffiness.It is used to ease allergy signs.
Drug Class
Antihistamine and Decongestant Combination
Pharmacologic Class
H1-receptor antagonist and Alpha-adrenergic agonist
Pregnancy Category
Category C
FDA Approved
Jan 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
This medication is a combination of an antihistamine (fexofenadine) and a decongestant (pseudoephedrine). It helps relieve symptoms of seasonal allergies like sneezing, runny nose, itchy eyes, and also clears up nasal congestion.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
Take your medication on an empty stomach.
Swallow the tablet whole, without chewing, breaking, crushing, or dissolving it.
Avoid taking antacids that contain magnesium or aluminum at the same time as your medication. If you have any questions, consult your doctor or pharmacist.
Do not consume fruit juice when taking this medication.
It's common to see the tablet shell in your stool after taking this medication. This is a normal occurrence and does not indicate a problem.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry location, avoiding bathrooms.
Keep all medications in a secure place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you take your medication on a regular schedule and miss a dose:
Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses.
If you take your medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely.
Take your medication on an empty stomach.
Swallow the tablet whole, without chewing, breaking, crushing, or dissolving it.
Avoid taking antacids that contain magnesium or aluminum at the same time as your medication. If you have any questions, consult your doctor or pharmacist.
Do not consume fruit juice when taking this medication.
It's common to see the tablet shell in your stool after taking this medication. This is a normal occurrence and does not indicate a problem.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication:
Store it at room temperature in a dry location, avoiding bathrooms.
Keep all medications in a secure place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist.
If you're unsure about the best way to dispose of your medication, consult your pharmacist. You may also have access to drug take-back programs in your area.
Missing a Dose
If you take your medication on a regular schedule and miss a dose:
Take the missed dose as soon as you remember.
If it's close to the time for your next dose, skip the missed dose and resume your regular dosing schedule.
* Do not take two doses at the same time or take extra doses.
If you take your medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
Lifestyle & Tips
- Take this medication with water, not with fruit juices (like grapefruit, orange, or apple juice), as fruit juices can reduce the effectiveness of fexofenadine. Wait at least 4 hours after drinking fruit juice before taking this medicine.
- Do not crush, chew, or break the extended-release tablet; swallow it whole.
- Pseudoephedrine can cause sleeplessness, so avoid taking the evening dose too close to bedtime.
- Stay hydrated to help with dry mouth, a common side effect.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg extended-release tablet taken twice daily
Dose Range:
60 - 120 mg
Condition-Specific Dosing:
allergicRhinitisAndNasalCongestion:
One tablet (60 mg fexofenadine / 120 mg pseudoephedrine) orally twice daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not recommended for children under 12 years of age due to pseudoephedrine component.
Adolescent:
For adolescents 12 years and older: One tablet (60 mg fexofenadine / 120 mg pseudoephedrine) orally twice daily.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment for mild impairment (CrCl > 80 mL/min).
Moderate:
For moderate to severe renal impairment (CrCl < 80 mL/min): One tablet (60 mg fexofenadine / 120 mg pseudoephedrine) orally once daily.
Severe:
For moderate to severe renal impairment (CrCl < 80 mL/min): One tablet (60 mg fexofenadine / 120 mg pseudoephedrine) orally once daily.
Dialysis:
Not well studied in dialysis patients; use with caution and consider once daily dosing.
Hepatic Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
No specific adjustment required.
Pharmacology
Mechanism of Action
Fexofenadine is a selective peripheral H1-receptor antagonist that inhibits histamine release from mast cells. Pseudoephedrine is a sympathomimetic amine that directly and indirectly stimulates alpha-adrenergic receptors in the nasal mucosa, causing vasoconstriction and reducing swelling.
Pharmacokinetics
Absorption:
Bioavailability:
Fexofenadine: Approximately 33%; Pseudoephedrine: Well absorbed.
Tmax:
Fexofenadine: 2-3 hours; Pseudoephedrine: 4-6 hours (for ER formulation).
FoodEffect:
Fexofenadine absorption is decreased by fruit juices (grapefruit, orange, apple). Pseudoephedrine absorption is not significantly affected by food.
Distribution:
Vd:
Fexofenadine: 5.4-18 L/kg; Pseudoephedrine: Widely distributed.
ProteinBinding:
Fexofenadine: 60-70%; Pseudoephedrine: Minimally bound.
CnssPenetration:
Fexofenadine: Limited; Pseudoephedrine: Yes (can cause CNS stimulation).
Elimination:
HalfLife:
Fexofenadine: 11-15 hours; Pseudoephedrine: 9-16 hours (for ER formulation).
Clearance:
Not available
ExcretionRoute:
Fexofenadine: Primarily unchanged in feces (80%) and urine (10%); Pseudoephedrine: Primarily unchanged in urine (55-90%), excretion rate is pH-dependent.
Unchanged:
Fexofenadine: ~80% (feces), ~10% (urine); Pseudoephedrine: 55-90% (urine).
Pharmacodynamics
OnsetOfAction:
Approximately 1 hour for symptomatic relief.
PeakEffect:
Fexofenadine: 2-6 hours; Pseudoephedrine: 4-8 hours.
DurationOfAction:
12 hours.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
- Symptoms of high blood pressure, including severe headache or dizziness, fainting, or changes in vision.
- Chest pain or pressure, rapid heartbeat, or irregular heartbeat.
- Shakiness.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Feeling dizzy or drowsy.
- Feeling nervous and excitable.
- Difficulty sleeping.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help right away:
- Signs of an allergic reaction, such as rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
- Symptoms of high blood pressure, including severe headache or dizziness, fainting, or changes in vision.
- Chest pain or pressure, rapid heartbeat, or irregular heartbeat.
- Shakiness.
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or do not go away, contact your doctor for advice:
- Feeling dizzy or drowsy.
- Feeling nervous and excitable.
- Difficulty sleeping.
Reporting Side Effects
This list does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or lightheadedness
- Fast, pounding, or irregular heartbeat (palpitations)
- Severe headache
- Extreme nervousness or anxiety
- Trouble sleeping (insomnia) that is severe or persistent
- Hallucinations or unusual thoughts/behavior
- Seizures
- Difficulty urinating
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reactions you have experienced.
Difficulty swallowing, as this may affect how you take the medication.
Recent use of certain medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this can lead to very high blood pressure.
Current use of linezolid or methylene blue, as these medications can interact with this drug.
Special Considerations for Children:
If the patient is under 12 years of age, do not administer this medication, as it is not recommended for children younger than 12 years old.
Additional Important Information:
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have.
Always verify with your doctor that it is safe to take this medication with your other medications and health conditions.
Never start, stop, or change the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reactions you have experienced.
Difficulty swallowing, as this may affect how you take the medication.
Recent use of certain medications for depression or Parkinson's disease within the last 14 days, such as isocarboxazid, phenelzine, tranylcypromine, selegiline, or rasagiline, as this can lead to very high blood pressure.
Current use of linezolid or methylene blue, as these medications can interact with this drug.
Special Considerations for Children:
If the patient is under 12 years of age, do not administer this medication, as it is not recommended for children younger than 12 years old.
Additional Important Information:
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have.
Always verify with your doctor that it is safe to take this medication with your other medications and health conditions.
Never start, stop, or change the dose of any medication without consulting your doctor first.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Adhere strictly to the dosage instructions provided by your doctor, as taking more than prescribed may increase your risk of experiencing severe side effects. Do not exceed the recommended treatment duration, and only take this medication for the length of time specified by your doctor.
Until you are familiar with how this medication affects you, exercise caution when engaging in activities that require alertness, such as driving. Additionally, avoid consuming alcohol while taking this drug, as it may interact with the medication.
Before using marijuana, other cannabis products, or prescription and over-the-counter (OTC) medications that can cause drowsiness, consult with your doctor to discuss potential interactions. If you are following a low-sodium or sodium-free diet, inform your doctor, as some formulations of this medication may contain sodium.
When administering this medication to children, use caution, as they may be at a higher risk of experiencing excitability. Elderly patients (65 years and older) should also exercise caution, as they may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to discuss the potential benefits and risks of taking this medication, both for you and your baby.
Until you are familiar with how this medication affects you, exercise caution when engaging in activities that require alertness, such as driving. Additionally, avoid consuming alcohol while taking this drug, as it may interact with the medication.
Before using marijuana, other cannabis products, or prescription and over-the-counter (OTC) medications that can cause drowsiness, consult with your doctor to discuss potential interactions. If you are following a low-sodium or sodium-free diet, inform your doctor, as some formulations of this medication may contain sodium.
When administering this medication to children, use caution, as they may be at a higher risk of experiencing excitability. Elderly patients (65 years and older) should also exercise caution, as they may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to discuss the potential benefits and risks of taking this medication, both for you and your baby.
Overdose Information
Overdose Symptoms:
- Fexofenadine: Drowsiness, dizziness, dry mouth, flushing, nausea, vomiting, abdominal pain.
- Pseudoephedrine: Restlessness, tremor, hyperreflexia, rapid breathing, confusion, hallucinations, palpitations, arrhythmias, hypertension, seizures, coma.
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center. In the US, call 1-800-222-1222.
Drug Interactions
Contraindicated Interactions
- Monoamine Oxidase Inhibitors (MAOIs) within 14 days (due to pseudoephedrine)
- Severe hypertension (due to pseudoephedrine)
- Severe coronary artery disease (due to pseudoephedrine)
- Narrow-angle glaucoma (due to pseudoephedrine)
- Urinary retention (due to pseudoephedrine)
Major Interactions
- Other sympathomimetics (e.g., decongestants, appetite suppressants, amphetamines) - additive effects, increased risk of cardiovascular events.
- Beta-adrenergic blocking agents - reduced antihypertensive effect, risk of hypertension.
- Tricyclic antidepressants - additive sympathomimetic effects.
- Digitalis glycosides - increased risk of ectopic pacemaker activity.
Moderate Interactions
- Antacids containing aluminum or magnesium hydroxide - decrease fexofenadine absorption.
- Erythromycin or Ketoconazole - may increase fexofenadine plasma levels (though not clinically significant for fexofenadine itself, caution advised).
Minor Interactions
- Alcohol - no potentiation of CNS depressant effects with fexofenadine.
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: Pseudoephedrine can increase blood pressure, especially in susceptible individuals.
Timing: Prior to initiation of therapy.
Heart Rate
Rationale: Pseudoephedrine can cause tachycardia or palpitations.
Timing: Prior to initiation of therapy.
Routine Monitoring
Blood Pressure
Frequency: Periodically, especially in patients with pre-existing hypertension or cardiovascular conditions.
Target: Maintain within patient's normal range.
Action Threshold: Significant increase (e.g., >20 mmHg systolic or >10 mmHg diastolic) warrants re-evaluation or discontinuation.
Heart Rate
Frequency: Periodically.
Target: Maintain within patient's normal range.
Action Threshold: Persistent tachycardia or palpitations warrants re-evaluation.
Symptom Relief (Allergy/Congestion)
Frequency: Daily during initial therapy, then as needed.
Target: Significant reduction in sneezing, rhinorrhea, itchy eyes/nose, and nasal congestion.
Action Threshold: Lack of efficacy after appropriate trial period.
Adverse Effects (e.g., insomnia, nervousness, dry mouth)
Frequency: Daily during initial therapy, then as needed.
Target: Absence or tolerability of side effects.
Action Threshold: Intolerable side effects warrant dose adjustment or discontinuation.
Symptom Monitoring
- Nasal congestion
- Sneezing
- Rhinorrhea (runny nose)
- Itchy eyes/nose/throat
- Insomnia
- Nervousness
- Dizziness
- Dry mouth
- Headache
- Palpitations
- Increased blood pressure
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Pseudoephedrine has been associated with gastroschisis in some studies, though causality is not definitively established.
Trimester-Specific Risks:
First Trimester:
Pseudoephedrine: Potential association with gastroschisis; use with caution.
Second Trimester:
Generally considered safer than first trimester, but still Category C.
Third Trimester:
Pseudoephedrine: May cause maternal hypertension or fetal tachycardia; avoid close to term.
Lactation
L3 (Moderately safe). Both fexofenadine and pseudoephedrine pass into breast milk. Pseudoephedrine can decrease milk supply, especially in mothers with established lactation.
Infant Risk:
Low risk of adverse effects in breastfed infants with fexofenadine. Pseudoephedrine may cause irritability or sleep disturbances in infants. Risk of decreased milk supply for the mother.
Pediatric Use
Not recommended for children under 12 years of age due to the pseudoephedrine component and potential for serious adverse effects, especially in younger children. Over-the-counter cough and cold products containing decongestants are generally not recommended for children under 4-6 years.
Geriatric Use
Use with caution in elderly patients due to increased susceptibility to the sympathomimetic effects of pseudoephedrine (e.g., CNS stimulation, cardiovascular effects, urinary retention). Start with the lower end of the dosing range and monitor closely.
Clinical Information
Clinical Pearls
- Advise patients to avoid taking this medication with fruit juices (grapefruit, orange, apple) as they can significantly reduce fexofenadine absorption.
- Due to the pseudoephedrine component, this medication is typically sold behind the pharmacy counter and may have purchase limits.
- Patients with hypertension, heart disease, thyroid disease, diabetes, or prostate enlargement should consult their doctor before using this medication due to the pseudoephedrine content.
- Pseudoephedrine can cause insomnia; advise patients not to take the evening dose too close to bedtime.
Alternative Therapies
- Nasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis and congestion.
- Oral antihistamines alone (e.g., fexofenadine, loratadine, cetirizine) for allergy symptoms without congestion.
- Topical decongestant nasal sprays (e.g., oxymetazoline, phenylephrine) for short-term congestion relief (use limited to 3-5 days to avoid rebound congestion).
- Saline nasal sprays for nasal irrigation and moisturizing.
Cost & Coverage
Average Cost:
Varies widely, typically $20-$60 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Generics are typically Tier 1 or 2; Brand-name products are typically Tier 3 or higher.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.