Fexofenadine 60mg Tablets
It is used to ease allergy signs.It is used to treat hives.
Drug Class
Antihistamine
Pharmacologic Class
H1-receptor antagonist (second-generation)
Pregnancy Category
Category C
FDA Approved
Jul 1996
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fexofenadine is a non-drowsy antihistamine used to relieve allergy symptoms like sneezing, runny nose, itchy eyes, and hives. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. When taking this medication, avoid consuming fruit juice. Additionally, do not take antacids containing magnesium or aluminum at the same time as your medication; instead, consult with your doctor or pharmacist for guidance. Take your medication with a full glass of water.
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. If you have questions about the best disposal method, consult your pharmacist. You may also want to inquire about drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. When taking this medication, avoid consuming fruit juice. Additionally, do not take antacids containing magnesium or aluminum at the same time as your medication; instead, consult with your doctor or pharmacist for guidance. Take your medication with a full glass of water.
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. If you have questions about the best disposal method, consult your pharmacist. You may also want to inquire about drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take with water, not fruit juices (like grapefruit, orange, or apple juice), as these can reduce the effectiveness of the medication.
- Do not take with antacids containing aluminum or magnesium within 2 hours of taking fexofenadine, as they can also reduce absorption.
- This medication is generally non-drowsy, but individual responses can vary. Avoid activities requiring mental alertness until you know how it affects you.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
60 mg twice daily or 180 mg once daily
Dose Range:
60 - 180 mg
Condition-Specific Dosing:
Seasonal Allergic Rhinitis:
60 mg twice daily or 180 mg once daily
Chronic Idiopathic Urticaria:
60 mg twice daily
Pediatric Dosing
Neonatal:
Not established
Infant:
6 months to <2 years: 15 mg oral suspension twice daily (for SAR)
Child:
2-11 years: 30 mg oral suspension twice daily (for SAR/CIU); 6-11 years: 30 mg tablet twice daily (for SAR/CIU)
Adolescent:
12 years and older: Same as adult dosing (60 mg twice daily or 180 mg once daily)
Dose Adjustments
Renal Impairment:
Mild:
Adults: 60 mg once daily; Pediatric (6-11 years): 30 mg once daily
Moderate:
Adults: 60 mg once daily; Pediatric (6-11 years): 30 mg once daily
Severe:
Adults: 60 mg once daily; Pediatric (6-11 years): 30 mg once daily
Dialysis:
No additional dose adjustment needed after dialysis, as minimal drug is removed by hemodialysis.
Hepatic Impairment:
Mild:
No adjustment
Moderate:
No adjustment
Severe:
No adjustment
Pharmacology
Mechanism of Action
Fexofenadine is a selective peripheral H1-blocker. It inhibits histamine-induced wheal and flare reactions. It does not readily cross the blood-brain barrier, which accounts for its non-sedating properties.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely determined (rapidly absorbed)
Tmax:
1-3 hours
FoodEffect:
Food decreases Cmax and AUC slightly (by 17% and 16% respectively), but not considered clinically significant. However, fruit juices can significantly reduce bioavailability.
Distribution:
Vd:
5.6 L/kg
ProteinBinding:
60-70%
CnssPenetration:
Limited
Elimination:
HalfLife:
14.4 hours
Clearance:
Not available
ExcretionRoute:
Primarily fecal (80%), with a smaller portion in urine (11.5%)
Unchanged:
Approximately 80% (feces) and 11.5% (urine)
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
2-3 hours
DurationOfAction:
24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Dizziness or fainting
- Drooling
- Flushing
Other Possible Side Effects
Most medications can cause side effects, but many people either do not experience them or have only mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Headache
- In children: Vomiting
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.
If you experience any of the following symptoms, call your doctor or seek medical attention immediately, as they may be signs of a severe and potentially life-threatening reaction:
- 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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Dizziness or fainting
- Drooling
- Flushing
Other Possible Side Effects
Most medications can cause side effects, but many people either do not experience them or have only mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- Headache
- In children: Vomiting
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:
- Signs of an allergic reaction (e.g., rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing) - seek immediate medical attention.
- Worsening of allergy symptoms or no improvement after several days of use.
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, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken in conjunction with your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting 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, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.
To ensure your safety, it is crucial to verify that this medication can be taken in conjunction with your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. Adhere to the prescribed dosage and duration of treatment, and do not exceed the recommended frequency or duration of use as indicated by your doctor or the product label.
This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
Before consuming alcohol, marijuana, or other forms of cannabis, or using prescription or over-the-counter (OTC) medications that may cause drowsiness or slow your reactions, consult with your doctor. Additionally, if you regularly drink grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with the medication.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of the medication to you and your baby.
Specific Instructions for Hives
If you are being treated for hives, your doctor may prescribe an additional medication, epinephrine, to be used in case of a severe allergic reaction. It is essential to carry this medication with you at all times and understand how and when to use it. Do not use this medication (the original drug) as a substitute for epinephrine to treat a severe allergic reaction.
When taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are using this drug. Adhere to the prescribed dosage and duration of treatment, and do not exceed the recommended frequency or duration of use as indicated by your doctor or the product label.
This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.
Before consuming alcohol, marijuana, or other forms of cannabis, or using prescription or over-the-counter (OTC) medications that may cause drowsiness or slow your reactions, consult with your doctor. Additionally, if you regularly drink grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with the medication.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor, as they will need to discuss the potential benefits and risks of the medication to you and your baby.
Specific Instructions for Hives
If you are being treated for hives, your doctor may prescribe an additional medication, epinephrine, to be used in case of a severe allergic reaction. It is essential to carry this medication with you at all times and understand how and when to use it. Do not use this medication (the original drug) as a substitute for epinephrine to treat a severe allergic reaction.
Overdose Information
Overdose Symptoms:
- Dizziness
- Drowsiness
- Dry mouth
What to Do:
In case of overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive and symptomatic.
Drug Interactions
Moderate Interactions
- Aluminum and magnesium-containing antacids (e.g., Maalox, Mylanta): Decreased fexofenadine absorption.
- Fruit juices (e.g., grapefruit, orange, apple): Significantly decreased fexofenadine bioavailability.
Minor Interactions
- Erythromycin: May slightly increase fexofenadine plasma levels (not clinically significant).
- Ketoconazole: May slightly increase fexofenadine plasma levels (not clinically significant).
Monitoring
Routine Monitoring
Symptom relief (e.g., sneezing, rhinorrhea, itching, urticaria)
Frequency: Daily
Target: Significant reduction or absence of symptoms
Action Threshold: If symptoms persist or worsen after several days of use, re-evaluate diagnosis or treatment plan.
Symptom Monitoring
- Reduction in sneezing
- Reduction in runny nose
- Reduction in itchy eyes/nose/throat
- Reduction in watery eyes
- Reduction in skin itching and hives (urticaria)
Special Patient Groups
Pregnancy
Fexofenadine is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies show some adverse effects at high doses. Use only if clearly needed.
Second Trimester:
Limited human data; generally considered safer than first trimester, but still Category C.
Third Trimester:
Limited human data; generally considered safer than first trimester, but still Category C.
Lactation
Fexofenadine is excreted into breast milk in small amounts. It is generally considered compatible with breastfeeding (LactMed rating L2 - Safer).
Infant Risk:
Low risk of adverse effects in breastfed infants. Monitor infants for drowsiness or unusual irritability, though these are unlikely.
Pediatric Use
Dosing is established for children 6 months and older for specific indications (seasonal allergic rhinitis, chronic idiopathic urticaria). Use appropriate formulations (oral suspension for younger children). Safety and efficacy in children younger than 6 months have not been established.
Geriatric Use
No specific dose adjustment is generally required in elderly patients with normal renal function. However, due to the higher likelihood of decreased renal function in the elderly, dose adjustment may be necessary based on renal impairment guidelines. Monitor for adverse effects.
Clinical Information
Clinical Pearls
- Fexofenadine is a second-generation antihistamine known for its non-sedating profile due to limited CNS penetration.
- Advise patients to take fexofenadine with water, and to avoid taking it with fruit juices (grapefruit, orange, apple) as they can significantly reduce its absorption and effectiveness.
- Also, advise patients to separate administration from aluminum- or magnesium-containing antacids by at least 2 hours.
- It has a relatively long half-life, allowing for once-daily dosing for many indications (e.g., 180 mg once daily for seasonal allergic rhinitis).
- Consider renal dose adjustment in patients with impaired kidney function.
Alternative Therapies
- Other second-generation antihistamines (e.g., Loratadine, Cetirizine, Desloratadine, Levocetirizine)
- Nasal corticosteroids (e.g., Fluticasone, Mometasone)
- Mast cell stabilizers (e.g., Cromolyn sodium nasal spray)
- Leukotriene receptor antagonists (e.g., Montelukast)
Cost & Coverage
Average Cost:
Typically low (generic) per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure 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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.