Fexofenadine 180mg Tablets

Manufacturer PADAGIS Active Ingredient Fexofenadine Tablets(feks oh FEN a deen) Pronunciation feks oh FEN a deen
It is used to ease allergy signs.It is used to treat hives.
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Drug Class
Antihistamine
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Pharmacologic Class
Histamine H1-receptor antagonist, second-generation
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Pregnancy Category
Category C
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FDA Approved
Jul 1996
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Fexofenadine is an antihistamine that helps 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. Unlike some older antihistamines, it is less likely to make you feel drowsy.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most benefit from your medication, follow these guidelines:

Take your medication exactly as directed by your doctor. Read all the information provided with your prescription and follow the instructions carefully.
Avoid consuming fruit juice while taking this medication.
Do not take antacids containing magnesium or aluminum at the same time as your medication. If you have any questions, consult with your doctor or pharmacist.
Swallow 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 the bathroom.
Keep all medications in a secure place, out of 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. Check with your pharmacist for guidance on the best disposal method, as there may be drug take-back programs available 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's 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 a missed one.
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Lifestyle & Tips

  • Avoid taking with fruit juices (grapefruit, orange, apple) as they can reduce the drug's effectiveness.
  • If you take antacids containing aluminum or magnesium, take fexofenadine at least 2 hours before or after the antacid.
  • Can be taken with or without food, but avoid fruit juices.
  • Do not take more than the recommended dose.

Dosing & Administration

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Adult Dosing

Standard Dose: 180 mg orally once daily
Dose Range: 60 - 180 mg

Condition-Specific Dosing:

Chronic Idiopathic Urticaria: 180 mg orally once daily
Seasonal Allergic Rhinitis: 180 mg orally once daily (or 60 mg twice daily)
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 6 to 11 years: 30 mg orally twice daily for seasonal allergic rhinitis or chronic idiopathic urticaria. Not recommended for children under 6 years.
Adolescent: 12 years and older: 180 mg orally once daily (or 60 mg twice daily) for seasonal allergic rhinitis or chronic idiopathic urticaria.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: Adults: 60 mg orally once daily. Children 6-11 years: 30 mg orally once daily.
Severe: Adults: 60 mg orally once daily. Children 6-11 years: 30 mg orally once daily.
Dialysis: Adults: 60 mg orally once daily. Children 6-11 years: 30 mg orally once daily. Fexofenadine is not effectively removed by hemodialysis.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Fexofenadine is a selective peripheral H1-blocker. It inhibits histamine-induced wheal and flare reactions. It is a carboxylic acid metabolite of terfenadine and is non-sedating because it does not readily cross the blood-brain barrier.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified, but rapidly absorbed.
Tmax: 2-3 hours
FoodEffect: Food (especially high-fat meals) may decrease Cmax and AUC slightly, but not considered clinically significant. Fruit juices (grapefruit, orange, apple) can significantly reduce bioavailability.

Distribution:

Vd: 5.4-5.8 L/kg
ProteinBinding: 60-70%
CnssPenetration: Limited

Elimination:

HalfLife: 11-15 hours
Clearance: Not readily available, but primarily renal and biliary excretion.
ExcretionRoute: Approximately 80% excreted in feces and 11% in urine, largely as unchanged drug.
Unchanged: Approximately 80% (feces) and 11% (urine)
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Pharmacodynamics

OnsetOfAction: Within 1 hour
PeakEffect: 2-6 hours
DurationOfAction: At least 24 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. Immediately contact your doctor or seek medical attention if you experience any of the following symptoms:

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
+ Swelling of the mouth, face, lips, tongue, or throat
Dizziness or fainting
Drooling
Flushing

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is essential to discuss any concerns with your doctor. Contact your doctor or seek medical help if you experience any of the following side effects or if they persist or bother you:

Headache
Children: Vomiting

Important Note

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing) - seek immediate medical attention.
  • Unusual tiredness or weakness
  • Nausea, vomiting
  • Dizziness, drowsiness (though rare with fexofenadine)
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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.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is crucial to verify that this medication can be taken with all your current medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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, consult with your doctor.

If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor, as it may interact with the medication. Individuals 65 years or older should exercise caution when using this drug, as they may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, consult with your doctor to weigh the benefits and risks of using this medication to you and your baby.

Specific Instructions for Hives

In the event of severe allergic reactions associated with hives, your doctor may prescribe an additional medication, epinephrine, for emergency use. It is essential to carry this medication with you at all times and understand how and when to administer it. Do not use this medication as a substitute for epinephrine in the event of a severe allergic reaction; instead, use the epinephrine as directed.
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Overdose Information

Overdose Symptoms:

  • Dizziness
  • Drowsiness
  • Dry mouth

What to Do:

Contact a poison control center immediately (1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive and symptomatic.

Drug Interactions

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Moderate Interactions

  • Aluminum and magnesium-containing antacids (e.g., Maalox, Mylanta): Can decrease fexofenadine absorption. Administer fexofenadine at least 2 hours before or after antacids.
  • Fruit juices (e.g., grapefruit, orange, apple juice): Can significantly reduce fexofenadine bioavailability. Avoid taking fexofenadine with these juices.

Monitoring

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Symptom Monitoring

  • Effectiveness in reducing allergy symptoms (sneezing, runny nose, itchy eyes, skin rash/hives)
  • Absence of sedation or other CNS effects
  • Occurrence of adverse effects (e.g., headache, nausea, dizziness)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some adverse effects at high doses, but human data are limited.

Trimester-Specific Risks:

First Trimester: Limited human data; animal studies suggest potential risk at high doses.
Second Trimester: Limited human data.
Third Trimester: Limited human data.
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Lactation

Fexofenadine is excreted into breast milk in small amounts. The American Academy of Pediatrics considers it compatible with breastfeeding. Monitor the infant for drowsiness or unusual irritability.

Infant Risk: Low risk; monitor for sedation or irritability.
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Pediatric Use

Approved for children 6 years and older. Dosing adjustments are necessary for younger children and those with renal impairment. Not recommended for children under 6 years.

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Geriatric Use

No specific dose adjustment is generally needed based on age alone. However, elderly patients are more likely to have decreased renal function, so dose adjustment may be necessary if renal impairment is present. Monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Fexofenadine is a second-generation antihistamine, known for its non-sedating profile due to minimal CNS penetration.
  • Crucial patient education point: avoid taking with fruit juices (grapefruit, orange, apple) due to significant reduction in absorption via OATP inhibition.
  • Advise patients to separate administration from aluminum/magnesium-containing antacids by at least 2 hours.
  • Effective for both seasonal allergic rhinitis and chronic idiopathic urticaria.
  • Consider lower doses in patients with renal impairment.
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Alternative Therapies

  • Loratadine (Claritin)
  • Desloratadine (Clarinex)
  • Cetirizine (Zyrtec)
  • Levocetirizine (Xyzal)
  • Azelastine (nasal spray)
  • Olopatadine (nasal spray)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with 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 seeking help, be prepared to provide information about the medication taken, the amount, and the time it happened.