Fexofenadine 180mg Tablets (otc)

Manufacturer DR.REDDY'S 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
Selective peripheral H1-receptor antagonist
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Pregnancy Category
Not available
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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 without causing drowsiness. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure you get the most out of your medication, follow these guidelines:

Take your medication exactly as directed by your doctor.
Carefully read all the information provided with your medication and follow the instructions closely.
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 your doctor or pharmacist.
Swallow your medication with a full glass of water.

Storing and Disposing of Your Medication

To maintain the quality and safety of your medication:

Store it at room temperature in a dry place, avoiding the bathroom.
Keep all medications in a secure location, 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.
If you are 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.

What to Do If You Miss a Dose

If you miss a dose, follow these steps:

Take the missed dose as soon as you remember.
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.
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Lifestyle & Tips

  • Take with water, not fruit juices (e.g., grapefruit, orange, apple juice) as they can reduce the drug's effectiveness.
  • Avoid taking antacids containing aluminum or magnesium within 2 hours of taking fexofenadine, as they can also reduce absorption.
  • This medication is generally non-drowsy, so it can be taken during the day.
  • 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: 180 - 180 mg

Condition-Specific Dosing:

seasonal_allergic_rhinitis: 180 mg orally once daily
chronic_idiopathic_urticaria: 180 mg orally once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established for 180 mg dose (6-11 years: 30 mg twice daily for SAR; 60 mg once daily for CIU)
Adolescent: 12 years and older: 180 mg orally once daily
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: 60 mg orally once daily
Severe: 60 mg orally once daily
Dialysis: 60 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-receptor antagonist. It inhibits histamine release from mast cells and basophils, thereby preventing the effects of histamine on H1 receptors, which include vasodilation, increased vascular permeability, and pruritus. It has minimal to no sedative or anticholinergic effects due to its inability to cross the blood-brain barrier significantly.
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely defined (variable, influenced by efflux transporters)
Tmax: 1-3 hours
FoodEffect: Food (especially high-fat meals) can decrease absorption. Fruit juices (grapefruit, orange, apple) significantly decrease absorption.

Distribution:

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

Elimination:

HalfLife: 11-15 hours
Clearance: Not readily available (primarily renal and biliary excretion)
ExcretionRoute: Primarily feces (approximately 80%) and urine (approximately 10%)
Unchanged: Approximately 80% (feces), 10% (urine)
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Pharmacodynamics

OnsetOfAction: Approximately 1 hour
PeakEffect: 2-3 hours
DurationOfAction: 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 may not experience any side effects or only minor ones, it's 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 or vomiting that is severe or persistent
  • Dizziness or lightheadedness
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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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor identify 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 it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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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 to discuss potential interactions.

If you regularly consume grapefruit juice or eat grapefruit, consult with your doctor to determine if any adjustments to your treatment plan are necessary. Elderly patients (65 years or older) should exercise caution when using this medication, as they may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks of this medication to you and your baby. Your doctor will help you weigh the advantages and disadvantages of treatment.

Special Considerations for Hives

In cases of hives, your doctor may prescribe an additional medication, epinephrine, to be used in emergency situations involving severe allergic reactions. It is essential to carry this medication with you at all times and understand how and when to administer it. However, do not use this medication (the original drug) as a substitute for epinephrine in treating severe allergic reactions.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Dizziness
  • Dry mouth

What to Do:

In case of overdose, call your poison control center at 1-800-222-1222. If the person has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Drug Interactions

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Moderate Interactions

  • Aluminum and magnesium-containing antacids (e.g., Maalox, Mylanta)
  • Fruit juices (e.g., grapefruit, orange, apple juice)
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Minor Interactions

  • Erythromycin
  • Ketoconazole

Monitoring

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Routine Monitoring

Symptom relief (e.g., sneezing, runny nose, itchy eyes, hives)

Frequency: Daily, as needed

Target: Reduction or absence of symptoms

Action Threshold: Persistent or worsening symptoms despite regular use

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Symptom Monitoring

  • Effectiveness in reducing allergy symptoms (sneezing, runny nose, itchy/watery eyes, itchy nose/throat)
  • Effectiveness in reducing hives and itching (for CIU)
  • Occurrence of side 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. Limited human data are available.

Trimester-Specific Risks:

First Trimester: Limited data, generally considered low risk based on animal studies.
Second Trimester: Limited data, generally considered low risk.
Third Trimester: Limited data, generally considered low risk.
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Lactation

Fexofenadine is excreted in human breast milk in small amounts. Generally considered compatible with breastfeeding, but monitor infant for potential drowsiness or irritability.

Infant Risk: Low risk (L3 - Moderately safe)
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Pediatric Use

The 180 mg dose is approved for children 12 years and older. Lower doses (30 mg or 60 mg) are available for younger children (6-11 years) for specific indications. Not recommended for children under 6 years of age.

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Geriatric Use

No specific dose adjustment is needed based on age alone. However, dose adjustment is recommended for elderly patients with renal impairment.

Clinical Information

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Clinical Pearls

  • Fexofenadine is a non-sedating antihistamine, making it suitable for daytime use.
  • Crucially, advise patients to take fexofenadine with water only, and to avoid fruit juices (especially grapefruit, orange, and apple) as they can significantly reduce its absorption and effectiveness.
  • Patients should also separate antacid administration (containing aluminum or magnesium) by at least 2 hours from fexofenadine to prevent reduced absorption.
  • It is a good option for patients who experience sedation with first-generation antihistamines or even some other second-generation agents like cetirizine.
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Alternative Therapies

  • Loratadine (Claritin)
  • Cetirizine (Zyrtec)
  • Desloratadine (Clarinex)
  • Levocetirizine (Xyzal)
  • Azelastine (nasal spray)
  • Corticosteroid nasal sprays (e.g., fluticasone, mometasone)
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Cost & Coverage

Average Cost: $10 - $30 per 30 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic) or Tier 2/3 (Brand)
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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 this 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.