Loratadine 10mg Tablets

Manufacturer PERRIGO PHARMACEUTICALS Active Ingredient Loratadine Capsules and Tablets(lor AT a deen) Pronunciation lor AT 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
Peripherally selective H1-receptor antagonist
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Pregnancy Category
Category B
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FDA Approved
Apr 1993
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Loratadine 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. It's known for being 'non-drowsy' for most people.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize this side effect.

Storing and Disposing of Your Medication

Store your medication at room temperature, away from freezing temperatures. Keep it in a dry place, avoiding bathrooms and areas where it may get wet. Ensure that all medications are kept in a safe location, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or inquire about potential drug take-back programs in your area.

Missing a Dose

If you take this medication on a regular schedule and miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and resume your normal dosing schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Take once daily, with or without food.
  • Do not take more than the recommended dose.
  • Avoid activities requiring mental alertness (e.g., driving) until you know how this medication affects you, although drowsiness is uncommon.
  • Store at room temperature away from moisture and heat.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg orally once daily
Dose Range: 10 - 10 mg

Condition-Specific Dosing:

allergicRhinitis: 10 mg orally once daily
chronicUrticaria: 10 mg orally once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (contraindicated under 2 years)
Child: 2-5 years: 5 mg orally once daily; >= 6 years: 10 mg orally once daily
Adolescent: 10 mg orally once daily
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: CrCl < 30 mL/min: 10 mg orally every other day
Dialysis: 10 mg orally every other day (not significantly removed by hemodialysis)

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: Child-Pugh C: 10 mg orally every other day
Confidence: High

Pharmacology

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Mechanism of Action

Loratadine is a long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonist activity. It inhibits the release of histamine from mast cells and basophils, thereby preventing the effects of histamine on H1 receptors, which include vasodilation, increased vascular permeability, pruritus, and bronchoconstriction. It has minimal to no sedative or anticholinergic effects due to its poor penetration of the blood-brain barrier.
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Pharmacokinetics

Absorption:

Bioavailability: Not explicitly reported as a percentage for oral, but well absorbed.
Tmax: Loratadine: 1-1.5 hours; Desloratadine (active metabolite): 2.5 hours
FoodEffect: Food slightly delays Tmax and increases AUC of loratadine and desloratadine.

Distribution:

Vd: Loratadine: 119 L/kg; Desloratadine: 164 L/kg (extensive tissue distribution)
ProteinBinding: Loratadine: 97-99%; Desloratadine: 73-76%
CnssPenetration: Limited

Elimination:

HalfLife: Loratadine: 8.4 hours (range 3-20 hours); Desloratadine: 27 hours (range 8.8-92 hours)
Clearance: Not available
ExcretionRoute: Approximately 40% in urine and 42% in feces over 10 days, primarily as conjugated metabolites.
Unchanged: <1% (both loratadine and desloratadine)
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Pharmacodynamics

OnsetOfAction: 1-3 hours
PeakEffect: 8-12 hours
DurationOfAction: 24 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, 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
+ Swelling of the mouth, face, lips, tongue, or throat
Feeling extremely tired or weak

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:

Headache
Feeling sleepy

Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, don't hesitate to reach out to 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 dizziness or fainting
  • Fast or irregular heartbeat (rare)
  • Signs of an allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing) - seek immediate medical attention.
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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 it is safe to take this medication 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

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This will help ensure they have a complete understanding of your treatment regimen. Additionally, be sure to notify all healthcare providers and laboratory personnel that you are taking this drug, as it may impact the results of certain laboratory tests.

To minimize the risk of excessive drowsiness, it is crucial to adhere to the recommended dosage. Do not exceed the dose prescribed by your doctor or the amount indicated on the package label. Taking high doses of this medication can cause significant drowsiness, which may impair your daily activities.

If you are pregnant, planning to become pregnant, or are currently breast-feeding, it is vital to discuss the potential benefits and risks of this medication with your doctor. This conversation will help you and your healthcare provider make an informed decision about the use of this drug during this critical period, weighing the potential advantages against the potential risks to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Somnolence (most common)
  • Tachycardia
  • Headache
  • Extrapyramidal symptoms (in children)

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is symptomatic and supportive. Gastric lavage may be considered if appropriate. Activated charcoal may be administered. Loratadine is not significantly removed by hemodialysis.

Drug Interactions

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Moderate Interactions

  • Ketoconazole
  • Erythromycin
  • Cimetidine
  • Fluoxetine
  • Quinidine

Monitoring

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Routine Monitoring

Symptom relief (e.g., reduction in sneezing, runny nose, itching, hives)

Frequency: Daily, as needed

Target: Significant improvement in allergy symptoms

Action Threshold: Lack of symptom improvement after 3-5 days of consistent use, or worsening symptoms, warrants re-evaluation.

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Symptom Monitoring

  • Allergy symptoms (sneezing, rhinorrhea, nasal itching, ocular itching, urticaria, pruritus)
  • Adverse effects (headache, somnolence, fatigue, dry mouth)

Special Patient Groups

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Pregnancy

Generally considered low risk during pregnancy. Studies in animals have not shown harm to the fetus, and human data suggest no increased risk of major birth defects. Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk, Category B
Second Trimester: Low risk, Category B
Third Trimester: Low risk, Category B
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Lactation

Loratadine and its active metabolite desloratadine are excreted into breast milk. While levels are low, potential for infant drowsiness or irritability exists. Use with caution, or consider alternative agents if possible, especially in newborns or preterm infants.

Infant Risk: Low risk (L2)
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Pediatric Use

Approved for children 2 years and older. Dosing varies by age (5 mg for 2-5 years, 10 mg for >= 6 years). Safety and efficacy not established in children younger than 2 years.

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Geriatric Use

No specific dose adjustment is typically needed based on age alone. However, dose adjustment may be necessary for elderly patients with significant renal or hepatic impairment (refer to renal/hepatic impairment dosing).

Clinical Information

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Clinical Pearls

  • Loratadine is a non-sedating antihistamine, making it suitable for daytime use.
  • Its long half-life allows for once-daily dosing, improving patient adherence.
  • Available over-the-counter (OTC), making it easily accessible for allergy relief.
  • Onset of action is relatively slow compared to some other antihistamines (e.g., cetirizine), so patients should be advised it may take a few hours to feel full effects.
  • Less effective for acute, severe allergic reactions (e.g., anaphylaxis) where epinephrine is the first-line treatment.
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Alternative Therapies

  • Cetirizine (Zyrtec)
  • Fexofenadine (Allegra)
  • Desloratadine (Clarinex)
  • Levocetirizine (Xyzal)
  • Nasal corticosteroids (e.g., fluticasone, mometasone)
  • Cromolyn sodium nasal spray
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (generic 10mg)
Generic Available: Yes
Insurance Coverage: Tier 1 (Generic)
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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 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 seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.