Desloratadine 5mg Tablets

Manufacturer LUPIN PHARMACEUTICALS Active Ingredient Desloratadine Tablets(des lor AT a deen) Pronunciation des 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
Selective peripheral H1-receptor antagonist
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Pregnancy Category
Category C
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FDA Approved
Jan 2002
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Desloratadine 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. It's essential to follow the dosage instructions carefully to ensure safe and effective treatment.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, away from the bathroom. Protect it from heat sources to maintain its potency. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or explore local drug take-back programs.

Missing a Dose

If you take this medication on a regular schedule, take a missed dose 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.
  • If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
  • Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how this medication affects you, although it is generally non-drowsy.
  • Inform your doctor or pharmacist about all other medications you are taking, including over-the-counter drugs and herbal supplements.

Dosing & Administration

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Adult Dosing

Standard Dose: 5 mg orally once daily
Dose Range: 5 - 5 mg

Condition-Specific Dosing:

allergicRhinitis: 5 mg orally once daily
chronicIdiopathicUrticaria: 5 mg orally once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (under 6 months)
Child: 6-11 months: 1 mg (2.5 mL of syrup) orally once daily; 1-5 years: 1.25 mg (2.5 mL of syrup) orally once daily; 6-11 years: 2.5 mg (5 mL of syrup or 1 tablet) orally once daily
Adolescent: 12 years and older: 5 mg orally once daily
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: 5 mg every other day
Severe: 5 mg every other day
Dialysis: 5 mg every other day (desloratadine is not effectively removed by hemodialysis)

Hepatic Impairment:

Mild: No adjustment needed
Moderate: 5 mg every other day
Severe: 5 mg every other day
Confidence: Medium

Pharmacology

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Mechanism of Action

Desloratadine is a long-acting tricyclic antihistamine with selective peripheral H1-receptor antagonist activity. It inhibits histamine release from mast cells and basophils and also inhibits the release of other inflammatory mediators from mast cells and basophils. It also has anti-allergic and anti-inflammatory effects.
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Pharmacokinetics

Absorption:

Bioavailability: Not directly reported for oral tablets, but well absorbed
Tmax: 3 hours (desloratadine), 7 hours (3-hydroxydesloratadine)
FoodEffect: No effect on desloratadine absorption

Distribution:

Vd: 49 L/kg
ProteinBinding: 83-87%
CnssPenetration: Limited

Elimination:

HalfLife: 27 hours
Clearance: Not readily available, but primarily hepatic metabolism and renal excretion
ExcretionRoute: Approximately 40% urine, 40% feces
Unchanged: Less than 2% (urine), less than 7% (feces)
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Pharmacodynamics

OnsetOfAction: Within 1 hour
PeakEffect: 3 hours (for symptom relief)
DurationOfAction: 24 hours

Safety & Warnings

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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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Shortness of breath
Feeling irritable

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:

Headache
Upset stomach
Feeling tired or weak
Dry mouth
Sore throat
Muscle pain
Feeling sleepy
* Period (menstrual) pain

Reporting Side Effects
This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult 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:

  • Signs of a serious allergic reaction (e.g., rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble breathing)
  • Unusual tiredness or weakness
  • Fast or irregular heartbeat
  • Seizures
  • Yellowing of skin or eyes (jaundice)
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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 allergic reaction you experienced, including any symptoms that occurred.
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 health problems you have, as this medication may interact with certain conditions.

To ensure your safety, do not start, stop, or change the dose of any medication without first consulting your doctor. It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Your doctor and pharmacist will work together to determine the best course of treatment for you.
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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.

To minimize the risk of severe side effects, do not exceed the dosage prescribed by your doctor. Taking more than the recommended amount may increase your chance of experiencing severe side effects. Additionally, do not take this medication for a longer duration than specified by your doctor.

Until you understand how this medication affects you, it is crucial to avoid driving and other activities that require alertness. It is also recommended to avoid consuming alcohol while taking this drug.

Before using marijuana, other forms of cannabis, or any prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor. This medication may interfere with allergy skin tests, so it is vital to notify your doctor and laboratory personnel that you are taking this drug.

If you are pregnant, planning to become pregnant, or are breast-feeding, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Somnolence (drowsiness)
  • Headache
  • Tachycardia (fast heart rate)
  • Extrapyramidal symptoms (in children)

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is symptomatic and supportive. Desloratadine is not eliminated by hemodialysis.

Drug Interactions

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Moderate Interactions

  • Ketoconazole (increased desloratadine plasma concentrations)
  • Erythromycin (increased desloratadine plasma concentrations)
  • Azithromycin (increased desloratadine plasma concentrations)
  • Fluoxetine (increased desloratadine plasma concentrations)
  • Cimetidine (increased desloratadine plasma concentrations)
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Minor Interactions

  • Alcohol (no potentiation of alcohol-induced impairment of psychomotor performance)

Monitoring

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Routine Monitoring

Symptom relief (e.g., sneezing, rhinorrhea, itching, hives)

Frequency: Daily, as needed

Target: Significant reduction or resolution of symptoms

Action Threshold: Lack of efficacy after 7-14 days, consider alternative or re-evaluation

Adverse effects (e.g., headache, dry mouth, fatigue)

Frequency: Daily, as needed

Target: Minimal to no adverse effects

Action Threshold: Persistent or bothersome adverse effects, consider dose reduction or discontinuation

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Symptom Monitoring

  • Effectiveness in reducing allergy symptoms (sneezing, runny nose, itchy eyes/nose, hives)
  • Occurrence of side effects (headache, dry mouth, fatigue, somnolence, nausea, dizziness)
  • Signs of hypersensitivity reaction (rash, itching, swelling, difficulty breathing)

Special Patient Groups

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Pregnancy

Desloratadine is classified as Pregnancy Category C. Animal studies have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Use only if the potential benefit justifies the potential risk to the fetus.

Trimester-Specific Risks:

First Trimester: Limited human data, animal studies show some risk. Use with caution.
Second Trimester: Limited human data, animal studies show some risk. Use with caution.
Third Trimester: Limited human data, animal studies show some risk. Use with caution.
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Lactation

Desloratadine and its active metabolite are excreted into human milk. The American Academy of Pediatrics considers loratadine (the parent drug of desloratadine) to be compatible with breastfeeding. However, caution is advised, especially in newborns and premature infants, due to potential for sedation or other adverse effects.

Infant Risk: L3 (Moderately Safe) - Potential for infant adverse effects (e.g., drowsiness, irritability) exists, especially with higher doses or in sensitive infants. Monitor infant for sedation or unusual irritability.
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Pediatric Use

Dosing varies significantly by age. Not recommended for infants under 6 months. Use syrup formulation for younger children. Monitor for paradoxical excitation or sedation, especially in very young children.

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Geriatric Use

No specific dose adjustment is generally needed based on age alone, but consider age-related decline in renal and hepatic function. Start with the lowest effective dose and monitor for adverse effects, particularly those related to anticholinergic effects (though desloratadine has low anticholinergic activity) or CNS effects.

Clinical Information

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Clinical Pearls

  • Desloratadine is the active metabolite of loratadine, offering similar efficacy with potentially less variability in metabolism.
  • Generally considered non-sedating, making it suitable for daytime use.
  • Effective for both seasonal and perennial allergic rhinitis, as well as chronic idiopathic urticaria.
  • Dose adjustment is crucial in patients with severe renal or hepatic impairment.
  • Unlike some other antihistamines, desloratadine has minimal interaction with alcohol and does not potentiate alcohol-induced psychomotor impairment.
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Alternative Therapies

  • Loratadine
  • Fexofenadine
  • Cetirizine
  • Levocetirizine
  • Azelastine (nasal spray)
  • Corticosteroid nasal sprays (e.g., fluticasone, mometasone)
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Cost & Coverage

Average Cost: Varies, typically $10-$30 per 30 tablets
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 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 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 details about the medication taken, the amount, and the time it happened.