Loratadine ODT 10mg Tablets
It is used to ease allergy signs.It is used to treat hives.
Drug Class
Antihistamine
Pharmacologic Class
Selective peripheral H1-receptor antagonist
Pregnancy Category
Category B
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Loratadine is an antihistamine that helps relieve allergy symptoms like sneezing, runny nose, itchy or watery eyes, and itching of the nose or throat. It works by blocking a natural substance (histamine) that your body makes during an allergic reaction. This specific form is an orally disintegrating tablet, meaning it dissolves quickly on your tongue without needing water.
How to Use This Medicine
Taking Your Medication
To take this medication correctly, follow your doctor's instructions and read all the information provided. You can take it with or without food, but if it causes stomach upset, take it with food.
When taking this medication, do not remove it from the blister pack until you are ready to take it. After opening the blister pack, take the medication immediately. Do not store the removed medication for later use.
To take the tablet, use dry hands to remove it from the foil. Place the tablet on your tongue and let it dissolve. You do not need water, and do not swallow the tablet whole. Additionally, do not chew, break, or crush the tablet.
Storing and Disposing of Your Medication
Store this medication at room temperature, avoiding freezing. Keep it in a dry place, away from the bathroom. Store the medication in its original container, and keep all medications in a safe location, out of the reach of children and pets.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To take this medication correctly, follow your doctor's instructions and read all the information provided. You can take it with or without food, but if it causes stomach upset, take it with food.
When taking this medication, do not remove it from the blister pack until you are ready to take it. After opening the blister pack, take the medication immediately. Do not store the removed medication for later use.
To take the tablet, use dry hands to remove it from the foil. Place the tablet on your tongue and let it dissolve. You do not need water, and do not swallow the tablet whole. Additionally, do not chew, break, or crush the tablet.
Storing and Disposing of Your Medication
Store this medication at room temperature, avoiding freezing. Keep it in a dry place, away from the bathroom. Store the medication in its original container, and keep all medications in a safe location, out of the reach of children and pets.
Missing a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time or take extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Take once daily, at any time of day.
- Place the tablet on your tongue and allow it to dissolve completely before swallowing. No water is needed.
- Avoid activities requiring mental alertness (e.g., driving, operating machinery) until you know how the medication affects you, although drowsiness is rare with loratadine.
- Avoid alcohol, as it may increase drowsiness, though this is less common with loratadine than with older antihistamines.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg orally once daily
Dose Range:
10 - 10 mg
Condition-Specific Dosing:
severe_renal_impairment:
10 mg every other day
severe_hepatic_impairment:
10 mg every other day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (generally not recommended for <2 years without physician consultation)
Child:
2-5 years: 5 mg orally once daily; âĨ6 years: 10 mg orally once daily
Adolescent:
10 mg orally once daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
10 mg every other day (CrCl < 30 mL/min)
Dialysis:
10 mg every other day (consider administering after dialysis)
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
10 mg every other day (Child-Pugh Class C)
Confidence:
Medium
Pharmacology
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, such as vasodilation, increased vascular permeability, pruritus, and bronchoconstriction. Unlike first-generation antihistamines, loratadine has minimal to no sedative or anticholinergic effects due to its poor penetration of the blood-brain barrier.
Pharmacokinetics
Absorption:
Bioavailability:
High (well absorbed)
Tmax:
Loratadine: ~1.3 hours; Descarboethoxyloratadine: ~2.5 hours
FoodEffect:
Food can delay Tmax by approximately 1 hour, but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Loratadine: ~119 L/kg; Descarboethoxyloratadine: ~21 L/kg
ProteinBinding:
Loratadine: ~97-99%; Descarboethoxyloratadine: ~73-76%
CnssPenetration:
Limited
Elimination:
HalfLife:
Loratadine: ~8.4 hours (range 3-20 hours); Descarboethoxyloratadine: ~28 hours (range 8.8-92 hours)
Clearance:
Not available (highly variable)
ExcretionRoute:
Approximately 40% in urine and 42% in feces over 10 days
Unchanged:
<1% (both loratadine and descarboethoxyloratadine)
Pharmacodynamics
OnsetOfAction:
1-3 hours
PeakEffect:
8-12 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 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.
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.
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
- Fast or irregular heartbeat (rare)
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 as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
It is crucial to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust 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, any of its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are currently taking
Any natural products or vitamins you are using
* Existing health problems or conditions
It is crucial to verify that it is safe to take this medication in conjunction with your other medications and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial because this drug may interfere with certain laboratory tests, so be sure to also notify your healthcare providers and laboratory personnel that you are taking this medication.
To minimize the risk of excessive drowsiness, do not exceed the recommended dose as prescribed by your doctor or as indicated on the package label. Taking high doses of this medication can cause sleepiness, so it is vital to adhere to the recommended dosage.
If you have phenylketonuria (PKU), a condition where your body cannot break down the amino acid phenylalanine, consult with your doctor before taking this medication. Some formulations of this drug may contain phenylalanine, which could be harmful to you.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of taking this medication with your doctor. This conversation will help you understand the potential effects on you and your baby, allowing you to make an informed decision about your treatment.
To minimize the risk of excessive drowsiness, do not exceed the recommended dose as prescribed by your doctor or as indicated on the package label. Taking high doses of this medication can cause sleepiness, so it is vital to adhere to the recommended dosage.
If you have phenylketonuria (PKU), a condition where your body cannot break down the amino acid phenylalanine, consult with your doctor before taking this medication. Some formulations of this drug may contain phenylalanine, which could be harmful to you.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of taking this medication with your doctor. This conversation will help you understand the potential effects on you and your baby, allowing you to make an informed decision about your treatment.
Overdose Information
Overdose Symptoms:
- Somnolence (drowsiness)
- Tachycardia (rapid heart rate)
- Headache
- Extrapyramidal symptoms (in children)
What to Do:
Call 1-800-222-1222 (Poison Control Center) or seek emergency medical attention. Treatment is symptomatic and supportive. Gastric lavage may be considered if appropriate. Activated charcoal may be administered.
Drug Interactions
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, cimetidine): May increase plasma concentrations of loratadine and its active metabolite, but generally without clinically significant adverse effects due to wide therapeutic index.
- CYP2D6 inhibitors: May increase plasma concentrations of loratadine.
Monitoring
Symptom Monitoring
- Effectiveness of symptom relief (e.g., sneezing, runny nose, itchy eyes, hives)
- Adverse effects (e.g., headache, dry mouth, fatigue, somnolence - though rare with loratadine)
Special Patient Groups
Pregnancy
Loratadine is generally considered a low-risk option for allergy relief during pregnancy. It is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and human data suggest no increased risk of major birth defects.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk; limited human data but no consistent evidence of harm.
Second Trimester:
Generally considered low risk; more human data available.
Third Trimester:
Generally considered low risk; no specific concerns identified.
Lactation
Loratadine and its active metabolite are excreted into breast milk. While the amount is small, caution is advised. Monitor the infant for signs of drowsiness or irritability. It is generally considered compatible with breastfeeding, but alternative non-sedating antihistamines with less milk transfer (e.g., fexofenadine) might be preferred by some clinicians.
Infant Risk:
Low to moderate risk; potential for infant drowsiness or irritability, though generally well-tolerated.
Pediatric Use
Approved for children 2 years of age and older. Dosing is weight/age-dependent. Not recommended for children under 2 years without specific medical advice.
Geriatric Use
No specific dose adjustment is typically required based on age alone. However, dose adjustment may be necessary for elderly patients with severe renal or hepatic impairment, similar to adult recommendations.
Clinical Information
Clinical Pearls
- Loratadine is a non-sedating antihistamine, making it suitable for daytime use.
- The orally disintegrating tablet (ODT) formulation is convenient for patients who have difficulty swallowing pills or for on-the-go administration as it does not require water.
- Onset of action is relatively quick, but peak effect may take several hours, so consistent daily use is important for chronic allergy symptoms.
- Less likely to cause drowsiness or anticholinergic side effects compared to first-generation antihistamines (e.g., diphenhydramine).
Alternative Therapies
- Other second-generation antihistamines (e.g., Cetirizine, Fexofenadine, Desloratadine, Levocetirizine)
- First-generation antihistamines (e.g., Diphenhydramine, Chlorpheniramine - generally more sedating)
- Nasal corticosteroids (e.g., Fluticasone, Mometasone - for nasal allergy symptoms)
- Mast cell stabilizers (e.g., Cromolyn sodium - for allergy prevention)
- Leukotriene receptor antagonists (e.g., Montelukast - for allergic rhinitis and asthma)
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic) or OTC (often not covered by prescription plans unless prescribed)
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 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.