Loratadine 5mg Child Chewable Tabs
It is used to ease allergy signs.It is used to treat hives.
Drug Class
Antihistamine
Pharmacologic Class
Second-generation H1-receptor antagonist
Pregnancy Category
Category B
FDA Approved
Apr 1993
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. It's known for being 'non-drowsy' for most people.
How to Use This Medicine
Taking Your Medication
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize discomfort. Before swallowing, chew or crush the medication as needed.
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 prone to moisture. 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 specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area.
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. Avoid taking two doses at the same time or taking extra doses. If you take this medication as needed, do not take it more frequently than directed by your doctor.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize discomfort. Before swallowing, chew or crush the medication as needed.
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 prone to moisture. 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 specifically instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to inquire about drug take-back programs in your area.
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. Avoid taking two doses at the same time or taking 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, with or without food.
- Do not take more than the recommended dose.
- For chewable tablets, chew thoroughly before swallowing.
- Avoid activities requiring mental alertness (e.g., driving) until you know how the medication affects you, although drowsiness is uncommon.
- Store at room temperature away from moisture and heat.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg orally once daily
Dose Range:
10 - 10 mg
Condition-Specific Dosing:
seasonal_allergic_rhinitis:
10 mg orally once daily
chronic_idiopathic_urticaria:
10 mg orally once daily
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (generally not recommended under 2 years)
Child:
2 to 5 years: 5 mg (one 5mg chewable tablet) orally once daily; 6 years and older: 10 mg (two 5mg chewable tablets) orally once daily
Adolescent:
10 mg (two 5mg chewable tablets) orally once daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
For CrCl < 30 mL/min, administer 10 mg every other day
Dialysis:
Administer 10 mg every other day; not significantly removed by hemodialysis
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
For moderate to severe hepatic impairment, administer 10 mg every other day
Severe:
For moderate to severe hepatic impairment, administer 10 mg every other day
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, which include vasodilation, increased vascular permeability, pruritus, and bronchoconstriction. It has minimal sedative and anticholinergic effects due to its poor penetration of the blood-brain barrier.
Pharmacokinetics
Absorption:
Bioavailability:
High (rapidly absorbed)
Tmax:
Loratadine: 1-1.5 hours; Desloratadine (active metabolite): 2.5 hours
FoodEffect:
Food delays Tmax by approximately 1 hour but does not significantly affect the extent of absorption (AUC).
Distribution:
Vd:
Not available (extensively distributed)
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)
Pharmacodynamics
OnsetOfAction:
1-3 hours
PeakEffect:
8-12 hours
DurationOfAction:
24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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
- Difficulty 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. Contact your doctor or seek medical help if you experience:
- Headache
- Drowsiness
Please note that this list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for advice.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also available to provide guidance on managing side effects.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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
- Difficulty 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. Contact your doctor or seek medical help if you experience:
- Headache
- Drowsiness
Please note that this list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, consult your doctor for advice.
Reporting Side Effects
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch. Your doctor is also available to provide guidance on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe dizziness or fainting
- Fast or irregular heartbeat
- Signs of an allergic reaction (e.g., rash, itching/swelling, severe dizziness, trouble breathing)
- Unusual tiredness or weakness
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 you are taking.
* 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.
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 you are taking.
* 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.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial because it may impact the results of certain laboratory tests. Therefore, be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug.
To minimize the risk of excessive drowsiness, do not exceed the recommended dosage as prescribed by your doctor or 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 breast-feeding, 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 dosage as prescribed by your doctor or 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 breast-feeding, 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 (fast heartbeat)
- Headache
- 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. Gastric lavage may be considered if appropriate.
Drug Interactions
Moderate Interactions
- Ketoconazole
- Erythromycin
- Cimetidine
- Fluconazole
- Quinidine
Monitoring
Symptom Monitoring
- Effectiveness in relieving allergy symptoms (e.g., sneezing, runny nose, itchy eyes, hives)
- Occurrence of adverse effects (e.g., headache, fatigue, dry mouth, somnolence)
- Signs of overdose (e.g., somnolence, tachycardia, headache)
Special Patient Groups
Pregnancy
Loratadine is generally considered a low-risk option for allergic rhinitis during pregnancy. It is classified as Pregnancy Category B, meaning animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk; some studies suggest no increased risk of major malformations.
Second Trimester:
Generally considered safe.
Third Trimester:
Generally considered safe.
Lactation
Loratadine and its active metabolite, desloratadine, are excreted into breast milk. While the amount is small, caution is advised. The American Academy of Pediatrics considers loratadine to be compatible with breastfeeding. Monitor the infant for signs of drowsiness or irritability.
Infant Risk:
L3 (Moderately Safe) - There are no controlled studies in breastfeeding women, but the risk of adverse effects to the infant appears to be low. Monitor for sedation or irritability.
Pediatric Use
Approved for children 2 years and older. Dosing is weight/age-dependent. For children 2-5 years, 5 mg once daily. For children 6 years and older, 10 mg once daily. Chewable tablets are suitable for children who can chew safely.
Geriatric Use
No specific dose adjustment is generally needed based on age alone. However, due to potential age-related decreases in renal or hepatic function, consider dose adjustment (e.g., 10 mg every other day) for severe impairment, similar to adult recommendations. Elderly patients may be more sensitive to adverse effects, though loratadine is generally well-tolerated.
Clinical Information
Clinical Pearls
- Loratadine is a second-generation antihistamine, known for its non-sedating properties compared to first-generation antihistamines like diphenhydramine.
- Its long half-life allows for convenient once-daily dosing.
- Chewable tablets are a good option for children who have difficulty swallowing pills.
- While generally non-drowsy, some individuals may experience mild sedation, especially at higher doses or when combined with other CNS depressants.
- Onset of action is typically within 1-3 hours, making it suitable for daily allergy management rather than acute, immediate relief.
Alternative Therapies
- Cetirizine (Zyrtec)
- Fexofenadine (Allegra)
- Desloratadine (Clarinex - active metabolite of loratadine)
- Levocetirizine (Xyzal)
- Intranasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis
- Mast cell stabilizers (e.g., cromolyn sodium) for allergic rhinitis
Cost & Coverage
Average Cost:
$10 - $30 per 30 tablets (generic)
Generic Available:
Yes
Insurance Coverage:
Tier 1 (Generic) or Tier 2 (Brand)
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.