Loratadine 5mg/5ml Child Syrup (sf)
It is used to ease allergy signs.It is used to treat hives.
Drug Class
Antihistamine
Pharmacologic Class
Peripherally selective H1-receptor antagonist
Pregnancy Category
Category B
FDA Approved
Apr 1993
DEA Schedule
Not Controlled
Overview
What is this medicine?
Loratadine is an antihistamine medicine that helps relieve allergy symptoms like sneezing, runny nose, itchy eyes, and hives. It works by blocking a natural substance called 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 Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort. When taking the liquid form of this medication, measure the dose accurately using the measuring device that comes with it. If no device is provided, ask your pharmacist for a suitable measuring tool.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding freezing. Keep it in a dry place, away from the bathroom, to maintain its effectiveness. Ensure all medications are kept in a safe location, out of the 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 have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses. If your medication is prescribed on an as-needed basis, do not give it to your child more frequently than advised by your doctor.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions precisely. You can take this medication with or without food, but if it causes stomach upset, take it with food to help minimize discomfort. When taking the liquid form of this medication, measure the dose accurately using the measuring device that comes with it. If no device is provided, ask your pharmacist for a suitable measuring tool.
Storing and Disposing of Your Medication
Store your medication at room temperature, avoiding freezing. Keep it in a dry place, away from the bathroom, to maintain its effectiveness. Ensure all medications are kept in a safe location, out of the 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 have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication regularly and miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses. If your medication is prescribed on an as-needed basis, do not give it to your child more frequently than advised by your doctor.
Lifestyle & Tips
- Take once daily, with or without food.
- Do not exceed the recommended dose.
- For children, use the provided measuring device to ensure accurate dosing.
- Store at room temperature away from moisture and heat.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg (10 ml of 5mg/5ml syrup) once daily
Dose Range:
10 - 10 mg
Condition-Specific Dosing:
severe renal impairment (CrCl < 30 mL/min):
10 mg every other day
hepatic impairment:
10 mg every other day
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for <2 years
Child:
2 to 5 years: 5 mg (5 ml) once daily; 6 years and older: 10 mg (10 ml) once daily
Adolescent:
10 mg (10 ml) once daily
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
5 mg (5 ml) every other day for patients 2-5 years; 10 mg (10 ml) every other day for patients 6 years and older
Dialysis:
Administer after dialysis; 5 mg (5 ml) every other day for patients 2-5 years; 10 mg (10 ml) every other day for patients 6 years and older
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
5 mg (5 ml) every other day for patients 2-5 years; 10 mg (10 ml) every other day for patients 6 years and older
Severe:
5 mg (5 ml) every other day for patients 2-5 years; 10 mg (10 ml) every other day for patients 6 years and older
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, and pruritus. It has minimal sedative and anticholinergic effects due to its low affinity for central H1-receptors and its inability to readily cross the blood-brain barrier.
Pharmacokinetics
Absorption:
Bioavailability:
Not explicitly stated as a single percentage, but well-absorbed orally.
Tmax:
Loratadine: 1-1.5 hours; Desloratadine (active metabolite): 2.5 hours
FoodEffect:
Food delays Tmax by approximately 1 hour and increases AUC slightly.
Distribution:
Vd:
Loratadine: 119 L/kg; Desloratadine: 2.1 L/kg
ProteinBinding:
Loratadine: 97-99%; Desloratadine: 73-76%
CnssPenetration:
Limited
Elimination:
HalfLife:
Loratadine: 8.4 hours (range 3-20 hours); Desloratadine: 27 hours (range 8.9-92 hours)
Clearance:
Not readily available as a single value, varies with metabolism.
ExcretionRoute:
Approximately 40% in urine and 42% in feces over 10 days, primarily as conjugated metabolites.
Unchanged:
<1% (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, 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, or 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
- Feeling sleepy
- Any other side effects that bother you or do not go away
Reporting Side Effects
This list does not include all possible side effects. 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.
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, or 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
- Feeling sleepy
- Any other side effects that bother you or do not go away
Reporting Side Effects
This list does not include all possible side effects. 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.
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
- Seizures (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, 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 identify 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 other medications and health conditions. Never start, stop, or change the dose 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 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 identify 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 other medications and health conditions. Never start, stop, or change the dose 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 drug may interfere with certain laboratory tests, so be sure to notify your healthcare providers and laboratory personnel that you are taking this medication.
To avoid excessive drowsiness, do not exceed the recommended dose prescribed by your doctor or specified on the package label. If you are following a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication may contain sodium.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to determine the best course of action for you and your baby.
To avoid excessive drowsiness, do not exceed the recommended dose prescribed by your doctor or specified on the package label. If you are following a low-sodium or sodium-free diet, consult with your doctor, as some formulations of this medication may contain sodium.
If you are pregnant, planning to become pregnant, or are breastfeeding, discuss the potential benefits and risks of this medication with your doctor to determine the best course of action for you and your baby.
Overdose Information
Overdose Symptoms:
- Somnolence (drowsiness)
- Tachycardia (fast heartbeat)
- Headache
- Extrapyramidal symptoms (in children)
What to Do:
In case of overdose, contact a poison control center immediately (e.g., 1-800-222-1222) 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 desloratadine, but generally without clinically significant adverse effects due to wide therapeutic index.
- CYP2D6 inhibitors (e.g., quinidine, fluoxetine): May increase plasma concentrations of loratadine and desloratadine.
Monitoring
Routine Monitoring
Symptom relief (e.g., sneezing, runny nose, itchy eyes, hives)
Frequency: Daily
Target: Reduction or resolution of allergy symptoms
Action Threshold: Lack of symptom improvement after 3-5 days, or worsening of symptoms
Symptom Monitoring
- Allergy symptoms (sneezing, rhinorrhea, nasal pruritus, ocular pruritus, urticaria)
- Adverse effects (headache, somnolence, fatigue, dry mouth)
Special Patient Groups
Pregnancy
Loratadine is generally considered low risk during pregnancy. Animal studies have not shown harm, and human data suggest no increased risk of major birth defects. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk, but use with caution and only if benefits outweigh risks.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Loratadine and its active metabolite desloratadine are excreted into breast milk. However, levels are generally low, and adverse effects in breastfed infants are unlikely. Monitor infants for drowsiness or irritability. Considered compatible with breastfeeding by many experts.
Infant Risk:
Low risk (L2 - likely compatible)
Pediatric Use
Approved for children 2 years of age and older. Dosing is weight/age-based. Safety and efficacy not established for children younger than 2 years.
Geriatric Use
No specific dose adjustment is typically required for elderly patients unless they have significant renal or hepatic impairment, in which case dose adjustment as per impairment guidelines should be followed. Elderly patients may be more sensitive to adverse effects, though loratadine is generally well-tolerated.
Clinical Information
Clinical Pearls
- Loratadine is a non-sedating antihistamine, making it suitable for daytime use.
- It has a 24-hour duration of action, allowing for once-daily dosing.
- Available widely over-the-counter, making it easily accessible.
- Food can slightly delay the onset of action but does not significantly affect efficacy.
- Less likely to cause drowsiness compared to first-generation antihistamines like diphenhydramine.
Alternative Therapies
- Cetirizine (Zyrtec)
- Fexofenadine (Allegra)
- Desloratadine (Clarinex)
- Levocetirizine (Xyzal)
- Intranasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis
- Mast cell stabilizers (e.g., cromolyn sodium) for allergic rhinitis/conjunctivitis
Cost & Coverage
Average Cost:
Varies widely, typically low per 120ml bottle
Generic Available:
Yes
Insurance Coverage:
Often covered by most insurance plans, typically Tier 1 or 2 due to generic availability and OTC status.
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 overdose, including the medication taken, the amount, and the time it occurred.