Levocetirizine 2.5mg/5ml Oral Sol
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 2007
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levocetirizine is an antihistamine medication used to relieve symptoms of allergies 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 is often taken in the evening because it can cause some drowsiness.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose in the evening, with or without food. When measuring liquid doses, use the device that comes with the medication. If one is not included, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding bathrooms. Keep all medications in a safe place, out of 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. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you 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 resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Take your dose in the evening, with or without food. When measuring liquid doses, use the device that comes with the medication. If one is not included, ask your pharmacist for a suitable measuring device.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding bathrooms. Keep all medications in a safe place, out of 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. If you have questions about disposal, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you 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 resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Avoid alcohol and other medications that cause drowsiness while taking levocetirizine, as this can increase sedation.
- Take the medication in the evening to minimize daytime drowsiness.
- Do not drive or operate heavy machinery until you know how this medication affects you.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
5 mg (10 mL) orally once daily in the evening
Dose Range:
2.5 - 5 mg
Condition-Specific Dosing:
chronicidiopathicurticaria:
5 mg (10 mL) orally once daily in the evening
seasonalallergicrhinitis:
5 mg (10 mL) orally once daily in the evening
Pediatric Dosing
Neonatal:
Not established
Infant:
1.25 mg (2.5 mL) orally once daily in the evening for infants 6 months to <2 years of age.
Child:
1.25 mg (2.5 mL) orally once daily in the evening for children 2 to 5 years of age; 2.5 mg (5 mL) orally once daily in the evening for children 6 to 11 years of age.
Adolescent:
5 mg (10 mL) orally once daily in the evening for adolescents 12 years of age and older.
Dose Adjustments
Renal Impairment:
Mild:
CrCl 50-80 mL/min: 2.5 mg (5 mL) orally once daily in the evening.
Moderate:
CrCl 30-49 mL/min: 2.5 mg (5 mL) orally every other day in the evening.
Severe:
CrCl 10-29 mL/min: 2.5 mg (5 mL) orally twice weekly in the evening.
Dialysis:
CrCl <10 mL/min or End-Stage Renal Disease (ESRD) requiring dialysis: Contraindicated.
Hepatic Impairment:
Mild:
No dosage adjustment necessary for hepatic impairment alone.
Moderate:
No dosage adjustment necessary for hepatic impairment alone.
Severe:
No dosage adjustment necessary for hepatic impairment alone.
Pharmacology
Mechanism of Action
Levocetirizine, the active (R)-enantiomer of cetirizine, is a potent and selective peripheral H1-receptor antagonist. It inhibits the release of histamine from mast cells and reduces eosinophil chemotaxis, thereby alleviating symptoms associated with allergic reactions such as sneezing, rhinorrhea, pruritus, and urticaria.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 100%
Tmax:
Approximately 0.9-1 hour
FoodEffect:
Food delays Tmax by 1.25 hours and decreases Cmax by 36%, but does not affect the extent of absorption (AUC).
Distribution:
Vd:
Approximately 0.4 L/kg
ProteinBinding:
Approximately 90%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 7-10 hours (adults); shorter in children
Clearance:
Approximately 0.63 mL/min/kg
ExcretionRoute:
Primarily renal (85.4% of dose excreted in urine, 12.9% in feces)
Unchanged:
Approximately 85.4%
Pharmacodynamics
OnsetOfAction:
Within 1 hour
PeakEffect:
Approximately 1 hour
DurationOfAction:
Approximately 24 hours
Safety & Warnings
Side Effects
Serious 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
- Difficulty urinating
- Fever
- Ear pain
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 if they persist or bother you, contact your doctor for advice:
- Feeling tired or weak
- Feeling sleepy
- Nose or throat irritation
- Nosebleed
- Dry mouth
- Cough
- Vomiting
- Diarrhea or constipation
Reporting Side Effects
This list does not include all possible 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.
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
- Difficulty urinating
- Fever
- Ear pain
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 if they persist or bother you, contact your doctor for advice:
- Feeling tired or weak
- Feeling sleepy
- Nose or throat irritation
- Nosebleed
- Dry mouth
- Cough
- Vomiting
- Diarrhea or constipation
Reporting Side Effects
This list does not include all possible 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.
Seek Immediate Medical Attention If You Experience:
- Severe drowsiness or dizziness
- Difficulty urinating
- Allergic reaction symptoms (rash, itching/swelling, severe dizziness, trouble breathing)
- Unusual weakness or fatigue
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.
If you have kidney disease, as this may affect your ability to take this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
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.
If you have kidney disease, as this may affect your ability to take this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription and over-the-counter drugs, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine whether it is safe to take this medication in conjunction with your other medications and health conditions.
Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor to ensure your safety.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. Be aware that high doses of this drug can cause drowsiness. Adhere strictly to the dosage instructions provided by your doctor or as indicated on the package label, and do not exceed the recommended dose.
Prior to consuming alcohol, using marijuana or other cannabis products, or taking any prescription or over-the-counter medications that may impair your physical or mental reactions, consult with your doctor.
This medication is available in various forms, which may be suitable for children of different ages. Therefore, it is crucial to consult with your doctor before administering this drug to a child to ensure the appropriate formulation and dosage are used.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. Be aware that high doses of this drug can cause drowsiness. Adhere strictly to the dosage instructions provided by your doctor or as indicated on the package label, and do not exceed the recommended dose.
Prior to consuming alcohol, using marijuana or other cannabis products, or taking any prescription or over-the-counter medications that may impair your physical or mental reactions, consult with your doctor.
This medication is available in various forms, which may be suitable for children of different ages. Therefore, it is crucial to consult with your doctor before administering this drug to a child to ensure the appropriate formulation and dosage are used.
If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor. It is necessary to discuss the potential benefits and risks of this medication to both you and your baby to make an informed decision.
Overdose Information
Overdose Symptoms:
- Adults: Drowsiness, sedation
- Children: Agitation, restlessness, followed by drowsiness
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is symptomatic and supportive. There is no specific antidote.
Drug Interactions
Monitoring
Routine Monitoring
Symptom relief (e.g., reduction in sneezing, rhinorrhea, pruritus, urticaria)
Frequency: Daily
Target: Significant improvement
Action Threshold: Lack of efficacy after 1-2 weeks of consistent use may warrant re-evaluation or alternative therapy.
Adverse effects (e.g., somnolence, fatigue, dry mouth, headache)
Frequency: Daily, especially during initial therapy
Target: Minimal to no adverse effects
Action Threshold: Persistent or severe adverse effects may require dose reduction or discontinuation.
Symptom Monitoring
- Drowsiness/Sedation
- Fatigue
- Dry mouth
- Headache
- Nausea
- Dizziness
- Urinary retention (rare, especially in elderly)
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Generally considered low risk, but use with caution.
Second Trimester:
Generally considered low risk.
Third Trimester:
Generally considered low risk.
Lactation
Levocetirizine is excreted into human milk. Due to the potential for adverse reactions in breastfed infants (e.g., sedation, irritability), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderately safe; potential for infant drowsiness or irritability)
Pediatric Use
Approved for use in children 6 months of age and older. Dosage adjustments are necessary based on age. Not recommended for infants younger than 6 months due to lack of established efficacy and safety.
Geriatric Use
Use with caution in elderly patients (65 years and older) due to increased risk of adverse effects such as drowsiness, fatigue, and urinary retention. Start with the lowest effective dose (e.g., 2.5 mg daily) and adjust based on renal function and tolerability.
Clinical Information
Clinical Pearls
- Levocetirizine is the active enantiomer of cetirizine, offering similar efficacy with potentially less sedation for some patients.
- Taking the dose in the evening can help mitigate potential drowsiness during the day.
- Patients with renal impairment require significant dose adjustments; contraindicated in ESRD/dialysis.
- Less sedating than first-generation antihistamines, but still advise caution with driving or operating machinery until individual response is known.
Alternative Therapies
- Cetirizine (Zyrtec)
- Loratadine (Claritin)
- Fexofenadine (Allegra)
- Desloratadine (Clarinex)
- Azelastine (nasal spray)
- Corticosteroid nasal sprays (e.g., fluticasone, mometasone)
Cost & Coverage
Average Cost:
Varies widely, typically $10-$50 per 150 mL bottle (2.5mg/5mL)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic)
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 medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to ensure you receive the best possible care.