Cetirizine 1mg/ml Syrup (otc)

Manufacturer PERRIGO Active Ingredient Cetirizine Liquid(se TI ra zeen) Pronunciation se TI ra zeen
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
Second-generation H1-receptor antagonist
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Pregnancy Category
Category B
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FDA Approved
Dec 1995
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Cetirizine 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 as a 'non-drowsy' antihistamine, though some people may still feel sleepy.
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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. If it causes stomach upset, take it with food to help minimize this side effect. When taking the liquid form, measure your dose carefully using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, avoiding the bathroom. Keep all medications 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. If you have questions about disposing of your medication, consult your pharmacist. You may also want to check if there are any drug take-back programs available in your area.

Missing 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. 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.
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Lifestyle & Tips

  • Avoid alcohol or other sedating medications while taking cetirizine, as it may increase drowsiness.
  • Take with or without food.
  • Measure liquid medicine carefully with a special measuring spoon or device, not a household spoon.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg (10 ml of 1mg/ml syrup) once daily
Dose Range: 5 - 10 mg

Condition-Specific Dosing:

mildSymptoms: 5 mg (5 ml) once daily
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Pediatric Dosing

Neonatal: Not established
Infant: 6-11 months: 2.5 mg (2.5 ml) once daily. May increase to 2.5 mg twice daily if needed.
Child: 1-5 years: 2.5 mg (2.5 ml) once daily. May increase to 5 mg (5 ml) once daily or 2.5 mg twice daily if needed. 6-11 years: 5 mg (5 ml) or 10 mg (10 ml) once daily, depending on severity of symptoms.
Adolescent: 12 years and older: 5 mg (5 ml) or 10 mg (10 ml) once daily, depending on severity of symptoms.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl 50-79 mL/min)
Moderate: 5 mg (5 ml) once daily (CrCl 30-49 mL/min)
Severe: 5 mg (5 ml) every other day (CrCl <30 mL/min)
Dialysis: 5 mg (5 ml) every other day (Cetirizine is minimally dialyzable)

Hepatic Impairment:

Mild: No adjustment
Moderate: 5 mg (5 ml) once daily
Severe: 5 mg (5 ml) once daily

Pharmacology

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Mechanism of Action

Cetirizine, a piperazine derivative and a metabolite of hydroxyzine, is a potent and selective peripheral H1-receptor antagonist. It inhibits the effects of histamine by competitively binding to H1 receptors on effector cells, thereby preventing the symptoms associated with allergic reactions (e.g., sneezing, itching, rhinorrhea, urticaria). It has minimal anticholinergic or antiserotonergic activity and does not readily cross the blood-brain barrier, leading to less sedation compared to first-generation antihistamines.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (well-absorbed)
Tmax: 1 hour
FoodEffect: Food delays Tmax by 1.7 hours and decreases Cmax by 23%, but the extent of absorption (AUC) is not affected.

Distribution:

Vd: 0.5 L/kg
ProteinBinding: 93%
CnssPenetration: Limited

Elimination:

HalfLife: Adults: 8-11 hours (average 8.3 hours); Children 6-12 years: 6 hours; Children 2-5 years: 5 hours; Children 6-23 months: 3.1 hours
Clearance: Not available
ExcretionRoute: Primarily renal (approximately 60% unchanged in urine)
Unchanged: 60%
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Pharmacodynamics

OnsetOfAction: Within 20-60 minutes
PeakEffect: 1 hour
DurationOfAction: At least 24 hours

Safety & Warnings

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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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.

Other Possible Side Effects
All medications can cause side effects, although not everyone will experience them. Many people have no side effects or only mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
- For all patients taking this medication:
- Drowsiness
- Feeling tired or weak
- Dry mouth
- Difficulty sleeping
- For children:
- Headache
- Stomach pain

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.
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Seek Immediate Medical Attention If You Experience:

  • Severe drowsiness or dizziness
  • Difficulty urinating
  • Unusual weakness
  • Fast or pounding heartbeat (rare)
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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, 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 worsen certain health problems.

To ensure safe use, tell your doctor and pharmacist about:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Your existing health problems

Before making any changes to your medication regimen, consult with your doctor to confirm it is safe to:
Start taking this medication
Stop taking this medication
Change the dosage of this medication or any other medication you are taking
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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. Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require your full attention.

This medication may interfere with certain laboratory tests, so it is crucial to notify all your healthcare providers and laboratory personnel that you are taking this drug.

To minimize potential risks, refrain from consuming alcohol while taking this medication. Before using marijuana, other forms of cannabis, or any prescription or over-the-counter drugs that may cause drowsiness, consult with your doctor to discuss potential interactions.

If you are 65 years or older, exercise caution when taking this medication, as you may be more susceptible to side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, 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:

  • Drowsiness
  • Sedation
  • Tachycardia
  • Irritability (in children)
  • Restlessness (in children)

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is generally supportive and symptomatic.

Drug Interactions

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Moderate Interactions

  • CNS depressants (e.g., alcohol, sedatives, tranquilizers, opioids): May increase CNS depression (drowsiness, dizziness).
  • Theophylline: A small decrease in cetirizine clearance was observed with co-administration of theophylline (400 mg/day); however, no significant clinical effect was noted.

Monitoring

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Symptom Monitoring

  • Effectiveness in reducing allergy symptoms (e.g., sneezing, runny nose, itchy eyes, hives)
  • Sedation/drowsiness (especially when initiating therapy or increasing dose)
  • Dry mouth
  • Fatigue

Special Patient Groups

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Pregnancy

Cetirizine is generally considered safe for use during pregnancy (Category B). Studies in animals have shown no evidence of harm to the fetus, and human data suggest a low risk.

Trimester-Specific Risks:

First Trimester: Low risk, no increased risk of major birth defects observed.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Cetirizine is excreted into breast milk in small amounts. While generally considered compatible with breastfeeding (L3), monitor the infant for drowsiness or irritability. Use the lowest effective dose.

Infant Risk: Low to moderate risk; potential for infant drowsiness or irritability, especially in preterm or jaundiced infants.
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Pediatric Use

Dosing varies significantly by age. Cetirizine is approved for use in children as young as 6 months for chronic urticaria and 2 years for perennial allergic rhinitis and seasonal allergic rhinitis. Always follow age-appropriate dosing and consult a healthcare professional for infants under 6 months.

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Geriatric Use

Elderly patients may be more sensitive to the sedative effects of cetirizine and may require lower doses (e.g., 5 mg once daily), especially if they have renal impairment. Monitor for increased drowsiness or dizziness.

Clinical Information

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Clinical Pearls

  • Cetirizine is a second-generation antihistamine, offering effective allergy relief with less sedation than first-generation agents like diphenhydramine.
  • It has a rapid onset of action (within 20-60 minutes) and a long duration (24 hours), allowing for once-daily dosing.
  • While generally considered 'non-drowsy,' some individuals, particularly at higher doses or when combined with other CNS depressants, may experience sedation.
  • Liquid formulation is convenient for pediatric dosing and for individuals who have difficulty swallowing pills.
  • Renal dose adjustment is crucial due to its primary renal excretion.
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Alternative Therapies

  • Loratadine (Claritin)
  • Fexofenadine (Allegra)
  • Levocetirizine (Xyzal)
  • Desloratadine (Clarinex)
  • Intranasal corticosteroids (e.g., fluticasone, mometasone) for allergic rhinitis
  • Cromolyn sodium (nasal spray or eye drops)
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Cost & Coverage

Average Cost: Varies, typically $10-$30 per 120 ml bottle
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 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 it's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.