Cetirizine 5mg Chewable Tablets

Manufacturer SANDOZ Active Ingredient Cetirizine Chewable Tablets(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
Piperazine derivative; Selective peripheral 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 often called a 'non-drowsy' antihistamine, but 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. Be sure to chew or crush the medication thoroughly before swallowing. Do not swallow it whole.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, 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 instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. 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 on a regular schedule, take the 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. 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

  • Take once daily, with or without food.
  • Do not take more than directed.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it can cause drowsiness in some individuals.
  • Avoid alcohol and other sedating medications while taking cetirizine, as this can increase drowsiness.
  • For chewable tablets, chew thoroughly before swallowing.

Dosing & Administration

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Adult Dosing

Standard Dose: 5 mg or 10 mg once daily
Dose Range: 5 - 10 mg

Condition-Specific Dosing:

mild_symptoms: 5 mg once daily
severe_symptoms: 10 mg once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended under 6 months)
Child: 6 to <12 years: 5 mg or 10 mg once daily; 2 to <6 years: 2.5 mg once daily, may increase to 5 mg once daily given as 2.5 mg every 12 hours
Adolescent: 12 years and older: 5 mg or 10 mg once daily
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (CrCl 50-80 mL/min)
Moderate: 5 mg once daily (CrCl 30-49 mL/min)
Severe: 5 mg every other day (CrCl <30 mL/min)
Dialysis: 5 mg every other day (hemodialysis patients); Cetirizine is minimally removed by dialysis.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: 5 mg once daily
Severe: 5 mg once daily
Confidence: Medium

Pharmacology

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Mechanism of Action

Cetirizine, a human metabolite of hydroxyzine, is a potent and highly selective peripheral H1-receptor antagonist. Its antihistaminic activity is due to the selective antagonism of H1-receptors on effector cells, thereby preventing the effects of histamine (e.g., vasodilation, increased capillary permeability, pruritus, bronchoconstriction). 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: High (approximately 70-85%)
Tmax: 1 hour (oral solution), 1-2 hours (tablet)
FoodEffect: Food delays Tmax by 1.7 hours and decreases Cmax by 23%, but the extent of absorption (AUC) is not affected.

Distribution:

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

Elimination:

HalfLife: Approximately 8-10 hours (adults); 6 hours (children 6-12 years); 5 hours (children 2-5 years)
Clearance: Approximately 0.5 L/hr/kg
ExcretionRoute: Primarily renal (approximately 60% unchanged in urine, 10% in feces)
Unchanged: Approximately 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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.

Other Possible Side Effects
Most medications can cause side effects, but many people either do not experience them or have only mild symptoms. If you are bothered by any of the following side effects or if they do not go away, contact your doctor for advice:
- 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 concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or through their website at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe drowsiness or dizziness
  • Difficulty breathing or swallowing (signs of severe allergic reaction)
  • Rash or itching (may indicate an allergic reaction to the drug itself)
  • Fast or irregular 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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial to avoid potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.

To ensure your safety, it is vital to verify that it is safe to take this medication with all your current medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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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 activities that require alertness. Be aware that this medication may impact the results of 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 cannabis products, or prescription or over-the-counter (OTC) medications that may cause drowsiness, consult with your doctor to discuss potential interactions.

If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to side effects. If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Sedation
  • Tachycardia
  • Agitation (especially in children)
  • Irritability
  • Restlessness
  • Urinary retention

What to Do:

Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and symptomatic. There is no specific antidote.

Drug Interactions

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Moderate Interactions

  • Alcohol (increased CNS depression)
  • CNS depressants (e.g., sedatives, tranquilizers, opioids - increased CNS depression)
  • Theophylline (decreased cetirizine clearance, though clinical significance is minor)

Monitoring

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Symptom Monitoring

  • Effectiveness of allergy symptom relief (e.g., sneezing, runny nose, itchy eyes, hives)
  • Occurrence of adverse effects (e.g., drowsiness, dry mouth, fatigue, headache)
  • Signs of allergic reaction (rare)

Special Patient Groups

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Pregnancy

Cetirizine is generally considered a low-risk antihistamine for use during pregnancy (Pregnancy Category B). Studies in animals have not shown harm to the fetus, and human data suggest no increased risk of major birth defects. However, use should be based on clinical need and discussed with a healthcare provider.

Trimester-Specific Risks:

First Trimester: Generally considered low risk; limited human data but no clear evidence of harm.
Second Trimester: Generally considered low risk; more human data available.
Third Trimester: Generally considered low risk; no specific concerns identified.
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Lactation

Cetirizine is excreted into breast milk in small amounts. While the amount is generally low and adverse effects in breastfed infants are rare, drowsiness or irritability in the infant is theoretically possible. It is considered L2 (Safer) by some sources. Use with caution, especially in preterm or jaundiced infants, or if the infant has other medical conditions. Monitor the infant for sedation or unusual fussiness.

Infant Risk: Low risk; monitor for drowsiness or irritability.
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Pediatric Use

Dosing must be carefully adjusted by age and weight. Younger children (2-5 years) require lower doses and may be more susceptible to side effects like drowsiness or paradoxical excitation. Not recommended for infants under 6 months unless specifically directed by a physician.

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Geriatric Use

Elderly patients may be more sensitive to the sedating effects and may have age-related decreases in renal function, requiring a lower starting dose (e.g., 5 mg once daily) and careful monitoring for adverse effects. Renal dose adjustments are particularly important.

Clinical Information

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Clinical Pearls

  • Cetirizine is a second-generation antihistamine, generally preferred over first-generation agents due to its lower incidence of sedation and anticholinergic side effects.
  • While considered 'non-drowsy,' some individuals may still experience sedation, especially at higher doses or when combined with alcohol or other CNS depressants.
  • Taking the dose in the evening may be beneficial if drowsiness occurs.
  • Chewable tablets are convenient for children and adults who have difficulty swallowing pills.
  • Tolerance to the antihistaminic effect is generally not observed with long-term use.
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Alternative Therapies

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

Average Cost: $5 - $20 per 30 tablets (generic 5mg)
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'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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.