Cetirizine 10mg Tablets

Manufacturer PACK PHARMACEUTICALS, LLC Active Ingredient Cetirizine Capsules and 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
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, 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, taking it with food may help.

Storing and Disposing of Your Medication

Keep your medication at room temperature in a dry place, avoiding storage in a bathroom. Ensure all medications are stored safely and out of 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 your pharmacist for guidance on proper disposal. Many areas have drug take-back programs, which your pharmacist can help you find.

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 dose, skip the missed dose and resume your regular schedule. Do not take two doses at the same time or extra doses. If you take this medication as needed, follow your doctor's instructions and do not take it more frequently than recommended.
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Lifestyle & Tips

  • Avoid or limit alcohol consumption while taking cetirizine, as it can increase drowsiness.
  • Use caution when driving or operating machinery until you know how this medication affects you.
  • Take with or without food. If stomach upset occurs, take with food.

Dosing & Administration

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Adult Dosing

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

Condition-Specific Dosing:

mild_symptoms: 5 mg once daily
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (generally not recommended under 6 months)
Child: 6 months to <2 years: 2.5 mg once daily; may increase to 2.5 mg twice daily if needed. 2 to <6 years: 2.5 mg once daily; may increase to 5 mg once daily or 2.5 mg twice daily. 6 to <12 years: 5 mg or 10 mg once daily.
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 50-79 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 (due to minimal removal by dialysis)

Hepatic Impairment:

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

Pharmacology

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Mechanism of Action

Cetirizine, a piperazine derivative, is a potent and selective peripheral H1-receptor antagonist. It inhibits the effects of histamine on H1-receptors, thereby reducing symptoms associated with allergic reactions (e.g., sneezing, rhinorrhea, pruritus, 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: High (approximately 70-85%)
Tmax: 1 hour (range 0.5-1.5 hours)
FoodEffect: Food delays Tmax by 1.7 hours and decreases Cmax by 23%, but the extent of absorption (AUC) is not affected.

Distribution:

Vd: 0.45 L/kg
ProteinBinding: Approximately 93%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 8-10 hours (adults); shorter in children (6 hours in 6-12 years, 5 hours in 2-6 years, 3.1 hours in 6-24 months)
Clearance: Approximately 0.53 mL/min/kg
ExcretionRoute: 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
While not everyone experiences side effects, it's essential to be aware of the potential ones. If you're bothered by any of the following side effects or if they don't 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 is not exhaustive, and you may experience other side effects. If you have questions or concerns, don't hesitate to reach out to your doctor. You can also 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:

  • Signs of an allergic reaction (e.g., rash, itching/swelling (especially of face/tongue/throat), severe dizziness, trouble breathing) - seek immediate medical attention.
  • Severe drowsiness or dizziness that interferes with daily activities.
  • Unusual tiredness or weakness.
  • Difficulty urinating.
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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 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 is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.

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. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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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 and engaging in other 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 using this medication. Before using marijuana, other forms of cannabis, or prescription or over-the-counter (OTC) 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 experiencing side effects.

If you are pregnant, planning to become pregnant, or breastfeeding, inform 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.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Sedation
  • Tachycardia (fast heart rate)
  • Urinary retention
  • Fatigue
  • Headache
  • Dizziness
  • In children: irritability, restlessness, followed by drowsiness

What to Do:

Call 1-800-222-1222 (Poison Control Center) immediately or seek emergency medical attention. Treatment is generally supportive and symptomatic.

Drug Interactions

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Moderate Interactions

  • CNS depressants (e.g., alcohol, sedatives, tranquilizers, opioids): May cause additive CNS depression (drowsiness, dizziness).
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Minor Interactions

  • Theophylline: A small decrease in cetirizine clearance has been observed, but is not clinically significant.

Monitoring

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Symptom Monitoring

  • Efficacy of symptom relief (e.g., reduction in sneezing, runny nose, itching, hives)
  • Adverse effects, particularly drowsiness or sedation
  • Paradoxical excitation (rare, especially in children)

Special Patient Groups

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Pregnancy

Cetirizine is generally considered a preferred antihistamine for use during pregnancy due to its Category B classification and extensive human data showing no increased risk of major birth defects. However, use only if clearly needed and after consulting a healthcare provider.

Trimester-Specific Risks:

First Trimester: No increased risk of major birth defects observed in human studies.
Second Trimester: Considered safe based on available data.
Third Trimester: Considered safe based on available data.
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Lactation

Cetirizine is excreted into breast milk. While the amount is small, it may cause drowsiness or irritability in the infant. It may also decrease milk supply. Use with caution, especially in newborns or premature infants. Consider alternative antihistamines or monitor the infant for adverse effects.

Infant Risk: Low to moderate risk (L3 - Moderately Safe)
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Pediatric Use

Dosing must be carefully adjusted by age and weight, especially in infants and young children, due to differences in metabolism and potential for increased sensitivity to sedative effects. Not recommended for infants under 6 months without medical supervision.

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Geriatric Use

Elderly patients may be more susceptible to the sedative effects and may have age-related decreases in renal function. A lower starting dose (e.g., 5 mg once daily) is recommended, especially if renal impairment is present. Monitor for increased drowsiness or confusion.

Clinical Information

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Clinical Pearls

  • Cetirizine is a second-generation antihistamine, generally less sedating than first-generation agents like diphenhydramine, but drowsiness can still occur, especially at higher doses or in sensitive individuals.
  • Take cetirizine in the evening if drowsiness is a concern, as its effects last for 24 hours.
  • It is effective for both seasonal and perennial allergic rhinitis, as well as chronic idiopathic urticaria.
  • Patients with renal impairment require dose adjustment due to its primary renal excretion.
  • Avoid concurrent use with alcohol or other CNS depressants due to additive sedative effects.
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Alternative Therapies

  • Loratadine (Claritin)
  • Fexofenadine (Allegra)
  • Levocetirizine (Xyzal)
  • Desloratadine (Clarinex)
  • Azelastine (nasal spray)
  • Olopatadine (nasal spray/eye drops)
  • Corticosteroid nasal sprays (e.g., fluticasone, mometasone)
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Cost & Coverage

Average Cost: Varies widely, typically $5-$20 per 30 tablets
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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it occurred.