Cetirizine 5mg 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

Store your 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. 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 the best disposal method. You may also have access to local drug take-back programs.

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, 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 the recommended dose.
  • Be cautious when driving or operating machinery until you know how this medication affects you, as it may cause drowsiness.
  • Avoid or limit alcohol consumption while taking cetirizine, as it can increase drowsiness.
  • For seasonal allergies, start taking cetirizine before the allergy season begins if possible, or at the first sign of symptoms.

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: 6 months to <2 years: 2.5 mg once daily. May increase to a maximum of 2.5 mg twice daily if needed.
Child: 2 to 5 years: 2.5 mg once daily. May increase to a maximum of 5 mg/day given as 2.5 mg twice daily or 5 mg once daily. 6 to 11 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 mL/min)
Moderate: 5 mg once daily (CrCl 31-50 mL/min)
Severe: 5 mg every other day (CrCl <31 mL/min)
Dialysis: 5 mg every other day (ESRD patients on dialysis)

Hepatic Impairment:

Mild: No adjustment
Moderate: 5 mg once daily
Severe: 5 mg once daily

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 by competitively binding to H1-receptors on effector cells, thereby preventing the symptoms of allergic reactions. It also has anti-inflammatory effects, including inhibition of eosinophil chemotaxis and release of inflammatory mediators.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (well absorbed)
Tmax: Approximately 1 hour
FoodEffect: Food delays Tmax by 1.7 hours and decreases peak plasma concentration by 23%, but the extent of absorption is not reduced.

Distribution:

Vd: Approximately 0.45 L/kg
ProteinBinding: Approximately 93%
CnssPenetration: Limited (contributes to low sedation)

Elimination:

HalfLife: Approximately 8-11 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: Primarily renal (approximately 70% unchanged in urine), with a smaller portion excreted in feces (approximately 10%).
Unchanged: Approximately 70%
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Pharmacodynamics

OnsetOfAction: Within 20-60 minutes
PeakEffect: Approximately 6 hours
DurationOfAction: Up to 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
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 if you experience any of the following side effects or if they persist or bother you:
- 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, you can also contact your doctor. Additionally, you can 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
  • Fast or irregular heartbeat
  • Signs of an allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing) - seek immediate medical attention.
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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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.

To ensure your safety, it is crucial to verify that this medication can be taken 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. This medication may interfere with certain laboratory tests, so be sure to notify all your healthcare providers and laboratory personnel that you are taking it.

To minimize potential risks, refrain from consuming alcohol while using this medication. Before using marijuana, cannabis products, or prescription or over-the-counter medications that can 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 to discuss the potential benefits and risks to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Drowsiness
  • Sedation
  • Tachycardia (fast heart rate)
  • Tremor
  • Irritability
  • Urinary retention

What to Do:

Call 1-800-222-1222 (Poison Control). Treatment is symptomatic and supportive. There is no specific antidote. Gastric lavage may be considered if ingestion is recent.

Drug Interactions

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Moderate Interactions

  • Alcohol (increased CNS depression)
  • CNS depressants (e.g., sedatives, hypnotics, anxiolytics, opioids - increased CNS depression)
  • Ritonavir (increased cetirizine exposure)
  • Theophylline (decreased cetirizine clearance, minor effect)

Monitoring

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Routine Monitoring

Symptom relief (e.g., allergy symptoms, urticaria)

Frequency: Daily

Target: Reduction or resolution of symptoms

Action Threshold: Lack of efficacy after appropriate trial period

Adverse effects (e.g., drowsiness, dry mouth)

Frequency: As needed, especially during initial therapy

Target: Minimal or tolerable side effects

Action Threshold: Intolerable side effects requiring dose adjustment or discontinuation

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Symptom Monitoring

  • Allergy symptoms (sneezing, runny nose, itchy eyes, hives)
  • Drowsiness or sedation
  • Dry mouth
  • Fatigue
  • Dizziness

Special Patient Groups

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Pregnancy

Cetirizine is generally considered a low-risk antihistamine for use during pregnancy. It is classified as Pregnancy Category B. Human data from observational studies and meta-analyses have not shown an increased risk of major birth defects or other adverse outcomes.

Trimester-Specific Risks:

First Trimester: Limited data, but no clear evidence of increased risk of malformations.
Second Trimester: Generally considered safe for use.
Third Trimester: Generally considered safe for use.
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Lactation

Cetirizine is excreted into breast milk. While the amount is generally small, there is a potential for infant drowsiness or irritability, especially with higher doses or in very young infants. Use with caution, and monitor the infant for sedation or other adverse effects. Consider alternative antihistamines with lower milk transfer if possible.

Infant Risk: Low to Moderate (L3)
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Pediatric Use

Dosing is established for children 6 months and older. Lower doses are used for younger children. Monitor for sedation, especially in infants and toddlers, as they may be more sensitive to its effects.

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Geriatric Use

Elderly patients may be more susceptible to the sedating effects and anticholinergic side effects (e.g., dry mouth, urinary retention) of antihistamines. Dose adjustment is recommended for elderly patients with impaired renal function. Start with the lower end of the dosing range (5 mg once daily).

Clinical Information

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Clinical Pearls

  • Cetirizine is a second-generation antihistamine, generally less sedating than first-generation agents (e.g., diphenhydramine) but can still cause drowsiness in some individuals.
  • It is effective for both seasonal and perennial allergic rhinitis, as well as chronic idiopathic urticaria.
  • For patients experiencing significant drowsiness with 10 mg, a 5 mg dose may be sufficient for symptom control with less sedation.
  • Onset of action is relatively rapid, making it suitable for acute symptom relief.
  • Due to its long half-life, once-daily dosing is effective.
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Alternative Therapies

  • Loratadine (Claritin)
  • Fexofenadine (Allegra)
  • Desloratadine (Clarinex)
  • Levocetirizine (Xyzal)
  • Azelastine (nasal spray)
  • Olopatadine (nasal spray)
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Cost & Coverage

Average Cost: $5 - $20 per 30 tablets (5mg or 10mg generic)
Generic Available: Yes
Insurance Coverage: Tier 1 (Preferred Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is 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 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 information about the medication taken, the amount, and the time it happened.