Cetirizine 1mg/ml Oral Solution

Manufacturer PHARMACEUTICAL ASSOCIATES 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 called histamine that your body makes during an allergic reaction. It's a 'non-drowsy' type of antihistamine for most people, but some 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. When measuring liquid doses, use the measuring device that comes with the medication. If one is not provided, ask your pharmacist for a suitable device to ensure accurate measurement.

Storing and Disposing of Your Medication

Store this medication at room temperature in a dry place, avoiding bathrooms. 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 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 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 take 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 alcohol and other sedating medications, as they can increase drowsiness.
  • Be cautious when driving or operating machinery until you know how this medication affects you.
  • Take with or without food, but food may slightly delay onset of action.
  • Measure liquid dose accurately using the provided measuring device, not a household spoon.

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg (10 ml) once daily
Dose Range: 5 - 10 mg

Condition-Specific Dosing:

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

Neonatal: Not established
Infant: 6 to <12 months: 2.5 mg (2.5 ml) once daily. Max 2.5 mg/day.
Child: 12 months to <6 years: Initial 2.5 mg (2.5 ml) once daily; may increase to 5 mg (5 ml) once daily or 2.5 mg (2.5 ml) twice daily. 6 years and older: 5 mg (5 ml) or 10 mg (10 ml) once daily.
Adolescent: 12 years and older: 5 mg (5 ml) or 10 mg (10 ml) once daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment typically needed for CrCl >50 mL/min.
Moderate: CrCl 31-50 mL/min: 5 mg (5 ml) once daily.
Severe: CrCl <31 mL/min: 5 mg (5 ml) every other day.
Dialysis: Hemodialysis: 5 mg (5 ml) every other day. Cetirizine is minimally dialyzable.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: Consider 5 mg (5 ml) once daily.
Severe: Consider 5 mg (5 ml) once daily.

Pharmacology

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Mechanism of Action

Cetirizine 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 such as sneezing, rhinorrhea, pruritus, and urticaria. It also inhibits the release of histamine from mast cells and reduces eosinophil chemotaxis and activation.
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Pharmacokinetics

Absorption:

Bioavailability: High (not precisely quantified, but well absorbed)
Tmax: Approximately 1 hour
FoodEffect: Food delays Tmax by about 1.7 hours but does not affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 0.5 L/kg
ProteinBinding: Approximately 93%
CnssPenetration: Limited (contributes to its non-sedating profile compared to first-generation antihistamines)
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Pharmacodynamics

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

Safety & Warnings

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Side Effects

Serious Side Effects: Seek Medical Help 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 attention 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.

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 all patients taking this medication:
- Drowsiness
- Feeling tired or weak
- Dry mouth
- Trouble 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
  • Fast or pounding heartbeats
  • Signs of an allergic reaction (hives, difficulty breathing, swelling of face/lips/tongue/throat) - 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 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 information will help your doctor and pharmacist assess potential interactions between this medication and other substances you are taking.
* Any existing health problems, as this medication may interact with certain conditions or exacerbate underlying health issues.

To ensure your safety, it is crucial to verify that this medication can be taken safely 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 taking this medication. Before using marijuana, other forms of cannabis, or prescription and over-the-counter (OTC) 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 experiencing 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
  • Agitation (especially in children)
  • Irritability
  • Urinary retention

What to Do:

Call 911 or Poison Control (1-800-222-1222) immediately. Treatment is generally supportive and symptomatic. There is no specific antidote.

Drug Interactions

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Moderate Interactions

  • Alcohol
  • CNS depressants (e.g., sedatives, tranquilizers, opioids)
  • Theophylline

Monitoring

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Routine Monitoring

Symptom relief (e.g., reduction in sneezing, itching, rhinorrhea)

Frequency: Daily

Target: Significant improvement

Action Threshold: Lack of improvement after 3-5 days, consider alternative therapy or dose adjustment.

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

Frequency: Daily, especially during initial therapy

Target: Minimal to no adverse effects

Action Threshold: Persistent or bothersome side effects, consider dose reduction or alternative therapy.

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Symptom Monitoring

  • Allergy symptoms (sneezing, runny nose, itchy eyes/nose/throat, hives)
  • Sedation/drowsiness
  • Dry mouth
  • Fatigue
  • Headache

Special Patient Groups

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Pregnancy

Cetirizine is considered a low-risk option for allergic rhinitis and urticaria during pregnancy (Pregnancy Category B). Use only if clearly needed.

Trimester-Specific Risks:

First Trimester: Limited data, but 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. Use with caution, monitor infant for sedation or poor feeding. Loratadine or fexofenadine may be preferred due to lower milk levels.

Infant Risk: L3 (Moderate risk - compatible, but monitor infant for sedation/irritability).
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Pediatric Use

Dosing is age-dependent and lower than adult doses. Oral solution is suitable for accurate dosing in infants and young children. Monitor for paradoxical excitation (rare) or increased sedation, especially in younger children.

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Geriatric Use

Elderly patients may be more susceptible to adverse effects, particularly sedation and anticholinergic effects (e.g., urinary retention, dry mouth). Start with the lower end of the dosing range (5 mg once daily) and adjust based on renal function and response. Monitor for cognitive impairment.

Clinical Information

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Clinical Pearls

  • Cetirizine is generally less sedating than first-generation antihistamines but can still cause drowsiness in some individuals, especially at higher doses or when combined with alcohol/CNS depressants.
  • The oral solution is particularly useful for pediatric patients or those who have difficulty swallowing tablets.
  • Taking the dose in the evening may help mitigate any residual drowsiness.
  • Tolerance to the sedating effects may develop over time.
  • Patients with significant renal impairment require dose adjustment to prevent accumulation and increased side effects.
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Alternative Therapies

  • Loratadine (Claritin)
  • Fexofenadine (Allegra)
  • Desloratadine (Clarinex)
  • Levocetirizine (Xyzal)
  • Diphenhydramine (Benadryl - first-generation, more sedating)
  • Corticosteroid nasal sprays (e.g., fluticasone, mometasone) for allergic rhinitis
  • Mast cell stabilizers (e.g., cromolyn sodium) for allergic rhinitis
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Cost & Coverage

Average Cost: Varies widely, typically low per 120 ml bottle
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 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 facilitate prompt and effective treatment.