Atarax 50mg Tablet
It is used to treat itching.It is used to treat anxiety.It is used to put you to sleep for surgery.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Antihistamine, Anxiolytic, Sedative/Hypnotic
Pharmacologic Class
First-generation H1-receptor antagonist
Pregnancy Category
C
FDA Approved
Mar 1956
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydroxyzine is an antihistamine that can help relieve anxiety and itching, and can also be used to help you relax before or after surgery. It works by affecting certain natural substances in your brain and body.
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 this medication at room temperature, protected from light, and in a dry place. Do not store it in a 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, check with your pharmacist for guidance on the best disposal method. You may also have access to drug take-back programs 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, do not take it more frequently than directed by your doctor.
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 this medication at room temperature, protected from light, and in a dry place. Do not store it in a 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, check with your pharmacist for guidance on the best disposal method. You may also have access to drug take-back programs 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, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Avoid alcohol and other CNS depressants (e.g., sedatives, opioids) as they can increase drowsiness and dizziness.
- Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause significant drowsiness.
- To relieve dry mouth, suck on sugarless candy or ice chips, or use a saliva substitute.
- Stay hydrated to help with potential constipation.
- Avoid prolonged exposure to sunlight or tanning beds as hydroxyzine can increase sensitivity to the sun.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
For anxiety: 50-100 mg four times daily; For pruritus: 25 mg three or four times daily; For sedation (pre-operative/post-operative): 50-100 mg single dose
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
anxiety:
50-100 mg QID
pruritus:
25 mg TID or QID
sedation:
50-100 mg single dose
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (use with caution, consult specialist)
Child:
For pruritus: 0.5-1 mg/kg/dose every 6 hours as needed; For pre-operative sedation: 0.6 mg/kg single dose
Adolescent:
For pruritus: 25 mg three or four times daily; For anxiety: 50-100 mg four times daily (adjust based on weight and response)
Dose Adjustments
Renal Impairment:
Mild:
Consider dose reduction (e.g., 50% of usual dose)
Moderate:
Consider dose reduction (e.g., 50% of usual dose)
Severe:
Significant dose reduction required (e.g., 50% or more), monitor closely for adverse effects
Dialysis:
Hydroxyzine is not significantly removed by dialysis; dose adjustment based on residual renal function and clinical response
Hepatic Impairment:
Mild:
Consider dose reduction (e.g., 50% of usual dose)
Moderate:
Significant dose reduction required (e.g., 50% or more), monitor closely for adverse effects
Severe:
Contraindicated or significant dose reduction required, monitor closely for adverse effects
Pharmacology
Mechanism of Action
Hydroxyzine is a first-generation antihistamine that acts as a potent antagonist of histamine H1-receptors in the central nervous system and periphery. Its anxiolytic and sedative effects are primarily due to its CNS depressant activity, which may be related to its subcortical depressant action on the central nervous system. It also possesses anticholinergic, antiemetic, and bronchodilator properties.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified, but well-absorbed orally
Tmax:
Approximately 2 hours
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
Not precisely quantified, but widely distributed into body tissues
ProteinBinding:
Approximately 93%
CnssPenetration:
Yes
Elimination:
HalfLife:
Adults: 7-20 hours (highly variable); Elderly: Prolonged (up to 29 hours); Children: Shorter (e.g., 4 hours in young children)
Clearance:
Not precisely quantified, but primarily hepatic metabolism and renal excretion.
ExcretionRoute:
Renal (primarily as metabolites, with a small amount of unchanged drug)
Unchanged:
<1%
Pharmacodynamics
OnsetOfAction:
15-30 minutes
PeakEffect:
Approximately 2 hours
DurationOfAction:
4-6 hours (sedation), up to 24 hours (antihistamine effects)
Confidence:
Medium
Safety & Warnings
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
+ Swelling of the mouth, face, lips, tongue, or throat
Abnormal or rapid heartbeat
Severe dizziness or fainting
Difficulty controlling body movements
Confusion
A rare but serious skin reaction, characterized by:
+ Fever
+ Multiple small skin spots within large areas of redness and swelling
If you develop a rash or any of these symptoms, contact your doctor immediately.
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 any other unusual symptoms that bother you or do not go away, contact your doctor:
Dry mouth
Drowsiness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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
+ Swelling of the mouth, face, lips, tongue, or throat
Abnormal or rapid heartbeat
Severe dizziness or fainting
Difficulty controlling body movements
Confusion
A rare but serious skin reaction, characterized by:
+ Fever
+ Multiple small skin spots within large areas of redness and swelling
If you develop a rash or any of these symptoms, contact your doctor immediately.
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 any other unusual symptoms that bother you or do not go away, contact your doctor:
Dry mouth
Drowsiness
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe drowsiness or dizziness
- Difficulty breathing or swallowing
- Severe skin rash or hives
- Swelling of the face, lips, tongue, or throat
- Irregular or fast heartbeat, palpitations, or fainting spells (seek immediate medical attention)
- Difficulty urinating
- Confusion or hallucinations
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.
A history of prolonged QT interval on an electrocardiogram (ECG).
If you are in the early stages of pregnancy. Note that this medication should not be taken during early pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting 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.
A history of prolonged QT interval on an electrocardiogram (ECG).
If you are in the early stages of pregnancy. Note that this medication should not be taken during early pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
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. Before consuming alcohol, using marijuana or other cannabis products, or taking any prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.
This medication has been associated with an abnormal and potentially life-threatening heart rhythm known as long QT interval on an electrocardiogram (ECG), which may increase the risk of sudden death. Discuss this risk with your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to experiencing side effects.
If you are pregnant or planning to become pregnant, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication during pregnancy.
Until you understand how this drug affects you, avoid operating a vehicle or engaging in any activities that require your full attention. Before consuming alcohol, using marijuana or other cannabis products, or taking any prescription or over-the-counter medications that may cause drowsiness, consult with your doctor.
This medication has been associated with an abnormal and potentially life-threatening heart rhythm known as long QT interval on an electrocardiogram (ECG), which may increase the risk of sudden death. Discuss this risk with your doctor.
If you are 65 years or older, exercise caution when using this medication, as you may be more susceptible to experiencing side effects.
If you are pregnant or planning to become pregnant, inform your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Severe sedation or stupor
- Coma
- Seizures
- Severe anticholinergic effects (e.g., severe dry mouth, blurred vision, dilated pupils, urinary retention, constipation, hyperthermia)
- Hypotension
- Tachycardia
- QT prolongation, Torsade de Pointes, cardiac arrest
What to Do:
Seek immediate medical attention. Call 911 or Poison Control (1-800-222-1222). Treatment is supportive and symptomatic. Gastric lavage may be considered if performed soon after ingestion. Activated charcoal may be administered. Monitor vital signs, cardiac rhythm (ECG), and mental status. Physostigmine may be considered for severe anticholinergic symptoms, but use with caution due to potential for adverse cardiac effects.
Drug Interactions
Contraindicated Interactions
- Drugs known to prolong the QT interval (e.g., Class IA and III antiarrhythmics, certain antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics, certain antifungals, tricyclic antidepressants, some antiemetics)
- Strong CYP3A4/5 inhibitors (use with caution, consider dose reduction)
Major Interactions
- CNS depressants (e.g., alcohol, benzodiazepines, opioids, other sedatives/hypnotics, tricyclic antidepressants, muscle relaxants) - increased sedation and CNS depression
- Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants, some antipsychotics) - increased anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
- Beta-blockers (e.g., metoprolol, propranolol) - potential for additive bradycardia
Moderate Interactions
- Monoamine Oxidase Inhibitors (MAOIs) - potential for increased anticholinergic effects and CNS depression
- Antihypertensives - potential for additive hypotensive effects
- Cholinergic drugs (e.g., donepezil, rivastigmine) - hydroxyzine may antagonize their effects
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Patient history (cardiac conditions, electrolyte imbalances, concomitant medications)
Rationale: To identify risk factors for QT prolongation and drug interactions
Timing: Prior to initiation
Baseline ECG (if risk factors for QT prolongation are present)
Rationale: To assess baseline QTc interval and identify pre-existing cardiac abnormalities
Timing: Prior to initiation
Routine Monitoring
Level of sedation/alertness
Frequency: Daily, especially during initiation or dose changes
Target: Appropriate for patient's activity level, without excessive drowsiness
Action Threshold: Excessive sedation, impaired cognitive function, or falls
Anticholinergic side effects (dry mouth, blurred vision, constipation, urinary retention)
Frequency: Daily, especially during initiation or dose changes
Target: Minimal to tolerable
Action Threshold: Severe or intolerable symptoms
Cardiac rhythm (symptoms of palpitations, dizziness, syncope)
Frequency: As needed, if symptoms arise
Target: Normal sinus rhythm, no symptoms of arrhythmia
Action Threshold: New onset of palpitations, dizziness, syncope, or signs of arrhythmia
Symptom Monitoring
- Excessive drowsiness or sedation
- Dizziness or lightheadedness
- Dry mouth
- Blurred vision
- Constipation
- Difficulty urinating
- Confusion or disorientation (especially in elderly)
- Palpitations or irregular heartbeat
- Rash or allergic reaction
Special Patient Groups
Pregnancy
Hydroxyzine is classified as Pregnancy Category C. Animal studies have shown adverse effects on the fetus, but there are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Potential for fetal abnormalities based on animal studies; generally avoided.
Second Trimester:
Use with caution, only if clearly needed.
Third Trimester:
Use with caution, potential for neonatal withdrawal symptoms or respiratory depression if used close to delivery.
Lactation
Hydroxyzine and its active metabolite, cetirizine, are excreted in human milk. Due to the potential for sedation, anticholinergic effects, and respiratory depression in the infant, and potential for decreased milk supply, hydroxyzine is generally not recommended during breastfeeding.
Infant Risk:
L3 (Moderately safe) to L4 (Possibly hazardous) - risk of sedation, anticholinergic effects (e.g., irritability, poor feeding), and respiratory depression in the infant. Monitor infant closely if used.
Pediatric Use
Hydroxyzine is used in pediatric patients for pruritus and sedation. Dosing is weight-based. Children may be more susceptible to CNS effects (paradoxical excitation or profound sedation) and anticholinergic effects. Use with caution, especially in very young children.
Geriatric Use
Elderly patients are more susceptible to the sedative and anticholinergic effects of hydroxyzine (e.g., confusion, urinary retention, constipation, falls). It is listed on the Beers Criteria as a medication to avoid in older adults due to its strong anticholinergic properties and potential for sedation. Use lowest effective dose and monitor closely.
Clinical Information
Clinical Pearls
- Hydroxyzine is a versatile first-generation antihistamine useful for anxiety, pruritus, and sedation, but its sedative and anticholinergic effects are prominent.
- Due to its potential for QT prolongation, especially at higher doses or in susceptible individuals, careful patient selection and monitoring for cardiac risk factors are crucial.
- The active metabolite, cetirizine, is a second-generation antihistamine with less CNS penetration, explaining why hydroxyzine is more sedating.
- Often used as a non-benzodiazepine alternative for anxiety, particularly when sedation is desired or benzodiazepines are contraindicated.
- Caution is advised in elderly patients due to increased sensitivity to adverse effects and inclusion in the Beers Criteria.
Alternative Therapies
- For anxiety: Buspirone, SSRIs/SNRIs, benzodiazepines (short-term), gabapentin, pregabalin
- For pruritus: Second-generation antihistamines (e.g., cetirizine, loratadine, fexofenadine), topical corticosteroids, doxepin (topical or oral)
- For sedation: Diphenhydramine, zolpidem, eszopiclone, melatonin
Cost & Coverage
Average Cost:
$10 - $50 per 30 tablets (50mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (Generic)
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 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.