Atarax Syrup 10mg/5ml
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
Pharmacologic Class
First-generation H1-receptor antagonist, Piperazine derivative
Pregnancy Category
C
FDA Approved
Mar 1956
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydroxyzine is an antihistamine that can help relieve itching from allergies, reduce anxiety, and cause drowsiness to help you relax before a procedure. It works by blocking a natural substance (histamine) that your body makes.
How to Use This Medicine
Taking Your Medication Correctly
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize discomfort.
When taking the liquid form of this medication, measure the dose carefully using the measuring device provided. If a measuring device is not included, ask your pharmacist for one to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. Ensure all medications are stored in a safe location, 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to inquire about 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 scheduled dose, skip the missed dose and resume your regular dosing 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.
To ensure you get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. You can take this medication with or without food. If it causes stomach upset, take it with food to help minimize discomfort.
When taking the liquid form of this medication, measure the dose carefully using the measuring device provided. If a measuring device is not included, ask your pharmacist for one to ensure accurate dosing.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light and moisture. Keep it in a dry place, away from the bathroom. Ensure all medications are stored in a safe location, 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method. You may also want to inquire about 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 scheduled dose, skip the missed dose and resume your regular dosing 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.
Lifestyle & Tips
- Avoid alcohol and other medications that cause drowsiness, as this can worsen sedation.
- Do not drive or operate heavy machinery until you know how this medication affects you.
- To relieve dry mouth, suck on sugarless candy or ice chips, or use a saliva substitute.
- Stay hydrated to help with dry mouth and constipation.
- Avoid grapefruit juice as it may interact with the medication (though less significant for hydroxyzine than some other drugs).
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Varies by indication. For pruritus: 25 mg (12.5 mL) orally 3 to 4 times daily. For anxiety/tension: 50-100 mg (25-50 mL) orally 4 times daily. For sedation pre-op: 50-100 mg (25-50 mL) single dose.
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
pruritus:
25 mg (12.5 mL) orally 3 to 4 times daily
anxiety:
50-100 mg (25-50 mL) orally 4 times daily
preoperative_sedation:
50-100 mg (25-50 mL) orally as a single dose
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established (generally >6 months for specific indications)
Child:
For pruritus/allergy: 0.6 mg/kg/day in divided doses (e.g., 0.2 mg/kg TID). For sedation: 0.6 mg/kg as a single dose. Max 100 mg/day.
Adolescent:
Similar to adult dosing, but consider lower end of range and individual response.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment, but monitor for increased sedation.
Moderate:
Consider 50% dose reduction; monitor closely.
Severe:
Consider 50% dose reduction; monitor closely. Avoid if possible.
Dialysis:
Hydroxyzine is not significantly dialyzable. Administer after dialysis. Consider dose reduction.
Hepatic Impairment:
Mild:
Consider 50% dose reduction; monitor closely.
Moderate:
Consider 50% dose reduction; monitor closely.
Severe:
Consider 50% dose reduction; monitor closely. Avoid if possible.
Pharmacology
Mechanism of Action
Hydroxyzine is a first-generation antihistamine that acts as a potent H1-receptor antagonist. Its anxiolytic, sedative, antiemetic, and anticholinergic properties are attributed to its central nervous system (CNS) depressant effects, including activity at subcortical areas. It also has some antispasmodic and local anesthetic properties.
Pharmacokinetics
Absorption:
Bioavailability:
High (well-absorbed)
Tmax:
Approximately 2 hours
FoodEffect:
Minimal effect on absorption rate or extent.
Distribution:
Vd:
Large (approximately 16 L/kg)
ProteinBinding:
Approximately 93%
CnssPenetration:
Yes
Elimination:
HalfLife:
Hydroxyzine: 7-20 hours (highly variable, longer in elderly and renally impaired); Cetirizine: 8-10 hours
Clearance:
Not readily available, but primarily hepatic metabolism and renal excretion of metabolites.
ExcretionRoute:
Mainly renal excretion of metabolites (including cetirizine).
Unchanged:
Less than 1% of unchanged drug excreted in urine.
Pharmacodynamics
OnsetOfAction:
15-30 minutes
PeakEffect:
Approximately 2 hours
DurationOfAction:
4-6 hours (sedation), antihistaminic effects may last longer.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention 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 help 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 heartbeat or fast heart rate
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 or seek medical help:
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 help 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 heartbeat or fast heart rate
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 or seek medical help:
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 dizziness or fainting
- Difficulty urinating
- Severe constipation
- Blurred vision or eye pain
- Confusion or hallucinations
- Tremors or uncontrolled movements
- Fast, pounding, or irregular heartbeat (palpitations)
- Seizures
- Any signs of an allergic reaction (rash, itching/swelling, severe dizziness, trouble breathing)
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.
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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues. Never start, stop, or adjust 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 allergic reaction you experienced, including any symptoms that occurred.
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 conditions with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health issues. Never start, stop, or adjust 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.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. It is also crucial to discuss the use of alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness, with your doctor beforehand.
This medication has been associated with an abnormal and potentially life-threatening heartbeat, known as a prolonged QT interval on an electrocardiogram (ECG), which may increase the risk of sudden death. Therefore, it is vital to consult with your doctor about this risk.
If you are 65 years of age 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, notify your doctor, as it is necessary to discuss the potential benefits and risks of using this medication during pregnancy.
Before operating a vehicle or engaging in any activity that requires your full attention, wait until you understand how this medication affects you. It is also crucial to discuss the use of alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) medications that may cause drowsiness, with your doctor beforehand.
This medication has been associated with an abnormal and potentially life-threatening heartbeat, known as a prolonged QT interval on an electrocardiogram (ECG), which may increase the risk of sudden death. Therefore, it is vital to consult with your doctor about this risk.
If you are 65 years of age 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, notify your doctor, as it is necessary to discuss the potential benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Severe sedation or stupor
- Confusion
- Hallucinations
- Seizures
- Severe dry mouth
- Blurred vision
- Urinary retention
- Rapid heartbeat
- Hypotension
- Respiratory depression
- Coma
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive, including gastric lavage, activated charcoal, and maintaining vital signs. Physostigmine may be considered for severe anticholinergic symptoms but is rarely used due to potential for adverse effects.
Drug Interactions
Contraindicated Interactions
- Drugs known to prolong the QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics, certain antifungals, tricyclic antidepressants, some antiemetics)
- Other CNS depressants (e.g., alcohol, opioids, benzodiazepines, barbiturates, sedatives, hypnotics) due to additive CNS depression, especially in patients with pre-existing cardiac conditions or electrolyte imbalances.
Major Interactions
- Alcohol
- Other CNS depressants (e.g., opioids, benzodiazepines, barbiturates, sedatives, hypnotics, general anesthetics)
- Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, benztropine, some antipsychotics) due to additive anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation)
- QT prolonging drugs (increased risk of Torsade de Pointes)
Moderate Interactions
- CYP3A4/5 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) may slightly increase hydroxyzine levels, but clinical significance is generally low.
- Antihypertensives (may cause additive hypotensive effects)
Minor Interactions
- Not typically associated with minor interactions of significant clinical concern beyond those listed above.
Monitoring
Baseline Monitoring
Patient history (cardiac conditions, electrolyte imbalances, seizure history, glaucoma, urinary retention)
Rationale: To identify contraindications or risk factors for adverse effects (e.g., QT prolongation, anticholinergic effects, seizures).
Timing: Prior to initiation of therapy.
Concomitant medications
Rationale: To identify potential drug-drug interactions, especially with CNS depressants, anticholinergics, or QT prolonging drugs.
Timing: Prior to initiation and periodically during therapy.
Baseline ECG (if risk factors for QT prolongation are present)
Rationale: To assess baseline QTc interval in patients with pre-existing cardiac conditions, electrolyte abnormalities, or on other QT-prolonging drugs.
Timing: Prior to initiation in high-risk patients.
Routine Monitoring
Sedation/Drowsiness level
Frequency: Daily, especially during dose titration or initiation.
Target: Acceptable level of sedation without excessive impairment.
Action Threshold: Excessive drowsiness, impaired coordination, or inability to perform daily activities; consider dose reduction or discontinuation.
Anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
Frequency: Daily, especially in elderly or susceptible patients.
Target: Minimal to no anticholinergic symptoms.
Action Threshold: Significant discomfort, urinary hesitancy/retention, or severe constipation; consider dose reduction or alternative.
Mental status/Cognitive function
Frequency: Periodically, especially in elderly patients.
Target: Stable cognitive function.
Action Threshold: New onset or worsening confusion, disorientation, or memory impairment; consider dose reduction or discontinuation.
QTc interval (if risk factors present)
Frequency: As clinically indicated, especially if new QT-prolonging drugs are added or electrolyte imbalances occur.
Target: <450 ms (men), <470 ms (women)
Action Threshold: Significant QTc prolongation (>500 ms or increase of >60 ms from baseline); discontinue hydroxyzine and investigate.
Symptom Monitoring
- Excessive drowsiness
- Dizziness
- Blurred vision
- Dry mouth
- Urinary retention
- Constipation
- Confusion
- Tremor
- Seizures (rare)
- Palpitations or irregular heartbeat (seek immediate medical attention)
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects, but there are no adequate and well-controlled studies in pregnant women. Avoid use, especially in early pregnancy, unless absolutely necessary.
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm based on animal studies; avoid if possible.
Second Trimester:
Limited data; use with caution if benefits outweigh risks.
Third Trimester:
Potential for neonatal withdrawal symptoms (e.g., tremors, irritability) if used close to delivery; avoid if possible.
Lactation
L4 (Potentially Hazardous). Hydroxyzine and its active metabolite, cetirizine, are excreted into breast milk. Due to the potential for sedation, anticholinergic effects, and respiratory depression in the infant, use is generally not recommended. If use is unavoidable, monitor infant closely for adverse effects.
Infant Risk:
Sedation, irritability, anticholinergic effects (e.g., dry mouth, constipation), respiratory depression.
Pediatric Use
Used for pruritus, anxiety, and sedation. Dosing is weight-based. Children may be more susceptible to CNS effects (paradoxical excitation or profound sedation) and anticholinergic effects. Avoid in neonates and infants under 6 months.
Geriatric Use
Elderly patients are more susceptible to the sedative and anticholinergic effects (e.g., confusion, urinary retention, constipation, dry mouth, falls) of hydroxyzine. Start with lower doses (e.g., 10 mg 3-4 times daily) and titrate slowly. Avoid if possible in patients with dementia or significant cognitive impairment due to increased risk of delirium. Consider Beers Criteria recommendations.
Clinical Information
Clinical Pearls
- Hydroxyzine is a good option for short-term anxiety or pruritus when benzodiazepines are not preferred or contraindicated, as it has less abuse potential.
- Warn patients about significant drowsiness and impaired coordination; advise against driving or operating machinery.
- Be mindful of its anticholinergic properties, especially in the elderly or patients with conditions like glaucoma or prostatic hypertrophy.
- Always assess for concomitant use of other CNS depressants or QT-prolonging drugs.
- The active metabolite, cetirizine, is less sedating and has a longer half-life, making it suitable for daily allergy relief without significant sedation.
Alternative Therapies
- For anxiety: Buspirone, SSRIs (e.g., escitalopram, sertraline), SNRIs (e.g., venlafaxine), benzodiazepines (e.g., lorazepam, alprazolam - for short-term use).
- For pruritus: Second-generation antihistamines (e.g., cetirizine, loratadine, fexofenadine), topical corticosteroids, doxepin (topical or oral).
- For sedation: Diphenhydramine, zolpidem, melatonin.
Cost & Coverage
Average Cost:
Low to moderate per 120 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 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 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 overdose, including the medication taken, the amount, and the time it occurred.