Hydroxyzine Hcl 25mg Tabs
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, Antiemetic
Pharmacologic Class
H1-receptor antagonist
Pregnancy Category
Category C
FDA Approved
Mar 1956
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydroxyzine is an antihistamine that can help reduce anxiety, relieve itching from allergies, 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
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, take it with food to help minimize this side effect.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Ensure that all medications are kept 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.
Missing a Dose
If you take this medication on a regular schedule 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 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 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, take it with food to help minimize this side effect.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Ensure that all medications are kept 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a local drug take-back program if available.
Missing a Dose
If you take this medication on a regular schedule 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 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 CNS depressants (e.g., sleeping pills, pain medications) 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, chew sugarless gum, or use a saliva substitute.
- If you experience blurred vision or difficulty urinating, contact your doctor.
- Take exactly as prescribed; do not take more or less than directed.
Available Forms & Alternatives
Available Strengths:
- Hydroxyzine Pamoate 100mg Capsules
- Hydroxyzine 10mg/5ml Syrup
- Hydroxyzine 50mg/ml Inj, 1ml
- Hydroxyzine Hcl 50mg/ml For Inj
- Hydroxyzine Hcl 25mg/ml Inj 1ml
- Hydroxyzine Hcl 25mg Tabs (white)
- Hydroxyzine Hcl 50mg Tabs (white)
- Hydroxyzine Hcl 10mg Tablets
- Hydroxyzine Pamoate 25mg Capsules
- Hydroxyzine 10mg/5ml Syrup
- Hydroxyzine Pamoate 50mg Capsules
- Hydroxyzine Pamoate 25mg Capsules
- Hydroxyzine Hcl 25mg Tabs
- Hydroxyzine Pamoate 50mg Capsules
Dosing & Administration
Adult Dosing
Standard Dose:
25 mg three to four times daily for pruritus; 50-100 mg up to four times daily for anxiety; 50-100 mg single dose for pre-operative sedation
Dose Range:
25 - 400 mg
Condition-Specific Dosing:
anxiety:
50-100 mg up to four times daily (initial 50 mg QID, then adjust as needed, max 400 mg/day)
pruritus:
25 mg three to four times daily
sedation_pre_operative:
50-100 mg single dose
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established for routine use; consult specialist for specific indications.
Child:
Pruritus: 0.5-1 mg/kg/dose every 6-8 hours (max 2 mg/kg/day in divided doses). Pre-operative sedation: 0.6 mg/kg single dose.
Adolescent:
Pruritus: 25 mg three to four times daily. Anxiety: 50-100 mg up to four times daily. Pre-operative sedation: 50-100 mg single dose.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor for increased sedation.
Moderate:
Consider dose reduction by 50% or increased dosing interval.
Severe:
Consider dose reduction by 50% or increased dosing interval; monitor closely for adverse effects.
Dialysis:
Hydroxyzine is not significantly dialyzable. Administer after dialysis. Consider dose reduction.
Hepatic Impairment:
Mild:
No specific adjustment recommended, but monitor for increased sedation.
Moderate:
Consider dose reduction by 50% or increased dosing interval.
Severe:
Consider dose reduction by 50% or increased dosing interval; 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 peripheral and central nervous system. It also possesses anticholinergic, antiemetic, antispasmodic, and mild analgesic properties. Its anxiolytic and sedative effects are attributed to its action on subcortical areas of the central nervous system.
Pharmacokinetics
Absorption:
Bioavailability:
Not available (rapidly absorbed)
Tmax:
2-4 hours
FoodEffect:
Food may delay absorption but does not significantly affect the extent of absorption.
Distribution:
Vd:
16 L/kg (highly lipophilic)
ProteinBinding:
Approximately 93%
CnssPenetration:
Yes
Elimination:
HalfLife:
14-25 hours (highly variable, longer in elderly and renally/hepatically impaired patients)
Clearance:
Not available
ExcretionRoute:
Primarily renal (as cetirizine and other metabolites)
Unchanged:
<1% (hydroxyzine); approximately 60% (cetirizine)
Pharmacodynamics
OnsetOfAction:
15-30 minutes
PeakEffect:
2-4 hours
DurationOfAction:
4-6 hours (sedation); antihistaminic effects may last longer
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While 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 immediate medical attention:
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. Although 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 persist, 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.
While 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 immediate medical attention:
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. Although 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 persist, 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 drowsiness or dizziness
- Difficulty breathing or swallowing
- Tremors or uncontrolled muscle movements
- Seizures
- Severe skin rash or hives
- Swelling of the face, lips, tongue, or throat
- Fast, pounding, or irregular heartbeat
- Confusion or hallucinations
- Difficulty urinating
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. It is crucial to avoid taking this medication during early pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is vital 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 whether it is safe to take this medication in combination with your other medications and health issues. Never start, stop, or adjust the dosage 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. It is crucial to avoid taking this medication during early pregnancy.
If you are breastfeeding. You should not breastfeed while taking this medication.
This list is not exhaustive, and it is vital 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 whether it is safe to take this medication in combination with your other medications and health issues. Never start, stop, or adjust the dosage 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 drug 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 heart rhythm known as long 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 or older, exercise caution when using this drug, as you may be more susceptible to experiencing side effects.
If you are pregnant or planning to become pregnant, notify your doctor. It is necessary to have a discussion with your doctor about 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 drug 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 heart rhythm known as long 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 or older, exercise caution when using this drug, as you may be more susceptible to experiencing side effects.
If you are pregnant or planning to become pregnant, notify your doctor. It is necessary to have a discussion with your doctor about the potential benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Severe sedation
- Stupor or coma
- Respiratory depression
- Hypotension
- Tachycardia
- Arrhythmias (including QT prolongation and Torsades de Pointes)
- Convulsions
- Severe anticholinergic effects (e.g., severe dry mouth, dilated pupils, urinary retention, delirium)
What to Do:
Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Gastric lavage may be considered if recent ingestion. Activated charcoal may be administered. Monitor vital signs, ECG, and mental status. Physostigmine may be used for severe anticholinergic symptoms but carries risks. Do not induce vomiting.
Drug Interactions
Contraindicated Interactions
- QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, moxifloxacin, erythromycin, antipsychotics like pimozide, thioridazine)
- Drugs that significantly inhibit CYP3A4/5 (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) if co-administered with other QT-prolonging drugs
Major Interactions
- CNS depressants (e.g., alcohol, opioids, benzodiazepines, barbiturates, other sedatives/hypnotics): Increased sedation and respiratory depression.
- Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, some antipsychotics): Increased anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation).
- Drugs that prolong QT interval (even if not strictly contraindicated, use with extreme caution): Increased risk of torsades de pointes.
- Cholinesterase inhibitors (e.g., donepezil, rivastigmine): Antagonism of therapeutic effect.
Moderate Interactions
- CYP3A4/5 inhibitors (e.g., diltiazem, verapamil, grapefruit juice): May increase hydroxyzine levels, leading to increased sedation and anticholinergic effects.
- CYP3A4/5 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease hydroxyzine levels, reducing efficacy.
- Antihypertensives: May cause additive hypotensive effects.
- Betahistine: Antagonism of therapeutic effect.
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Patient history (cardiac, renal, hepatic disease, glaucoma, urinary retention)
Rationale: To identify contraindications or conditions requiring dose adjustment or increased monitoring.
Timing: Prior to initiation of therapy
ECG (if patient has pre-existing cardiac conditions or is on other QT-prolonging drugs)
Rationale: To assess baseline QT interval and risk of Torsades de Pointes.
Timing: Prior to initiation of therapy
Routine Monitoring
Sedation level/Mental status
Frequency: Daily or as needed, especially during dose titration
Target: Acceptable level of sedation without excessive impairment
Action Threshold: Excessive drowsiness, confusion, or impaired coordination; consider dose reduction or discontinuation.
Anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
Frequency: Daily or as needed
Target: Minimal to tolerable side effects
Action Threshold: Severe or bothersome anticholinergic symptoms; consider dose reduction or alternative.
QTc interval (if patient has risk factors or on concomitant QT-prolonging drugs)
Frequency: As clinically indicated, e.g., after dose changes or initiation of interacting drugs
Target: <450 ms (men), <470 ms (women)
Action Threshold: Significant QTc prolongation (>500 ms or >60 ms increase from baseline); discontinue hydroxyzine.
Symptom Monitoring
- Excessive drowsiness
- Dizziness
- Confusion
- Dry mouth
- Blurred vision
- Urinary retention
- Constipation
- Tremor
- Involuntary muscle movements (rare, paradoxical)
- Palpitations or irregular heartbeat
Special Patient Groups
Pregnancy
Category C. Use only if the potential benefit justifies the potential risk to the fetus. Avoid, especially in the first trimester, due to potential for fetal harm (e.g., congenital malformations observed in animal studies at high doses).
Trimester-Specific Risks:
First Trimester:
Potential for fetal harm; generally avoided.
Second Trimester:
Use with caution; limited human data.
Third Trimester:
Use with caution; potential for neonatal withdrawal symptoms (e.g., tremors, hypotonia) if used close to delivery.
Lactation
L4 (Potentially Hazardous). Hydroxyzine and its active metabolite, cetirizine, are excreted into breast milk. Due to the long half-life of hydroxyzine and the potential for infant sedation, anticholinergic effects (e.g., dry mouth, constipation), and theoretical risk of decreased milk supply, it is generally recommended to avoid use during breastfeeding. If use is necessary, monitor the infant closely for drowsiness, poor feeding, and developmental milestones.
Infant Risk:
High (sedation, anticholinergic effects, potential for decreased milk supply)
Pediatric Use
Use with caution, especially in younger children, due to potential for paradoxical excitation (hyperactivity, agitation) or excessive sedation. Dosing is weight-based. Not recommended for long-term use in children for anxiety.
Geriatric Use
High risk population. Included in the Beers Criteria as a medication to avoid in older adults due to its potent anticholinergic properties and risk of sedation, confusion, falls, and urinary retention. Start with lower doses (e.g., 10 mg TID/QID) and titrate slowly. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Hydroxyzine is a first-generation antihistamine with significant sedative and anticholinergic effects, making it useful for short-term anxiety, pruritus, and pre-operative sedation.
- It is not recommended for long-term management of anxiety disorders due to its side effect profile and the availability of safer, more effective alternatives.
- Due to its anticholinergic burden and sedative effects, it should be used with extreme caution in the elderly and avoided if possible (Beers Criteria).
- Patients should be warned about impaired driving and operating machinery, and advised to avoid alcohol and other CNS depressants.
- Monitor for QT prolongation, especially in patients with cardiac risk factors or on concomitant QT-prolonging medications.
- The active metabolite, cetirizine, is also an antihistamine but with less CNS penetration and anticholinergic effects.
Alternative Therapies
- For anxiety: SSRIs, SNRIs, buspirone, benzodiazepines (short-term), gabapentin, pregabalin.
- For pruritus: Second-generation antihistamines (e.g., cetirizine, loratadine, fexofenadine), topical corticosteroids, doxepin (topical or oral at bedtime for severe pruritus).
- For sedation: Benzodiazepines (e.g., lorazepam, midazolam), zolpidem, melatonin.
Cost & Coverage
Average Cost:
Price range varies widely (e.g., $10-$30) per 30 tablets
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 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 happened.