Hydroxyzine 10mg/5ml Syrup
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 antihistamine (piperazine derivative)
Pregnancy Category
Category C
FDA Approved
Mar 1956
DEA Schedule
Not Controlled
Overview
What is this medicine?
Hydroxyzine is an antihistamine medication that can help reduce anxiety, relieve itching from allergies, and act as a mild sedative to help you relax or sleep before a procedure. It works by blocking a natural substance in your body called histamine.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food. If you experience an upset stomach, 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 measuring device.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. 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 by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose 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, do not take it more frequently than directed by your doctor.
To get the most benefit from your medication, it's essential to follow your doctor's instructions carefully. Read all the information provided with your medication and follow the instructions closely. You can take this medication with or without food. If you experience an upset stomach, 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 measuring device.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. 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 by your pharmacist. If you have questions about disposing of your medication, consult your pharmacist, who may be aware of drug take-back programs in your area.
What to Do If You Miss a Dose
If you take this medication on a regular schedule, take the missed dose 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, do not take it more frequently than directed by your doctor.
Lifestyle & Tips
- Avoid alcohol and other sedating medications while taking hydroxyzine, as this 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 sugar-free candy or ice chips, or use artificial saliva products.
- If taking for itching, avoid known allergens and irritants.
- Take exactly as prescribed; do not take more than recommended.
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:
Varies by indication
Condition-Specific Dosing:
Anxiety and Tension:
50-100 mg orally 4 times daily
Pruritus:
25 mg orally 3-4 times daily
Pre-operative Sedation:
50-100 mg orally as a single dose
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Pruritus: 0.5-1 mg/kg/dose orally every 6 hours; Pre-operative Sedation: 0.6 mg/kg orally as a single dose
Adolescent:
Pruritus: 25 mg orally 3-4 times daily; Pre-operative Sedation: 50-100 mg orally as a single dose
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed, monitor for increased sedation.
Moderate:
Consider 50% dose reduction; monitor for increased sedation and anticholinergic effects.
Severe:
Consider 50% dose reduction; monitor for increased sedation and anticholinergic effects.
Dialysis:
Hydroxyzine is not significantly dialyzable. Administer after dialysis. Consider dose reduction.
Hepatic Impairment:
Mild:
No specific adjustment needed, monitor for increased sedation.
Moderate:
Consider 50% dose reduction; monitor for increased sedation and anticholinergic effects.
Severe:
Consider 50% dose reduction; monitor for increased sedation and anticholinergic effects.
Pharmacology
Mechanism of Action
Hydroxyzine is a first-generation antihistamine that acts as a potent antagonist of histamine H1 receptors in the periphery and central nervous system. Its anxiolytic and sedative effects are attributed to its action on subcortical areas of the CNS, including the limbic system and reticular formation. It also possesses anticholinergic, antiemetic, and bronchodilator properties.
Pharmacokinetics
Absorption:
Bioavailability:
Not precisely quantified, but well-absorbed orally.
Tmax:
2-4 hours
FoodEffect:
Minimal effect on absorption rate or extent.
Distribution:
Vd:
16 L/kg (adults)
ProteinBinding:
Approximately 93%
CnssPenetration:
Yes
Elimination:
HalfLife:
Adults: 20-25 hours (parent drug); Cetirizine: 8-10 hours
Clearance:
Not precisely quantified, primarily hepatic metabolism.
ExcretionRoute:
Renal (primarily as metabolites, with cetirizine being the major renally excreted metabolite)
Unchanged:
<1% (parent drug)
Pharmacodynamics
OnsetOfAction:
15-30 minutes
PeakEffect:
2-4 hours
DurationOfAction:
4-6 hours (sedation), up to 24 hours (antihistaminic effects due to cetirizine)
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
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 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
Fast or abnormal 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 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.
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 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
Fast or abnormal 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 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 that interferes with daily activities.
- Confusion, disorientation, or hallucinations (especially in older adults).
- Difficulty urinating or severe constipation.
- Blurred vision or eye pain.
- Fast, pounding, or irregular heartbeat (palpitations).
- Muscle tremors or uncontrolled movements.
- 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. Be sure to describe the allergic reaction and its symptoms.
A history of prolonged QT interval on an electrocardiogram (ECG).
If you are in the early stages of pregnancy. 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 (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 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. Be sure to describe the allergic reaction and its symptoms.
A history of prolonged QT interval on an electrocardiogram (ECG).
If you are in the early stages of pregnancy. 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 (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 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 alertness. Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
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. Discuss this risk with your doctor.
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. 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 alertness. Before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor.
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. Discuss this risk with your doctor.
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. 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 somnolence
- Confusion
- Disorientation
- Slurred speech
- Ataxia (loss of coordination)
- Hypotension (low blood pressure)
- Tachycardia (fast heart rate)
- Anticholinergic effects (severe dry mouth, blurred vision, urinary retention, dilated pupils)
- Seizures (rare)
- Coma
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 ingestion is recent. Activated charcoal may be administered. Monitor vital signs, cardiac rhythm (ECG), and mental status. Physostigmine may be used for severe anticholinergic symptoms but is generally reserved for life-threatening cases due to potential for adverse effects.
Drug Interactions
Contraindicated Interactions
- QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, certain antipsychotics, macrolide antibiotics, fluoroquinolones, methadone, ondansetron)
- Drugs that cause bradycardia or hypokalemia/hypomagnesemia (increase risk of Torsade de Pointes)
Major Interactions
- CNS depressants (e.g., alcohol, opioids, benzodiazepines, barbiturates, other sedatives/hypnotics, tricyclic antidepressants): Increased sedation and CNS depression.
- Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants, some antipsychotics): Increased anticholinergic effects (dry mouth, urinary retention, constipation, blurred vision).
Moderate Interactions
- Monoamine Oxidase Inhibitors (MAOIs): May prolong and intensify anticholinergic and CNS depressant effects.
- Betahistine: May reduce efficacy of betahistine (histamine analog).
Minor Interactions
- Not specifically noted for minor interactions with significant clinical impact.
Monitoring
Baseline Monitoring
Cardiac history and ECG (if risk factors for QT prolongation)
Rationale: To assess baseline cardiac rhythm and identify risk factors for QT prolongation (e.g., congenital long QT syndrome, significant cardiac disease, electrolyte imbalances).
Timing: Prior to initiation, especially in patients with cardiac risk factors or on concomitant QT-prolonging medications.
Renal and Hepatic Function Tests
Rationale: To assess baseline organ function, as dose adjustments may be necessary in impairment.
Timing: Prior to initiation in patients with suspected or known renal/hepatic impairment.
Routine Monitoring
Level of Sedation/Alertness
Frequency: Daily or as needed, especially during initial therapy or dose changes.
Target: Appropriate level of sedation for indication, without excessive drowsiness or impairment.
Action Threshold: Excessive sedation, somnolence, or impaired cognitive function warrants dose reduction or discontinuation.
Anticholinergic Side Effects (e.g., dry mouth, blurred vision, urinary retention, constipation)
Frequency: Daily or as needed.
Target: Absence or mild, tolerable symptoms.
Action Threshold: Severe or bothersome anticholinergic symptoms warrant dose reduction or discontinuation.
Mental Status (especially in elderly)
Frequency: Regularly, especially during initial therapy.
Target: No new or worsening confusion, disorientation, or paradoxical excitation.
Action Threshold: New onset or worsening confusion, agitation, or paradoxical excitation warrants immediate re-evaluation and potential 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: QTc >500 ms or increase of >60 ms from baseline warrants immediate discontinuation and cardiac evaluation.
Symptom Monitoring
- Drowsiness
- Dizziness
- Dry mouth
- Blurred vision
- Urinary retention
- Constipation
- Confusion (especially in elderly)
- Paradoxical excitation (rare)
- Palpitations or irregular heartbeat (rare, but serious)
Special Patient Groups
Pregnancy
Category C. Use during pregnancy should be avoided unless the potential benefits outweigh the potential risks to the fetus. Studies in animals have shown adverse effects. There are no adequate and well-controlled studies in pregnant women. Use in late pregnancy, particularly the third trimester, may lead to neonatal withdrawal symptoms (e.g., hypotonia, tremor, irritability) or anticholinergic effects in the neonate.
Trimester-Specific Risks:
First Trimester:
Potential for teratogenicity, though human data are limited and conflicting. Generally avoided.
Second Trimester:
Less data, but still generally avoided due to potential for CNS effects and lack of clear benefit outweighing risk.
Third Trimester:
Risk of neonatal withdrawal symptoms (e.g., hypotonia, tremor, irritability) and anticholinergic effects in the neonate if used close to delivery.
Lactation
L3 (Moderately safe). Hydroxyzine and its active metabolite, cetirizine, are excreted into breast milk. Due to the potential for sedation, anticholinergic effects, and paradoxical excitation in the infant, use during breastfeeding is generally discouraged. If use is necessary, monitor the infant closely for drowsiness, poor feeding, and irritability. Consider alternative agents if possible.
Infant Risk:
Potential for sedation, lethargy, poor feeding, irritability, and anticholinergic effects (e.g., dry mouth, constipation).
Pediatric Use
Dosing is established for pruritus and pre-operative sedation. Children may be more susceptible to CNS effects (sedation or paradoxical excitation). Use with caution and at the lowest effective dose. Not recommended for use in infants under 6 months.
Geriatric Use
Elderly patients are more susceptible to the sedative and anticholinergic effects of hydroxyzine, including confusion, urinary retention, and constipation. They are also at increased risk for falls. Hydroxyzine is on the Beers Criteria list as a potentially inappropriate medication for older adults due to its strong anticholinergic properties and risk of sedation. Use with extreme caution, start with lower doses, and titrate slowly. Avoid if possible, especially in those with cognitive impairment or prostatic hypertrophy.
Clinical Information
Clinical Pearls
- Hydroxyzine is a versatile first-generation antihistamine used for anxiety, pruritus, and sedation, but its anticholinergic and sedative side effects limit its use, especially in the elderly.
- Due to its active metabolite, cetirizine, its antihistaminic effects can last longer than its sedative effects.
- Caution is advised with concomitant use of other CNS depressants (e.g., alcohol, opioids, benzodiazepines) due to additive sedation.
- There is a risk of QT prolongation, especially in patients with pre-existing cardiac conditions, electrolyte imbalances, or on other QT-prolonging medications. ECG monitoring may be warranted in high-risk patients.
- Often used as a non-benzodiazepine alternative for short-term anxiety or as an adjunct for sleep in patients where benzodiazepines are contraindicated or undesirable.
- Patients should be advised to avoid driving or operating machinery until they know how the drug affects them.
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 at bedtime).
- For sedation/insomnia: Trazodone, zolpidem, eszopiclone, ramelteon, melatonin, diphenhydramine (short-term, with similar anticholinergic risks).
Cost & Coverage
Average Cost:
Varies, typically low per 120ml bottle (10mg/5ml)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.