Atarax 25mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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 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 by your pharmacist. Instead, check with your pharmacist for guidance on the best disposal method or participate in a drug take-back program in your area.
Missing a Dose
If you take this medication on a regular schedule, take a 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 normal 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 CNS depressants (e.g., sedatives, tranquilizers) 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 and impair your ability to perform tasks requiring alertness.
- To relieve dry mouth, suck on sugarless candy or ice chips, chew sugarless gum, or use a saliva substitute.
- Avoid overheating and dehydration, as this medication can reduce sweating and increase risk of heatstroke.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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
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 experience a rash or any of these symptoms, contact your doctor right away.
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 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, 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.
Seek Immediate Medical Attention If You Experience:
- Severe drowsiness or dizziness
- Difficulty urinating
- Blurred vision
- Confusion or hallucinations
- Fast, pounding, or irregular heartbeat (palpitations)
- Fainting or severe dizziness (may indicate QT prolongation)
- Unusual muscle movements or tremors
Before Using This Medicine
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 conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
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 cannabis products, as well as prescription or over-the-counter 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 medication, as you may be more susceptible to experiencing side effects.
If you are pregnant or planning to become pregnant, inform your doctor, as it is necessary to weigh the benefits and risks of using this medication during pregnancy.
Overdose Information
Overdose Symptoms:
- Severe sedation
- Stupor or coma
- Seizures
- Severe anticholinergic effects (e.g., severe dry mouth, dilated pupils, flushed skin, hyperthermia, urinary retention, absent bowel sounds)
- Respiratory depression
- Hypotension
- Cardiac arrhythmias (including QT prolongation and Torsade de Pointes)
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 ingestion is recent. Activated charcoal may be administered. Monitor vital signs, cardiac rhythm (ECG), and respiratory function. Physostigmine may be used for severe anticholinergic symptoms, but with caution due to potential for cardiac effects. Do not induce vomiting.
Drug Interactions
Contraindicated Interactions
- QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, certain antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics, tricyclic antidepressants, some antifungals)
- Patients with known acquired or congenital QT prolongation
- Patients with significant cardiovascular disease (e.g., recent myocardial infarction, uncompensated heart failure, clinically significant bradycardia, uncorrected hypokalemia or hypomagnesemia)
Major Interactions
- CNS depressants (e.g., alcohol, opioids, benzodiazepines, barbiturates, other sedatives/hypnotics): Increased CNS depression
- Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, benztropine): Increased anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation)
- Cholinesterase inhibitors (e.g., donepezil, rivastigmine): Reduced efficacy of cholinesterase inhibitors
Moderate Interactions
- CYP3A4/5 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin): May increase hydroxyzine levels (minor interaction)
- CYP3A4/5 inducers (e.g., rifampin, carbamazepine, phenytoin): May decrease hydroxyzine levels (minor interaction)
Minor Interactions
- Not available
Monitoring
Baseline Monitoring
Rationale: To identify risk factors for QT prolongation and drug interactions
Timing: Prior to initiation
Rationale: To assess baseline QTc interval, especially in patients with cardiac risk factors or on other QT-prolonging drugs
Timing: Prior to initiation (if risk factors present)
Rationale: To ensure normal levels, as imbalances can increase risk of QT prolongation
Timing: Prior to initiation (if risk factors present)
Routine Monitoring
Frequency: Daily, especially during dose titration
Target: Acceptable level of drowsiness without excessive impairment
Action Threshold: Excessive sedation, somnolence, impaired coordination; consider dose reduction or discontinuation
Frequency: Daily
Target: Minimal to tolerable side effects
Action Threshold: Severe or intolerable anticholinergic symptoms; consider dose reduction or alternative
Frequency: As needed, if symptoms arise
Target: Normal rhythm
Action Threshold: New onset of palpitations, dizziness, syncope; perform ECG, discontinue drug, investigate
Symptom Monitoring
- Drowsiness
- Dizziness
- Dry mouth
- Blurred vision
- Urinary retention
- Constipation
- Confusion (especially in elderly)
- Tremor
- Palpitations
- Syncope
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:
Lactation
L4 (Potentially Hazardous). Not recommended during breastfeeding. Hydroxyzine and its active metabolite, cetirizine, are excreted into breast milk. May cause sedation, irritability, or anticholinergic effects in the infant. May also decrease milk supply due to anticholinergic effects.
Pediatric Use
Use with caution, especially in infants and young children, due to increased susceptibility to CNS depression and anticholinergic effects. Dosing is weight-based. Not recommended for neonates. Paradoxical excitation may occur in some children.
Geriatric Use
Use with extreme caution. Elderly patients are more susceptible to the sedative and anticholinergic effects (e.g., confusion, urinary retention, constipation, dry mouth, falls). Start with the lowest effective dose and titrate slowly. Avoid if possible in patients with dementia or cognitive impairment due to increased risk of delirium and falls. Consider Beers Criteria recommendations.
Clinical Information
Clinical Pearls
- Hydroxyzine is a first-generation antihistamine with significant sedative and anticholinergic properties, making it useful for anxiety, pruritus, and pre-operative sedation.
- Due to its sedative effects, it is often prescribed for bedtime use for pruritus or anxiety.
- Caution is advised regarding its potential for QT prolongation, especially in patients with pre-existing cardiac conditions or those taking other QT-prolonging medications. An ECG may be warranted in high-risk patients.
- The active metabolite, cetirizine, is a second-generation antihistamine with less sedation and anticholinergic effects.
- Avoid concomitant use with alcohol or other CNS depressants.
- Elderly patients are particularly vulnerable to adverse effects, including falls and cognitive impairment; use with extreme caution or consider alternatives.
Alternative Therapies
- For pruritus: Second-generation antihistamines (e.g., cetirizine, loratadine, fexofenadine), topical corticosteroids.
- For anxiety: Buspirone, benzodiazepines (short-term), SSRIs/SNRIs (long-term), gabapentin, pregabalin.
- For sedation: Diphenhydramine, benzodiazepines.