Hydroxyzine Hcl 50mg Tabs (white)

Hydroxyzine is a first-generation antihistamine that acts as a potent H1-receptor antagonist. Its anxiolytic and sedative effects are attributed to its action on subcortical areas of the central nervous system, including the limbic system and reticular formation. It also possesses anticholinergic, antiemetic, and bronchodilator properties.

Urgent Side Effects: Seek Medical Help Right Away

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
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 experience 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 symptoms that bother you or persist, contact your doctor or seek medical help:

Dry mouth
Drowsiness

Reporting Side Effects

This list is not exhaustive, and you may experience other 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.

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 not to take 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 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 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 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, notify your doctor. You and your doctor will need to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.

• QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, moxifloxacin, pimozide, thioridazine, sotalol, quinidine, procainamide, amiodarone, dofetilide)
• Drugs that cause bradycardia or hypokalemia/hypomagnesemia (increase risk of Torsades de Pointes)

• CNS depressants (e.g., alcohol, opioids, benzodiazepines, barbiturates, other sedatives/hypnotics, tricyclic antidepressants): Additive CNS depression, increased sedation, respiratory depression.
• Anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants, some antipsychotics): Additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation).

• Monoamine Oxidase Inhibitors (MAOIs): May prolong and intensify anticholinergic and CNS depressant effects.
• Betahistine: Hydroxyzine may antagonize the effects of betahistine.

• Not available

• Excessive sedation or drowsiness
• Dizziness or lightheadedness
• Dry mouth
• Blurred vision
• Urinary retention or difficulty urinating
• Constipation
• Palpitations or irregular heartbeat
• Tremor or involuntary movements
• Confusion or disorientation (especially in elderly)

Hydroxyzine is contraindicated in early pregnancy and generally not recommended during any trimester due to potential fetal harm. It is classified as Pregnancy Category D.

Not recommended during breastfeeding. Hydroxyzine and its active metabolite, cetirizine, are excreted into breast milk. Due to the potential for sedation, anticholinergic effects, and other adverse reactions in the infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Use with caution, especially in very young children. Dosing is weight-based. Children may be more susceptible to paradoxical excitation or CNS depression. Not recommended for infants under 6 months.

Use with extreme caution. Elderly patients are more susceptible to the anticholinergic effects (e.g., confusion, urinary retention, constipation, dry mouth, blurred vision) and CNS depressant effects (e.g., sedation, dizziness, falls). Start with lower doses and titrate slowly. Included in the Beers Criteria as a medication to avoid in older adults due to high anticholinergic activity and risk of sedation/falls.

• Hydroxyzine is a versatile drug used for anxiety, pruritus, and sedation, but its anticholinergic and sedative properties limit its use, especially in the elderly.
• The active metabolite, cetirizine, contributes to its prolonged antihistaminic effects.
• Always assess for concomitant use of other CNS depressants or anticholinergic medications to avoid additive side effects.
• Counsel patients on the risk of drowsiness and impaired ability to drive or operate machinery.
• Be mindful of the QT prolongation risk, especially in patients with cardiac risk factors or on other QT-prolonging drugs. ECG monitoring may be warranted in high-risk patients.
• Due to its anticholinergic burden, it is generally not a first-line agent for anxiety or insomnia, especially in older adults.

• For anxiety: SSRIs, SNRIs, buspirone, benzodiazepines (short-term)
• For pruritus: Second-generation antihistamines (e.g., cetirizine, loratadine, fexofenadine), topical corticosteroids, doxepin (topical or oral)
• For sedation/insomnia: Zolpidem, eszopiclone, ramelteon, trazodone, low-dose antidepressants, melatonin, cognitive behavioral therapy for insomnia (CBT-I)

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 emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened.