Hydroxyzine Hcl 25mg Tabs (white)

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 primarily due to its central nervous system depression, likely related to its H1-receptor antagonism and possibly its anticholinergic and antiserotonergic properties. It also has antiemetic and bronchodilator properties.

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 medical attention immediately:

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 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 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.

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 conditions. Do not initiate, stop, or adjust the dosage 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 activities that require 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 side effects.

If you are pregnant or planning to become pregnant, notify your doctor. It is necessary 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, certain antipsychotics, macrolide antibiotics, fluoroquinolone antibiotics, tricyclic antidepressants, certain antifungals) due to increased risk of Torsades de Pointes.
• CNS depressants (e.g., alcohol, opioids, benzodiazepines, barbiturates, other sedating antihistamines) due to additive CNS depression.

• Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, benztropine) due to additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation).
• CYP3A4/5 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) may increase hydroxyzine levels, though this pathway is minor for hydroxyzine metabolism.
• Betahistine (may antagonize effects).

• Cholinesterase inhibitors (e.g., donepezil) may have reduced efficacy due to hydroxyzine's anticholinergic effects.

• Excessive drowsiness
• Dizziness
• Confusion
• Dry mouth
• Blurred vision
• Difficulty urinating
• Constipation
• Palpitations
• Fainting spells
• Seizures (rare)

Generally not recommended during pregnancy, especially in the first trimester, due to potential for fetal harm observed in animal studies. Use only if the potential benefit justifies the potential risk to the fetus.

Not recommended during breastfeeding. Hydroxyzine and its active metabolite, cetirizine, are excreted into breast milk. Can cause sedation, anticholinergic effects (e.g., dry mouth, urinary retention), and potentially respiratory depression in the infant.

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 sedative and anticholinergic effects (e.g., confusion, urinary retention, constipation, dry mouth, falls). They also have a prolonged half-life of hydroxyzine. Start with the lowest effective dose and titrate slowly. Included in the Beers Criteria as a medication to avoid in older adults due to high anticholinergic burden and risk of sedation/falls.

• Hydroxyzine is a useful short-term agent for anxiety or pruritus, but generally not recommended for long-term management of anxiety disorders.
• Its sedative properties make it useful for pre-operative sedation or for insomnia related to anxiety/itching.
• Be mindful of its anticholinergic side effects, 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.
• Patients should be advised to avoid alcohol and activities requiring mental alertness.
• The active metabolite, cetirizine, is a non-sedating antihistamine, but hydroxyzine itself is highly sedating.

• Other first-generation antihistamines (e.g., diphenhydramine for sedation/pruritus)
• Second-generation antihistamines (e.g., cetirizine, loratadine, fexofenadine for pruritus/allergies with less sedation)
• Benzodiazepines (e.g., lorazepam, alprazolam for acute anxiety, but with higher abuse potential)
• Buspirone (for generalized anxiety disorder, non-sedating, non-addictive)
• SSRIs/SNRIs (for chronic anxiety disorders)
• Non-pharmacological interventions (e.g., cognitive behavioral therapy, relaxation techniques for anxiety; emollients, cool compresses for pruritus)

If your symptoms or health issues persist or worsen, it is 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 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.