Hydroxyzine Pamoate 100mg Capsules

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, sedative, and antiemetic effects are primarily attributed to its central nervous system depression, likely due to its anticholinergic and anti-serotonergic properties, and possibly its effects on subcortical areas.

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. Contact your doctor or seek medical help if you experience:

Dry mouth
Drowsiness

These are not all the possible side effects that may occur. If you have questions or concerns about side effects, consult your doctor.

Reporting Side Effects

To report side effects, you can:

Call your doctor for medical advice
Contact the FDA at 1-800-332-1088
* Visit the FDA's MedWatch website 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 issues 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 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 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 a prolonged QT interval, as seen on an electrocardiogram (ECG). This condition may increase the risk of sudden death, so it is vital to consult with your doctor about this potential risk.

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. It is necessary to have a discussion with your doctor about the potential benefits and risks of using this medication during pregnancy to make an informed decision.

• Drugs known to prolong the QT interval (e.g., Class IA and Class III antiarrhythmics, certain antipsychotics, macrolide antibiotics, fluoroquinolones, azole antifungals, ondansetron, methadone, citalopram, escitalopram)
• Patients with known acquired or congenital QT prolongation

• CNS depressants (e.g., alcohol, benzodiazepines, opioids, barbiturates, other sedating antihistamines, tricyclic antidepressants) - increased sedation and respiratory depression
• Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, benztropine, ipratropium) - increased anticholinergic side effects (dry mouth, blurred vision, urinary retention, constipation)
• CYP3A4/5 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, grapefruit juice) - may increase hydroxyzine levels and risk of adverse effects
• Beta-blockers (e.g., metoprolol, propranolol) - may increase hydroxyzine levels due to shared metabolic pathways

• Monoamine Oxidase Inhibitors (MAOIs) - may prolong and intensify anticholinergic and CNS depressant effects
• Antihypertensives - additive hypotensive effects
• Cholinergic drugs (e.g., donepezil, rivastigmine) - hydroxyzine may antagonize their effects

• Not specifically identified as minor, most interactions are significant due to CNS or cardiac effects.

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

Hydroxyzine is Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects, and there are no adequate and well-controlled studies in pregnant women.

Hydroxyzine is excreted into breast milk. Due to the potential for sedation, anticholinergic effects, and the long half-life in infants, it is generally not recommended during breastfeeding. The active metabolite, cetirizine, is also present in milk.

Use with caution. Dosing is weight-based. Children may be more susceptible to paradoxical excitation or anticholinergic effects. Not recommended for use in neonates or infants due to lack of established safety and efficacy.

Use with extreme caution. Elderly patients are more susceptible to the sedative and anticholinergic effects (e.g., confusion, urinary retention, constipation, falls) and have an increased risk of QTc prolongation. Start with lower doses (e.g., 25 mg) and titrate slowly. Avoid if possible in patients with dementia or cognitive impairment. Consider Beers Criteria recommendations.

• Hydroxyzine pamoate (Vistaril) is often preferred for anxiety due to its longer duration of action and less frequent dosing compared to hydroxyzine HCl (Atarax), though both are effective.
• Due to its sedative properties, hydroxyzine can be a good alternative for anxiety or insomnia when benzodiazepines are contraindicated or undesirable.
• Always assess for other CNS depressants or QTc-prolonging medications before initiating hydroxyzine.
• Educate patients about the potential for significant drowsiness and anticholinergic side effects.
• In elderly patients, consider the 'start low, go slow' approach and be vigilant for cognitive impairment and falls.
• Hydroxyzine is not recommended for long-term management of generalized anxiety disorder; it is typically used for short-term relief of anxiety symptoms or for pruritus.

• For anxiety: Buspirone, benzodiazepines (e.g., lorazepam, alprazolam), SSRIs/SNRIs (for long-term management).
• For pruritus: Other antihistamines (e.g., cetirizine, loratadine, diphenhydramine), topical corticosteroids, doxepin.
• For sedation: Diphenhydramine, zolpidem, melatonin, benzodiazepines.
• For nausea/vomiting: Ondansetron, promethazine, prochlorperazine.

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