Hydroxyzine 50mg/ml Inj, 1ml

Hydroxyzine is a first-generation piperazine derivative antihistamine that acts as a potent H1-receptor antagonist. It also exhibits anticholinergic, antiemetic, antispasmodic, and local anesthetic properties. 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.

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while 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
Tissue damage at the injection site, which may lead to surgery. Inform your nurse if you experience:
+ Burning
+ Color changes
+ Pain
+ Skin breakdown
+ Swelling where the shot was given

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 persist, contact your doctor:

Dry mouth
* Drowsiness

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns, 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.
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 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 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 impair your reactions, 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.

Rarely, the use of this medication in combination with alcohol or certain other substances that can slow your reactions has led to severe heart problems and, in some cases, death. It is essential to discuss this risk with your doctor.

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, inform your doctor, as it is necessary to weigh the benefits and risks of using this medication during pregnancy.

• CNS depressants (e.g., alcohol, benzodiazepines, opioids, barbiturates, other sedating antihistamines): Potentiation of CNS depression.
• QT-prolonging drugs (e.g., antiarrhythmics like amiodarone, quinidine; antipsychotics like thioridazine, ziprasidone; macrolide antibiotics like erythromycin; fluoroquinolones like moxifloxacin; certain antidepressants): Increased risk of QT prolongation and Torsade de Pointes.

• Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, benztropine): Additive anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation).
• Monoamine Oxidase Inhibitors (MAOIs): May prolong and intensify the anticholinergic and CNS depressant effects of hydroxyzine.

• Excessive drowsiness or sedation
• Dizziness or lightheadedness
• Blurred vision
• Dry mouth
• Difficulty urinating
• Constipation
• Confusion or disorientation (especially in elderly)
• Tremors or involuntary movements
• Palpitations or irregular heartbeat (rare, but serious)

Hydroxyzine is 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.

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 nursing infant, use is generally not recommended. A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Hydroxyzine injection is approved for pediatric use for anxiety, sedation, and pruritus. Dosing is weight-based. Children may be more susceptible to paradoxical excitation or anticholinergic effects. Close monitoring is required.

Elderly patients are more susceptible to the sedative and anticholinergic effects of hydroxyzine (e.g., confusion, urinary retention, constipation, dry mouth, falls). Lower initial doses and careful titration are recommended. Avoid in elderly patients with dementia or cognitive impairment due to increased risk of adverse CNS effects. Consider Beers Criteria recommendations.

• Hydroxyzine injection is for IM use only. NEVER administer IV, SC, or IA due to severe tissue damage risk.
• Rotate injection sites to minimize local irritation and tissue damage.
• Due to its sedative effects, hydroxyzine can impair mental and physical abilities; caution patients about driving or operating machinery.
• Be mindful of additive CNS depression when co-administering with other sedatives, alcohol, or opioids.
• Exercise caution in patients with pre-existing cardiac conditions or those on other QT-prolonging drugs due to the risk of QT prolongation.
• The active metabolite, cetirizine, has a longer half-life, contributing to prolonged effects and potential accumulation, especially in renal impairment.

• For anxiety/sedation: Benzodiazepines (e.g., lorazepam, midazolam), promethazine, diphenhydramine.
• For pruritus: Other antihistamines (e.g., diphenhydramine, cetirizine, loratadine), corticosteroids (topical or systemic), doxepin (oral).

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult your pharmacist for guidance. Many communities have drug take-back programs that provide a safe and environmentally responsible way to dispose of unwanted medications.

Some medications may come with an additional patient information leaflet. Check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, do not 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. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in prompt and effective treatment.