Hydroxyzine Hcl 50mg/ml For Inj

Hydroxyzine is a first-generation antihistamine that acts as a potent H1-receptor antagonist. Its anxiolytic, sedative, and antiemetic effects are primarily due to its central nervous system (CNS) depressant activity, which is thought to be related to subcortical activity in the CNS, including the limbic system and reticular formation. It also possesses anticholinergic, antiemetic, and antispasmodic 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
Tissue damage at the injection site, which may cause:
+ Burning
+ Color changes
+ Pain
+ Skin breakdown
+ Swelling

If you experience any of these symptoms, notify your doctor or nurse immediately.

Other Possible Side Effects

Like all medications, this drug can cause side effects. Although many people do not experience any side effects or only have mild ones, it is 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:

Dry mouth
* Drowsiness

This is not an exhaustive list of possible 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, 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.

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.

In rare instances, the use of this medication in combination with alcohol or certain other substances that can cause drowsiness 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 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, inform your doctor, as it is necessary to weigh the benefits and risks of using this medication during pregnancy.

• Drugs that prolong the QT interval (e.g., Class IA and III antiarrhythmics, some antipsychotics, macrolide antibiotics, fluoroquinolones, certain antifungals) due to risk of Torsades de Pointes.
• Patients with known acquired or congenital QT prolongation.

• CNS depressants (e.g., alcohol, opioids, benzodiazepines, barbiturates, other sedatives/hypnotics, tricyclic antidepressants): Potentiation of CNS depression.
• Anticholinergic drugs (e.g., atropine, tricyclic antidepressants, some antipsychotics): Additive anticholinergic effects (e.g., dry mouth, urinary retention, constipation, blurred vision).
• Monoamine Oxidase Inhibitors (MAOIs): May prolong and intensify the anticholinergic and CNS depressant effects of hydroxyzine.

• Betahistine: Hydroxyzine may antagonize the effects of betahistine.
• Adrenergic agonists (e.g., epinephrine): Hydroxyzine may antagonize the pressor effects of epinephrine.

• Not available

• Excessive drowsiness or sedation
• Dizziness or lightheadedness
• Dry mouth
• Blurred vision
• Urinary retention
• Constipation
• Confusion or disorientation (especially in elderly)
• Palpitations or irregular heartbeat (seek immediate medical attention)
• Difficulty breathing

Hydroxyzine is classified as Pregnancy Category D. It should not be used during pregnancy, especially in the first trimester, due to potential for fetal harm. Studies in animals have shown teratogenic effects at doses considerably above the human therapeutic range. There are reports of congenital abnormalities in humans, though a causal link is not definitively established. 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, hydroxyzine is generally not recommended during breastfeeding. A safer alternative should be considered.

Use with caution. Dosing is weight-based. Children may be more susceptible to paradoxical excitation or CNS depression. IM injection site reactions are a concern. Not recommended for neonates or infants under 6 months.

Use with extreme caution and initiate at the lowest effective dose (e.g., 25 mg IM). Elderly patients are more susceptible to CNS depressant effects (sedation, confusion, dizziness) and anticholinergic side effects (e.g., urinary retention, constipation, dry mouth, blurred vision). Increased risk of falls. Renal and hepatic impairment are more common in this population, requiring further dose adjustments. Avoid in elderly patients with dementia or cognitive impairment due to anticholinergic burden.

• Hydroxyzine IM is for intramuscular use only; do NOT administer intravenously, subcutaneously, or intra-arterially due to risk of severe tissue damage, thrombosis, and gangrene.
• Deep IM injection into a large muscle (e.g., gluteal region in adults, vastus lateralis in children) is crucial to minimize local irritation and tissue damage.
• Rotate injection sites if multiple doses are required.
• Due to its sedative properties, hydroxyzine can impair mental and physical abilities; caution patients about driving or operating machinery.
• Be aware of the potential for QT prolongation, especially in patients with pre-existing cardiac conditions or on other QT-prolonging medications.
• Consider the anticholinergic burden, especially in elderly patients or those with conditions like glaucoma or benign prostatic hyperplasia (BPH).

• For anxiety: Benzodiazepines (e.g., lorazepam, diazepam), buspirone, SSRIs/SNRIs (for chronic anxiety).
• For sedation: Benzodiazepines, propofol (for procedural sedation), melatonin, diphenhydramine (oral).
• For pruritus: Other antihistamines (e.g., cetirizine, loratadine, fexofenadine for non-sedating; diphenhydramine for sedating), topical corticosteroids, doxepin (oral).

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact 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 to ensure prompt and effective treatment.