Hydroxyzine Hcl 25mg/ml Inj 1ml

Manufacturer AMER REGENT Active Ingredient Hydroxyzine Injection(hye DROKS i zeen) Pronunciation hye DROKS i zeen
It is used to treat anxiety.It is used to treat mood problems.It is used to treat upset stomach and throwing up.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antihistamine, Anxiolytic, Sedative
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Pharmacologic Class
First-generation H1-receptor antagonist
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Pregnancy Category
Category C
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FDA Approved
Mar 1956
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Hydroxyzine is a medication that can help reduce anxiety, calm you down before a procedure, or relieve itching. It works by affecting certain natural substances in your brain and body.
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How to Use This Medicine

To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Take this medication exactly as directed, and follow all instructions provided. This drug is administered via intramuscular injection.

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

In the event that you miss a dose, contact your doctor to receive guidance on the appropriate course of action.
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Lifestyle & Tips

  • Avoid alcohol and other sedating medications while taking hydroxyzine, as this can increase drowsiness and dizziness.
  • Do not drive or operate heavy machinery until you know how this medication affects you, as it can cause significant drowsiness.
  • Inform your doctor about all other medications you are taking, especially those that can cause drowsiness or affect your heart rhythm.
  • Stay hydrated to help with dry mouth, a common side effect.

Dosing & Administration

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Adult Dosing

Standard Dose: 25-100 mg IM, single dose or multiple doses as needed
Dose Range: 25 - 100 mg

Condition-Specific Dosing:

Anxiety and Tension: 50-100 mg IM, 3-4 times daily
Pruritus: 25-100 mg IM, 3-4 times daily
Pre-operative Sedation: 50-100 mg IM, single dose
Post-operative Sedation: 25-100 mg IM, single dose
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: 0.5-1 mg/kg IM, single dose or multiple doses as needed (max 100 mg/dose)
Adolescent: 0.5-1 mg/kg IM, single dose or multiple doses as needed (max 100 mg/dose)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment recommended, monitor for increased sedation.
Moderate: Consider dose reduction by 50% or extended dosing interval.
Severe: Consider dose reduction by 50% or extended dosing interval (e.g., every 12-24 hours).
Dialysis: Not significantly dialyzable. Administer after dialysis if possible, or monitor closely for increased effects.

Hepatic Impairment:

Mild: No specific adjustment recommended, monitor for increased sedation.
Moderate: Consider dose reduction by 50% or extended dosing interval.
Severe: Consider dose reduction by 50% or extended dosing interval.

Pharmacology

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Mechanism of Action

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, antispasmodic, and local anesthetic properties.
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Pharmacokinetics

Absorption:

Bioavailability: Not available (IM route, rapid absorption)
Tmax: Approximately 1-2 hours (oral, but IM is faster)
FoodEffect: Not applicable for IM injection

Distribution:

Vd: Approximately 16 L/kg
ProteinBinding: Approximately 93%
CnssPenetration: Yes

Elimination:

HalfLife: Approximately 20-25 hours (parent drug), 7-10 hours (cetirizine)
Clearance: Not available
ExcretionRoute: Renal (primarily as metabolites, with a small amount of unchanged drug)
Unchanged: Less than 1% (parent drug)
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Pharmacodynamics

OnsetOfAction: 15-30 minutes (IM)
PeakEffect: 1-2 hours (IM)
DurationOfAction: 4-6 hours (sedation), up to 24 hours (antihistaminic effects)

Safety & Warnings

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Side Effects

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
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
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 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.
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Seek Immediate Medical Attention If You Experience:

  • Severe drowsiness or dizziness that interferes with daily activities
  • Difficulty breathing or shallow breathing
  • Irregular or fast heartbeat, palpitations, or fainting (seek immediate medical attention)
  • Severe confusion or hallucinations
  • Difficulty urinating
  • Unusual muscle movements or tremors
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Before Using This Medicine

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 to avoid taking 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 you determine whether it is safe to take this medication in combination with your other medications and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Before engaging in activities that require alertness, such as driving, wait until you understand how this drug affects you.

Prior to consuming alcohol, using marijuana or other forms of cannabis, or taking prescription or over-the-counter medications that may impair your reactions, consult with your doctor. This precaution is crucial because combining these substances with this medication can increase the risk of adverse effects.

This drug has been associated with a potentially life-threatening heart rhythm disorder known as long QT interval on an electrocardiogram (ECG), which may increase the risk of sudden death. Discuss this risk with your doctor to understand the implications.

Rarely, the use of this medication in combination with alcohol or certain other drugs that slow your reactions has resulted in severe heart problems and, in some cases, death. It is vital to discuss this risk with your doctor to ensure safe use.

If you are 65 years or older, exercise caution when using this drug, as you may be more susceptible to side effects.

If you are pregnant or planning to become pregnant, inform your doctor. It is crucial to discuss the potential benefits and risks of using this medication during pregnancy to make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Severe sedation
  • Confusion
  • Hallucinations
  • Slurred speech
  • Ataxia (loss of coordination)
  • Seizures
  • Hypotension
  • Tachycardia
  • QT prolongation
  • Respiratory depression
  • Coma

What to Do:

Seek immediate medical attention. Call 911 or Poison Control at 1-800-222-1222. Treatment is supportive and symptomatic. Gastric lavage may be considered if ingestion was recent. Activated charcoal may be administered. Monitor vital signs, cardiac rhythm (ECG), and respiratory status. Naloxone may be considered if opioids are co-ingested. Physostigmine may be used for severe anticholinergic symptoms but carries risks.

Drug Interactions

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Contraindicated Interactions

  • QT-prolonging drugs (e.g., Class IA and III antiarrhythmics, certain antipsychotics, macrolide antibiotics, fluoroquinolones, methadone, ondansetron) due to risk of Torsades de Pointes.
  • Other CNS depressants (e.g., alcohol, opioids, benzodiazepines, barbiturates) if severe additive effects are unacceptable.
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Major Interactions

  • CNS depressants (e.g., alcohol, opioids, benzodiazepines, barbiturates, other sedatives, hypnotics): Increased CNS depression, sedation, respiratory depression.
  • Anticholinergic drugs (e.g., tricyclic antidepressants, atropine, scopolamine, certain antipsychotics): Increased anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation).
  • QT-prolonging drugs: Increased risk of QT prolongation and Torsades de Pointes (even if not strictly contraindicated, caution is advised).
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Moderate Interactions

  • 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.
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Patient history (cardiac, renal, hepatic, glaucoma, urinary retention)

Rationale: To identify contraindications or conditions requiring dose adjustment/caution.

Timing: Prior to initiation

ECG (if patient has pre-existing cardiac conditions or is on other QT-prolonging drugs)

Rationale: To assess baseline QT interval due to risk of QT prolongation.

Timing: Prior to initiation

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Routine Monitoring

Level of sedation/alertness

Frequency: Regularly, especially after initial doses and dose changes

Target: Desired level of sedation without excessive drowsiness or impairment

Action Threshold: Excessive sedation, somnolence, or paradoxical excitation

Vital signs (heart rate, blood pressure)

Frequency: Periodically, especially in hospitalized patients

Target: Within normal limits for the patient

Action Threshold: Significant bradycardia, tachycardia, or hypotension

Mental status (especially in elderly)

Frequency: Regularly

Target: Appropriate for desired effect

Action Threshold: Confusion, disorientation, delirium

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Symptom Monitoring

  • Excessive drowsiness
  • Dizziness
  • Dry mouth
  • Blurred vision
  • Urinary retention
  • Constipation
  • Confusion
  • Tremor
  • Involuntary muscle movements
  • Palpitations or irregular heartbeat (seek immediate medical attention)

Special Patient Groups

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Pregnancy

Category C. Should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Avoid use, especially in early pregnancy, due to potential for fetal harm (e.g., cleft palate, limb deformities observed in animal studies at high doses).

Trimester-Specific Risks:

First Trimester: Potential for fetal malformations (animal data). Generally avoided.
Second Trimester: Limited human data. Use with caution if clearly needed.
Third Trimester: Potential for neonatal withdrawal symptoms (e.g., tremors, hypertonia) if used close to delivery. Avoid if possible.
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Lactation

Excreted into breast milk. Use is generally not recommended due to potential for infant sedation, irritability, and anticholinergic effects. Consider alternative agents or temporary discontinuation of breastfeeding.

Infant Risk: Sedation, irritability, poor feeding, anticholinergic effects (e.g., dry mouth, constipation).
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Pediatric Use

Use with caution. Dosing is weight-based. Children may experience paradoxical excitation. Monitor closely for sedation and anticholinergic effects. Not recommended for neonates or infants.

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Geriatric Use

Increased sensitivity to sedative and anticholinergic effects (e.g., confusion, urinary retention, constipation, dry mouth). Increased risk of falls. Start with lower doses and titrate slowly. Avoid if possible in elderly patients with cognitive impairment or prostatic hypertrophy. Consider Beers Criteria recommendations.

Clinical Information

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Clinical Pearls

  • Hydroxyzine injection is for intramuscular (IM) use only. It must NOT be administered intravenously (IV), subcutaneously (SC), or intra-arterially due to the risk of severe tissue damage, necrosis, and gangrene.
  • When administering IM, use the Z-track method in a large muscle (e.g., gluteal region in adults, vastus lateralis in children) to minimize irritation and leakage into subcutaneous tissue.
  • Due to its anticholinergic properties, use with caution in patients with glaucoma, prostatic hypertrophy, or bladder neck obstruction.
  • Monitor for QT prolongation, especially in patients with pre-existing cardiac conditions or those on other QT-prolonging medications.
  • The active metabolite, cetirizine, is also an antihistamine and contributes to the overall effect and duration of action.
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Alternative Therapies

  • For anxiety: Benzodiazepines (e.g., lorazepam, diazepam), buspirone, SSRIs/SNRIs (for chronic anxiety).
  • For sedation: Diphenhydramine, promethazine, benzodiazepines.
  • For pruritus: Other antihistamines (e.g., cetirizine, loratadine, fexofenadine for less sedation; diphenhydramine for more sedation), topical corticosteroids.
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Cost & Coverage

Average Cost: Varies, typically low per 1ml vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to 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; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional. 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 quantity, and the time of ingestion to ensure prompt and effective treatment.