HydrOXYzine (Lexi-Drugs)

Drug Shortages

One or more forms of this drug may be in short supply or unavailable. Refer to the following for additional information:

ASHP: http://www.ashp.org/menu/DrugShortages

FDA: https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Hydroxyzine+Pamoate+Oral+Capsules&st=c&tab=tabs-4&panels=0

Pronunciation

(hye DROKS i zeen)

Brand Names: US

Vistaril

Brand Names: Canada

Atarax; NOVO-Hydroxyzin; PMS-HydrOXYzine; PMS-HydrOXYzine HCl

Dosing: Adult

Antiemetic: IM: 25 to 100 mg/dose

Anxiety:

Oral:

Manufacturer’s labeling: 50 to 100 mg 4 times daily

Alternative recommendations (off-label dosing): 37.5 to 75 mg daily in divided doses (WFSBP [Bandelow 2008]; WFSBP [Bandelow 2012])

IM: Initial: 50 to 100 mg, then every 4 to 6 hours as needed

Peripartum adjunct: IM: 25 to 100 mg

Perioperative adjunct:

Oral: 50 to 100 mg

IM: 25 to 100 mg

Pruritus: Oral: 25 mg 3 to 4 times daily

Dosing: Geriatric

Initiate dosing using the lower end of the recommended dosage range. Refer to adult dosing.

Dosing: Renal Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling; however, the following guidelines have been used by some clinicians (Aronoff, 2007):

GFR >50 mL/minute: No adjustment recommended.

GFR ≤50 mL/minute: Administer 50% of normal dose.

Continuous renal replacement therapy (CRRT): Administer 50% of the normal dose.

Intermittent hemodialysis: Administer 50% of the normal dose.

Peritoneal dialysis: Administer 50% of the normal dose.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer’s labeling. In patients with primary biliary cirrhosis, change dosing interval to every 24 hours (Simons F 1989)

Dosing: Pediatric

Antiemetic: Note: Expert recommendations for postoperative nausea and vomiting (PONV) management do not suggest hydroxyzine as a therapeutic option; use has typically been replaced by newer agents with an improved safety profile (SAA [Gan 2014]). Infants, Children, and Adolescents: IM: 1.1 mg/kg/dose; maximum dose: 100 mg/dose.

Anxiety: Note: Although FDA approved for use in anxiety, data in pediatric patients are sparse; expert recommendations for pediatric patients do not consider hydroxyzine a therapeutic option for the management of anxiety disorders (eg, generalized anxiety disorder, separation anxiety, specific phobias, panic disorder, PTSD); use has generally been replaced by newer, more effective agents (AACAP [Connolly 2007]; Bushnell 2018; Gale 2016)

Children and Adolescents: Oral: 0.5 mg/kg/dose every 6 hours; maximum dose is age-dependent: Age <6 years: 12.5 mg/dose; age ≥6 years: 25 mg/dose (Kliegman 2016; Nelson 1996; manufacturer’s labeling). Note: In pediatric patients, some experts have recommended lower initial doses, although reported experience is lacking. In adults, experts suggest a lower daily dosing regimen of 37.5 to 75 mg/day in divided doses (WFSBP [Bandelow 2008]; WFSBP [Bandelow 2012]).

Pruritus; associated with allergic conditions or chronic urticaria: Children and Adolescents:

Age-directed dosing:

Children <6 years: Oral: 12.5 mg 3 to 4 times daily (Nelson 1996; manufacturer’s labeling)

Children ≥6 years and Adolescents: Oral: 12.5 to 25 mg 3 to 4 times daily (Nelson 1996; manufacturer’s labeling). Note: Based on pharmacokinetic studies, dosing once daily (at bedtime) or twice daily may be adequate due to the long half-life (Simons 1984a).

Weight-directed dosing:

Patient weight ≤40 kg: Oral: 2 mg/kg/day divided every 6 to 8 hours as needed; maximum dose: 25 mg/dose. Note: Based on pharmacokinetic studies, dosing once daily (at bedtime) or twice daily may be adequate due to the long half-life (Nelson 1996; Simons 1984; Simons 1984a; Simons 1994).

Patient weight >40 kg: Oral: 25 to 50 mg once daily at bedtime or twice daily (Simons 1984a; Simons 1994)

Pruritus; associated with opioid use: Limited data available: Children and Adolescents: IM, Oral: 0.5 mg/kg/dose every 6 hours as needed; usual maximum dose: 50 mg/dose (Berde 1990; Kliegman 2016)

Sedation; pre-/postoperative, adjunctive therapy: Note: Although FDA approved, pre-/postoperative hydroxyzine use has largely been replaced by other agents.

Oral: Children and Adolescents: 0.6 mg/kg/dose; maximum dose: 100 mg/dose

IM: Infants, Children, and Adolescents: 1.1 mg/kg/dose; maximum dose: 100 mg/dose

Sedation; procedural, adjunctive therapy (eg, dental, echocardiography): Limited data available: Children 2 to 12 years: Oral: 1 mg/kg/dose as a single dose 30 to 45 minutes prior to procedure in combination with other sedatives (eg, midazolam, chloral hydrate) has been used in children prior to dental procedures or echocardiograms; maximum dose: 100 mg/dose (Chowdhury 2005; Olacke 2018; Roach 2010)

Dosing: Renal Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer’s labeling; active metabolite (cetirizine) is renally eliminated (Simons 1994); based on experience in adult patients, dosing adjustment suggested.

Dosing: Hepatic Impairment: Pediatric

There are no pediatric-specific recommendations; based on experience in adults, dosing adjustment suggested.

Use: Labeled Indications

Oral:

Anxiety: Symptomatic relief of anxiety and tension associated with psychoneurosis; adjunct in organic disease states in which anxiety is manifested.

Perioperative adjunct: As a sedative when used as premedication and following general anesthesia

Pruritus: Management of pruritus due to allergic conditions (eg, chronic urticaria, atopic and contact dermatoses) and in histamine-mediated pruritus.

Intramuscular:

Allergic conditions: Adjunctive therapy in allergic conditions with strong emotional overlay (eg, asthma, chronic urticaria, pruritus).

Antiemetic: Control of nausea and vomiting.

Anxiety: Management of anxiety, tension, and psychomotor agitation in conditions of emotional stress, in preparation for dental procedures, and as adjunctive therapy in alcoholism; management of anxiety associated with organic disturbances. Note: Should not be used as the sole treatment of psychosis or of clearly demonstrated cases of depression.

Perioperative adjunct: As pre- and postoperative adjunctive medication to permit reduction in opioid dosage, allay anxiety, and control emesis.

Peripartum adjunct: As pre- and postpartum adjunctive medication to permit reduction in opioid dosage, allay anxiety, and control emesis.

Clinical Practice Guidelines

Anxiety Disorders:

World Federation of Societies of Biological Psychiatry (WFSBP), “Guidelines for the Pharmacological Treatment of Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders, First Revision,” 2008

Administration: IM

For IM use only. Aspirate before injection to avoid inadvertent injection into a blood vessel. Do NOT administer IV, SubQ, or intra-arterially (contraindicated). Administer IM deep in large muscle. The preferred site is the upper outer quadrant of the buttock or midlateral thigh. The upper outer quadrant of the gluteal region should be used only when necessary to minimize potential damage to the sciatic nerve. The deltoid region should be only used with caution to avoid radial nerve injury. Injections should not be made in the lower or mid-third of the upper arm.

Administration: Oral

Administer without regard to food. Shake suspension vigorously prior to use.

Administration: Pediatric

Oral: May be administered without regard to food

Parenteral: For IM use only. Subcutaneous, intra-arterial, and IV administration are contraindicated and not recommended under any circumstances; intravascular hemolysis, thrombosis, and digital gangrene can occur; extravasation can result in sterile abscess and marked tissue induration (Baumgartner 1979).

Administer IM deep in large muscle. For IM administration in children, injections should be made into the midlateral muscles of the thigh. In infants and children, the upper outer quadrant of the gluteal region should be used only when necessary (eg, burn patients) to minimize potential damage to the sciatic nerve. In adults, the upper outer quadrant of the buttock is considered the preferred injection site. In older children and adolescents, the deltoid region should be only used if well developed and with caution to avoid radial nerve injury. Injections should not be made in the lower or mid-third of the upper arm. Aspirate before injection to avoid inadvertent injection into a blood vessel.

In the very rare instance that IV administration may be necessary, slow IV injection through a central venous line has been used in pediatric oncology patients (Berde 1990).

Vesicant; the manufacturer considers IV administration a contraindication; however, if IV administration is necessary ensure proper needle or catheter placement prior to and during IV infusion. Avoid extravasation. If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity.

Vesicant/Extravasation Risk

Vesicant (IV administration is contraindicated)

Storage/Stability

Injection: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light.

Oral: Store at 20°C to 25°C (68°F to 77°F). Protect oral solution from light; do not freeze.

Compatibility

See Trissel’s IV Compatibility Database

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience dry mouth or fatigue. Have patient report immediately to prescriber abnormal heartbeat; tachycardia; severe dizziness; passing out; abnormal movements; pinpoint red spots on skin; severe skin irritation; injection site burning, skin discoloration, pain, edema, or irritation; or confusion (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
  Geriatric Patients: High-Risk Medication:
  International issues:
Contraindications

Hypersensitivity to hydroxyzine or any component of the formulation; early pregnancy; prolonged QT interval

Additional contraindications:

Oral: Hypersensitivity to cetirizine or levocetirizine

Injection: SubQ, intra-arterial, or IV administration

Canadian labeling: Additional contraindications (not in US labeling): Oral: Hypersensitivity to other piperazine derivatives, aminophylline or ethylenediamine; history of history of cardiac arrhythmias; significant electrolyte imbalance (eg, hypokalemia, hypomagnesemia); significant bradycardia; family history of sudden cardiac death; concomitant use with other QT interval prolonging drugs or with CYP3A4/5 inhibitors; asthmatics who have previously experienced a serious anti-histamine induced adverse bronchopulmonary effect; porphyria.

Warnings/Precautions

Concerns related to adverse effects:

• Acute generalized exanthematous pustulosis: May rarely cause acute generalized exanthematous pustulosis (AGEP), a serious skin reaction involving fever, pustules and large areas of edematous erythema. Discontinue at first sign of skin rash, worsening of pre-existing skin reactions or any other sign of hypersensitivity; if signs or symptoms suggest AGEP, do not resume therapy.

• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).

• QT prolongation/torsades de pointes: Has been reported, with the majority occurring in patients with other risk factors for QT prolongation/torsades de pointes (eg, preexisting cardiac disease, electrolyte imbalances, concomitant arrhythmogenic use). Use with caution in patients with risk factors for QT prolongation, congenital long QT syndrome, a family history of long QT syndrome, other conditions that predispose to QT prolongation and ventricular arrhythmia, as well as recent myocardial infarction, uncompensated heart failure, and bradyarrhythmias. Oral hydroxyzine is contraindicated in patients with a prolonged QT interval.

Disease-related concerns:

• Glaucoma: Use with caution in patients with narrow-angle glaucoma; condition may be exacerbated by cholinergic blockade. Screening is recommended.

• Prostatic hyperplasia/urinary stricture: Use with caution in patients with prostatic hyperplasia and/or urinary stricture.

• Respiratory disease: Use with caution in patients with asthma or chronic obstructive pulmonary disease (COPD).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Special populations:

Elderly: May cause over sedation in the elderly; initiate elderly patients on low does and monitor closely.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol and/or sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP [“Inactive” 1997]; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol and/or benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated with hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007). See manufacturer’s labeling.

Other warnings/precautions:

• Appropriate administration: Parenteral: For IM use only. Severe injection-site reactions have been reported with IM administration (eg, extensive tissue damage, necrosis, gangrene) requiring surgical intervention (including debridement, skin grafting, and amputation). SubQ, IV, and intra-arterial routes of administration are contraindicated. Intravascular hemolysis, thrombosis, and digital gangrene have been reported with IV or intra-arterial administration (Baumgartner 1979); SubQ administration may result in significant tissue damage. If inadvertent IV administration results in extravasation, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity.

• Long-term use: The effectiveness of hydroxyzine for long-term use (>4 months) has not been assessed; periodically reassess use.

Geriatric Considerations

Anticholinergic effects are not well tolerated in the elderly and frequently result in bowel, bladder, and mental status changes (ie, constipation, confusion, and urinary retention). Hydroxyzine may be useful as a short-term antipruritic, but it is not recommended for use as a sedative or anxiolytic in the elderly.

Warnings: Additional Pediatric Considerations

Neonatal withdrawal symptoms, including seizures, have been reported following long-term maternal use or the use of large doses near term (Serreau 2005).

Pregnancy Considerations

Hydroxyzine crosses the placenta. Possible withdrawal symptoms have been observed in neonates following chronic maternal use of hydroxyzine during pregnancy (Prenner 1977; Serreau 2005).

Hydroxyzine is approved for pre- and postpartum adjunctive therapy to control emesis, reduce opioid dosage, and treat anxiety. However, use in early pregnancy is contraindicated by the manufacturer and other agents are recommended for the treatment of nausea and vomiting of pregnancy (ACOG 189 2018). Hydroxyzine may be used as an antipruritic if systemic therapy is needed (use caution late in pregnancy) (Murase 2014); although other agents may be preferred (Powell 2015; Zuberbier 2014). Antihistamines are not recommended for treatment of pruritus associated with intrahepatic cholestasis in pregnancy (Ambros-Rudolph 2011; Kremer 2014).

Breast-Feeding Considerations

It is not known if hydroxyzine is present in breast milk.

Sedation has been reported in breastfed infants exposed to hydroxyzine (Soussan 2014). Breastfeeding is not recommended by the manufacturer. In general, if a breastfed infant is exposed to a first generation antihistamine via breast milk, they should be monitored for irritability or drowsiness.

When treatment with an antihistamine is needed in breastfeeding women, second generation antihistamines are preferred (Butler 2014; Powell 2015; Zuberier 2014).

Antihistamines may decrease maternal serum prolactin concentrations when administered prior to the establishment of lactation (Messinis 1985).

Lexicomp Pregnancy & Lactation, In-Depth
Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

Frequency not defined:

Central nervous system: Drowsiness (transient)

Gastrointestinal: Xerostomia

Respiratory: Respiratory depression (high doses)

<1%, postmarketing, and/or case reports: Acute generalized exanthematous pustulosis, fixed drug eruption, hallucination, headache, hypersensitivity reaction, involuntary movements, prolonged Q-T interval on ECG, pruritus, seizure (high doses), skin rash, torsades de pointes, tremor (high doses), urticaria

Allergy and Idiosyncratic Reactions
Metabolism/Transport Effects

None known.

Drug Interactions 

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Amantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Amezinium: Antihistamines may enhance the stimulatory effect of Amezinium. Risk C: Monitor therapy

Amphetamines: May diminish the sedative effect of Antihistamines. Risk C: Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapy

Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). Risk X: Avoid combination

Barbiturates: HydrOXYzine may enhance the CNS depressant effect of Barbiturates. Management: Consider a decrease in the barbiturate dose, as appropriate, when used together with hydroxyzine. With concurrent use, monitor patients closely for excessive response to the combination. Risk D: Consider therapy modification

Benzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine. Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider therapy modification

Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Risk C: Monitor therapy

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Risk D: Consider therapy modification

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine patches (Butrans brand) at 5 mcg/hr in adults when used with other CNS depressants.Risk D: Consider therapy modification

Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Cannabis: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination

CNS Depressants: HydrOXYzine may enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Doxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. Risk C: Monitor therapy

Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk D: Consider therapy modification

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Risk D: Consider therapy modification

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Haloperidol: QT-prolonging Agents (Indeterminate Risk – Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy

Hyaluronidase: Antihistamines may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving antihistamines (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Risk D: Consider therapy modification

HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Avoid concomitant use of hydrocodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.Risk D: Consider therapy modification

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination

Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Management: Drugs listed as exceptions to this monograph are discussed in further detail in separate drug interaction monographs. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Meperidine: HydrOXYzine may enhance the CNS depressant effect of Meperidine. Management: Consider a decrease in meperidine dose, as appropriate, when used together with hydroxyzine. With concurrent use, monitor patients closely for excessive response to the combination. Risk D: Consider therapy modification

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce adult dose of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk D: Consider therapy modification

MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Minocycline: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Risk C: Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug.Risk D: Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Management: Patients taking perampanel with any other drug that has CNS depressant activities should avoid complex and high-risk activities, particularly those such as driving that require alertness and coordination, until they have experience using the combination. Risk D: Consider therapy modification

Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy

Pitolisant: Antihistamines may diminish the therapeutic effect of Pitolisant. Risk C: Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Risk X: Avoid combination

Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Risk C: Monitor therapy

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk D: Consider therapy modification

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk – Caution) may enhance the QTc-prolonging effect of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination

ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy

Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification

Selective Serotonin Reuptake Inhibitors: CNS Depressants may enhance the adverse/toxic effect of Selective Serotonin Reuptake Inhibitors. Specifically, the risk of psychomotor impairment may be enhanced. Risk C: Monitor therapy

Sodium Oxybate: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to combined use. When combined use is needed, consider minimizing doses of one or more drugs. Use of sodium oxybate with alcohol or sedative hypnotics is contraindicated. Risk D: Consider therapy modification

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Avoid concomitant use of tapentadol and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Tetrahydrocannabinol and Cannabidiol: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Risk C: Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification

Test Interactions

May cause false-positive serum TCA screen (Dasgupta 2007).

Monitoring Parameters

Relief of symptoms, mental status, blood pressure

Advanced Practitioners Physical Assessment/Monitoring

Monitor blood pressure. Assess mental status. Assess for relief of symptoms. Assess other medicines patient may be taking; alternate therapy or dosage adjustments may be needed. Institute precautions to prevent falls.

Nursing Physical Assessment/Monitoring

Monitor blood pressure. Ensure patient safety to prevent falls (side rails up, call light within reach). Educate patient on CNS side effects and the importance of knowing how the drug effects them before driving or performing other tasks requiring mental alertness.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Capsule, Oral, as pamoate:

Vistaril: 25 mg, 50 mg

Generic: 25 mg, 50 mg, 100 mg

Solution, Intramuscular, as hydrochloride:

Generic: 25 mg/mL (1 mL); 50 mg/mL (1 mL, 2 mL, 10 mL [DSC])

Solution, Oral, as hydrochloride:

Generic: 10 mg/5 mL (473 mL [DSC])

Syrup, Oral, as hydrochloride:

Generic: 10 mg/5 mL (25 mL, 118 mL, 473 mL)

Tablet, Oral, as hydrochloride:

Generic: 10 mg, 25 mg, 50 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Capsule, Oral:

Generic: 10 mg, 25 mg, 50 mg

Solution, Intramuscular, as hydrochloride:

Generic: 50 mg/mL (1ml, 10ml)

Syrup, Oral, as hydrochloride:

Atarax: 10 mg/5 mL (473ml, 500ml) [contains ALCOHOL, USP, MENTHOL, SODIUM BENZOATE]

Generic: 10 mg/5 mL (500ml)

Anatomic Therapeutic Chemical (ATC) Classification
  • N05BB01
Generic Available (US)

Yes

Pricing: US

Capsules (hydrOXYzine Pamoate Oral)

25 mg (per each): $0.21 – $0.57

50 mg (per each): $0.22 – $0.61

100 mg (per each): $1.19

Capsules (Vistaril Oral)

25 mg (per each): $2.95

50 mg (per each): $3.60

Solution (hydrOXYzine HCl Intramuscular)

25 mg/mL (per mL): $24.20

50 mg/mL (per mL): $26.70

Syrup (hydrOXYzine HCl Oral)

10 mg/5 mL (per mL): $0.08

Tablets (hydrOXYzine HCl Oral)

10 mg (per each): $0.29 – $0.65

25 mg (per each): $0.30 – $0.92

50 mg (per each): $0.41 – $1.12

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Competes with histamine for H1-receptor sites on effector cells in the gastrointestinal tract, blood vessels, and respiratory tract (Simons 1994). Possesses skeletal muscle relaxing, bronchodilator, antihistamine, antiemetic, and analgesic properties.

Pharmacodynamics/Kinetics

Onset of action: Oral: 15 to 30 minutes; IM: Rapid

Duration: Decreased histamine-induced wheal and flare areas: 2 to ≥36 hours; Suppression of pruritus: 1 to 12 hours (Simon F 1984)

Absorption: Oral: Rapid

Distribution: Children and Adolescents 1 to 14 years: 18.5 ± 8.6 L/kg (Simons F 1984a); Adults: Vd: 16 ± 3 L/kg (Simons F 1984); Elderly: ~23 L/kg (Simons K 1989); Hepatic dysfunction: ~23 L/kg (Simons F 1989)

Metabolism: Hepatic to multiple metabolites, including cetirizine (active) (Simons F 1989)

Half-life elimination:

Children and Adolescents 1 to 14 years (mean age: 6.1 ± 4.6 years): 7.1 ± 2.3 hours; Note: Half-life increased with increasing age and was 4 hours in patients 1 year of age and 11 hours in a 14-year-old patient (Simons F 1984a)

Adults: ~20 hours (Simons 1984); Elderly: ~29 hours (Simons K 1989); Hepatic dysfunction: ~37 hours (Simons F 1989)

Time to peak: Oral administration: Serum: ~2 hours; Peak suppression of antihistamine-induced wheal and flare: 4 to 12 hours (Simons F 1984)

Excretion: Urine; active metabolite (cetirizine) is renally eliminated (Simons F 1994)

Dental Use

Treatment of anxiety, as a preoperative sedative in pediatric dentistry

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Dental Health Professional Considerations

An adult companion should accompany the patient to and from dental office.

Effects on Dental Treatment

Key adverse event(s) related to dental treatment: Xerostomia (normal salivary flow resumes upon discontinuation) (see Dental Health Professional Considerations)

Effects on Bleeding

No information available to require special precautions

Dental Usual Dosing

Anxiety: Adults: Oral: 50-100 mg 4 times/day

Preoperative sedation:

Children:

Oral: 0.6 mg/kg/dose

IM: 0.5-1 mg/kg/dose

Adults:

Oral: 50-100 mg

IM: 25-100 mg

Index Terms

Hydroxyzine HCl; Hydroxyzine Hydrochloride; Hydroxyzine Pamoate

FDA Approval Date
April 01, 1956
References

ACOG Committee on Practice Bulletins-Obstetrics. ACOG practice bulletin no. 189: nausea and vomiting of pregnancy. Obstet Gynecol. 2018;131(1):e15-e30.[PubMed 29266076]

Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319.[PubMed 11487763]

Ambros-Rudolph CM. Dermatoses of pregnancy – clues to diagnosis, fetal risk and therapy. Ann Dermatol. 2011;23(3):265-275.[PubMed 21909194]

American Geriatrics Society 2015 Beers Criteria Update Expert Panel. American Geriatrics Society 2015 updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc. 2015;63(11):2227-2246. doi:10.1111/jgs.13702.[PubMed 26446832]

Anderka M, Mitchell AA, Louik C, Werler MM, Hernández-Diaz S, Rasmussen SA; National Birth Defects Prevention Study. Medications used to treat nausea and vomiting of pregnancy and the risk of selected birth defects. Birth Defects Res A Clin Mol Teratol. 2012;94(1):22-30.[PubMed 22102545]

Aronoff GR, Bennett WM, Berns JS, et al, Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children, 5th ed. Philadelphia, PA: American College of Physicians; 2007, p 97.

Atarax syrup (hydroxyzine) [product monograph]. Montreal, Quebec, Canada: ERFA Canada 2012 Inc; May 2016.

Bandelow B, Sher L, Bunevicius R, et al. Guidelines for the pharmacological treatment of anxiety disorders, obsessive-compulsive disorder and posttraumatic stress disorder in primary care. Int J Psychiat Clin. 2012;16:77.[PubMed 22540422]

Bandelow B, Zohar J, Hollander E, et al. World Federation of Societies of Biological Psychiatry (WFSBP) Guidelines for the Pharmacological Treatment of Anxiety, Obsessive-Compulsive and Post-Traumatic Stress Disorders, First Revision. World J Biol Psychiatry. 2008;9(4):248-312.[PubMed 18949648]

Baumgartner T, “Administration of Hydroxyzine Injection,” Am J Hosp Pharm, 1979, 36(12):1660.[PubMed 525641]

Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: part II. Lactation. J Am Acad Dermatol. 2014;70(3):417.[PubMed 24528912]

Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. http://www.cdc.gov/mmwr/preview/mmwrhtml/00001109.htm[PubMed 6810084]

Chowdhury J, Vargas KG. Comparison of chloral hydrate, meperidine, and hydroxyzine to midazolam regimens for oral sedation of pediatric dental patients. Pediatr Dent. 2005;27(3):191-197.[PubMed 16173222]

Dasgupta A, Wells A, and Datta P, “False-Positive Serum Tricyclic Antidepressant Concentrations Using Fluorescence Polarization Immunoassay due to the Presence of Hydroxyzine and Cetirizine,” Ther Drug Monit, 2007, 29(1):134-9.[PubMed 17333576]

Einarson A, Bailey B, Jung G, Spizzirri D, Baillie M, Koren G. Prospective controlled study of hydroxyzine and cetirizine in pregnancy. Ann Allergy Asthma Immunol. 1997;78(2):183-186.[PubMed 9048526]

Erez S, Schifrin BS, Dirim O. Double-blind evaluation of hydroxyzine as an antiemetic in pregancy. J Reprod Med. 1971;7(1):35-37.[PubMed 4948652]

Gilboa SM, Strickland MJ, Olshan AF, Werler MM, Correa A; National Birth Defects Prevention Study. Use of antihistamine medications during early pregnancy and isolated major malformations. Birth Defects Res A Clin Mol Teratol. 2009;85(2):137-150.[PubMed 19161158]

Heinonen OP, Slone D, Shapiro S. Birth Defects and Drugs in Pregnancy. Publishing Sciences Group Inc; Littleton, MA: 1977.

Hydroxyzine injection [prescribing information]. Shirley, NY: American Regent Inc; August 2016.

Hydroxyzine tablets [prescribing information]. Morgantown, WV: Mylan Pharmaceuticals Inc; October 2016.

Hydroxyzine syrup [prescribing information]. Parsippany, NJ: Wockhardt USA; January 2016.

“Inactive” ingredients in pharmaceutical products: update (subject review). American Academy of Pediatrics (AAP) Committee on Drugs. Pediatrics. 1997;99(2):268-278.[PubMed 9024461]

Kremer AE, Bolier R, van Dijk R, et al. Advances in pathogenesis and management of pruritus in cholestasis. Dig Dis. 2014;32(5):637-645.[PubMed 25034299]

Kremer AE, Oude Elferink RP, Beuers U. Pathophysiology and current management of pruritus in liver disease. Clin Res Hepatol Gastroenterol. 2011;35(2):89-97.[PubMed 21809485]

Messinis IE, Souvatzoglou A, Fais N, Lolis D. Histamine H1 receptor participation in the control of prolactin secretion in postpartum. J Endocrinol Invest. 1985;8(2):143-146.[PubMed 3928731]

Murase JE, Heller MM, Butler DC. Safety of dermatologic medications in pregnancy and lactation: part I. Pregnancy. J Am Acad Dermatol. 2014;70(3):401.[PubMed 24528911]

Pharmacy Quality Alliance. Use of high-risk medications in the elderly (HRM). http://pqaalliance.org/images/uploads/files/HRM2015.pdf. Published 2015. Accessed October 26, 2015.

Powell RJ, Leech SC, Till S, et al; British Society for Allergy and Clinical Immunology. BSACI guideline for the management of chronic urticaria and angioedema.Clin Exp Allergy. 2015;45(3):547-565.[PubMed 25711134]

Prenner BM. Neonatal withdrawal syndrome associated with hydroxyzine hydrochloride. Am J Dis Child. 1977;131(5):529-530.[PubMed 855838]

Roach CL, Husain N, Zabinsky J, Welch E, Garg R. Moderate sedation for echocardiography of preschoolers. Pediatr Cardiol. 2010;31(4):469-473.[PubMed 20047024]

Serreau R, Komiha M, Blanc F, Guillot F, Jacqz-Aigrain E. Neonatal seizures associated with maternal hydroxyzine hydrochloride in late pregnancy. Reprod Toxicol. 2005;20(4):573-574.[PubMed 16199350]

Simons FE, Simons KJ, and Frith EM, “The Pharmacokinetics and Antihistaminic of the H1 Receptor Antagonist Hydroxyzine,” J Allergy Clin Immunol, 1984, 73(1 Pt 1):69-75.[PubMed 6141198]

Simons FE, Simons KJ, Becker AB, et al, “Pharmacokinetics and Antipruritic Effects of Hydroxyzine in Children With Atopic Dermatitis,” J Pediatr, 1984a, 104(1):123-7.[PubMed 6361228]

Simons FE, Watson WT, Chen XY, et al, “The Pharmacokinetics and Pharmacodynamics of Hydroxyzine in Patients With Primary Biliary Cirrhosis,” J Clin Pharmacol, 1989, 29(9):809-15.[PubMed 2572611]

Simons FE and Simons KJ, “The Pharmacology and Use of H1-Receptor-Antagonist Drugs,” N Engl J Med, 1994, 330(23):1663-70.[PubMed 7909915]

Simons KJ, Watson WT, Chen XY, et al, “Pharmacokinetic and Pharmacodynamic Studies of the H1-Receptor Antagonist Hydroxyzine in the Elderly,” Clin Pharmacol Ther, 1989, 45(1):9-14.[PubMed 2562944]

Soussan C, Gouraud A, Portolan G, et al. Drug-induced adverse reactions via breastfeeding: adescriptive study in the French Pharmacovigilance Database. Eur J Clin Pharmacol. 2014;70(11):1361-1366.[PubMed 25183382]

Vistaril (hydroxyzine) [prescribing information]. New York, NY: Pfizer; November 2016.

Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219.[PubMed 17555487]

Zuberbier T, Aberer W, Asero R, et al. The EAACI/GA(2) LEN/EDF/WAO guideline for the definition, classification, diagnosis, and management of urticaria: the 2013 revision and update. Allergy. 2014;69(7):868-887.[PubMed 24785199]

Brand Names: International

Arax (TW); Artica (BD); Atarax (AE, AT, AU, BB, BE, BG, BM, BS, BZ, CH, CR, CY, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GR, GT, GY, HK, HN, HU, IN, IS, IT, JM, JO, KW, LB, LK, LU, MT, MX, MY, NI, NL, NO, PA, PE, PL, PT, QA, RU, SA, SE, SI, SK, SR, SV, TH, TR, TT, TW, UA, VN); Atarax Uce (PK); Ataraxone (AR, UY); Aterax (ZA); Bestalin (ID); Centilax (KR); Dalun (CL); Disron-P (JP); Dormirex (GT); Drotizin (BR); Evazine (PH); Fasarax (CL); Fedox (PY); Hadarax (TH); Hiderax (CO); Hidroxin (MX); Hidroxina (EC); Histan (TH); Histarax (CR, DO, GT, HN, NI, PA, SV); Hixizine (BR); Hizin (SG, TH); Hydarax (VN); Hytis (BD); Iremofar (GR); Iterax (ID, PH); Nexit (CL); Nirax (TW); Paxistil (BE); Pergo (BR); Polizine (TH); Prurid (PY); Prurizin (BR); Qualidrozine (HK); Roxyzin (BD); Sedazine (PH); Serecid (NZ); Ucerax (IE, KR); Vistaril (KE, SE, TR, TW); Warazix (JP); Xyril (BD)

Hydroxyzine (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(hye DROKS i zeen)

Brand Names: US

Vistaril

Brand Names: Canada

Apo-Hydroxyzine; Atarax; Hydroxyzine Hydrochloride Injection, USP; Novo-Hydroxyzin; PMS-Hydroxyzine

What is this drug used for?
  • It is used to treat itching.
  • It is used to treat anxiety.
  • It is used to put you to sleep for surgery.
  • 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.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to hydroxyzine or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have ever had a long QT on ECG.
  • If you are in early pregnancy. Do not take this drug during early pregnancy.
  • If you are breast-feeding. Do not breast-feed while you take this drug.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • All products:
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Avoid driving and doing other tasks or actions that call for you to be alert until you see how this drug affects you.
  • Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
  • An unsafe heartbeat that is not normal (long QT on ECG) has happened with this drug. This may raise the chance of sudden death. Talk with the doctor.
  • If you are 65 or older, use this drug with care. You could have more side effects.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this drug while you are pregnant.
  • Injection:
  • Unsafe heart problems and sometimes death have rarely happened when this drug was given with alcohol or certain other drugs that may slow your actions. Talk with your doctor.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like 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; or swelling of the mouth, face, lips, tongue, or throat.
  • A heartbeat that does not feel normal.
  • A fast heartbeat.
  • Very bad dizziness or passing out.
  • Trouble controlling body movements.
  • Feeling confused.
  • Rarely, a very bad skin reaction has happened with this drug. Signs include fever and many small skin spots within large areas of redness and swelling. Call your doctor right away if you have a rash or any of these signs.
  • Injection:
  • Tissue damage has happened with this drug. Sometimes, this has led to surgery. Tell your nurse if you have any burning, color changes, pain, skin breakdown, or swelling where the shot was given.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Dry mouth.
  • Feeling sleepy.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Take with or without food. Take with food if it causes an upset stomach.
  • Liquid:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Injection:
  • It is given as a shot into a muscle.
What do I do if I miss a dose?
  • All oral products:
  • If you take this drug on a regular basis, take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
  • Many times this drug is taken on an as needed basis. Do not take more often than told by the doctor.
  • Injection:
  • Call your doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Injection:
  • If you need to store this drug at home, talk with your doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Hydroxyzine (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(hye DROKS i zeen)

Brand Names: US

Vistaril

Brand Names: Canada

Apo-Hydroxyzine; Atarax; Hydroxyzine Hydrochloride Injection, USP; Novo-Hydroxyzin; PMS-Hydroxyzine

What is this drug used for?
  • It is used to treat itching.
  • It is used to treat anxiety.
  • It is used to put your child to sleep for surgery.
  • It is used to treat mood problems.
  • It is used to treat upset stomach and throwing up.
  • It may be given to your child for other reasons. Talk with the doctor.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has ever had a long QT on ECG.
  • If your child is pregnant or breast-feeding a baby:
  • Do not give this drug to your child during early pregnancy.
  • Be sure your child does not breast-feed a baby while taking this drug.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • All products:
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
  • Alcohol may interact with this drug. Be sure your child does not drink alcohol.
  • Talk with the doctor before giving your child other drugs and natural products that may slow your child’s actions.
  • An unsafe heartbeat that is not normal (long QT on ECG) has happened with this drug. This may raise the chance of sudden death. Talk with the doctor.
  • If your child is pregnant:
  • Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
  • Injection:
  • Unsafe heart problems and sometimes death have rarely happened when this drug was given with alcohol or certain other drugs that may slow your child’s actions. Talk with your child’s doctor.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • All products:
  • Signs of an allergic reaction, like 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; or swelling of the mouth, face, lips, tongue, or throat.
  • A heartbeat that does not feel normal.
  • A fast heartbeat.
  • Very bad dizziness or passing out.
  • Trouble controlling body movements.
  • Feeling confused.
  • Rarely, a very bad skin reaction has happened with this drug. Signs include fever and many small skin spots within large areas of redness and swelling. Call your child’s doctor right away if your child has a rash or any of these signs.
  • Injection:
  • Tissue damage has happened with this drug. Sometimes, this has led to surgery. Tell your child’s nurse if your child has any burning, color changes, pain, skin breakdown, or swelling where the shot was given.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Feeling sleepy.
  • Dry mouth.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • All oral products:
  • Give this drug with or without food. Give with food if it causes an upset stomach.
  • Liquid:
  • Measure liquid doses carefully. Use the measuring device that comes with this drug. If there is none, ask the pharmacist for a device to measure this drug.
  • Injection:
  • It is given as a shot into a muscle.
What do I do if my child misses a dose?
  • All oral products:
  • If your child takes this drug on a regular basis, give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not use 2 doses at the same time or extra doses.
  • Many times this drug is given on an as needed basis. Do not give to your child more often than told by the doctor.
  • Injection:
  • Call your child’s doctor to find out what to do.
How do I store and/or throw out this drug?
  • All oral products:
  • Store at room temperature.
  • Protect from light.
  • Store in a dry place. Do not store in a bathroom.
  • Injection:
  • If you need to store this drug at home, talk with your child’s doctor, nurse, or pharmacist about how to store it.
  • All products:
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.