(hye DROKS i zeen)
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 narcotic dosage, allay anxiety, and control emesis.
Peripartum adjunct: As pre- and postpartum adjunctive medication to permit reduction in narcotic dosage, allay anxiety, and control emesis.
Hypersensitivity to hydroxyzine or any component of the formulation; early pregnancy
Additional contraindications:
Hydroxyzine hydrochloride oral: Hypersensitivity to cetirizine or levocetirizine
Oral: Prolonged QT interval
Injection: SubQ, intra-arterial, or IV administration
Antiemetic: IM: 25 to 100 mg/dose
Anxiety:
Oral:
Manufacturer 's labeling: 50 to100 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
Initiate dosing using the lower end of the recommended dosage range. Refer to adult dosing.
Antiemetic: IM: 1.1 mg/kg/dose
Anxiety: Oral:
Children <6 years: 50 mg/day in divided doses
Children ≥6 years and Adolescents: 50 to 100 mg/day in divided doses
Perioperative adjunct:
Manufacturers labeling: Children and Adolescents:
Oral: 0.6 mg/kg/dose
IM: 1.1 mg/kg/dose
Alternate dosing: Oral: Children 2 to 5 years: 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 preschool children prior to dental procedures or echocardiograms (Chowdhury 2005; Roach 2010)
Pruritus: Oral:
Manufacturer's labeling:
Children <6 years: 50 mg/day in divided doses
Children ≥6 years and Adolescents: 50 to 100 mg/day in divided doses
Alternate dosing:
Patient weighing ≤40 kg: 2 mg/kg/day in divided doses (Simons 1994)
Patient weighing >40 kg: 25 to 50 mg once daily at bedtime or twice daily (Simons 1994)
There are no dosage adjustments provided in the manufacturers labeling; however, the following guidelines have been used by some clinicians (Aronoff, 2007):
Adults:
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.
There are no dosage adjustments provided in the manufacturers labeling. In adults with primary biliary cirrhosis, change dosing interval to every 24 hours (Simons F 1989)
Injection: 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. In adults, the preferred site is the upper outer quadrant of the buttock or midlateral thigh. In children, the preferred site is the 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.
Oral: Administer without regard to food. Shake suspension vigorously prior to use.
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.
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 [DSC]); 50 mg/mL (1 mL [DSC], 2 mL [DSC], 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
Y-site administration: Incompatible with allopurinol, amifostine, amphotericin B cholesteryl sulfate complex, doxorubicin liposome, fluconazole, fludarabine, paclitaxel, sargramostim.
Compatibility in syringe: Incompatible with dimenhydrinate, haloperidol, ketorolac, pentobarbital, ranitidine.
AbobotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of AbobotulinumtoxinA. Monitor therapy
Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Monitor therapy
Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Monitor therapy
Amphetamines: May diminish the sedative effect of Antihistamines. Monitor therapy
Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Monitor therapy
Azelastine (Nasal): CNS Depressants may enhance the CNS depressant effect of Azelastine (Nasal). 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. 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. Consider therapy modification
Betahistine: Antihistamines may diminish the therapeutic effect of Betahistine. Monitor therapy
Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Consider therapy modification
Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
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. Consider therapy modification
Cannabis: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Avoid combination
CNS Depressants: HydrOXYzine may enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Dimethindene: May enhance the CNS depressant effect of CNS Depressants. 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. Monitor therapy
Dronabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Droperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (e.g., opioids, barbiturates) with concomitant use. Consider therapy modification
Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Avoid combination
Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Consider therapy modification
Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Monitor therapy
Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Avoid combination
Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Avoid combination
Highest Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification
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. Consider therapy modification
HYDROcodone: CNS Depressants may enhance the CNS depressant effect of HYDROcodone. Management: Consider starting with a 20% to 30% lower hydrocodone dose when using together with any other CNS depressant. Dose reductions in the other CNS depressant may also be warranted. Consider therapy modification
Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Monitor therapy
Kava Kava: May enhance the adverse/toxic effect of CNS Depressants. Monitor therapy
Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Avoid combination
Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. 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. 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. Consider therapy modification
MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Monitor therapy
Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Monitor therapy
MiFEPRIStone: May enhance the QTc-prolonging effect of QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying). Management: Though the drugs listed here have uncertain QT-prolonging effects, they all have some possible association with QT prolongation and should generally be avoided when possible. Consider therapy modification
Minocycline: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Monitor therapy
Mirtazapine: CNS Depressants may enhance the CNS depressant effect of Mirtazapine. Monitor therapy
Moderate Risk QTc-Prolonging Agents: QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying) may enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy
Nabilone: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
OnabotulinumtoxinA: Anticholinergic Agents may enhance the anticholinergic effect of OnabotulinumtoxinA. Monitor therapy
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Avoid combination
Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Avoid combination
OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: When oxycodone is combined with another CNS depressant, a dose reduction of one or both agents should be considered. The extended release oxycodone starting dose should be reduced 50% to 67% when initiated in patients already receiving CNS depressants. Consider therapy modification
Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. 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. Consider therapy modification
Piribedil [INT]: CNS Depressants may enhance the CNS depressant effect of Piribedil [INT]. 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. Avoid combination
Pramipexole: CNS Depressants may enhance the sedative effect of Pramipexole. Monitor therapy
Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Consider therapy modification
Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Monitor therapy
RimabotulinumtoxinB: Anticholinergic Agents may enhance the anticholinergic effect of RimabotulinumtoxinB. Monitor therapy
ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Monitor therapy
Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Monitor therapy
Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Monitor therapy
Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid using drugs with substantial anticholinergic effects in patients receiving secretin whenever possible. If such agents must be used in combination, monitor closely for a diminished response to secretin. 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. 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. 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. Consider therapy modification
Tapentadol: May enhance the CNS depressant effect of CNS Depressants. Management: Start tapentadol at a dose of one-third to one-half of the normal dose if being initiated in a patient who is taking another drug with CNS depressant effects. Monitor closely for evidence of excessive CNS depression. Consider therapy modification
Tetrahydrocannabinol: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Avoid combination
Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Monitor therapy
Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Avoid combination
Topiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate. Monitor therapy
Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Monitor therapy
Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. 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. Consider therapy modification
Relief of symptoms, mental status, blood pressure
May cause false-positive serum TCA screen (Dasgupta 2007).
Frequency not defined.
Cardiovascular: Prolonged Q-T interval on ECG, torsades de pointes
Central nervous system: Dizziness, drowsiness (transient), fatigue, involuntary movements, seizure (high doses), tremor (high doses)
Gastrointestinal: Xerostomia
Hypersensitivity: Hypersensitivity reaction
Ophthalmic: Blurred vision
Respiratory: Respiratory depression (high doses)
<1% (Limited to important or life-threatening): Fixed drug eruption, hallucination
Concerns related to adverse effects:
- 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 manufacturers 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.
Adverse events have been observed in animal reproduction studies. Hydroxyzine crosses the placenta (Prenner 1977; Serreau 2005). Maternal hydroxyzine use has generally not resulted in an increased risk of birth defects (Anderka 2011; Einarson 1997; Erez 1971; Gilboa 2009; Heinonen 1977). Use of hydroxyzine early in pregnancy is contraindicated but hydroxyzine is approved for pre- and postpartum adjunctive therapy to reduce opioid dosage, treat anxiety, and control emesis. Antihistamines are recommended for the treatment of pruritus with rash in pregnant women (although second-generation antihistamines may be preferred). Antihistamines are not recommended for treatment of pruritus associated with intrahepatic cholestasis in pregnancy (Ambros-Rudolph 2011; Kremer 2011). Possible withdrawal symptoms have been observed in neonates following chronic maternal use of hydroxyzine during pregnancy (Prenner 1977; Serreau 2005).
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.
Oral: Rapid
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)
Hepatic to multiple metabolites, including cetirizine (active) (Simons F 1989)
Urine; active metabolite (cetirizine) is renally eliminated (Simons F 1994)
Oral: 15 to 30 minutes; IM: Rapid
Oral administration: Serum: ~2 hours; Peak suppression of antihistamine-induced wheal and flare: 4 to 12 hours (Simons F 1984)
Decreased histamine-induced wheal and flare areas: 2 to ≥36 hours; Suppression of pruritus: 1 to 12 hours (Simon F 1984)
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 old 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)
- 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, 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.