(For Intramuscular Use Only)

Rx Only

Hydroxyzine hydrochloride has the chemical name of (±)-2-[2-[4-(p-Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy]ethanol dihydrochloride and occurs as a white, odorless powder which is very soluble in water.

It has the following structural formula:

Hydroxyzine Hydrochloride Injection, USP is a sterile aqueous solution intended for intramuscular administration.

Each mL contains: Hydroxyzine HCl 25 mg or 50 mg, Benzyl Alcohol 0.9%, and Water for Injection q.s.  pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid.

Hydroxyzine hydrochloride is unrelated chemically to phenothiazine, reserpine, and meprobamate. Hydroxyzine has demonstrated its clinical effectiveness in the chemotherapeutic aspect of the total management of neuroses and emotional disturbances manifested by anxiety, tension, agitation, apprehension or confusion.

Hydroxyzine has been shown clinically to be a rapid-acting true ataraxic with a wide margin of safety. It induces a calming effect in anxious, tense, psychoneurotic adults and also in anxious, hyperkinetic children without impairing mental alertness. It is not a cortical depressant, but its action may be due to a suppression of activity in certain key regions of the subcortical area of the central nervous system.

Primary skeletal muscle relaxation has been demonstrated experimentally.

Hydroxyzine has been shown experimentally to have antispasmodic properties, apparently mediated through interference with the mechanism that responds to spasmogenic agents such as serotonin, acetylcholine, and histamine.

Antihistaminic effects have been demonstrated experimentally and confirmed clinically.

An antiemetic effect, both by the apomorphine test and the veriloid test, has been demonstrated. Pharmacological and clinical studies indicate that hydroxyzine in therapeutic dosage does not increase gastric secretion or acidity and in most cases provides mild antisecretory benefits.

The total management of anxiety, tension, and psychomotor agitation in conditions of emotional stress requires in most instances a combined approach of psychotherapy and chemotherapy. Hydroxyzine has been found to be particularly useful for this latter phase of therapy in its ability to render the disturbed patient more amenable to psychotherapy in long term treatment of the psychoneurotic and psychotic, although it should not be used as the sole treatment of psychosis or of clearly demonstrated cases of depression.

Hydroxyzine is also useful in alleviating the manifestations of anxiety and tension as in the preparation for dental procedures and in acute emotional problems. It has also been recommended for the management of anxiety associated with organic disturbances and as adjunctive therapy in alcoholism and allergic conditions with strong emotional overlay, such as in asthma, chronic urticaria, and pruritus.

Hydroxyzine hydrochloride intramuscular solution is useful in treating the following types of patients when intramuscular administration is indicated:

1. The acutely disturbed or hysterical patient.

2. The acute or chronic alcoholic with anxiety withdrawal symptoms or delirium tremens.

3. As pre-and postoperative and pre- and postpartum adjunctive medication to permit reduction in narcotic dosage, allay anxiety and control emesis.

Hydroxyzine hydrochloride has also demonstrated effectiveness in controlling nausea and vomiting, excluding nausea and vomiting of pregnancy. (See CONTRAINDICATIONS).

In prepartum states, the reduction in narcotic requirement effected by hydroxyzine is of particular benefit to both mother and neonate.

Hydroxyzine benefits the cardiac patient by its ability to allay the associated anxiety and apprehension attendant to certain types of heart disease. Hydroxyzine is not known to interfere with the action of digitalis in any way and may be used concurrently with this agent.

The effectiveness of hydroxyzine in long term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.

Hydroxyzine hydrochloride intramuscular solution is intended only for intramuscular administration and should not, under any circumstances, be injected subcutaneously, intra-arterially or intravenously.

Hydroxyzine is contraindicated in patients with a prolonged QT interval.

This drug is contraindicated for patients who have shown a previous hypersensitivity to it.

Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat at doses substantially above the human therapeutic range. Clinical data in human beings are inadequate to establish safety in early pregnancy. Until such data are available, hydroxyzine is contraindicated in early pregnancy.

Tissue damage: Intramuscular hydroxyzine hydrochloride may result in severe injection site reactions (including extensive tissue damage, necrosis and gangrene) requiring surgical intervention (including debridement, skin grafting and amputation).

THE POTENTIATING ACTION OF HYDROXYZINE MUST BE CONSIDERED WHEN THE DRUG IS USED IN CONJUNCTION WITH CENTRAL NERVOUS SYSTEM DEPRESSANTS SUCH AS NARCOTICS, BARBITURATES AND ALCOHOL. Rarely, cardiac arrests and death have been reported in association with the combined use of hydroxyzine hydrochloride intramuscularly and other CNS depressants. Therefore, when central nervous system depressants are administered concomitantly with hydroxyzine their dosage should be reduced up to 50 percent. The efficacy of hydroxyzine as adjunctive pre- and postoperative sedative medication has also been well established, especially as regards its ability to allay anxiety, control emesis, and reduce the amount of narcotic required.

HYDROXYZINE MAY POTENTIATE NARCOTICS AND BARBITURATES, so their use in preanesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug.

When hydroxyzine is used preoperatively or prepartum, narcotic requirements may be reduced as much as 50 percent. Thus, when 50 mg of hydroxyzine hydrochloride intramuscular solution is employed, meperidine dosage may be reduced from 100 mg to 50 mg. The administration of meperidine may result in severe hypotension in the postoperative patient or any individual whose ability to maintain blood pressure has been compromised by a depleted blood volume. Meperidine should be used with great caution and in reduced dosage in patients who are receiving other pre- and/or postoperative medications and in whom there is a risk of respiratory depression, hypotension, and profound sedation or coma occurring. Before using any medications concomitant with hydroxyzine, the manufacturer"s prescribing information should be read carefully.

Since drowsiness may occur with the use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking this drug.

As with all intramuscular preparations, hydroxyzine hydrochloride intramuscular solution should be injected well within the body of a relatively large muscle. Inadvertent subcutaneous injection may result in significant tissue damage.

Therapeutic doses of hydroxyzine seldom produce impairment of mental alertness. However, drowsiness may occur; if so, it is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Dryness of the mouth may be encountered at higher doses. Extensive clinical use has substantiated the absence of toxic effects on the liver or bone marrow when administered in the recommended doses for over four years of uninterrupted therapy. The absence of adverse effects has been further demonstrated in experimental studies in which excessively high doses were administered.

Involuntary motor activity, including rare instances of tremor and convulsions, has been reported, usually with doses considerably higher than those recommended. Continuous therapy with over one gram per day has been employed in some patients without these effects having been encountered. Hydroxyzine hydrochloride is associated with Acute Generalized Exanthematous Pustulosis (AGEP) in post marketing reports.

The recommended dosages for hydroxyzine hydrochloride intramuscular solution are:

As with all potent medications, the dosage should be adjusted according to the patient's response to therapy.

FOR ADDITIONAL INFORMATION ON THE ADMINISTRATION AND SITE OF SELECTION SEE PRECAUTIONS SECTION. NOTE: Hydroxyzine hydrochloride intramuscular solution may be administered without further dilution.

Patients may be started on intramuscular therapy when indicated. They should be maintained on oral therapy whenever this route is practicable.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Storage Condition: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature). Protect from light. Discard unused portion of the single dose vial.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

IN4201
Rev. 10/16

PRINCIPAL DISPLAY PANEL – 1 mL (25 mg) Container

NDC 0517-4201-25

HYDROXYZINE HCl
INJECTION, USP

25 mg/mL

1 mL SINGLE DOSE VIAL

FOR IM USE ONLY

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

PRINCIPAL DISPLAY PANEL – 1 mL (25 mg) Carton

HYDROXYZINE HCl
INJECTION, USP

25 mg/mL

NDC 0517-4201-25

25 x 1 mL SINGLE DOSE VIALS

FOR INTRAMUSCULAR USE ONLY

Rx Only

Each mL contains: Hydroxyzine HCl 25 mg, Benzyl Alcohol 0.9%, Water for Injection q.s. pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid.
WARNING: PROTECT FROM LIGHT. DISCARD UNUSED PORTION.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05

PRINCIPAL DISPLAY PANEL – 1 mL (50 mg) Container

NDC 0517-5601-25

HYDROXYZINE HCl
INJECTION, USP

50 mg/mL

1 mL SINGLE DOSE VIAL

FOR IM USE ONLY

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

PRINCIPAL DISPLAY PANEL – 1 mL (50 mg) Carton

HYDROXYZINE HCl
INJECTION, USP

50 mg/mL

NDC 0517-5601-25

25 x 1 mL SINGLE DOSE VIALS

FOR INTRAMUSCULAR USE ONLY

Rx Only

Each mL contains: Hydroxyzine HCl 50 mg, Benzyl Alcohol 0.9%, Water for Injection q.s. pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid.
WARNING: PROTECT FROM LIGHT. DISCARD UNUSED PORTION.
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev.11/05

PRINCIPAL DISPLAY PANEL – 2 mL  (50 mg) Container

NDC 0517-5602-25

HYDROXYZINE HCl
INJECTION, USP

100 mg/2 mL (50 mg/mL)

2 mL SINGLE DOSE VIAL

FOR IM USE ONLY

Rx Only

AMERICAN REGENT, INC.
SHIRLEY, NY  11967

PRINCIPAL DISPLAY PANEL – 2 mL (50 mg) Carton

HYDROXYZINE HCl
INJECTION, USP

100 mg/2 mL (50 mg/mL)

NDC 0517-5602-25

25 x 2 mL SINGLE DOSE VIALS

FOR INTRAMUSCULAR USE ONLY

Rx Only

Each mL contains: Hydroxyzine HCl 50 mg, Benzyl Alcohol 0.9%, Water for Injection q.s. pH adjusted with Sodium Hydroxide and/or Hydrochloric Acid.
WARNING: PROTECT FROM LIGHT. DISCARD UNUSED PORTION.
Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) (See USP Controlled Room Temperature).
Directions for Use: See Package Insert.

AMERICAN
REGENT, INC.
SHIRLEY, NY 11967

Rev. 11/05