Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Product No. Strength Size NDC-0517-4201-25 25 mg/mL 1 mL Single Dose Vial Boxes of 25 NDC-0517-5601-25 50 mg/mL 1 mL Single Dose Vial Boxes of 25 NDC-0517-5602-25 50 mg/mL 2 mL Single Dose Vial Boxes of 25 NDC-0517-5610-25 50 mg/mL 10 mL Multiple Dose Vial Boxes of 25 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; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 mL (25 mg) PRINCIPAL DISPLAY PANEL – 1 mL (25 mg) Container NDC 0517-4201-01 Rx Only Hydroxyzine HCl Injection, USP 25 mg/mL For Intramuscular Use Only 1 mL Single-Dose Vial 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 Container Label (1 mL) 25 mg 1 mL (25 mg) Carton; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 mL (50 mg) PRINCIPAL DISPLAY PANEL – 1 mL (50 mg) Container NDC 0517-5601-01 Rx Only Hydroxyzine HCl Injection, USP 50 mg/mL For Intramuscular Use Only 1 mL Single-Dose Vial 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 Container Label 1 mL (50 mg) 1 mL (50 mg) Carton; PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 2 mL (50 mg) PRINCIPAL DISPLAY PANEL – 2 mL (50 mg) Container NDC 0517-5602-01 Rx Only Hydroxyzine HCl Injection, USP 100 mg/2 mL (50 mg/mL) For Intramuscular Use Only 2 mL Single-Dose Vial 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 Container Label 2 mL (100 mg/2 mL) 2 mL (50 mg) Carton; Serialization Label - 4201-25 4201-25 Serialization Label; Serialization Label - 5601-25 5601-25 Serialization Label; Serialization Label - 5602-25 5602-25 Serialization Label
- HOW SUPPLIED Product No. Strength Size NDC-0517-4201-25 25 mg/mL 1 mL Single Dose Vial Boxes of 25 NDC-0517-5601-25 50 mg/mL 1 mL Single Dose Vial Boxes of 25 NDC-0517-5602-25 50 mg/mL 2 mL Single Dose Vial Boxes of 25 NDC-0517-5610-25 50 mg/mL 10 mL Multiple Dose Vial Boxes of 25 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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 mL (25 mg) PRINCIPAL DISPLAY PANEL – 1 mL (25 mg) Container NDC 0517-4201-01 Rx Only Hydroxyzine HCl Injection, USP 25 mg/mL For Intramuscular Use Only 1 mL Single-Dose Vial 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 Container Label (1 mL) 25 mg 1 mL (25 mg) Carton
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 1 mL (50 mg) PRINCIPAL DISPLAY PANEL – 1 mL (50 mg) Container NDC 0517-5601-01 Rx Only Hydroxyzine HCl Injection, USP 50 mg/mL For Intramuscular Use Only 1 mL Single-Dose Vial 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 Container Label 1 mL (50 mg) 1 mL (50 mg) Carton
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 2 mL (50 mg) PRINCIPAL DISPLAY PANEL – 2 mL (50 mg) Container NDC 0517-5602-01 Rx Only Hydroxyzine HCl Injection, USP 100 mg/2 mL (50 mg/mL) For Intramuscular Use Only 2 mL Single-Dose Vial 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 Container Label 2 mL (100 mg/2 mL) 2 mL (50 mg) Carton
- Serialization Label - 4201-25 4201-25 Serialization Label
- Serialization Label - 5601-25 5601-25 Serialization Label
- Serialization Label - 5602-25 5602-25 Serialization Label
Overview
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. 6e26bbb9-figure-01
Indications & Usage
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.
Dosage & Administration
The recommended dosages for hydroxyzine hydrochloride intramuscular solution are: For adult psychiatric and emotional emergencies, including acute alcoholism. Intramuscular: 50 to100 mg stat., and every 4 to 6 hours as needed. Nausea and vomiting excluding nausea and vomiting of pregnancy. Adults: 25 to 100 mg intramuscularly Children: 0.5 mg/lb body weight intramuscularly Pre- and postoperative adjunctive medication. Adults: 25 to 100 mg intramuscularly Children: 0.5 mg/lb body weight intramuscularly Pre- and postpartum adjunctive therapy. 25 to 100 mg intramuscularly 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.
Warnings & Precautions
WARNINGS 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).
Contraindications
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.
Adverse Reactions
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.
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