Source: FDA, National Drug Code (US) Revision Year: 2024
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.
The recommended dosages for hydroxyzine hydrochloride intramuscular solution are:
| For adult psychiatric and emotional emergencies, including acute alcoholism. | Intramuscular: 50 to 100 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.
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.
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