Hydroxyzine Injection

• It is used to treat anxiety.
• 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.

• If you have an allergy to hydroxyzine or any other part of hydroxyzine injection.
• 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 medicine during early pregnancy.
• If you are breast-feeding. Do not breast-feed while you take hydroxyzine injection.

This is not a list of all drugs or health problems that interact with this medicine.

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 hydroxyzine injection with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

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 the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Hydroxyzine hydrochloride has the chemical name of (±)-2-[2-[4-(p-Chloro-a-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.

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 IM 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.
Adults: The preferred site is the upper outer quadrant of the buttock, (i.e., the gluteus maximus), or the mid-lateral thigh.
Children: It is recommended that intramuscular injections be given preferably in the mid-lateral muscles of the thigh. In infants and small children the periphery of the upper outer quadrant of the gluteal region should be used only when necessary, such as in burn patients, in order to minimize the possibility of damage to the sciatic nerve. The deltoid area should be used only if well developed such as in certain adults and older children, and then only with caution to avoid radial nerve injury. Intramuscular injections should not be made into the lower and mid-third of the upper arm. As with all intramuscular injections, aspiration is necessary to help avoid inadvertent injection into a blood vessel.
Geriatric Use: A determination has not been made whether controlled clinical studies of hydroxyzine hydrochloride included sufficient numbers of subjects aged 65 and over to define a difference in response from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. The extent of renal excretion of hydroxyzine hydrochloride has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.Sedating drugs may cause confusion and over-sedation in the elderly; elderly patients generally should be started on low doses of hydroxyzine hydrochloride and observed closely.