Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride Tablets USP, 10 mg are 7/32", unscored, round, orange, film-coated tablets imprinted DAN and 5522 supplied in bottles of 100 and 500.

Hydroxyzine Hydrochloride Tablets USP, 25 mg are 7/32", unscored, round, green, film-coated tablets imprinted DAN and 5523 supplied in bottles of 100, 500 and 1000.

Hydroxyzine Hydrochloride Tablets USP, 50 mg are 10/32", unscored, round, yellow, film-coated tablets imprinted DAN and 5565 supplied in bottles of 100, 500 and 1000.

Dispense in a tight container with child-resistant closure.

Store at controlled room temperature 15°-30°C (59°-86°F).

Watson Laboratories, Inc, Corona, CA 92880 USA. Revised: September 2004. FDA rev date:

Hydroxyzine hydrochloride is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines. Hydroxyzine hydrochloride 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. Bronchodilator activity, and antihistaminic and analgesic 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 has mild antisecretory activity.

Hydroxyzine is rapidly absorbed from the gastrointestinal tract and hydroxyzine hydrochloride's clinical effects are usually noted within 15 to 30 minutes after oral administration.

Side effects reported with the administration of hydroxyzine hydrochloride are usually mild and transitory in nature.

Anticholinergic: Dry mouth.

Central Nervous System: Drowsiness is usually transitory and may disappear in a few days of continued therapy or upon reduction of the dose. Involuntary motor activity including rare instances of tremor and convulsions have been reported, usually with doses considerably higher than those recommended. Clinically significant respiratory depression has not been reported at recommended doses.

Read the entire FDA prescribing information for Atarax (Hydroxyzine Hydrochloride)

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Administration

Administer orally or by IM injection.a b

Do not administer parenteral preparation by sub-Q, intra-arterial, or IV injection.b c

Oral therapy should replace IM therapy as soon as possible.b

IM Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer commercially available injection without further dilution.b

Use caution to avoid extravasation or inadvertent sub-Q, IV, or intra-arterial injection (see Local Effects under Cautions).b c Z-track injection technique may prevent sub-Q infiltration.c

Adults: Administer preferably deep into the upper outer quadrant of the gluteus maximus or the midlateral thigh.b c To avoid radial nerve injury, use the deltoid area with caution and only if well developed.b c Do not administer into the lower and mid-third of the upper arm.b c

Children: Administer into the midlateral muscles of the thigh.b c

Infants and small children: If IM injection is required, administer in the periphery of the upper outer quadrant of the gluteus maximus.b c (See Pediatric Use under Cautions.)

Dosage

Available as hydroxyzine pamoate and hydroxyzine hydrochloride; dosage expressed in terms of the hydrochloride.b

Use the smallest possible effective dosage.b c

Pediatric Patients

Children <6 years of age: 50 mg daily given in divided doses.a c

Children ≥6 years of age: 50–100 mg daily given in divided doses.a c

Children <6 years of age: 50 mg daily given in divided doses.a c

Children ≥6 years of age: 50–100 mg daily given in divided doses.a c

0.6 mg/kg administered before and following general anesthesia.a c

1.1 mg/kg administered before and following general anesthesia.b c

Initially, 1.1 mg/kg; adjust subsequent dosage according to individual requirements and response.b c

Adults

50–100 mg 4 times daily.a c

Initially, 25–100 mg; adjust subsequent dosage according to individual requirements and response.b c

50–100 mg repeated every 4–6 hours as needed to control symptoms.b c

25 mg 3 or 4 times daily.a c

50–100 mg administered before and following general anesthesia.a c

25–100 mg administered before and following general anesthesia.b

Initially, 25–100 mg; adjust subsequent dosage according to individual requirements and response.b

50–100 mg repeated every 4–6 hours as needed to control symptoms.b c

Initially, 25–100 mg; adjust subsequent dosage according to individual requirements and response.b

Special Populations

Geriatric Patients

Use initial dosage at low end of the recommended dosage range.a b (See Geriatric Use under Cautions.)

Specific Drugs