Hydroxyzine Oral Solution

Hydroxyzine hydrochloride is designated chemically as 1-(p-chlorobenzhydryl) 4-[2-(2 hydroxyethoxy)- ethyl] piperazine dihydrochloride, with the following structure:

Each 5 mL (teaspoonful), for oral administration, contains 10 mg of hydroxyzine hydrochloride.

The inactive ingredients for the oral solution are alcohol 0.5% v/v, corn syrup, methylparaben, peppermint flavor, propylene glycol, purified water, sodium benzoate, and sucrose. Sodium hydroxide and/or hydrochloric acid may be used to adjust the pH when necessary.

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 its clinical effects are usually noted within 15 to 30 minutes after oral administration.

For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested.

Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus.

As a sedative when used as premedication and following general anesthesia, Hydroxyzine may potentiate meperidine (Demerol®) and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent.

The effectiveness of hydroxyzine as an antianxiety agent for 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.

Oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride.

Hydroxyzine is contraindicated in patients with a prolonged QT interval.

Hydroxyzine, when administered to the pregnant mouse, rat and rabbit, induced fetal abnormalities in the rat and mouse 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.

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

HydrOXYzine Hydrochloride Oral Solution, USP

10 mg/5 mL

Each 5 mL (teaspoonful) contains:

Hydroxyzine Hydrochloride ………10 mg

Alcohol …………………………….0.5% v/v

USUAL DOSAGE: See package insert for dosage and full prescribing information.

Dispense in a tight, light-resistant container as define in the USP. Store at controlled room temperature 15° -30°C (59° -86°F).

Rx only

16 fl oz (473 mL)

HI-TECH PHARMACAL CO., INC

Amityville, NY 11701

Take this medicine by mouth with a full glass of water. Follow the directions on the prescription label. Use a specially marked spoon or dropper to measure every dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You may take this medicine with food or on an empty stomach. Take your medicine at regular intervals. Do not take your medicine more often than directed.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed. While this drug may be prescribed for children as young as 2 years of age for selected conditions, precautions do apply.

Patients over 65 years old may have a stronger reaction and need a smaller dose.

They need to know if you have any of these conditions:

• any chronic illness
• diabetes
• difficulty passing urine
• glaucoma
• heart disease
• kidney disease
• liver disease
• lung disease
• an unusual or allergic reaction to hydroxyzine, cetirizine, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Tell your doctor or health care professional if your symptoms do not improve.

You may get drowsy or dizzy. Do not drive, use machinery, or do anything that needs mental alertness until you know how this medicine affects you. Do not stand or sit up quickly, especially if you are an older patient. This reduces the risk of dizzy or fainting spells. Alcohol may interfere with the effect of this medicine. Avoid alcoholic drinks.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy, and drinking plenty of water may help. Contact your doctor if the problem does not go away or is severe.

This medicine may cause dry eyes and blurred vision. If you wear contact lenses you may feel some discomfort. Lubricating drops may help. See your eye doctor if the problem does not go away or is severe.

If you are receiving skin tests for allergies, tell your doctor you are using this medicine.

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Do not freeze. Protect from light. Throw away any unused medicine after the expiration date.