COMPOSITION :
HYRAX-10 Tablets
(each tablet contains)
Hydroxyzine Hydrochloride USP                   10mg
HYRAX-25 Tablets
(each tablet contains)
Hydroxyzine Hydrochloride USP                   25 mg

DESCRIPTION
Hydroxyzine hydrochloride is designated chemically as 2-[2-[4-(p-Chloro-phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride.
Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water.

CLINICAL PHARMACOLOGY :
HYRAX is unrelated chemically to the phenothiazines, reserpine, meprobamate, or the benzodiazepines. HYRAX 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 HYRAX’s clinical effects are usually noted within 15 to 30 minutes after oral administration.

INDICATIONS :
HYRAX tablets is useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine- mediated pruritus.

DOSAGE AND ADMINISTRATION :
For use in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses, and in histamine-mediated pruritus : in adults, 25 mg t.i.d. or q.i.d. ; children under 6 years, 50 mg daily in divided doses and over 6 years, 50-100 mg daily in divided doses.

CONTRAINDICATIONS :
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 in patients who have shown a previous hypersensitivity to it.

WARNINGS :
Nursing Mothers
It is not known whether this drug is excreted in human milk. Since many drugs are so excreted, hydroxyzine should not be given to nursing mothers.

PRECAUTIONS :
When CNS depressants are administered concomitantly with hydroxyzine, their dosage should be reduced. This is because hydroxyzine potentiates the action of CNS depressants, such as narcotics, non-narcotic analgesics and barbiturates. Since drowsiness may occur with use of this drug, patients should be warned of this possibility and cautioned against driving a car or operating dangerous machinery while taking HYRAX. Patients should be advised against the simultaneous use of other CNS depressant drugs, and cautioned that the effect of alcohol may be increased.

Geriatric Use :
The extent of renal excretion of hydroxyzine has not been determined. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selections.

ADVERSE REACTIONS :
Side effects with HYRAX are 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.

STORAGE INSTRUCTIONS :
Store in a cool dry place. Protect from moisture and light.