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Basic Drug Info
Drug Name:Vistaril
Manufacturer:Roerig
Other Info:

Rx only70-0843-00-6Oct.

2001



Clinical Trials:


Indications and Usage

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.VISTARIL (hydroxyzine hydrochloride) Intramuscular Solution is useful in treating the following types of patients when intramuscular administration is indicated:The acutely disturbed or hysterical patient.The acute or chronic alcoholic with anxiety withdrawal symptoms or delirium tremens.As pre- and postoperative and pre- and postpartum adjunctive medication to permit reduction in narcotic dosage, allay anxiety and control emesis.VISTARIL (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.
Agitation -- A feeling of restlessness associated with increased motor activity. This may occur as a manifestation of nervous system drug toxicity or other conditions.

Asthma -- A form of bronchial disorder with three distinct components: airway hyper-responsiveness (RESPIRATORY HYPERSENSITIVITY), airway INFLAMMATION, and intermittent AIRWAY OBSTRUCTION. It is characterized by spasmodic contraction of airway smooth muscle, WHEEZING, and dyspnea (DYSPNEA, PAROXYSMAL).

Alcohol Withdrawal Delirium -- An acute organic mental disorder induced by cessation or reduction in chronic alcohol consumption. Clinical characteristics include CONFUSION; DELUSIONS; vivid HALLUCINATIONS; TREMOR; agitation; insomnia; and signs of autonomic hyperactivity (e.g., elevated blood pressure and heart rate, dilated pupils, and diaphoresis). This condition may occasionally be fatal. It was formerly called delirium tremens. (From Adams et al., Principles of Neurology, 6th ed, p1175)

Nausea -- An unpleasant sensation in the stomach usually accompanied by the urge to vomit. Common causes are early pregnancy, sea and motion sickness, emotional stress, intense pain, food poisoning, and various enteroviruses.

Vomiting of pregnancy --

Heart Diseases -- Pathological conditions involving the HEART including its structural and functional abnormalities.

Contraindications

Hydroxyzine hydrochloride intramuscular solution is intended only for intramuscular administration and should not, under any circumstances, be injected subcutaneously, intra-arterially, or intravenously.This drug is contraindicated for patients who have shown a previous hypersensitivity to it.Hydroxyzine, when administered to the pregnant mouse, rat, and rabbit, induced fetal abnormalities in the rat 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.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.


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