HYDROXYZINE SUMMARY
AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, (CHEWABLE)
Rx only
Hydroxyzine hydrochloride is designated chemically as 2-[2-[4-(p -Chloro-α-phenylbenzyl)-1-piperazinyl]ethoxy] ethanol dihydrochloride.
Hydroxyzine (hydroxyzine) is indicated for the following:
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 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.
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NEWS HIGHLIGHTS
Published Studies Related to Hydroxyzine
Comparison of peripheral and central effects of single and repeated oral dose administrations of bilastine, a new H1 antihistamine: a dose-range study in healthy volunteers with hydroxyzine and placebo as control treatments. [2008.12]
Peripheral anti-H1 and central nervous system (CNS) activities after single (day 1) and repeated (day 7) administrations of increasing doses of bilastine (BIL) were assessed in 20 healthy volunteers throughout a crossover, randomized, double-blind, placebo (PLA)-controlled study... The 40-mg dose of BIL produced subjective report of sedation, whereas unwanted objective CNS side effects were observed only with the 80-mg dose.
Hydroxyzine and cetirizine pharmacokinetics and pharmacodynamics after oral and intravenous administration of hydroxyzine to healthy dogs. [2008.12]
Pharmacokinetic parameters of hydroxyzine and its active metabolite cetirizine were determined after oral and intravenous administration of 2 mg kg(-1) of hydroxyzine to six healthy dogs. Plasma drug levels were determined with high-pressure liquid chromatography... Pharmacodynamic modelling predicted that maximal antihistamine effect would occur with twice daily oral administration of hydroxyzine at 2 mg kg(-1).
Histamine H1 blocker hydroxyzine improves sleep in patients with cirrhosis and minimal hepatic encephalopathy: a randomized controlled pilot trial. [2007.04]
OBJECTIVES: Sleep difficulty is common in minimal hepatic encephalopathy (HE) and the mechanisms are not fully elucidated. Dysregulated histamine neurotransmission is associated with an altered circadian rhythmicity that is partially restored following central histamine H1 receptor blockade in cirrhotic animals. We studied the effects of the histamine H1 blocker hydroxyzine in sleep alterations in patients with cirrhosis in a double-blind, randomized controlled fashion... CONCLUSIONS: In contrast to placebo, hydroxyzine 25 mg at bedtime improved sleep behavior (subjectively and using wrist actigraphy) in patients with cirrhosis and minimal HE. The risk of precipitating overt HE warrants some caution when prescribing this drug.
[Hydroxyzine premedication does not alter bispectral index changes following etomidate induction of general anaesthesia] [2007.03]
OBJECTIVE: Various drugs including hydroxyzine are preoperatively administered to facilitate the induction of general anaesthesia. We investigated the effect of hydroxyzine premedication on BIS-based etomidate induction of general anaesthesia... CONCLUSION: Oral weight-related hydroxyzine premedication does not alter BIS-based etomidate induction of GA.
Histamine H1 Blocker Hydroxyzine Improves Sleep in Patients With Cirrhosis and Minimal Hepatic Encephalopathy: A Randomized Controlled Pilot Trial. [2007.01.11]
OBJECTIVES: Sleep difficulty is common in minimal hepatic encephalopathy (HE) and the mechanisms are not fully elucidated. Dysregulated histamine neurotransmission is associated with an altered circadian rhythmicity that is partially restored following central histamine H1 receptor blockade in cirrhotic animals. We studied the effects of the histamine H1 blocker hydroxyzine in sleep alterations in patients with cirrhosis in a double-blind, randomized controlled fashion... CONCLUSIONS: In contrast to placebo, hydroxyzine 25 mg at bedtime improved sleep behavior (subjectively and using wrist actigraphy) in patients with cirrhosis and minimal HE. The risk of precipitating overt HE warrants some caution when prescribing this drug. (Am J Gastroenterol 2007;102:1-10).
Clinical Trials Related to Hydroxyzine
Comparative Effects of Rupatadine 10 mg, Hydroxyzine 50 mg and Placebo on Actual Driving Performance [Terminated]
The primary objective of this study is to measure and compare the acute effects of rupatadine
10 mg, relative to placebo and hydroxyzine 50 mg as an active control on healthy volunteers’
performance on a standard over-the-road driving test and a car-following test.
Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients [Terminated]
IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to
evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional
status, dialysis efficacy, Karnofsky score
A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer [Recruiting]
The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere
in patients with advanced cancer.
Intradialytic Parenteral Nutrition in Hemodialysis Patients [Recruiting]
Malnutrition is a major cause of death in chronic hemodialysis patients. Primary treatment of
malnutrition in these patients is dietetic counseling, additional enteral nutrition and
occasionally drug therapy.
In cases where primary treatment of malnutrition is not effective, intradialytic parenteral
nutrition (IDPN)during dialysis therapy may be administered. Using IDPN aminoacids,
carbohydrates and fatty acids as well as vitamins and trace elements can be given to the
patients.
Effectiveness of IDPN has to be verified.
POWS: Palonosetron/Ondansetron Opioid Withdrawal Study [Recruiting]
Opioid medications are commonly used for pain relief. When given over time, physical
dependence can occur. This results in unpleasant side effects--such as agitation and
nausea--if opioid medications are suddenly stopped. We are interested in knowing if a
medication named Ondansetron can help ease or prevent symptoms associated with opioid
withdrawal. We are also interested in knowing if a similar (but more potent FDA-approved
drug, palonosetron) can more effectively treat withdrawal symptoms with or without
combination with an antihistamine called hydroxyzine (vistaril).
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