AMOXICILLIN AND CLAVULANATE POTASSIUM TABLETS USP, (CHEWABLE)
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.
Published Studies Related to Hydroxyzine
Short-term effects of morning versus evening dose of hydroxyzine 50 mg on cognition in healthy volunteers. [2011.06]
It is well known that the sedative properties of antihistamines can differ considerably between individual drugs... It is concluded that hydroxyzine-induced impairment at tmax is more prominent after morning doses compared with evening doses and that the present study could not present direct evidence to substantiate the hypothesis that histamine availability inversely affects the magnitude of antihistamine impairment.
[Effects of hydroxyzine on tolerance of facial mask during induction in children] [2010.01]
OBJECTIVE: To evaluate the effectiveness of hydroxyzine as a premedication agent for the acceptance of facial mask during induction of general anaesthesia in children... CONCLUSION: Hydroxyzine provided better acceptance of facial mask than placebo during induction of general anaesthesia in children. Copyright 2009 Elsevier Masson SAS. All rights reserved.
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.
Clinical Trials Related to Hydroxyzine
Levocetirizine Plus Bed-Time Hydroxyzine in the Management of Corticodependent Chronic Urticaria Versus Both Drugs Alone in High Doses [Recruiting]
Allen Kaplan is a prominent American allergist with the reputation of leader in the field of
chronic urticaria. He advocates treatment with first generation hydroxyzine, which he
considers at least as effective as modern second generation H1-blockers in suppressing the
symptoms of difficult-to-treat / systemic-steroid-dependant cases of chronic urticaria. He
further speculates that hydroxyzine may have the advantage to better suppress itch and
improve nighttime sleep. This has prompted many practitioners around the world to believe
that adding hydroxyzine to the treatment regimen at bed time at night may be beneficial to
patients. At the same time European guidelines indicate modern second generation H1-blockers
in higher than conventional doses as drugs of choice for such cases. However, there is no
evidence from clinical trials addressing this controversy. The investigators' previous
studies suggest that levocetirizine at quadruple doses may be beneficial in difficult to
treat urticaria by reducing lesions and itch, improving quality of life and night time
sleep, while not causing day time somnolence. First generation H1-receptor antagonists and
hydroxyzine among them are known to penetrate the blood / brain barrier and to cause
sedation. The question stays whether this sedation is beneficial to the subjects with
chronic urticaria at night, whether it has any hang-over unwanted effects the following day
and whether this has any influence on the overall urticaria-specific quality of life.
Does Hydroxyzine Decrease Anxiety in Patients With Anorexia Nervosa Study [Not yet recruiting]
The purpose of this study is to determine the effectiveness of hydroxyzine in the treatment
of meal-related anxiety in children and adolescents 8 to 17 years of age diagnosed with
anorexia nervosa. The investigators want to find out if hydroxyzine given before meals will
improve meal-related anxiety compared to no hydroxyzine.
Pain and Anxiety Management of Traumatic Emergency in a Pre-hospital Setting [Recruiting]
Unexpected acute pain in an emergency setting causes anxiety, insecurity, and stress that
can diminish perceptions of control over pain and diminish ability to decrease pain. This
may interfere with the opioid treatment and poses the question of whether an anxiolytic drug
added to the morphine titration could relief pain and/or anxiety. This randomized
double-blind group clinical trial is designed to determine the efficacy and safety of
hydroxyzine in addition to a conventional intravenous morphine titration protocol.
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
Reports of Suspected Hydroxyzine Side Effects
Completed Suicide (64),
Respiratory Arrest (39),
Cardiac Arrest (39),
Toxicity TO Various Agents (30),
Cardio-Respiratory Arrest (25),
Maternal Exposure During Pregnancy (18),
Drug Abuse (14),
Intentional Drug Misuse (11),
Foetal Growth Restriction (11), more >>