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PubMed1981

Pharmacologic prophylaxis of allergic rhinitis: relative efficacy of hydroxyzine and chlorpheniramine.

The efficacy of hydroxyzine and chlorpheniramine in preventing exacerbations of ragweed allergic rhinitis was compared in a double-blind, randomized manner. Ninety-five subjects with positive skin tests, a history of two previous symptomatic seasons, and discontinuation of immunotherapy for at least 1 yr received either hydroxyzine 150 mg/day, chlorpheniramine 24 mg/day, or placebo during the 1978 ragweed season. Subjects in the placebo group experienced annoying or disabling sneezing 50% of days during the period of highest pollen counts whereas those in the chlorpheniramine and hydroxyzine groups experienced this symptom with equal severity only 22% and 12% of days, respectively. Suppression of rhinorrhea and itchy nose was similar although less dramatic. Both antihistamines were more effective than placebo in altering conjunctivitis, but neither decreased the frequency or severity of nasal stuffiness. Skin tests to ragweed decreased in diameter during the season by 38%, 13%, and 3% among patients receiving hydroxyzine, chlorpheniramine, and placebo, respectively. Frequent drowsiness occurred initially in subjects taking both antihistamines but did not persist. Thus, prophylactic antihistamine therapy effectively prevents most symptoms of seasonal allergic rhinitis without persistent drowsiness. These data further suggest a therapeutic advantage for hydroxyzine over chlorpheniramine in the doses used.

Adolescent↗
PubMed2004

Cutaneous drug eruption from cetirizine and hydroxyzine.

Topical application of the antihistamines commonly leads to sensitization for patients, but skin reactions provoked by their systemic use are very rare. The antihistamines cetirizine and hydroxyzine are piperazine derivatives, on the structural basis of an ethylenediamine, but the cross-reactions between the 2 have rarely been reported. A 44-year-old man visited because of the generalized morbilliform eruptions with pruritus over his whole body, after intake of hydroxyzine (Ucerax) and azelastine (Azeptine), administered during a 2-day period for chronic urticaria. Previously, he had presented the same cutaneous reactions after oral administration of cetirizine (Lotec). Oral challenge tests performed with cetirizine and hydroxyzine led to the same cutaneous reactions. He was given the diagnosis of drug eruption from cetirizine and hydroxyzine, which suggests that there were cross-reactions among cetirizine, hydroxyzine, and ethylenediamine.

Adult↗
PubMed2005

Neonatal seizures associated with maternal hydroxyzine hydrochloride in late pregnancy.

This is the first report of a neonatal withdrawal syndrome associated with maternal hydroxyzine treatment (150 mg/day) confirmed by measurements of hydroxyzine plasma concentrations in the mother and infant after birth. Hydroxyzine plasma concentrations were measured by liquid chromatography-mass spectrometry. Neurological symptoms with low neonatal concentrations of hydroxyzine may be due to a withdrawal syndrome. According to previous observations and this case report, clinicians should be warned of this possible rare neurological complication of hydroxyzine in neonates born from long term treated mothers.

Adult↗
PubMed2003

A single-center, randomized, double-blind, placebo-controlled, crossover investigation of the effects of fexofenadine hydrochloride 180 mg alone and with alcohol, with hydroxyzine hydrochloride 50 mg as a positive internal control, on aspects of cognitive and psychomotor function related to driving a car.

BACKGROUND: Antihistamines (H(1)-receptor antagonists) are the mainstay of symptomatic therapy for allergic disorders. Antihistamines are needed that cause no disruptive effects on cognitive and psychomotor function. It is essential that antihistamines maintain the integrity of the cognitive system, not only in ambulatory patients at increased risk of drug-induced traffic- or work-related accidents, but also in students and others whose cognitive or intellectual impairment may adversely affect their performance.Objective; The goal of this study was to investigate the acute effects of fexofenadine hydrochloride 180 mg, alone and with a "social" dose of alcohol, on subjective feelings of sedation and on a battery of objective measures related to driving a car. These measures included information processing, psychomotor speed, and reaction time in an on-the-road car-driving task. Hydroxyzine hydrochloride 50 mg was included in the study as a positive internal control to validate the sensitivity of the psychometri tests to nonspecific impairment. METHODS: In this randomized, double-blind, 6-way, crossover study conducted at the Human Psychopharmacology Research Unit, Medical Research Centre (University of Surrey, Guildford, United Kingdom), 18 healthy volunteers received fexofenadine 180 mg, hydroxyzine 50 mg, and placebo alone and with alcohol (0.3 g/kg body weight or approximately 0.43-0.50 g/L blood-alcohol concentration). Treatment periods were separated by a washout period of at least 6 days. Subjects performed tests of cognitive and psychomotor performance at 1, 3, and 5 and hours after dosing. The test battery included subjective ratings of sedation, critical flicker fusion (CFF), choice reaction time (including recognition reaction time [RRT], motor reaction time [MRT], total reaction time [TRT], and brake reaction time [BRT]. RESULTS: Eighteen healthy male volunteers (median age, 30.5 years [range, 23-44 years]) were entered into the study. Fexofenadine alone and with alcohol had no significant effect on performance compared with placebo and was not distinguishable from placebo in any of the objective or subjective tests at any point. However, impairment was evident following the administration of hydroxyzine. Hydroxyzine caused significant impairment in CFF (P < 0.05), RRT (P < 0.001), and TRT (P < 0.001) compared with placebo. Hydroxyzine with alcohol significantly disrupted performance on all of the above measures with respect to both placebo and fexofenadine (P < 0.05) as well as MRT (P < 0.001). No significant treatment effects on BRT were found. CONCLUSION: Fexofenadine 180 mg did not have disruptive effects on objective measures related to driving a car and aspects of psychomotor and cognitive function, even when combined with a dose of alcohol equivalent to 0.3 g/kg body weight, in a study in which the psychometric assessments were shown to be sensitive to impairment.

Adult↗
PubMed1987

The effectiveness of nalbuphine and hydroxyzine for the emergency treatment of severe headache.

The present treatment for acute attacks of headache is empiric. Intramuscular nalbuphine (Nubain) and hydroxyzine (Vistaril) were assessed for pain relief in a prospective, double-blind clinical trial. Ninety-four patients were assigned randomly to treatment groups receiving nalbuphine 10 mg, nalbuphine 10 mg plus hydroxyzine 50 mg, hydroxyzine 50 mg, or placebo. The treatment groups were found to be adequately homogenous with regard to age, sex, type and duration of headaches, and history of prior narcotic use. All data were analyzed by one-way analysis of variance. Patients who had headaches diagnosed as other than classic migraine had significantly greater pain relief with nalbuphine compared to placebo (P less than .01). The combination of nalbuphine and hydroxyzine was not significantly more effective than other treatment groups. In 20 patients with classic migraine, none of the treatment regimens significantly outperformed placebo. There were no clinically significant adverse effects attributed to the study drugs. These findings are similar to others that showed a lack of efficacy of kappa receptor agonists in classic migraineurs. Nalbuphine appears to be clinically useful in other types of severe headache. This study does not support the routine addition of hydroxyzine for presumed synergistic effect.

Adult↗
PubMed1987

The relative antihistaminic and psychomotor effects of hydroxyzine and cetirizine.

Twelve healthy subjects with atopy received single doses of hydroxyzine, 25 mg, its metabolite cetirizine, 10 and 20 mg, and placebo in a four-way crossover study randomized by Latin square design. Skin wheal response to histamine, psychomotor effects, and serum concentrations of each drug were measured for 36 hours after each dose. Central nervous system (CNS) effects were measured with critical flicker frequency, Stroop word testing, and visual analog scales. All three active treatments (cetirizine, 10 mg, cetirizine, 20 mg, and hydroxyzine) produced an equivalent suppression of skin wheal response to histamine that was significantly greater than placebo (P less than 0.01). Hydroxyzine produced a significant change compared with placebo in all three CNS parameters. Neither cetirizine, 10 mg, nor cetirizine, 20 mg, produced any significant change in CNS parameters. Both the intensity and time course of CNS effects were related significantly (P less than 0.05) to hydroxyzine concentrations. The CNS changes measured after oral hydroxyzine are the result of the parent drug, whereas its metabolite cetirizine when administered alone produced significant antihistaminic effects without CNS changes.

Adult↗
PubMed2002

[Cutaneous drug eruption with two antihistaminic drugs of a same chemical family: cetirizine and hydroxyzine].

BACKGROUND: H1-antihistamines are widely used to relieve symptoms of allergic disorders. A few skins reactions to H1-antihistamines have been described in the literature. We report the first case of cutaneous drug eruption as fixed drug eruption with 2 antihistamines of the same chemical family: cetirizine and hydroxyzine. CASE REPORT: A 73 year-old man was admitted because of a third cutaneous eruption with the same morphologic features of the same sites as before. The first and second eruption appeared after 4 hours of cetirizine intake, the third eruption appeared after 4 hours of hydroxyzine intake. Healing was obtained after stopping the medication. Histology showed induced drug reaction. Patch tests with cetirizine and hydroxyzine were negative, except false positivity with dimethylsulfoxide vehicles. DISCUSSION: The diagnosis of cutaneous drug eruption as non pigmenting fixed drug eruption related to cetirizine and hydroxyzine was retained. Allergy to both H1 antihistamines can be explained by the fact that they've got the same chemical node that is piperazine, and by the fact that cetirizine is the main metabolite of hydroxyzine. Oral test provocation was omitted because the patient had already reexposed himself to the drugs. To identify the drug responsible for fixed drug eruption, peroral provocation tests are the most valuable method, but carry the risk of a strong reaction. Some authors use patch tests, but their positivity is inconstant. Their interest in fixed drug eruption is undergoing assessment.

Aged↗
PubMed2004

Hydroxyzine-induced supraventricular tachycardia in a nine-year-old child.

Hydroxyzine is a first generation antihistamine widely used in the paediatric population for a variety of conditions. A nine-year-old girl presented with supraventricular tachycardia while on clinical doses of hydroxyzine for pruritus. On arrival at the hospital, she was diaphoretic, with cool peripheries, poor peripheral pulses and a heart rate of 250/minute. There was a history of three palpitation episodes with chest tightness during the five months she was taking hydroxyzine. The supraventricular tachycardia eventually reverted to sinus rhythm with intravenous verapamil. Relevant cardiac examination and investigations had not shown any cardiac abnormalities. After discontinuing hydroxyzine, she had no further episodes of supraventricular tachycardia. To our knowledge, this is the first report of hydroxyzine induced-supraventricular tachycardia in the medical literature.

Child↗
PubMed2006

[A case of drug eruption induced by hydroxyzine pamoate].

A 62-year-old woman with rheumatoid arthritis, Basedow's disease and arrhythmia has been treated with antirheumatic, antiarrhythmic drugs and so on. She developed pruritic diffuse erythema with papules on the trunk and extremities 2 days after taking hydroxyzine pamoate for asteatotic eczema. Laboratory data showed increased levels of eosinophils. Histopathological examination revealed a infiltrate of inflammatory cells in the upper dermis. Patch tests with hydroxyzine pamoate and hydroxyzine hydrochloride were positive. From these findings, we diagnosed this case as drug eruption due to hydroxyzine. Her eruption subsided after she discontinued hydroxyzine pamoate and other drugs which were started within 5 days before the onset of the eruption and was treated with systemic steroid, systemic antiallergic drug and topical steroid.

Drug Eruptions↗
PubMed1988

Pharmacokinetic comparison of a slow-release theophylline-hydroxyzine combination and a plain slow-release theophylline preparation.

We have compared the pharmacokinetic properties of a slow-release theophylline-hydroxyzine combination and a slow-release theophylline preparation both after a single dose administration and at steady state after the dosage of twice/day for four days in ten healthy volunteers. After a single dose, theophylline was absorbed slightly faster from the combination preparation (Retafyllin comp.) than from a plain theophylline preparation (Theo-Dur). However, in a steady state phase the pharmacokinetic profiles were quite similar. Hydroxyzine showed a slight delay in absorption from the combination preparation, but in a steady state the overall pharmacokinetic profile of hydroxyzine was similar to that of theophylline. Cumulation of either hydroxyzine or theophylline was not evident. On the basis of the present study, the slow-release combination preparation of theophylline and hydroxyzine seems suitable for twice/day dosage.

Adult↗
PubMedDate not supplied

Anxiolytic activity of chloral hydrate and hydroxyzine.

The combination of chloral hydrate and hydroxyzine is given frequently to anxious pediatric dental patients. In order to observe and quantify the anxiolytic effects of these drugs given alone and in combination, highly explorative male C57/black mice were tested using the light/dark test box after injecting subhypnotic doses for increased transitions between the light and dark side of the test box. Fifty-one mice were subjected individually to a 10-min test in the box for dose responses following the i.p. administration of 32-, 64-, and 132-mg/kg doses of chloral hydrate; 1-, 4-, 7-, and 10-mg/kg doses of hydroxyzine; or a combination of each of these doses of hydroxyzine and chloral hydrate. The automated test box recorded the number of times a mouse crossed between the two chambers. Doses of chloral hydrate 132 mg/kg and hydroxyzine 1 mg/kg resulted in significantly increased transitions. None of the combinations studied produced significantly increased transitions when compared with the effective doses identified for each individual drug. The paradigm did not support the hypothesis that the anxiolytic effects of chloral hydrate and hydroxyzine are additive or synergistic.

Analysis of Variance↗
PubMed1979

Comparison of pirbuterol and pirbuterol and hydroxyzine in patients with reversible airway obstruction.

The effects of single oral doses of pirbuterol 10 mg plus hydroxyzine 10 mg, and of pirbuterol 10 mg plus placebo, were compared in a single-blind cross-over trial in 17 adult patients with reversible airway obstruction. The initial bronchodilator response after the two treatments was similar, but mean specific airway conductance at 3, 4, 6 and 8 h, and mean FEV1 and FVC after 3 and 4 hours, were significantly higher after pirbuterol + hydroxyzine than after pirbuterol + placebo. The mean thoracic gas volume measured at 3 and 4 h was lower after pirbuterol + hydroxyzine. Heart rate, blood pressure and a continuous ECG record did not differ after the two treatments. The findings suggest that the combination of pirbuterol and hydroxyzine brings about more prolonged bronchodilatation in patients with reversible airway obstruction than does pirbuterol alone.

Adult↗
PubMed1989

A double-blind, placebo-controlled, crossover trial of ketotifen versus hydroxyzine in the treatment of pediatric mastocytosis.

To asses the efficacy of ketotifen (Zaditen; Sandoz Pharmaceuticals, Basel, Switzerland) for the treatment of pediatric mastocytosis, eight children who exhibited symptoms as a result of mastocytosis were enrolled in a 12-week, double-blind, placebo-controlled, crossover trial of ketotifen versus hydroxyzine (Atarax; Roerig, New York, N.Y.). Efficacy of each drug was assessed by daily symptom scores and plasma- and 24-hour urine-histamine levels. After completion of the study, symptom scores revealed that seven of the eight children exhibited a greater reduction in symptoms while they were receiving hydroxyzine (p less than 0.05). The symptoms most likely to improve with treatment with hydroxyzine were flushing and abdominal pain. Analysis of plasma- and 24-hour urine-histamine levels at the beginning and end of each trial period of each drug revealed no significant differences (p greater than 0.20). Changes in 24-hour urine-histamine levels, but not plasma-histamine levels, correlated with changes in symptom scores. We conclude that ketotifen offers no advantage over hydroxyzine in the treatment of pediatric mastocytosis.

Child↗
PubMed2004

Hydroxyzine prevents isolation-induced vocalization in guinea pig pups: comparison with chlorpheniramine and immepip.

The present pharmacological study was conducted to investigate a possible role of the brain histaminergic system in vocalization induced in guinea pig pups by maternal separation and isolation in an unfamiliar environment. The effects of drugs acting at histamine receptors were determined after intraperitoneal injection, comprising hydroxyzine and chlorpheniramine, both histamine H1 antagonists, and the H3 agonist, immepip. A range of psychoactive drugs known to be active in this paradigm was also tested for comparison. Hydroxyzine, 4.3 to 14.3 mg/kg, dose-dependently suppressed vocalization but neither chlorpheniramine, 2 to 16 mg/kg, nor immepip, 5 to 20 mg/kg, was active. All reference drugs, fluoxetine, 5 and 10 mg/kg, imipramine, 16 and 32 mg/kg, and chlordiazepoxide, 5 and 10 mg/kg, were shown to be active. The present data indicate that, consistent with known anxiolytic effects in man, the antihistamine hydroxyzine proved effective in suppressing maternal-separation-induced vocalization in guinea pig pups. However, in view of the lack of effect of either chlorpheniramine or immepip, it is proposed that additional nonhistaminergic effects are involved in the tranquilizing action of hydroxyzine.

Animals↗
PubMed1984

Pharmacokinetics and antipruritic effects of hydroxyzine in children with atopic dermatitis.

We studied the pharmacokinetics and antipruritic effects of hydroxyzine hydrochloride in 12 children, mean age 6.1 +/- 4.6 years, with severe atopic dermatitis. After a single 0.7 mg/kg orally administered dose of the drug, the mean peak serum hydroxyzine concentration of 47.4 +/- 17.3 ng/ml occurred at a mean time of 2.0 +/- 0.9 hours. The mean elimination half-life was 7.1 +/- 2.3 hours, the mean clearance rate was 32.08 +/- 11.05 ml/min/kg, and the mean apparent volume of distribution was 18.5 +/- 8.6 L/kg. The elimination half-life increased with increasing age (r = 0.83). Pruritus was significantly suppressed from 1 to 24 hours after the administration of the dose, with greater than 85% suppression from 2 to 12 hours. The only adverse effect reported was sedation. In a subsequent double-blind, crossover, multiple-dose study of 2 weeks' duration, hydroxyzine 0.7 mg/kg three times daily was as effective as hydroxyzine 1.4 mg/kg three times daily in relieving pruritus and promoting resolution of the skin lesions. The 0.7 mg/kg tid dose caused significantly less sedation than the 1.4 mg/kg tid dose.

Antipruritics↗
PubMed1990

Urticaria: clinical efficacy of cetirizine in comparison with hydroxyzine and placebo.

Chronic urticaria is a problem for both physician and patient. In an effort to avoid the risks associated with corticosteroid treatment, many first-generation H1-receptor antagonists have been tried and found to induce undesirable levels of sedation when given in amounts sufficient to control urticaria. Cetirizine, a pharmacologically active oxidized metabolite of hydroxyzine, was developed to provide selective H1-receptor inhibition without depression of the central nervous system. In a 4-week, multicenter, double-blind, placebo-controlled safety and efficacy study, cetirizine, in a once-a-day dose (5 to 20 mg), was equivalent in efficacy to hydroxyzine in divided doses (25 to 75 mg/day). The incidence of somnolence in the cetirizine group was not significantly different from that of the placebo group. However, in the hydroxyzine group, the incidence of somnolence was significantly higher than that in the placebo group (p = 0.001). The results of this study demonstrate that cetirizine has a greater safety margin over the older parent drug hydroxyzine.

Adolescent↗
PubMed2000

Hydroxyzine inhibits experimental allergic encephalomyelitis (EAE) and associated brain mast cell activation.

Experimental allergic encephalomyelitis (EAE) has been used as an animal model for the human demyelinating disease multiple sclerosis (MS). In acute MS or EAE, early disruption in the integrity of the blood-brain-barrier (BBB) precedes brain infiltration by inflammatory cells or any clinical evidence of disease. BBB permeability could be affected by vasoactive mediators and cytokines released from perivascular brain mast cells. We investigated the number and degree of activation of brain mast cells in EAE and the effect of the heterocyclic histamine-1 receptor antagonist hydroxyzine, a piperazine compound known to also block mast cells. Acute EAE was induced in Lewis rats by immunization with whole guinea pig spinal cord homogenate and complete Freund's adjuvant (CFA). A second group of animals were treated orally with hydroxyzine for one day before immunization and then continuously for 14 days. Control rats were treated with CFA or hydroxyzine alone. The clinical progression of EAE was assessed on days 10, 12 and 14 after immunization. The number of metachromatic mast cells and the degree of degranulation was assessed in the thalamus with light microscopy. At day 14, there was a three-fold increase in the number of brain mast cells with EAE, as compared to controls. These cells were positive for the immunoglobulin E binding protein (FcepsilonRI), while those from control rats were not. Over 40% of all thalamic mast cells studied in EAE showed partial staining or extruded secretory granule indicative of secretion. Hydroxyzine treatment inhibited (p<0.05) the progression and severity of EAE by 50% and the extent of mast cell degranulation by 70% (p<0.05). These findings indicate that brain mast cells are associated with EAE development and that inhibition of their activation correlates positively with the clinical outcome.

Animals↗
PubMed1982

Comparison of i. m. diazepam and hydroxyzine as premedicants.

The effectiveness of diazepam as premedication when administered by two different i.m. techniques was compared with hydroxyzine in 84 male and 101 female patients. Variables studied were relief of anxiety, sedation, acceptance by both patient and anaesthetist and pain at the injection site. Diazepam 20 mg in male and diazepam 10 mg in female patients administered by a Z-track injection technique were as effective premedicants as hydroxyzine 100mg i.m. In men diazepam was good as hydroxyzine regardless of the injection technique. In women the technique of injection of the diazepam was critical to achieving good results. The Z-track injection method decreased the amount of severe pain on injection in both sexes to levels similar to those achieved with hydroxyzine.

Adolescent↗