United States - English - NLM (National Library of Medicine)

redpharm drug, inc. - hydroxyzine hydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - hydroxyzine hydrochloride 25 mg - 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 a 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. oral hydroxyzine hydrochloride i

United States - English - NLM (National Library of Medicine)

bryant ranch prepack - hydroxyzine dihydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - hydroxyzine hydrochloride 25 mg - 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 a 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. oral hydroxyzine hydrochloride

United States - English - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - hydroxyzine dihydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - hydroxyzine hydrochloride 10 mg - 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 a 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. oral hydroxyzine hydrochloride

United States - English - NLM (National Library of Medicine)

mutual pharmaceutical company, inc. - hydroxyzine hydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - tablet, film coated - 10 mg - 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. hydroxyzine, when administered t

United States - English - NLM (National Library of Medicine)

lupin pharmaceuticals,inc. - trimethobenzamide hydrochloride (unii: wdq5p1sx7q) (trimethobenzamide - unii:w2x096qy97) - trimethobenzamide hydrochloride 300 mg - trimethobenzamide hydrochloride capsules is indicated in adults for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis. limitation of use: trimethobenzamide hydrochloride capsules is not recommended for use in pediatric patients due to the risk of extrapyramidal signs and symptoms and other serious central nervous system (cns) effects, and the risk of exacerbation of the underlying disease in pediatric patients with reye's syndrome or other hepatic impairment. trimethobenzamide hydrochloride capsules are contraindicated in patients with known hypersensitivity to trimethobenzamide [see adverse reactions (6)] . risk summary the limited available data with trimethobenzamide in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage.  no adverse developmental effect was observed in animal reproduction studies with administration of trimethobenzamide hydrochloride during organogenesis in pregnant rats at doses 0.16 and 0.8 times the recommended human dose (rhd) and in pregnant rabbits at doses 1.6 times the rhd [see data]. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. data animal data reproduction studies with trimethobenzamide hydrochloride were conducted in rats and rabbits following administration of trimethobenzamide hydrochloride during organogenesis and no adverse developmental effect was observed in either species. the only effects observed were an increased percentage of embryonic resorptions or stillborn pups in rats administered 20 mg/kg and 100 mg/kg (0.16 and 0.8 times the rhd of 1200 mg/day, based on body surface area) and increased resorptions in rabbits receiving 100 mg/kg (1.6 times the rhd of 1200 mg/day, based on body surface area). in each study, these adverse effects were attributed to one or two dams. risk summary there is no information on the presence of trimethobenzamide in human milk, the effects of trimethobenzamide hydrochloride capsules on the breastfed infant or the effects of trimethobenzamide hydrochloride capsules on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of trimethobenzamide hydrochloride capsules to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for trimethobenzamide hydrochloride capsules and any potential adverse effects on the breastfed infant from trimethobenzamide hydrochloride capsules or from the underlying maternal condition. the safety and effectiveness of trimethobenzamide hydrochloride capsules in pediatric patients has not been established. trimethobenzamide hydrochloride capsules is not recommended for use in pediatric patients due to the risk of eps and other serious cns effects, and the risk of exacerbation of underlying disease in pediatric patients with reye's syndrome, or other hepatic impairment [see warnings and precautions (5.1, 5.2, 5.3, 5.4)]. clinical studies of trimethobenzamide did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently from younger patients. although there are studies reported in the literature that included geriatric patients 65 years and older with younger patients, it is not known if there are differences in efficacy or safety parameters for geriatric and non-geriatric patients treated with trimethobenzamide hydrochloride capsules. trimethobenzamide is excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because geriatric patients are more likely to have decreased renal function, reduce the daily dosage of trimethobenzamide hydrochloride capsules by increasing the dosing interval and adjust as needed based upon therapeutic response and tolerability. monitor renal function [see dosage and administration (2.2), use in specific populations (8.6)] . trimethobenzamide is eliminated by renal excretion [see clinical pharmacology (12.3)] . in patients with renal impairment (creatinine clearance 70 ml/min/1.73m2 or less), reduce the daily dosage by increasing the dosing interval and adjust as needed based upon therapeutic response and tolerability. monitor renal function [see dosage and administration (2.2)]. avoid trimethobenzamide hydrochloride capsules in patients whose signs and symptoms suggest the presence of hepatic impairment due to the risk of hepatotoxicity [see warnings and precautions (5.4)]. discontinue trimethobenzamide hydrochloride capsules in patients who develop impaired liver function while taking trimethobenzamide hydrochloride capsules.

United States - English - NLM (National Library of Medicine)

northstar rxllc - hydroxyzine dihydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - hydroxyzine hydrochloride 10 mg - 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 a 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. oral hydroxyzine hydrochloride

United States - English - NLM (National Library of Medicine)

ncs healthcare of ky, llc dba vangard labs - hydroxyzine dihydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - hydroxyzine hydrochloride 25 mg - 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 a 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. oral hydroxyzine hydrochloride

United States - English - NLM (National Library of Medicine)

proficient rx lp - hydroxyzine dihydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - hydroxyzine hydrochloride 50 mg - 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 a 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. oral hydroxyzine hydrochloride

United States - English - NLM (National Library of Medicine)

proficient rx lp - hydroxyzine dihydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - hydroxyzine hydrochloride 10 mg in 5 ml - 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. oral hydroxyzine hydrochloride i

United States - English - NLM (National Library of Medicine)

heritage pharmaceuticals inc. d/b/a avet pharmaceuticals inc. - hydroxyzine dihydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - hydroxyzine hydrochloride 10 mg - 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 a 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. oral hydroxyzine hydrochloride is contraindicated in patients with known hypersensitivity to hydroxyzine hydrochloride products, and in patients with known hypersensitivity to cetirizine hydrochloride or levocetirizine hydrochloride. hydroxyzine is contraindicated in patients with a prolonged qt interval. 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 for patients who have shown a previous hypersensitivity to any component of this medication.