Estats Units - anglès - NLM (National Library of Medicine)

direct rx - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual dur

Estats Units - anglès - NLM (National Library of Medicine)

remedyrepack inc. - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including this drug. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacolo

Estats Units - anglès - NLM (National Library of Medicine)

redpharm drug, inc. - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual dur

Estats Units - anglès - NLM (National Library of Medicine)

aphena pharma solutions - tennessee, llc - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii1 as follows: generalized, persistent anxiety (of at least 1 month continual du

Estats Units - anglès - NLM (National Library of Medicine)

remedyrepack inc. - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii 1 as follows: generalized, persistent anxiety (of at least 1 month

Estats Units - anglès - NLM (National Library of Medicine)

bryant ranch prepack - hydroxyzine dihydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - 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

Estats Units - anglès - NLM (National Library of Medicine)

proficient rx lp - hydroxyzine dihydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - 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

Estats Units - anglès - NLM (National Library of Medicine)

proficient rx lp - hydroxyzine dihydrochloride (unii: 76755771u3) (hydroxyzine - unii:30s50ym8og) - 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

Estats Units - anglès - NLM (National Library of Medicine)

medsource pharmaceuticals - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride tablets are indicated for the management of anxiety disorders or the short-term relief of the symptoms of anxiety. anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. the efficacy of buspirone hydrochloride tablets has been demonstrated in controlled clinical trials of outpatients whose diagnosis roughly corresponds to generalized anxiety disorder (gad). many of the patients enrolled in these studies also had coexisting depressive symptoms and buspirone hydrochloride tablets relieved anxiety in the presence of these coexisting depressive symptoms. the patients evaluated in these studies had experienced symptoms for periods of 1 month to over 1 year prior to the study, with an average symptom duration of 6 months. generalized anxiety disorder (300.02) is described in the american psychiatric association’s diagnostic and statistical manual, iii 1 as follows: generalized, persistent anxiety (of at least 1 month

Estats Units - anglès - NLM (National Library of Medicine)

teva pharmaceuticals usa, inc. - vardenafil hydrochloride (unii: 5m8s2cu0ts) (vardenafil - unii:uce6f4125h) - vardenafil hydrochloride tablets are indicated for the treatment of erectile dysfunction. administration of vardenafil hydrochloride tablets with nitrates (either regularly and/or intermittently) and nitric oxide donors is contraindicated [see clinical pharmacology (12.2)] . consistent with the effects of pde5 inhibition on the nitric oxide/cyclic guanosine monophosphate pathway, pde5 inhibitors, including vardenafil hydrochloride tablets, may potentiate the hypotensive effects of nitrates. a suitable time interval following dosing of vardenafil hydrochloride tablets for the safe administration of nitrates or nitric oxide donors has not been determined. do not use vardenafil hydrochloride tablets in patients who are using a gc stimulator, such as riociguat. pde5 inhibitors, including vardenafil hydrochloride tablets may potentiate the hypotensive effects of gc stimulators. risk summary vardenafil hydrochloride is not indicated for use in females. there are no data with the use of vardenafil hydrochloride in pregnant women to inform any drug-associated risks. in animal reproduction studies conducted in pregnant rats and rabbits, no adverse developmental outcomes were observed with oral administration of vardenafil during organogenesis at exposures for unbound vardenafil and its major metabolite at approximately 100 and 29 times, respectively, the maximum recommended human dose (mrhd) of 20 mg based on auc (see data) . data animal data no evidence of specific potential for teratogenicity, embryotoxicity or fetotoxicity was observed in rats and rabbits that received vardenafil at up to 18 mg/kg/day during organogenesis. this dose is approximately 100 fold (rat) and 29 fold (rabbit) greater than the auc values for unbound vardenafil and its major metabolite in humans given the mrhd of 20 mg. in the rat pre- and postnatal development study, the noael (no observed adverse effect level) for maternal toxicity was 8 mg/kg/day. retarded physical development of pups in the absence of maternal effects was observed following maternal exposure to 1 and 8 mg/kg possibly due to vasodilatation and/or secretion of the drug into milk. the number of living pups born to rats exposed pre- and postnatally was reduced at 60 mg/kg/day. based on the results of the pre- and postnatal study, the developmental noael is less than 1 mg/kg/day. based on plasma exposures in the rat developmental toxicity study, 1 mg/kg/day in the pregnant rat is estimated to produce total auc values for unbound vardenafil and its major metabolite comparable to the human auc at the mrhd of 20 mg. risk summary vardenafil hydrochloride is not indicated for use in females. there is no information on the presence of vardenafil and its major metabolite in human milk, the effects on the breastfed infant, or the effects on milk production. vardenafil is present in rat milk of lactating rats (see data) . data vardenafil was secreted into the milk of lactating rats at concentrations approximately 10-fold greater than found in the plasma. following a single oral dose of 3 mg/kg, 3.3% of the administered dose was excreted into the milk within 24 hours. vardenafil hydrochloride is not indicated for use in pediatric patients. safety and efficacy have not been established in this population. elderly males 65 years of age and older have higher vardenafil plasma concentrations than younger males (18 to 45 years), mean cmax and auc were 34% and 52% higher, respectively. phase 3 clinical trials included more than 834 elderly patients, and no differences in safety or effectiveness of vardenafil 5, 10, or 20 mg were noted when these elderly patients were compared to younger patients. however, due to increased vardenafil concentrations in the elderly, a starting dose of 5 mg vardenafil should be considered in patients ≥65 years of age [see clinical pharmacology (12.3)] . dosage adjustment is necessary in patients with moderate hepatic impairment. do not use vardenafil hydrochloride in patients with severe hepatic impairment (child-pugh c). vardenafil has not been evaluated in this patient population. a starting dose of 5 mg is recommended in patients with moderate hepatic impairment (child-pugh b) and the maximum dose should not exceed 10 mg. in volunteers with moderate hepatic impairment, the cmax and auc following a 10 mg vardenafil dose were increased by 130% and 160%, respectively, compared to healthy control subjects [see warnings and precautions (5.8) and dosage and administration (2.3)] . in volunteers with mild hepatic impairment (child-pugh a), the cmax and auc following a 10 mg vardenafil dose were increased by 22% and 17%, respectively, compared to healthy control subjects. no dosage adjustment is necessary in patients with mild hepatic impairment. do not use vardenafil hydrochloride in patients on renal dialysis as vardenafil has not been evaluated in such patients. no dosage adjustment is necessary in patients with creatinine clearance (clcr ) of 30 to 80 ml/min. in male volunteers with clcr = 50 to 80 ml/min, the pharmacokinetics of vardenafil were similar to those observed in a control group with clcr > 80 ml/min. in male volunteers with clcr = 30 to 50 ml/min or clcr < 30 ml/min, the auc of vardenafil was 20 to 30% higher compared to that observed in a control group with clcr > 80 ml/min [see dosage and administration (2.3) and warnings and precautions (5.9)] .