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impax generics - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 5 mg - 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 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 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, lll1 as follows: generalized, persistent anxiety (of at least 1 month continual duration), manifested by symptoms from three o

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

h.j. harkins company, inc. - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 10 mg - 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

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

avkare - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 30 mg - 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

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

strides pharma science limited - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 5 mg - 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 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 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 duration), manifested by symptoms from three o

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

oxford pharmaceuticals, llc - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride tablets, usp 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, usp 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, usp 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 duration), manifested by symptoms from three of the four following categories: the above symptoms would not be due to another mental disorder, such as a depressive disorder or schizophrenia. however, mild depressive symptoms are common in gad. the effectiveness of buspirone hydrochloride tablets, usp in long-term use, that is, for more than 3 to 4 weeks, has not been demonstrated in controlled trials. there is no body of evidence available that systematically addresses the appropriate duration of treatment for gad. however, in a study of long-term use, 264 patients were treated with buspirone hydrochloride tablets, usp for 1 year without ill effect. therefore, the physician who elects to use buspirone hydrochloride tablets, usp for extended periods should periodically reassess the usefulness of the drug for the individual patient. buspirone hydrochloride tablets, usp are contraindicated in patients hypersensitive to buspirone hydrochloride. the use of monoamine oxidase inhibitors (maois) intended to treat depression with buspirone or within 14 days of stopping treatment with buspirone is contraindicated because of an increased risk of serotonin syndrome and/or elevated blood pressure. the use of buspirone within 14 days of stopping an maoi intended to treat depression is also contraindicated. starting buspirone in a patient who is being treated with reversible maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome. (see warnings, dosage and administration and drug interactions). buspirone hydrochloride, usp is not a controlled substance. in human and animal studies, buspirone has shown no potential for abuse or diversion and there is no evidence that it causes tolerance, or either physical or psychological dependence. human volunteers with a history of recreational drug or alcohol usage were studied in two double-blind clinical investigations. none of the subjects were able to distinguish between buspirone hydrochloride tablets, usp and placebo. by contrast, subjects showed a statistically significant preference for methaqualone and diazepam. studies in monkeys, mice, and rats have indicated that buspirone lacks potential for abuse. following chronic administration in the rat, abrupt withdrawal of buspirone did not result in the loss of body weight commonly observed with substances that cause physical dependency. although there is no direct evidence that buspirone hydrochloride tablets, usp cause physical dependence or drug-seeking behavior, it is difficult to predict from experiments the extent to which a cns-active drug will be misused, diverted, and/or abused once marketed. consequently, physicians should carefully evaluate patients for a history of drug abuse and follow such patients closely, observing them for signs of buspirone hydrochloride tablets, usp misuse or abuse (e.g., development of tolerance, incrementation of dose, drug-seeking behavior).

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strides pharma 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 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 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 duration), manifested by symptoms from three o

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

redpharm drug, inc. - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 5 mg - 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 have 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

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

northstar rx llc - cefprozil (unii: 4w0459za4v) (cefprozil anhydrous - unii:1m698f4h4e) - cefprozil anhydrous 125 mg in 5 ml - to reduce the development of drug-resistant bacteria and maintain the effectiveness of cefprozil  and other antibacterial drugs, cefprozil should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. cefprozil for oral suspension is indicated for the treatment of patients with mild to moderate infections caused by susceptible strains of the designated microorganisms in the conditions listed below: upper respiratory tract pharyngitis/tonsillitis caused by streptococcus pyogenes . note: the usual drug of choice in the treatment and prevention of streptococcal infections, including the prophylaxis of rheumatic fever, is penicillin given by the intramuscular route. cefprozil

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northstar rx llc - amoxicillin (unii: 804826j2hu) (amoxicillin anhydrous - unii:9em05410q9), clavulanate potassium (unii: q42omw3at8) (clavulanic acid - unii:23521w1s24) - amoxicillin anhydrous 200 mg in 5 ml - amoxicillin and clavulanate potassium for oral suspension is indicated for the treatment of infections in adults and pediatric patients, due to susceptible isolates of the designated bacteria in the conditions listed below: - lower respiratory tract infections – caused by beta-lactamase–producing isolates of haemophilus influenzae and moraxella catarrhalis . - acute bacterial otitis media – caused by beta-lactamase–producing isolates of h. influenzae and m. catarrhalis . - sinusitis – caused by beta-lactamase–producing isolates of h. influenzae and m. catarrhalis . - skin and skin structure infections – caused by beta-lactamase–producing isolates of staphylococcus aureus , escherichia coli , and klebsiella species. - urinary tract infections – caused by beta-lactamase–producing isolates of e. coli , klebsiella species, and enterobacter species. limitations of use when susceptibility test results show susceptibility to amoxicillin, indicating no beta-lactamase production, amoxicillin and clavulanate potassium for oral suspension should not be used. usage to reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin and clavulanate potassium for oral suspension  and other antibacterial drugs, amoxicillin and clavulanate potassium for oral suspension  should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a history of serious hypersensitivity reactions (e.g., anaphylaxis or stevens-johnson syndrome) to amoxicillin, clavulanate or to other beta-lactam antibacterial drugs (e.g., penicillins and cephalosporins). amoxicillin and clavulanate potassium for oral suspension is contraindicated in patients with a previous history of cholestatic jaundice/hepatic dysfunction associated with amoxicillin and clavulanate potassium for oral suspension.   teratogenic effects : pregnancy category b. reproduction studies performed in pregnant rats and mice given amoxicillin and clavulanate potassium for oral suspension (2:1 ratio formulation of amoxicillin:clavulanate) at oral doses up to 1200 mg/kg/day revealed no evidence of harm to the fetus due to amoxicillin and clavulanate potassium for oral suspension. the amoxicillin doses in rats and mice (based on body surface area) were approximately 4 and 2 times the maximum recommended adult human oral dose (875 mg every 12 hours). for clavulanate, these dose multiples were approximately 9 and 4 times the maximum recommended adult human oral dose (125 mg every 8 hours). there are, however, no adequate and well-controlled studies in pregnant women. because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. oral ampicillin-class antibacterials are poorly absorbed during labor. it is not known whether use of amoxicillin and clavulanate potassium in humans during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor, or increases the likelihood of the necessity for an obstetrical intervention. amoxicillin has been shown to be excreted in human milk. amoxicillin and clavulanate potassium use by nursing mothers may lead to sensitization of infants. caution should be exercised when amoxicillin and clavulanate potassium is administered to a nursing woman. the safety and effectiveness of amoxicillin and clavulanate potassium for oral suspension and chewable tablets have been established in pediatric patients. use of amoxicillin and clavulanate potassium for oral suspension in pediatric patients is supported by evidence from studies of amoxicillin and clavulanate potassium tablets in adults with additional data from a study of amoxicillin and clavulanate potassium for oral suspension in pediatric patients aged 2 months to 12 years with acute otitis media [see clinical studies (14.2)] . because of incompletely developed renal function in neonates and young infants, the elimination of amoxicillin may be delayed; clavulanate elimination is unaltered in this age group. dosing of amoxicillin and clavulanate potassium for oral suspension should be modified in pediatric patients aged less than 12 weeks (less than 3 months) [see dosage and administration (2.3)] . of the 3,119 patients in an analysis of clinical studies of amoxicillin and clavulanate potassium for oral suspension, 32% were greater than or equal to 65 years old, and 14% were greater than or equal to 75 years old. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. this drug is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function. amoxicillin is primarily eliminated by the kidney and dosage adjustment is usually required in patients with severe renal impairment (gfr less than 30 ml/min). see patients with renal impairment [see dosage and administration (2.4)] for specific recommendations in patients with renal impairment.

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

preferred pharmaceuticals inc. - buspirone hydrochloride (unii: 207lt9j9oc) (buspirone - unii:tk65wks8hl) - buspirone hydrochloride 15 mg - 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 have 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 d