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aphena pharma solutions - tennessee, llc - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 20 mg - fluoxetine capsules usp are indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to18 years [see clinical studies (14.1)] . the usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods, should periodically be reevaluated [see dosage and administration (2.1)] . fluoxetine capsules usp are indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive compulsive disorder (ocd) [see clinical studies (14.2)] . the effectiveness of fluoxetine capsules usp in long-term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo-controlled trials. therefore, the physician who elects to use fluoxetine capsules usp for extended periods, should periodically re-evaluate the long-term usefulness of the drug for the individual patient [see dosage and administration (2.2)] . fluoxetine capsu

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

aphena pharma solutions - tennessee, llc - temazepam (unii: chb1qd2qss) (temazepam - unii:chb1qd2qss) - temazepam 15 mg - temazepam capsules are indicated for the short-term treatment of insomnia (generally 7 to 10 days). for patients with short-term insomnia, instructions in the prescription should indicate that temazepam capsules should be used for short periods of time (7 to 10 days). the clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. benzodiazepines may cause fetal harm when administered to a pregnant woman. an increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. transplacental distribution has resulted in neonatal cns depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. reproduction studies in animals with temazepam were performed in rats and rabbits. in a perinatal-postnatal study in rats, oral doses of 60 mg/kg/day result

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

aphena pharma solutions - tennessee, llc - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib 200 mg - carefully consider the potential benefits and risks of celebrex and other treatment options before deciding to use celebrex. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals [see warnings and precautions (5) ] celebrex is indicated for relief of the signs and symptoms of oa [see clinical studies (14.1) ] celebrex is indicated for relief of the signs and symptoms of ra [see clinical studies (14.2) ] celebrex is indicated for relief of the signs and symptoms of jra in patients 2 years and older [see clinical studies (14.3) ] celebrex is indicated for the relief of signs and symptoms of as [see clinical studies (14.4) ] celebrex is indicated for the management of ap in adults [see clinical studies (14.5) ] celebrex is indicated for the treatment of pd [see clinical studies (14.5) ] celebrex is contraindicated: - in patients with known hypersensitivity to celecoxib, aspirin, or other nsaids. - in patients who have demonstrated allergic-type reactions to su

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

aphena pharma solutions - tennessee, llc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine fumarate tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). the effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies (14.1)]. quetiapine fumarate tablets are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies (14.2)]. quetiapine fumarate tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week monother

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

aphena pharma solutions - tennessee, llc - aripiprazole (unii: 82vfr53i78) (aripiprazole - unii:82vfr53i78) - aripiprazole 10 mg - abilify is indicated for the treatment of schizophrenia. the efficacy of abilify was established in four 4-6 week trials in adults and one 6-week trial in adolescents (13 to 17 years). maintenance efficacy was demonstrated in one trial in adults and can be extrapolated to adolescents [see clinical studies (14.1)] . acute treatment of manic and mixed episodes abilify is indicated for the acute treatment of manic and mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or valproate. efficacy as monotherapy was established in four 3-week monotherapy trials in adults and one 4-week monotherapy trial in pediatric patients (10 to 17 years). efficacy as adjunctive therapy was established in one 6-week adjunctive trial in adults [see clinical studies (14.2)] . maintenance treatment of bipolar i disorder abilify is indicated for the maintenance treatment of bipolar i disorder, both as monotherapy and as an adjunct to either lithium or valproate. maintenance efficacy was d

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

aphena pharma solutions - tennessee, llc - pregabalin (unii: 55jg375s6m) (pregabalin - unii:55jg375s6m) - pregabalin 50 mg - lyrica is indicated for: - management of neuropathic pain associated with diabetic peripheral neuropathy - management of postherpetic neuralgia - adjunctive therapy for adult patients with partial onset seizures - management of fibromyalgia - management of neuropathic pain associated with spinal cord injury lyrica is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy. pregnancy category c. increased incidences of fetal structural abnormalities and other manifestations of developmental toxicity, including lethality, growth retardation, and nervous and reproductive system functional impairment, were observed in the offspring of rats and rabbits given pregabalin during pregnancy, at doses that produced plasma pregabalin exposures (auc) ≥5 times human exposure at the maximum recommended dose (mrd) of 600 mg/day. when pregnant rats were given pregabalin (500, 1250, or 2

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

aphena pharma solutions - tennessee, llc - divalproex sodium (unii: 644vl95ao6) (valproic acid - unii:614oi1z5wi) - valproic acid 500 mg - divalproex sodium extended-release tablets are a valproate and are indicated for the treatment of acute manic or mixed episodes associated with bipolar disorder, with or without psychotic features. a manic episode is a distinct period of abnormally and persistently elevated, expansive, or irritable mood. typical symptoms of mania include pressure of speech, motor hyperactivity, reduced need for sleep, flight of ideas, grandiosity, poor judgment, aggressiveness, and possible hostility. a mixed episode is characterized by the criteria for a manic episode in conjunction with those for a major depressive episode (depressed mood, loss of interest or pleasure in nearly all activities). the efficacy of divalproex sodium extended-release tablets is based in part on studies of divalproex sodium delayed-release tablets in this indication, and was confirmed in a 3-week trial with patients meeting dsm-iv tr criteria for bipolar i disorder, manic or mixed type, who were hospitalized for acute mania [see clinical studies (

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

aphena pharma solutions - tennessee, llc - valproic acid (unii: 614oi1z5wi) (valproic acid - unii:614oi1z5wi) - valproic acid 250 mg - valproic acid capsules, usp are indicated as monotherapy and adjunctive therapy in the treatment of patients with complex partial seizures that occur either in isolation or in association with other types of seizures. valproic acid capsules, usp are indicated for use as sole and adjunctive therapy in the treatment of simple and complex absence seizures, and adjunctively in patients with multiple seizure types which include absence seizures. simple absence is defined as very brief clouding of the sensorium or loss of consciousness accompanied by certain generalized epileptic discharges without other detectable clinical signs. complex absence is the term used when other signs are also present. see warnings and precaution (5.1) for statement regarding fatal hepatic dysfunction. because of the risk to the fetus of decreased iq, neural tube defects, and other major congenital malformations, which may occur very early in pregnancy, valproate should not be administered to a woman of childbearing potential unless th

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

aphena pharma solutions - tennessee, llc - pantoprazole sodium (unii: 6871619q5x) (pantoprazole - unii:d8tst4o562) - pantoprazole 40 mg - pantoprazole sodium delayed-release tablets are indicated for: pantoprazole sodium delayed-release tablets are indicated in adults and pediatric patients five years of age and older for the short-term treatment (up to 8 weeks) in the healing and symptomatic relief of erosive esophagitis. for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium may be considered. safety of treatment beyond 8 weeks in pediatric patients has not been established. pantoprazole sodium delayed-release tablets are indicated for maintenance of healing of erosive esophagitis and reduction in relapse rates of daytime and nighttime heartburn symptoms in adult patients with gerd. controlled studies did not extend beyond 12 months. pantoprazole sodium delayed-release tablets are indicated for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison syndrome. pantoprazole sodium delayed-release tablets are contraindicated in patients wi

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

aphena pharma solutions - tennessee, llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 75 mg - venlafaxine hydrochloride extended-release capsules are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride extended-release capsules in the treatment of major depressive disorder was established in 8 and 12 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii-r or dsm-iv category of major depressive disorder (seeclinical trials). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed mood or the loss of interest or pleasure in nearly all activities, representing a change from previous functioning, and includes the presence of at least five of the following nine symptoms during the same two week period: depressed mood, markedly diminished interest or pleasure in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness