USA - engelsk - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine 10 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 to 18 years [see clinical studies (14.1) ]. the usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [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 cap

USA - engelsk - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin 100 mg - gabapentin capsules, usp are indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin capsules, usp are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy category c : there are no adequate and well-controlled studies in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pregnant mice received oral doses of gabapentin (500 mg, 1000 mg, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no

USA - engelsk - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate 5 mg - hydrocodone bitartrate and acetaminophen tablets are indicated for the management of, pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses [see warnings], reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] - have not been tolerated, or are not expected to be tolerated, - have not provided adequate analgesia, or are not expected to provide adequate analgesia hydrocodonebitartrate and acetaminophen tablets are contraindicated in patients with: •significant respiratory depression [see warnings ] •acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings ] •known or suspected gastrointestinal obstruction, including paralytic ileus [see warnings ] •hypersensitivity to hydrocodone or acetamin

USA - engelsk - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 75 mg - venlafaxine hydrochloride extended-release capsules usp are indicated for the treatment of major depressive disorder. the efficacy of venlafaxine hydrochloride extended-release capsules usp 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 (see clinical 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 wor

USA - engelsk - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - duloxetine hydrochloride (unii: 9044sc542w) (duloxetine - unii:o5tnm5n07u) - duloxetine 60 mg - duloxetine delayed-release capsules are indicated for the treatment of: - major depressive disorder [see clinical studies (14.1)] - generalized anxiety disorder [see clinical studies (14.2)] - diabetic peripheral neuropathy [see clinical studies (14.3)] - chronic musculoskeletal pain [see clinical studies (14.5)] monoamine oxidase inhibitors (maois) — the use of maois intended to treat psychiatric disorders with duloxetine delayed-release capsules or within 5 days of stopping treatment with duloxetine delayed-release capsules is contraindicated because of an increased risk of serotonin syndrome. the use of duloxetine delayed-release capsules within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated [see dosage and administration (2.8) and warnings and precautions (5.4)] . starting duloxetine delayed-release capsules in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of seroto

USA - engelsk - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - nortriptyline hydrochloride (unii: 00fn6ih15d) (nortriptyline - unii:bl03sy4lxb) - nortriptyline 25 mg - nortriptyline hydrochloride capsules are indicated for the relief of symptoms of depression. endogenous depressions are more likely to be alleviated than are other depressive states. the use of maois intended to treat psychiatric disorders with nortriptyline hydrochloride or within 14 days of stopping treatment with nortriptyline hydrochloride is contraindicated because of an increased risk of serotonin syndrome. the use of nortriptyline hydrochloride within 14 days of stopping an maoi intended to treat psychiatric disorders is also contraindicated (see warnings and dosage and administration ). starting nortriptyline hydrochloride in a patient who is being treated with maois such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see   warnings and dosage and administration ). cross-sensitivity between nortriptyline hydrochloride and other dibenzazepines is a possibility. nortriptyline hydrochloride is contraindicated during the acute recov

USA - engelsk - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - buprenorphine hydrochloride (unii: 56w8mw3en1) (buprenorphine - unii:40d3scr4gz), naloxone hydrochloride (unii: f850569pqr) (naloxone - unii:36b82amq7n) - buprenorphine 8 mg - buprenorphine and naloxone sublingual tablets are indicated for the maintenance treatment of opioid dependence and should be used as part of a complete treatment plan to include counseling and psychosocial support. under the drug addiction treatment act (data) codified at 21 u.s.c. 823(g), prescription use of this product in the treatment of opioid dependence is limited to physicians who meet certain qualifying requirements, and who have notified the secretary of health and human services (hhs) of their intent to prescribe this product for the treatment of opioid dependence and have been assigned a unique identification number that must be included on every prescription. buprenorphine and naloxone sublingual tablets should not be administered to patients who have been shown to be hypersensitive to buprenorphine or naloxone as serious adverse reactions, including anaphylactic shock, have been reported [see warnings and precautions (5.8)] . pregnancy category c. risk summary there are no adequate and well-contr

USA - engelsk - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - fenoprofen calcium (unii: 0x2cw1qabj) (fenoprofen - unii:ra33eac7ky) - fenoprofen 400 mg - fenoprofen is indicated for: - relief of mild to moderate pain in adults. - relief of the signs and symptoms of rheumatoid arthrites. - relief of the signs and symptoms of osteoarthritis. fenoprofen is contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to fenoprofen or any components of the drug product [ see warnings and precautions ( 5.7, 5.9) ] - history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids have been reported in such patients [ see warnings and precautions ( 5.7, 5.8) ] - in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.1) ] risk summary use of nsaids, including fenoprofen, during the thir

USA - engelsk - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - bupropion hydrochloride extended-release tablets (xl) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with mdd. the efficacy of the sustained-release formulation of bupropion in the maintenance treatment of mdd was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see clinical studies (14.1)] . bupropion hydrochloride extended-release tablets (xl) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (sad). the efficacy of bupropion hydrochloride extended-release tablets in the prevention of seasonal major depressive episodes was established in 3 placebo-controlled trials in ad

USA - engelsk - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - escitalopram oxalate (unii: 5u85dbw7lo) (escitalopram - unii:4o4s742any) - escitalopram 10 mg - escitalopram tablets usp are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see clinical studies (14.1) ]. information related to usage of e scitalopram in adolescents is approved for forest laboratories, inc.'s escitalopram oxalate tablets and oral solution. however, due to forest laboratories, inc.'s marketing exclusivity rights, this drug product is not labeled with that adolescent usage information. a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attem