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proficient rx lp - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine tablets, usp are indicated for the treatment of major depressive disorder.  the efficacy of mirtazapine in the treatment of major depressive disorder was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the diagnostic and statistical manual of mental disorders-3rd edition (dsm-iii) category of major depressive disorder (see clinical pharmacology).  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 5 of the following 9 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 attempt, or suicidal ideation.  the effectiveness of mirtazapine in hospital

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

lake erie medical dba quality care products llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - hydrocodone bitartrate and acetaminophen tablets are indicated for the relief of moderate to moderately severe pain. this product should not be administered to patients who have previously exhibited hypersensitivity to hydrocodone or acetaminophen. patients known to be hypersensitive to other opioids may exhibit cross-sensitivity to hydrocodone. hydrocodone bitartrate and acetaminophen tablets contain hydrocodone, an opioid agonist, and is a schedule iii controlled substance. hydrocodone bitartrate and acetaminophen tablets, and other opioids used in analgesia can be abused and are subject to criminal diversion. addiction is a primary, chronic, neurobiologic disease, with genetic, psychosocial, and environmental factors influencing its development and manifestations. it is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. drug addiction is a treatable disease utilizing a multidisciplinary approach,

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

aurolife pharma llc - clorazepate dipotassium (unii: 63fn7g03xy) (clorazepic acid - unii:d51wo0g0l4) - clorazepate dipotassium tablets are indicated for the management of anxiety disorders or for 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. clorazepate dipotassium tablets are indicated as adjunctive therapy in the management of partial seizures. the effectiveness of  clorazepate dipotassium tablets in long-term management of anxiety, that is, more than 4 months, has not been assessed by systematic clinical studies. long-term studies in epileptic patients, however, have shown continued therapeutic activity. the physician should reassess periodically the usefulness of the drug for the individual patient. clorazepate dipotassium tablets are indicated for the symptomatic relief of acute alcohol withdrawal. clorazepate dipotassium tablets are contraindicated in patients with a known hypersensitivity to the drug and in those with acute narrow angle glaucoma. clorazepate dipotassium tablets contains clorazepate, a schedule iv controlled substance. clorazepate dipotassium is a benzodiazepine and a cns depressant with a potential for abuse and addiction. abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. abuse and misuse of benzodiazepines may lead to addiction. abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death. benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see warnings: abuse, misuse, and addiction). the following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. the following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. death is more often associated with polysubstance use (especially benzodiazepines with other cns depressants such as opioids and alcohol). physical dependence clorazepate dipotassium may produce physical dependence from continued therapy. physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life- threatening. patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see warnings: dependence and withdrawal reactions). to reduce the risk of withdrawal reactions, use a gradual taper to discontinue clorazepate dipotassium or reduce the dosage (see dosage and administration: discontinuation or dosage reduction of clorazepate dipotassium and warnings: dependence and withdrawal reactions). acute withdrawal signs and symptoms acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. more severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality. protracted withdrawal syndrome protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. protracted withdrawal symptoms may last weeks to more than 12 months. as a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. tolerance to clorazepate dipotassium may develop from continued therapy. tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). tolerance to the therapeutic effect of clorazepate dipotassium may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

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

ncs healthcare of ky, inc dba vangard labs - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin capsules, usp are indicated for the management of postherpetic neuralgia in adults. gabapentin capsules, usp are indicated as adjunctive therapy in the treatment of partial seizures with and without secondary generalization in patients over 12 years of age with epilepsy. gabapentin capsules, usp are also indicated as adjunctive therapy in the treatment of partial seizures in pediatric patients age 3 to 12 years. gabapentin capsules are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. gabapentin is not a scheduled drug. gabapentin does not exhibit affinity for benzodiazepine, opiate (mu, delta or kappa), or cannabinoid 1 receptor sites. a small number of postmarketing cases report gabapentin misuse and abuse. these individuals were taking higher than recommended doses of gabapentin for unapproved uses. most of the individuals described in these reports had a history of poly-substances abuse or used gabapentin to relieve symptoms of withdrawal from ot

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

redpharm drug, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 5 mg - oxycodone 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 oxycodone 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 oxycodone 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 oxycodone, acetaminophen, or any other component of the pr

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

proficient rx lp - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 10 mg - oxycodone 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 oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics ] oxycodone  and acetaminophen tablets are contraindicated in patients with:  controlled substance oxycodone  and acetaminophen tablet contains oxycodone and acetaminophen, a schedule cii controlled substance. abuse oxycodone and acetaminophen tablets contains oxycodone, a substance with a high potential for abuse similar to other opioids including fentanyl, hydrocodone, hydromorphone, methadone, morphine, oxymorphone, and tapentadol. oxycodone  and acetaminophen tablets can be abused and is   subject to misuse, addiction, and criminal diversion [see warnings ].  all patients tr

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

h.j harkins co., inc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - 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 hydrocodone bitartrate 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 warning

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

aphena pharma solutions - tennessee, llc - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets, usp are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] . raloxifene hydrochloride tablets, usp are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3) ]. raloxifene hydrochloride tablets, usp are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4 )]. the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4) ]. twenty-seven percent of  the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in si

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aphena pharma solutions - tennessee, llc - pioglitazone hydrochloride (unii: jqt35npk6c) (pioglitazone - unii:x4ov71u42s) - pioglitazone 45 mg - monotherapy and combination therapy pioglitazone tablets, usp are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings [see clinical studies (14)] . important limitations of use pioglitazone tablets, usp exert its antihyperglycemic effect only in the presence of endogenous insulin. pioglitazone tablets, usp should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these settings. use caution in patients with liver disease [see warnings and precautions (5.3)] . - initiation in patients with established nyha class iii or iv heart failure [see boxed warning]. - use in patients with known hypersensitivity to pioglitazone or any other component of pioglitazone tablets. teratogenic effects pregnancy category c. there are no adequate and well-controlled studies of pioglitazone in pregnant women. animal studies show increased rates of post-implantation

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

redpharm drug, inc. - codeine phosphate (unii: gsl05y1mn6) (codeine anhydrous - unii:ux6owy2v7j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - acetaminophen 300 mg - acetaminophen and codeine phosphate tablets are indicated for the management of mild to moderate pain,where treatment with an opioid is appropriate 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 acetaminophen and codeine phosphate tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics] have not provided adequate analgesia, or are not expected to provide adequate analgesia have not been tolerated, or are not expected to be tolerated acetaminophen and codeine phosphate tablets are contraindicated in patients with: patients with significant respiratory depression [see warnings]. patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see warnings]. postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy [see warni