Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - alprazolam tablets are indicated for the:  - acute treatment of generalized anxiety disorder (gad) in adults. - treatment of panic disorder (pd), with or without agoraphobia in adults. alprazolam tablets are contraindicated in patients: - with known hypersensitivity to alprazolam or other benzodiazepines. angioedema has been reported [see adverse reactions (6.2)] . -  taking strong cytochrome p450 3a (cyp3a) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see dosage and administration (2.6), warnings and precautions (5.5), drug interactions (7.1)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to alprazolam during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for other psychiatric medications at 1-866-961-2388 or visiting online at https:

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - levetiracetam (unii: 44yrr34555) (levetiracetam - unii:44yrr34555) - levetiracetam tablet is indicated as adjunctive therapy in the treatment of partial onset seizures in adults and children 1 month of age and older with epilepsy. levetiracetam tablet is indicated as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy. levetiracetam tablet is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults and children 6 years of age and older with idiopathic generalized epilepsy. levetiracetam tablets are contraindicated in patients with a hypersensitivity to levetiracetam. reactions have included anaphylaxis and angioedema [ see warnings and precautions ( 5.4) ]. levetiracetam blood levels may decrease during pregnancy [ see warnings and precautions ( 5.10)]. pregnancy category c there are no adequate and controlled studies in pregnan

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - clorazepate dipotassium (unii: 63fn7g03xy) (clorazepic acid - unii:d51wo0g0l4) - clorazepate dipotassium is 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 contain 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). 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 dipotassiumand warnings: dependence and withdrawal reactions ). 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 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.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - trazodone hydrochloride (unii: 6e8zo8lrnm) (trazodone - unii:ybk48bxk30) - trazodone hydrochloride 150 mg - trazodone hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd) in adults. trazodone hydrochloride tablets are contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions ( 7.1)]. patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions ( 7.1)]. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to registe

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 100 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . - bupropion hydrochloride tablets are contraindicated in patients with a seizure disorder. - bupropion hydrochloride tablets are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride tablets [see warnings and precautions (5.3)] . - bupropion hydrochloride tablets are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and an

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - alprazolam 2 mg - alprazolam tablets are indicated for the: - acute treatment of generalized anxiety disorder (gad) in adults. - treatment of panic disorder (pd), with or without agoraphobia in adults. alprazolam is contraindicated in patients: - with known hypersensitivity to alprazolam or other benzodiazepines. angioedema has been reported [see adverse reactions ( 6.2)] . - taking strong cytochrome p450 3a (cyp3a) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see dosage and administration ( 2.6), warnings and precautions ( 5.5), drug interactions ( 7.1)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistr

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 75 mg - bupropion hydrochloride tablets are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of bupropion hydrochloride tablets in the treatment of a major depressive episode was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult subjects with mdd [see clinical studies (14)] . - bupropion hydrochloride tablets are contraindicated in patients with a seizure disorder. - bupropion hydrochloride tablets are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrochloride tablets [see warnings and precautions (5.3)] . - bupropion hydrochloride tablets are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and an

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam tablets, usp is indicated for relief of the signs and symptoms of osteoarthritis [ see clinical studies ( 14.1) ]. meloxicam tablets, usp is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see clinical studies ( 14.1) ]. meloxicam tablets, usp is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients 2 years of age and older [ see clinical studies ( 14.2) ]. meloxicam is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions) to meloxicam. meloxicam should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other nsaids. severe, rarely fatal, anaphylactic-like reactions to nsaids have been reported in such patients [ see warnings and precautions ( 5.7, 5.13) ]. meloxicam is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (cabg) surgery [ see warnings and precautions ( 5.1) ]. pregnancy category c; category d starting 30 weeks gestation there are no adequate and well-controlled studies in pregnant women. meloxicam crosses the placental barrier. prior to 30 weeks gestation, use meloxicam during pregnancy only if the potential benefit justifies the potential risk to the fetus. starting at 30 weeks gestation, avoid meloxicam and other nsaids, in pregnant women as premature closure of the ductus arteriosus in the fetus may occur. if this drug is used during this time period in pregnancy, inform the patient of the potential hazard to a fetus [ see warnings and precautions ( 5.9) and patient counseling information ( 17.8) ]. teratogenic effects meloxicam was not teratogenic when administered to pregnant rats during fetal organogenesis at oral doses up to 4 mg/kg/day (2.6-fold greater than the maximum recommended human daily dose [mrhd] based on body surface area [bsa] comparison). administration of meloxicam to pregnant rabbits throughout embryogenesis produced an increased incidence of septal defects of the heart at an oral dose of 60 mg/kg/day. the no effect level was 20 mg/kg/day (26-fold greater than the mrhd based on bsa conversion). nonteratogenic effects in rats and rabbits, embryolethality occurred at oral meloxicam doses of 1 mg/kg/day and 5 mg/kg/day, respectively (0.65-and 6.5-fold greater, respectively, than the mrhd based on bsa comparison) when administered throughout organogenesis. the effects of meloxicam on labor and delivery of pregnant women are unknown. oral administration of meloxicam to pregnant rats during late gestation through lactation increased the incidence of dystocia, delayed parturition, and decreased offspring survival at meloxicam doses of 0.125 mg/kg/day or greater (at least 12.5 times lower than the maximum recommended human daily dose based on body surface area comparison). it is not known whether this drug is excreted in human milk; however, meloxicam was excreted in the milk of lactating rats at concentrations higher than those in plasma. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from meloxicam, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of meloxicam in pediatric jra patients from 2 to 17 years of age has been evaluated in three clinical trials [ see dosage and administration ( 2.3), adverse reactions ( 6.1), and clinical studies ( 14.2) ] as with any nsaid, caution should be exercised in treating the elderly (65 years and older). of the total number of subjects in clinical studies, 5157 were age 65 and over (4044 in oa studies and 1113 in ra studies). 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. no dose adjustment is necessary in patients with mild to moderate hepatic impairment. patients with severe hepatic impairment have not been adequately studied. since meloxicam is significantly metabolized in the liver; the use of meloxicam in these patients should be done with caution [ see warnings and precautions ( 5.3) and clinical pharmacology ( 12.3) ]. no dose adjustment is necessary in patients with mild to moderate renal impairment. patients with severe renal impairment have not been studied. the use of meloxicam in subjects with severe renal impairment is not recommended. following a single dose of meloxicam, the free c max plasma concentrations were higher in patients with renal failure on chronic hemodialysis (1% free fraction) in comparison to healthy volunteers (0.3% free fraction). therefore, it is recommended that meloxicam dosage in this population not exceed 7.5 mg per day hemodialysis did not lower the total drug concentration in plasma; therefore, additional doses are not necessary after hemodialysis. meloxicam is not dialyzable [ see dosage and administration ( 2.1), warnings and precautions ( 5.6), and clinical pharmacology ( 12.3) ]. data from several small studies in humans and from studies in animals indicate that nsaids, including meloxicam , may be associated with a reversible delay in ovulation. therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, use of meloxicam is not recommended.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - alprazolam (unii: yu55mq3izy) (alprazolam - unii:yu55mq3izy) - alprazolam tablets are indicated for the: - acute treatment of generalized anxiety disorder (gad) in adults. - treatment of panic disorder (pd), with or without agoraphobia in adults. alprazolam is contraindicated in patients: - with known hypersensitivity to alprazolam or other benzodiazepines. angioedema has been reported [see adverse reactions ( 6.2)] . - taking strong cytochrome p450 3a (cyp3a) inhibitors (e.g., ketoconazole, itraconazole), except ritonavir [see dosage and administration ( 2.6), warnings and precautions ( 5.5), drug interactions ( 7.1)] pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to psychiatric medications, including alprazolam, during pregnancy. healthcare providers are encouraged to register patients by calling the national pregnancy registry for psychiatric medications at 1-866-961-2388 or visiting online at https://womensmentalhealth.org/research/pregnancyregistr

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pd-rx pharmaceuticals, inc. - ketorolac tromethamine (unii: 4eve5946bq) (ketorolac - unii:yzi5105v0l) - carefully consider the potential benefits and risks of ketorolac tromethamine tablets, usp and other treatment options before deciding to use ketorolac tromethamine tablets, usp. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals. ketorolac tromethamine tablets, usp are indicated for the short-term (≤ 5 days) management of moderately severe acute pain that requires analgesia at the opioid level, usually in a postoperative setting. therapy should always be initiated with iv or im dosing of ketorolac tromethamine and ketorolac tromethamine tablets, usp are to be used only as continuation treatment, if necessary. the total combined duration of use of ketorolac tromethamine tablets, usp and ketorolac tromethamine is not to exceed 5 days of use because of the potential of increasing the frequency and severity of adverse reactions associated with the recommended doses (see warnings , precautions , dosage and adminis