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pd-rx pharmaceuticals, inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 25 mg - indomethacin capsules are indicated for: - moderate to severe rheumatoid arthritis including acute flares of chronic disease. - moderate to severe ankylosing spondylitis. - moderate to severe osteoarthritis. - acute painful shoulder (bursitis and/or tendinitis). - acute gouty arthritis. indomethacin capsules are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to indomethacin 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) ] use of nsaids, including indomethacin capsules, during the third trimester of pregnancy increases the risk of premature closure of the fetal d

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pd-rx pharmaceuticals, inc. - mirtazapine (unii: a051q2099q) (mirtazapine - unii:a051q2099q) - mirtazapine 15 mg - mirtazapine tablets are indicated for the treatment of major depressive disorder. the efficacy of mirtazapine tablets 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 tablets in hospitali

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pd-rx pharmaceuticals, inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - plavix is indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non–st-segment elevation acs (unstable angina [ua]/non–st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. plavix should be administered in conjunction with aspirin. - plavix is indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. plavix should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke plavix is indicated to reduce the rate of mi and stroke. plavix is contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. plavix is contraindicated in patients with hypersensitivity (e.g., anaphylaxis) to clopidogrel or any comp

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

pd-rx pharmaceuticals, inc. - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - clopidogrel tablets are indicated to reduce the rate of myocardial infarction (mi) and stroke in patients with non–st-segment elevation acs (unstable angina [ua]/non–st-elevation myocardial infarction [nstemi]), including patients who are to be managed medically and those who are to be managed with coronary revascularization. clopidogrel tablets should be administered in conjunction with aspirin. - clopidogrel tablets are indicated to reduce the rate of myocardial infarction and stroke in patients with acute st-elevation myocardial infarction (stemi) who are to be managed medically. clopidogrel tablets should be administered in conjunction with aspirin. in patients with established peripheral arterial disease or with a history of recent myocardial infarction (mi) or recent stroke clopidogrel tablets are indicated to reduce the rate of mi and stroke. clopidogrel tablets are contraindicated in patients with active pathological bleeding such as peptic ulcer or intracranial hemorrhage. clopidogrel tablets are c

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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

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pd-rx pharmaceuticals, inc. - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - lopinavir 200 mg - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection in adults and pediatric patients 14 days and older. limitations of use: - genotypic or phenotypic testing and/or treatment history should guide the use of kaletra. the number of baseline lopinavir resistance-associated substitutions affects the virologic response to kaletra [see microbiology ( 12.4)] . - kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme, urticaria, angioedema) to any of its ingredients, including ritonavir. - kaletra is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening reactions [see drug interactions ( 7.1) and clinical pharmacology ( 12.3)] . alpha 1- adr

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pd-rx pharmaceuticals, inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 12.5 mg - ambien cr (zolpidem tartrate extended-release tablets) is indicated for the treatment of insomnia characterized by difficulties with sleep onset and/or sleep maintenance (as measured by wake time after sleep onset). the clinical trials performed in support of efficacy were up to 3 weeks (using polysomnography measurement up to 2 weeks in both adult and elderly patients) and 24 weeks (using patient-reported assessment in adult patients only) in duration [see clinical studies (14)] . ambien cr is contraindicated in patients - who have experienced complex sleep behaviors after taking ambien cr [see warnings and precautions (5.1)]. - with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.4)]. risk summary neonates born to mothers using zolpidem late in the third trimester of pregnancy have been reported to experience symptoms of re

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pd-rx pharmaceuticals, inc. - sulindac (unii: 184sns8vuh) (sulindac - unii:184sns8vuh) - sulindac 200 mg - carefully consider the potential benefits and risks of sulindac and other treatment options before deciding to use sulindac. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). sulindac tablets, usp are indicated for acute or long-term use in the relief of signs and symptoms of the following: - osteoarthritis osteoarthritis - rheumatoid arthritis** rheumatoid arthritis** - ankylosing spondylitis ankylosing spondylitis - acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) - acute gouty arthritis acute gouty arthritis **the safety and effectiveness of sulindac have not been established in rheumatoid arthritis patients who are designated in the american rheumatism association classification as functional class iv (incapacitated, largely or wholly bedridden, or confined to wheelchair; little or no self-care). sulindac tablets are contraindicated in patients with known hypersensitivity to sulindac or the excipients (see description ). sulindac tablets 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/anaphylactoid reactions to nsaids have been reported in such patients (see warnings – anaphylactic/anaphylactoid reactions , and precautions – preexisting asthma ). • in the setting of coronary artery bypass graft (cabg) surgery (see warnings)

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pd-rx pharmaceuticals, inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 20 mg - paroxetine tablets are indicated in adults for the treatment of: - major depressive disorder (mdd) - obsessive compulsive disorder (ocd) - panic disorder (pd) - social anxiety disorder (sad) - generalized anxiety disorder (gad) - posttraumatic stress disorder (ptsd) paroxetine tablets are contraindicated in patients: - taking, or within 14 days of stopping, maois (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2), drug interactions ( 7)]. - taking thioridazine because of risk of qt prolongation [see warnings and precautions ( 5.3) and drug interactions ( 7)] - taking pimozide because of risk of qt prolongation [see warnings and precautions ( 5.3), drug interactions ( 7)]. - with known hypersensitivity (e.g., anaphylaxis, angioedema, stevens-johnson syndrome) to paroxetine or any of the inactive ingredients in paroxetine tablets [ see adverse reactions ( 6.1), ( 6.2)]. risk summary based on data from published observational studies, exposure to ssris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see warnings and precautions ( 5.5) and clinical considerations]. epidemiological studies have shown that infants exposed to paroxetine in the first trimester of pregnancy have an increased risk of congenital malformations, particularly cardiovascular malformations. if paroxetine is used during pregnancy, or if the patient becomes pregnant while taking paroxetine, advise the patient of the potential hazard to the fetus. clinical considerations  unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing paroxetine therapy or switching to another antidepressant [see warnings and precautions ( 5.7)]. for - a study based on swedish national registry data demonstrated that infants exposed to paroxetine during pregnancy (n = 815) had an increased risk of cardiovascular malformations (2% risk in paroxetine-exposed infants) compared to the entire registry population (1% risk), for an odds ratio (or) of 1.8 (95% confidence interval 1.1 to 2.8). no increase in the risk of overall congenital malformations was seen in the paroxetine-exposed infants. the cardiac malformations in the paroxetine-exposed infants were primarily ventricular septal defects (vsds) and atrial septal defects (asds). septal defects range in severity from those that resolve spontaneously to those which require surgery. - a separate retrospective cohort study from the united states (united healthcare data) evaluated 5,956 infants of mothers dispensed antidepressants during the first trimester (n = 815 for paroxetine). this study showed a trend towards an increased risk for cardiovascular malformations for paroxetine (risk of 1.5%) compared to other antidepressants (risk of 1%), for an or of 1.5 (95% confidence interval 0.8 to 2.9). of the 12 paroxetine-exposed infants with cardiovascular malformations, 9 had vsds. this study also suggested an increased risk of overall major congenital malformations including cardiovascular defects for paroxetine (4% risk) compared to other (2% risk) antidepressants (or 1.8; 95% confidence interval 1.2 to 2.8). - two large case-control studies using separate databases, each with > 9,000 birth defect cases and > 4,000 controls, found that maternal use of paroxetine during the first trimester of pregnancy was associated with a 2- to 3-fold increased risk of right ventricular outflow tract obstructions. in one study the or was 2.5 (95% confidence interval, 1.0 to 6.0, 7 exposed infants) and in the other study the or was 3.3 (95% confidence interval, 1.3 to 8.8, 6 exposed infants). other studies have found varying results as to whether there was an increased risk of overall, cardiovascular, or specific congenital malformations. a meta-analysis of epidemiological data over a 16-year period (1992 to 2008) on first trimester paroxetine use in pregnancy and congenital malformations included the above-noted studies in addition to others (n = 17 studies that included overall malformations and n = 14 studies that included cardiovascular malformations; n = 20 distinct studies). while subject to limitations, this meta-analysis suggested an increased occurrence of cardiovascular malformations (prevalence odds ratio [por] 1.5; 95% confidence interval 1.2 to 1.9) and overall malformations (por 1.2; 95% confidence interval 1.1 to 1.4) with paroxetine use during the first trimester. it was not possible in this meta-analysis to determine the extent to which the observed prevalence of cardiovascular malformations might have contributed to that of overall malformations, nor was it possible to determine whether any specific types of cardiovascular malformations might have contributed to the observed prevalence of all cardiovascular malformations. unless the benefits of paroxetine to the mother justify continuing treatment, consideration should be given to either discontinuing paroxetine therapy or switching to another antidepressant [see warnings and precautions ( 5.7)]. for women who intend to become pregnant or are in their first trimester  of pregnancy,  paroxetine  should  only  be  initiated  after consideration of  the  other available treatment options [see warnings and precautions ( 5.4)]. treatment of pregnant women during their third trimester: neonates exposed to ssris or serotonin and norepinephrine reuptake inhibitors (snris), including paroxetine, late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding. such complications can arise immediately upon delivery. reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. these features are consistent with either a direct toxic effect of ssris and snris or, possibly, a drug discontinuation syndrome. it should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome [see warnings and precautions ( 5.2)]. exposure to ssris in late pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (pphn). pphn occurs in 1to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. in a retrospective case-control study of 377 women whose infants were born with pphn and 836 women whose infants were born healthy, the risk for developing pphn was approximately six-fold higher for infants exposed to ssris after the 20 th week of gestation compared to infants who had not been exposed to antidepressants during pregnancy. there have also been postmarketing reports of premature births in pregnant women exposed to paroxetine or other ssris. when treating a pregnant woman with paroxetine during the third trimester, the physician should carefully consider both the potential risks and benefits of treatment. a prospective longitudinal study of 201 women with a history of major depression who were euthymic at the beginning of pregnancy. the women who discontinued antidepressant medication during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressant medication. maternal adverse reactions use of paroxetine in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions ( 5.5)]. animal findings reproduction studies were performed at doses up to 50 mg/kg/day in rats and 6 mg/kg/day in rabbits administered during organogenesis. these doses are approximately 6 (rat) and less than 2 (rabbit) times the maximum recommended human dose (mrhd – 75 mg) on an mg/m 2 basis. these studies have revealed no evidence of developmental effects. however, in rats, there was an increase in pup deaths during the first 4 days of lactation when dosing occurred during the last trimester of gestation and continued throughout lactation. this effect occurred at a dose of 1 mg/kg/day which is than the mrhd on an mg/m 2 basis. the no-effect dose for rat pup mortality was not determined. the cause of these deaths is not known. like many other drugs, paroxetine is secreted in human milk. because of the potential for serious adverse reactions in nursing infants from paroxetine, a decision should be made whether to discontinue nursing infants or to discontinue the drug, taking into account the importance of the drug to the mother. the safety and effectiveness of paroxetine in pediatric patients have not been established [see box warning]. effectiveness was not demonstrated in three placebo-controlled trials in 752 paroxetine-treated pediatric patients with mdd. antidepressants increase the risk of suicidal thoughts and behaviors in pediatric patients [see boxed warning, warnings and precautions ( 5.1)]. decreased appetite and weight loss have been observed in association with the use of ssris. in placebo-controlled clinical trials conducted with pediatric patients, the following adverse reactions were reported in at least 2% of pediatric patients treated with paroxetine and occurred at a rate at least twice that for pediatric patients receiving placebo: emotional lability (including self- harm, suicidal thoughts, attempted suicide, crying, and mood fluctuations), hostility, decreased appetite, tremor, sweating, hyperkinesia, and agitation. adverse reactions upon discontinuation of treatment with paroxetine in the pediatric clinical trials that included a taper phase regimen, which occurred in at least 2% of patients and at a rate at least twice that of placebo, were: emotional lability (including suicidal ideation, suicide attempt, mood changes, and tearfulness), nervousness, dizziness, nausea, and abdominal pain. in premarketing clinical trials with paroxetine, 17% of patients treated with paroxetine (approximately 700) were 65 years of age or older. pharmacokinetic studies revealed a decreased clearance in the elderly, and a lower starting dose is recommended; however, no overall differences in safety or effectiveness were observed between elderly and younger patients [see dosage and administration ( 2.4), clinical pharmacology ( 12.3)]. ssris including paroxetine, have been associated with cases of clinically significant hyponatremia in elderly patients, who may be at greater risk for this adverse reaction [see warnings and precautions ( 5.7)]. increased plasma concentrations of paroxetine occur in patients with renal and hepatic impairment. the initial dosage of paroxetine should be reduced in patients with severe renal impairment and in patients with severe hepatic impairment [see dosage and administration ( 2.4), clinical  pharmacology ( 12.3)].

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pd-rx pharmaceuticals, inc. - 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 (ee). for those adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of pantoprazole sodium  delayed-release tablets 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 ee 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 (ze) syndrome. - pantoprazole sodium delayed-release tablets are contra