মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

marlex pharmaceuticals inc - phenytoin sodium (unii: 4182431bjh) (phenytoin - unii:6158tkw0c5) - phenytoin sodium 100 mg - extended phenytoin sodium capsules, usp are indicated for the control of generalized tonic-clonic (grand mal) and complex partial (psychomotor, temporal lobe) seizures and prevention and treatment of seizures occurring during or following neurosurgery. phenytoin serum level determinations may be necessary for optimal dosage adjustments (see dosage and administration   and clinical pharmacology   sections). phenytoin, usp is contraindicated in those patients with a history of hypersensitivity to phenytoin, usp, its inactive ingredients, or other hydantoins. coadministration of extended phenytoin sodium is contraindicated with delavirdine due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

eagle pharmaceuticals, inc. - diclofenac sodium (unii: qtg126297q) (diclofenac - unii:144o8ql0l1), misoprostol (unii: 0e43v0bb57) (misoprostol - unii:0e43v0bb57) - diclofenac sodium 50 mg - carefully consider the potential benefits and risks of diclofenac sodium and misoprostol delayed-release tablets and other treatment options before deciding to use diclofenac sodium and misoprostol delayed-release tablets. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). diclofenac sodium and misoprostol delayed-release tablets are indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing nsaid-induced gastric and duodenal ulcers and their complications. see warnings, gastrointestinal effects - risk of ulceration, bleeding and perforation for a list of factors that may increase the risk of nsaid-induced gastric and duodenal ulcers and their complications. see boxed contraindications and warnings related to misoprostol. diclofenac sodium and misoprostol delayed-release tablets should not be taken by pregnant women. diclofenac sodium and misoprostol delayed-releas

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

actavis pharma, inc. - amoxapine (unii: r63vq857ot) (amoxapine - unii:r63vq857ot) - amoxapine 25 mg - amoxapine is indicated for the relief of symptoms of depression in patients with neurotic or reactive depressive disorders as well as endogenous and psychotic depressions. it is indicated for depression accompanied by anxiety or agitation. amoxapine is contraindicated in patients who have shown prior hypersensitivity to dibenzoxazepine compounds. it should not be given concomitantly with monoamine oxidase inhibitors. hyperpyretic crises, severe convulsions, and deaths have occurred in patients receiving tricyclic antidepressants and monoamine oxidase inhibitors simultaneously. when it is desired to replace a monoamine oxidase inhibitor with amoxapine, a minimum of 14 days should be allowed to elapse after the former is discontinued. amoxapine should then be initiated cautiously with gradual increase in dosage until optimum response is achieved. the drug is not recommended for use during the acute recovery phase following myocardial infarction.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

actavis pharma, inc. - estazolam (unii: 36s3eqv54c) (estazolam - unii:36s3eqv54c) - estazolam 1 mg - estazolam tablets, usp are indicated for the short-term management of insomnia characterized by difficulty in falling asleep, frequent nocturnal awakenings, and/or early morning awakenings. both outpatient studies and a sleep laboratory study have shown that estazolam administered at bedtime improved sleep induction and sleep maintenance (see clinical pharmacology ). because insomnia is often transient and intermittent, the prolonged administration of estazolam is generally neither necessary nor recommended. since insomnia may be a symptom of several other disorders, the possibility that the complaint may be related to a condition for which there is a more specific treatment should be considered. there is evidence to support the ability of estazolam to enhance the duration and quality of sleep for intervals up to 12 weeks (see clinical pharmacology ). estazolam is contraindicated with ketoconazole and itraconazole, since these medications significantly impair oxidative metabolism mediated by cyp3a (see warnin

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

actavis pharma, inc. - oxycodone hydrochloride (unii: c1enj2te6c) (oxycodone - unii:cd35pmg570), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - oxycodone hydrochloride 2.5 mg - oxycodone and acetaminophen tablets, usp 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 produc

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 75 mg - carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). indomethacin extended-release capsules have been found effective in active stages of the following: 1. moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. moderate to severe ankylosing spondylitis. 3. moderate to severe osteoarthritis. 4. acute painful shoulder (bursitis and/or tendinitis). indomethacin extended-release capsules, usp are not recommended for the treatment of acute gouty arthritis. indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. in such instances the steroid dosage should be reduced

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

camber pharmaceuticals, inc. - indomethacin (unii: xxe1cet956) (indomethacin - unii:xxe1cet956) - indomethacin 75 mg - carefully consider the potential benefits and risks of indomethacin extended-release capsules and other treatment options before deciding to use indomethacin extended-release capsules. use the lowest effective dose for the shortest duration consistent with individual patient treatment goals (see warnings ). indomethacin extended-release capsules have been found effective in active stages of the following: 1. moderate to severe rheumatoid arthritis including acute flares of chronic disease. 2. moderate to severe ankylosing spondylitis. 3. moderate to severe osteoarthritis. 4. acute painful shoulder (bursitis and/or tendinitis). indomethacin extended-release capsules, usp are not recommended for the treatment of acute gouty arthritis. indomethacin may enable the reduction of steroid dosage in patients receiving steroids for the more severe forms of rheumatoid arthritis. in such instances the steroid dosage should be reduced slowly and the patients followed very closely for any possible adverse effect

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

prestium pharma, inc. - miconazole nitrate (unii: vw4h1cyw1k) (miconazole - unii:7nno0d7s5m), zinc oxide (unii: soi2loh54z) (zinc oxide - unii:soi2loh54z), petrolatum (unii: 4t6h12bn9u) (petrolatum - unii:4t6h12bn9u) - miconazole nitrate 2.5 mg in 1 g - vusion ointment is indicated for the adjunctive treatment of diaper dermatitis only when complicated by documented candidiasis (microscopic evidence of pseudohyphae and/or budding yeast), in immunocompetent pediatric patients 4 weeks and older. a positive fungal culture for candida albicans is not adequate evidence of candidal infection since colonization with c. albicans can result in a positive culture. the presence of candidal infection should be established by microscopic evaluation prior to initiating treatment. vusion should be used as part of a treatment regimen that includes measures directed at the underlying diaper dermatitis, including gentle cleansing of the diaper area and frequent diaper changes. vusion should not be used as a substitute for frequent diaper changes. vusion should not be used to prevent the occurrence of diaper dermatitis, since preventative use may result in the development of drug resistance.  the safety and efficacy of vusion have not been demonstrated in immunocompromised pa

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

jubilant cadista pharmaceuticals inc. - paroxetine hydrochloride hemihydrate (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 10 mg - major depressive disorder: paroxetine tablets, usp are indicated for the treatment of major depressive disorder.   the efficacy of paroxetine in the treatment of a major depressive episode was established in 6-week controlled trials of outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical pharmacology: clinical trials). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. the effects of paroxetine in hospitalized depressed patients have not been adequately studied.

মার্কিন যুক্তরাষ্ট্র - ইংরেজি - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - paroxetine hydrochloride (unii: x2els050d8) (paroxetine - unii:41vrh5220h) - paroxetine 10 mg - paroxetine tablets are indicated in adults for the treatment of: paroxetine tablets are contraindicated in patients: 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. 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 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)] . neonates exposed to ssris or serotonin and norepinephrine reuptake inhibitors (snris), including paroxetine tablets, 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 1 – 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 20th 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. use of paroxetine tablets in the month before delivery may be associated with an increased risk of postpartum hemorrhage [see warnings and precautions (5.5)] . 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/m2 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/m2 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 tablets, 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 tablets in pediatric patients have not been established [see box warning] . effectiveness was not demonstrated in three placebo-controlled trials in 752 paroxetine tablets-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 tablets 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 tablets 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 tablets, 17% of patients treated with paroxetine tablets (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 tablets, 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 tablets 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)] .