САЩ - английски - NLM (National Library of Medicine)

aurobindo pharma limited - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j) - tramadol hydrochloride 100 mg - tramadol hydrochloride extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. limitations of use - because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see warnings and precautions (5.1)] , reserve tramadol hydrochloride extended-release tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. - tramadol hydrochloride extended-release tablets are not indicated as an as-needed (prn) analgesic. tramadol hydrochloride extended-release tablets are contraindicated for:   - all children younger than 12 years of  age [see warnings and precautions (5.4)] -

САЩ - английски - NLM (National Library of Medicine)

macleods pharmaceuticals limited - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tramadol hydrochloride 37.5 mg - tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. limitations of use tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less. because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1], reserve tramadol hydrochloride 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. tramadol hydrochloride and acetaminophen is contraindicated for: • all children younger than 12 years of age [see warnings and precautions ( 5.4 ) ] • post-operative management in children younger than 18 years of age following tonsillectomy and

САЩ - английски - NLM (National Library of Medicine)

apotex corp. - tramadol hydrochloride (unii: 9n7r477wck) (tramadol - unii:39j1lgj30j), acetaminophen (unii: 362o9itl9d) (acetaminophen - unii:362o9itl9d) - tramadol hydrochloride 37.5 mg - tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.   limitations of use tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less.   because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see warnings and precautions (5.1)] , reserve tramadol hydrochloride 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. tramadol hydrochloride and acetaminophen tablets are contraindicated for: - all children younger than 12 years of age [see warnings and precautions (5.4)]   - post-operative management in children younger than 18 years of age following tonsillectomy and/or adeno

САЩ - английски - NLM (National Library of Medicine)

sandoz inc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - bupropion hydrochloride extended-release tablets (sr) are indicated as an aid to smoking cessation treatment. pregnancy category c risk summary data from epidemiological studies of pregnant women exposed to bupropion in the first trimester indicate no increased risk of congenital malformations overall. all pregnancies, regardless of drug exposure, have a background rate of 2% to 4% for major malformations, and 15% to 20% for pregnancy loss. no clear evidence of teratogenic activity was found in reproductive developmental studies conducted in rats and rabbits; however, in rabbits, slightly increased incidences of fetal malformations and skeletal variations were observed at doses approximately 2 times the maximum recommended human dose (mrhd) and greater and decreased fetal weights were seen at doses three times the mrhd and greater. bupropion hydrochloride extended-release tablets (sr) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. clinical consideratio

САЩ - английски - NLM (National Library of Medicine)

rebel distributors corp - nefazodone hydrochloride (unii: 27x63j94gr) (nefazodone - unii:59h4fcv1tf) - nefazodone hydrochloride 200 mg - nefazodone hydrochloride tablets are indicated for the treatment of depression. when deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see warnings ). in many cases, this would lead to the conclusion that other drugs should be tried first. the efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iiir category of major depressive disorder (see clinical pharmacology ). 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 must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of in

САЩ - английски - NLM (National Library of Medicine)

stat rx usa llc - nefazodone hydrochloride (unii: 27x63j94gr) (nefazodone - unii:59h4fcv1tf) - nefazodone hydrochloride 100 mg - nefazodone hydrochloride tablets are indicated for the treatment of depression. when deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with nefazodone hydrochloride treatment (see warnings ). in many cases, this would lead to the conclusion that other drugs should be tried first. the efficacy of nefazodone in the treatment of depression was established in 6 to 8 week controlled trials of outpatients and in a 6 week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iiir category of major depressive disorder (see clinical pharmacology ). 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 must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of in

САЩ - английски - NLM (National Library of Medicine)

mylan institutional 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)]

САЩ - английски - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - pramipexole dihydrochloride (unii: 3d867np06j) (pramipexole - unii:83619peu5t) - pramipexole dihydrochloride 0.125 mg - pramipexole dihydrochloride tablets are indicated for the treatment of parkinson's disease. pramipexole dihydrochloride tablets are indicated for the treatment of moderate-to-severe primary restless legs syndrome (rls). none. risk summary there are no adequate data on the developmental risk associated with the use of pramipexole in pregnant women. no adverse developmental effects were observed in animal studies in which pramipexole was administered to rabbits during pregnancy. effects on embryofetal development could not be adequately assessed in pregnant rats; however, postnatal growth was inhibited at clinically relevant exposures [see data]. in the u.s. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data oral administration of pramipexole (0.1, 0.5, or 1.5 mg/kg/day) to pregna

САЩ - английски - NLM (National Library of Medicine)

st marys medical park pharmacy - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 150 mg - bupropion hydrochloride extended-release tablets, usp (sr) are indicated for the treatment of major depressive disorder. the efficacy of bupropion in the treatment of a major depressive episode was established in two 4-week controlled trials of depressed inpatients and in one 6-week controlled trial of depressed outpatients whose diagnoses corresponded most closely to the major depression category of the apa diagnostic and statistical manual (dsm) (see clinical pharmacology). a major depressive episode (dsm-iv) implies the presence of 1) depressed mood or 2) loss of interest or pleasure; in addition, at least 5 of the following symptoms have been present during the same 2-week period and represent a change from previous functioning: 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 worthlessness, slowed thinking or impaired concentrati

САЩ - английски - NLM (National Library of Medicine)

a-s medication solutions - diltiazem hydrochloride (unii: olh94387te) (diltiazem - unii:ee92bbp03h) - diltiazem hydrochloride 120 mg - diltiazem hydrochloride extended-release capsules, usp are indicated for the treatment of hypertension. it may be used alone or in combination with other antihypertensive medications. diltiazem hydrochloride extended-release capsules, usp are indicated for the management of chronic stable angina and angina due to coronary artery spasm. diltiazem hydrochloride is contraindicated in (1) patients with sick sinus syndrome except in the presence of a functioning ventricular pacemaker, (2) patients with second-or third-degree av block except in the presence of a functioning ventricular pacemaker, (3) patients with hypotension (less than 90 mm hg systolic), (4) patients who have demonstrated hypersensitivity to the drug, and (5) patients with acute myocardial infarction and pulmonary congestion documented by x-ray on admission.