Marekani - Kiingereza - NLM (National Library of Medicine)

apotheca inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,

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eisai inc. - perampanel (unii: h821664npk) (perampanel - unii:h821664npk) - perampanel 2 mg - fycompa is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. fycompa is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.  none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as fycompa, during pregnancy. encourage women who are taking fycompa during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no adequate data on the developmental risk associated with use in pregnant women.  in animal studies, perampanel induced developmental toxicity in pregnant rat and rabbit at clinically relevant doses [ see data ] . in the u.s. general population the estimated background risk

Marekani - Kiingereza - NLM (National Library of Medicine)

aurobindo pharma limited - valsartan (unii: 80m03yxj7i) (valsartan - unii:80m03yxj7i) - valsartan 40 mg - valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and pediatric patients one year of age and older. lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. these benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes, including the class to which valsartan principally belongs. there are no controlled trials in hypertensive patients demonstrating risk reduction with valsartan tablets. control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. many patients will require more than one drug to achieve blood pressure goals. for specific advice on goals and management, see published guidelines, such as those of the national high blood pressure education program’s joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc). numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. the largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmhg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (e.g., patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). these considerations may guide selection of therapy. valsartan tablets may be used alone or in combination with other antihypertensive agents. valsartan tablets are indicated to reduce the risk of hospitalization for heart failure in adult patients with heart failure (nyha class ii to iv). there is no evidence that valsartan tablets provides added benefits when they are used with an adequate dose of an angiotensin converting enzyme (ace) inhibitor [see clinical studies (14.2)]. in clinically stable adult patients with left ventricular failure or left ventricular dysfunction following myocardial infarction, valsartan tablets are indicated to reduce the risk of cardiovascular mortality [see clinical studies (14.3)]. do not use in patients with known hypersensitivity to any component. do not coadminister aliskiren with valsartan tablets in patients with diabetes [see drug interactions (7.3)]. risk summary valsartan can cause fetal harm when administered to a pregnant woman. use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin-angiotensin system from other antihypertensive agents. published reports include cases of anhydramnios and oligohydramnios in pregnant women treated with valsartan (see clinical considerations ). when pregnancy is detected, consider alternative drug treatment and discontinue valsartan as soon as possible. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk hypertension in pregnancy increases the maternal risk for pre-eclampsia, gestational diabetes, premature delivery, and delivery complications (e.g., need for cesarean section, and post-partum hemorrhage). hypertension increases the fetal risk for intrauterine growth restriction and intrauterine death. pregnant women with hypertension should be carefully monitored and managed accordingly. fetal/neonatal adverse reactions oligohydramnios in pregnant women who use drugs affecting the renin-angiotensin system in the second and third trimesters of pregnancy can result in the following: reduced fetal renal function leading to anuria and renal failure, fetal lung hypoplasia, skeletal deformations, including skull hypoplasia, hypotension and death. in the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. in patients taking valsartan during pregnancy, perform serial ultrasound examinations to assess the intra-amniotic environment. fetal testing may be appropriate, based on the week of gestation. patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. if oligohydramnios is observed, consider alternative drug treatment. closely observe neonates with histories of in utero exposure to valsartan for hypotension, oliguria, and hyperkalemia. in neonates with a history of in utero exposure to valsartan, if oliguria or hypotension occurs, support blood pressure and renal perfusion. exchange transfusions or dialysis may be required as a means of reversing hypotension and replacing renal function. data animal data no teratogenic effects were observed when valsartan was administered to pregnant mice and rats at oral doses of up to 600 mg/kg/day (9 and 18 times the maximum recommended human dose (mrhd) on a mg/m2 basis) and to pregnant rabbits at oral doses of up to 10 mg/kg/day.  in rats, oral valsartan administered at maternally toxic doses (600 mg/kg/day) during organogenesis or late gestation and lactation, resulted in decreased fetal and pup weight, pup survival and delayed developmental milestones. in rabbits administered maternally toxic doses of 5 and 10 mg/kg/day, fetotoxicity was observed. risk summary there is no information regarding the presence of valsartan in human milk, the effects on the breastfed infant, or the effects on milk production. valsartan is present in rat milk. because of the potential for serious adverse reactions in breastfed infants from exposure to valsartan, advise a nursing woman that breastfeeding is not recommended during treatment with valsartan. data valsartan was detected in the milk of lactating rats 15 minutes after oral administration of a 3 mg/kg dose. the antihypertensive effects of valsartan have been evaluated in 5 clinical studies in pediatric patients from 1 to 16 years of age [see clinical studies (14.1)]. the pharmacokinetics of valsartan have been evaluated in pediatric patients 1 to 16 years of age [see clinical pharmacology (12.3)]. the adverse experience profile of valsartan was similar to that described for adults [see adverse reactions (6.1)].   in children and adolescents with hypertension where underlying renal abnormalities may be more common, renal function and serum potassium should be closely monitored as clinically indicated. use of valsartan is not recommended in children less than 1 year of age. [see nonclinical toxicology (13.2)] . it is not known whether post-natal use of valsartan, before maturation of renal function is complete, has a long- term deleterious effect on the kidney.    no data are available in pediatric patients either undergoing dialysis or with a glomerular filtration rate less than 30 ml/min/1.73 m2 . in the controlled clinical trials of valsartan, 1,214 (36.2%) hypertensive patients treated with valsartan were ≥ 65 years and 265 (7.9%) were ≥ 75 years. no overall difference in the efficacy or safety of valsartan was observed in this patient population, but greater sensitivity of some older individuals cannot be ruled out. exposure [measured by area under the curve (auc)] to valsartan is higher by 70% in the elderly than in the young, however no dosage adjustment is necessary [see clinical pharmacology (12.3)] . of the 2,511 patients with heart failure randomized to valsartan in the valsartan heart failure trial, 45% (1,141) were 65 years of age or older. in the valsartan in acute myocardial infarction trial (valiant), 53% (2,596) of the 4,909 patients treated with valsartan and 51% (2,515) of the 4,885 patients treated with valsartan + captopril were 65 years of age or older. there were no notable differences in efficacy or safety between older and younger patients in either trial. safety and effectiveness of valsartan in patients with severe renal impairment (glomerular filtration rate less than 30 ml/min/1.73 m2 ) have not been established. no dose adjustment is required in patients with mild (glomerular filtration rate 60 to 90 ml/min/1.73 m2 ) or moderate (glomerular filtration rate 30 to 60 ml/min/1.73 m2 ) renal impairment. no dose adjustment is necessary for patients with mild-to-moderate liver disease. no dosing recommendations can be provided for patients with severe liver disease.

Marekani - Kiingereza - NLM (National Library of Medicine)

stat rx usa llc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq), esomeprazole magnesium (unii: r6dxu4way9) (esomeprazole - unii:n3pa6559ft) - naproxen 375 mg - vimovo is a combination product that contains naproxen and esomeprazole. it is indicated for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis and to decrease the risk of developing gastric ulcers in patients at risk of developing nsaid-associated gastric ulcers. vimovo is not recommended for initial treatment of acute pain because the absorption of naproxen is delayed compared to absorption from other naproxen-containing products. controlled studies do not extend beyond 6 months. vimovo is contraindicated in patients with known hypersensitivity to naproxen, esomeprazole magnesium, substituted benzimidazoles, or to any of the excipients. vimovo is contraindicated in 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 (5.8, 5.13) ]. hypersensitivity reactions, eg, angioedema a

Marekani - Kiingereza - NLM (National Library of Medicine)

stat rx usa - propoxyphene napsylate (unii: 38m219l1oj) (propoxyphene - unii:s2f83w92tk) - propoxyphene napsylate 100 mg - darvon-n is indicated for the relief of mild to moderate pain. darvon-n is contraindicated in patients with known hypersensitivity to propoxyphene. darvon-n is contraindicated in patients with significant respiratory depression (in unmonitored settings or the absence of resuscitative equipment) and patients with acute or severe asthma or hypercarbia. darvon-n is contraindicated in any patient who has or is suspected of having paralytic ileus. darvon-n is a schedule iv narcotic under the u.s. controlled substances act. darvon-n can produce drug dependence of the morphine type, and therefore, has the potential for being abused. psychic dependence, physical dependence and tolerance may develop upon repeated administration. darvon-n should be prescribed and administered with the same degree of caution appropriate to the use of other narcotic-containing medications. since darvon-n is a mu-opioid agonist, it may be subject to misuse, abuse, and addiction. addiction to opioids prescribed for pain manageme

Marekani - Kiingereza - NLM (National Library of Medicine)

stat rx usa llc - morphine sulfate (unii: x3p646a2j0) (morphine - unii:76i7g6d29c), naltrexone hydrochloride (unii: z6375yw9sf) (naltrexone - unii:5s6w795cqm) - morphine sulfate 20 mg - embeda is an extended-release oral formulation of morphine sulfate and naltrexone hydrochloride indicated for the management of moderate to severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. embeda is not intended for use as a prn analgesic. embeda is not indicated for acute/postoperative pain or if the pain is mild or not expected to persist for an extended period of time. embeda is only indicated for postoperative use if the patient is already receiving chronic opioid therapy prior to surgery or if the postoperative pain is expected to be moderate to severe and persist for an extended period of time. physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate embeda is contraindicated in patients with a known hypersensitivity to morphine, morphine salts, naltrexone, or in any situation where opioids are contraindicated. embeda is contraindicated in patients with significant respiratory depression in u

Marekani - Kiingereza - NLM (National Library of Medicine)

st marys medical park pharmacy - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 50 mg - major depressive disorder – sertraline hydrochloride is indicated for the treatment of major depressive disorder in adults. the efficacy of sertraline hydrochloride in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii category of major depressive disorder (see clinical trials under 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 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 antidepressant action of sertr

Marekani - Kiingereza - NLM (National Library of Medicine)

proficient rx lp - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14) ]. the clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.3)] . pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. studies in children to assess the effects of prenatal exposure to zolpidem have not been conducted; however, cases of severe neonatal respiratory depression have been reported when zolpidem was used at the end of pregnancy, especially when taken with other

Marekani - Kiingereza - NLM (National Library of Medicine)

h.j. harkins company, inc. - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 10 mg - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)]. the clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.2)]. pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. zolpidem tartrate tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. administration of zolpidem to pregnant rats and rabbits resul

Marekani - Kiingereza - NLM (National Library of Medicine)

aidarex pharmaceuticals llc - zolpidem tartrate (unii: wy6w63843k) (zolpidem - unii:7k383oqi23) - zolpidem tartrate 5 mg - zolpidem tartrate tablets, usp are indicated for the short-term treatment of insomnia characterized by difficulties with sleep initiation. zolpidem tartrate tablets, usp have been shown to decrease sleep latency for up to 35 days in controlled clinical studies [see clinical studies (14)]. the clinical trials performed in support of efficacy were 4-5 weeks in duration with the final formal assessments of sleep latency performed at the end of treatment. zolpidem tartrate tablets are contraindicated in patients with known hypersensitivity to zolpidem tartrate or to any of the inactive ingredients in the formulation. observed reactions include anaphylaxis and angioedema [see warnings and precautions (5.2)]. pregnancy category c there are no adequate and well-controlled studies of zolpidem tartrate tablets in pregnant women. zolpidem tartrate tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. administration of zolpidem to pregnant rats and rabbits resul