美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - ramelteon (unii: 901as54i69) (ramelteon - unii:901as54i69) - ramelteon tablets are indicated for the treatment of insomnia characterized by difficulty with sleep onset.   the clinical trials performed in support of efficacy were up to six months in duration. the final formal assessments of sleep latency were performed after two days of treatment during the crossover study (elderly only), at five weeks in the six week studies (adults and elderly), and at the end of the six month study (adults and elderly) [see clinical studies ( 14)] patients who develop angioedema after treatment with ramelteon tablets should not be rechallenged with the drug. patients should not take ramelteon tablets in conjunction with fluvoxamine [see drug interaction ( 7)] . risk summary available data from postmarketing reports with ramelteon use in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, ramelteon produced evidenc

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - pregabalin (unii: 55jg375s6m) (pregabalin - unii:55jg375s6m) - pregabalin capsules are indicated for: • management of neuropathic pain associated with diabetic peripheral neuropathy • management of postherpetic neuralgia • adjunctive therapy for the treatment of partial-onset seizures in patients 17 years of age and older • management of fibromyalgia • management of neuropathic pain associated with spinal cord injury pediatric use information is approved for pfizer’s lyrica (pregabalin) capsules and oral solution products. however, due to pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. pregabalin capsule is contraindicated in patients with known hypersensitivity to pregabalin or any of its components. angioedema and hypersensitivity reactions have occurred in patients receiving pregabalin therapy [see warnings and precautions (5.2)] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to pregabalin during pre

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - warfarin sodium (unii: 6153cwm0cl) (warfarin - unii:5q7zvv76ei) - warfarin sodium tablets, are indicated for: - prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (pe). - prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (af) and/or cardiac valve replacement. - reduction in the risk of death, recurrent myocardial infarction (mi), and thromboembolic events such as stroke or systemic embolization after myocardial infarction. limitations of use warfarin sodium tablets have no direct effect on an established thrombus, nor does it reverse ischemic tissue damage. once a thrombus has occurred, however, the goals of anticoagulant treatment are to prevent further extension of the formed clot and to prevent secondary thromboembolic complications that may result in serious and possibly fatal sequelae. warfarin sodium is contraindicated in - pregnancy warfarin sodium tablets are contraindicated in women who are pregnant except in pregnant women with mechanical heart valves, who are at high risk of thrombo

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate tablets in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13-17 years). the effectiveness of quetiapine fumarate tablets for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [see clinical studies ( 14.1) ]. quetiapine tablets are indicated for the acute treatment of manic episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [see clinical studies ( 14.2) ]. quetiapine tablets are indicated as monotherapy for the acute treatment of depressive episodes associated wi

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, 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)]. none. pregnancy category d   [see warnings and precautions ( 5.7)] topiramate can cause fetal harm when administered to a pregnant woman. data from

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine fumarate extended-release tablets are indicated for the treatment of schizophrenia. the efficacy of quetiapine fumarate extended-release tablets in schizophrenia was established in one 6-week and one maintenance trial in adults with schizophrenia. efficacy was supported by three 6-week trials in adults with schizophrenia and one 6-week trial in adolescents with schizophrenia (13-17 years) treated with quetiapine fumarate tablets [see clinical studies ( 14.1)]. quetiapine fumarate extended-release tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder, both as monotherapy and as an adjunct to lithium or divalproex. the efficacy of quetiapine fumarate extended-release tablets in manic or mixed episodes of bipolar i disorder was established in one 3-week trial in adults with manic or mixed episodes associated with bipolar i disorder. efficacy was supported by two 12-week monotherapy trials and one 3-week adjunctive t

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - tranylcypromine sulfate (unii: 7zat6es870) (tranylcypromine - unii:3e3v44j4z9) - tranylcypromine 10 mg - tranylcypromine sulfate is indicated for the treatment of major depressive disorder (mdd) in adult patients who have not responded adequately to other antidepressants. tranylcypromine sulfate is not indicated for the initial treatment of mdd due to the potential for serious adverse reactions and drug interactions, and the need for dietary restrictions [ see contraindications (4), warnings and precautions (5), and drug interactions (7)] . concomitant use of tranylcypromine sulfate or use in rapid succession with the products in table 1 is contraindicated. such use may cause severe or life-threatening reactions such as hypertensive crises or serotonin syndrome [see drug interactions (7.1)]. medication-free periods between administration of tranylcypromine sulfate and contraindicated agents are recommended [ see dosage and administration (2.2) and drug interactions (7.1) ]. table 1: pr

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - adjunctive therapy lamotrigine is indicated as adjunctive therapy for the following seizure types in patients aged 2 years and older: - partial-onset seizures. - primary generalized tonic-clonic (pgtc) seizures. - generalized seizures of lennox-gastaut syndrome. monotherapy lamotrigine is indicated for conversion to monotherapy in adults (aged 16 years and older) with partial-onset seizures who are receiving treatment with carbamazepine, phenytoin, phenobarbital, primidone, or valproate as the single antiepileptic drug (aed). safety and effectiveness of lamotrigine have not been established (1) as initial monotherapy; (2) for conversion to monotherapy from aeds other than carbamazepine, phenytoin, phenobarbital, primidone, or valproate; or (3) for simultaneous conversion to monotherapy from 2 or more concomitant aeds. lamotrigine is indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated f

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate monohydrate (unii: o1zpv620o4) (amphetamine - unii:ck833kgx7e), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules are indicated for the treatment of attention deficit hyperactivity disorder (adhd). the efficacy of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate and amphetamine sulfate extended-release capsules in the treatment of adhd was established on the basis of two controlled trials in children aged 6 to 12, one controlled trial in adolescents aged 13 to 17, and one controlled trial in adults who met dsm-iv ® criteria for adhd [ see clinical studies (14) ] . a diagnosis of adhd (dsm-iv ® ) implies the presence of hyperactive-impulsive or inattentive symptoms that caused impairment and were present before age 7 years. the symptoms must cause clinically significant impairment, e.g., in social, academic,  or occupational functioning, and be present in two or more

美国 - 英文 - NLM (National Library of Medicine)

golden state medical supply, inc. - terbinafine hydrochloride (unii: 012c11zu6g) (terbinafine - unii:g7riw8s0xp) - terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium). prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (koh) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis. terbinafine tablets are contraindicated in patients with: - chronic or active liver disease [see warnings and precautions (5.1)] - history of allergic reaction to oral terbinafine because of the risk of anaphylaxis [see adverse reactions (6.2)] risk summary available data from postmarketing cases on the use of terbinafine tablets in pregnant women are insufficient to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies, terbinafine did not cause malformations or any harm to the fetus when administered to pregnant rabbits and rats during the period of or