Соединенные Штаты - английский - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin capsules, usp are indicated for: - management of postherpetic neuralgia in adults - adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy gabapentin capsules, usp are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy category c: there are no adequate and well-controlled studies in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic when administered to pregnant animals at doses similar to or lower than those used clinically. gabapentin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. when pregnant mice received oral doses of gabapentin (500, 1000, or 3000 mg/kg/day) during the period of organogenesis, embryo-fetal toxicity (increased incidences of skeletal variations) was observed at the two highest doses. the no-effec

Соединенные Штаты - английский - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - buprenorphine (unii: 40d3scr4gz) (buprenorphine - unii:40d3scr4gz) - buprenorphine transdermal system is 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 buprenorphine transdermal system is contraindicated in patients with: risk summary prolonged use of opioid analgesics during pregnancy may cause neonatal opioid withdrawal syndrome [see warnings and precautions (5.3)]. available data with buprenorphine transdermal system in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage. in animal reproduction studies, buprenorphine caused an increase in the number of stillborn offspring, reduced litter size, and reduced offspring growth in rats at maternal exposure levels that were approximately 10 times that of human subjects who received one buprenorphine transdermal system 20 mcg/hour, the maximum recommended human dose (mrhd) [see data]. based on animal data, advise pregnant women of the

Соединенные Штаты - английский - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - oxcarbazepine (unii: vzi5b1w380) (oxcarbazepine - unii:vzi5b1w380) - oxcarbazepine tablets are indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures in adults and as monotherapy in the treatment of partial seizures in pediatric patients aged 4 years and above with epilepsy, and as adjunctive therapy in pediatric patients aged 2 years and above with partial seizures. oxcarbazepine tablets are contraindicated in patients with a known hypersensitivity to oxcarbazepine or to any of its components, or to eslicarbazepine acetate [see warnings and precautions (5.2, 5.3) ]. clinical considerations oxcarbazepine levels may decrease during pregnancy [see warnings and precautions (5.10) ]. pregnancy category c fetal risk summary there are no adequate and well-controlled clinical studies of oxcarbazepine in pregnant women; however, oxcarbazepine is closely related structurally to carbamazepine, which is considered to be teratogenic in humans. data on a limited number of pregnancies from pregnancy registries suggest congenital malformations associated

Соединенные Штаты - английский - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride extended-release tablets, usp (xl) are indicated for the treatment of major depressive disorder (mdd), as defined by the diagnostic and statistical manual (dsm). the efficacy of the immediate-release formulation of bupropion was established in two 4-week controlled inpatient trials and one 6-week controlled outpatient trial of adult patients with mdd. the efficacy of the sustained-release formulation of bupropion in the maintenance treatment of mdd was established in a long-term (up to 44 weeks), placebo-controlled trial in patients who had responded to bupropion in an 8-week study of acute treatment [see clinical studies (14.1)]. bupropion hydrochloride extended-release tablets, usp (xl) are indicated for the prevention of seasonal major depressive episodes in patients with a diagnosis of seasonal affective disorder (sad). the efficacy of bupropion hydrochloride extended-release tablets (xl) in the prevention of seasonal major depressive episodes was established in 3 placebo-controlle

Соединенные Штаты - английский - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - fluoxetine hydrochloride (unii: i9w7n6b1kj) (fluoxetine - unii:01k63sup8d) - fluoxetine is indicated for the acute and maintenance treatment of major depressive disorder in adult patients and in pediatric patients aged 8 to 18 years [see clinical studies (14.1)] . the usefulness of the drug in adult and pediatric patients receiving fluoxetine for extended periods should periodically be re-evaluated [see dosage and administration (2.1)] . fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with obsessive compulsive disorder (ocd [see clinical studies (14.2)] . the effectiveness of fluoxetine in long‑term use, i.e., for more than 13 weeks, has not been systematically evaluated in placebo‑controlled trials. therefore, the physician who elects to use fluoxetine for extended periods should periodically re-evaluate the long‑term usefulness of the drug for the individual patient [see dosage and administration (2.2)] . fluoxetine is indicated for the acute and maintenance treatment of bing

Соединенные Штаты - английский - NLM (National Library of Medicine)

sunrise pharmaceutical, inc. - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate tablets usp are indicated for: - narcolepsy . - attention deficit disorder with hyperactivity , as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in pediatric patients (ages 3 to 16 years) with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate to severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. the diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. nonlocalizing (soft) neurological signs, learning disability, and abnormal eeg may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. known hypersensitivity to amphetamine products. during or within 14 days following the administration of monoamine oxidase inhibitors (hypertensive crises may result

Соединенные Штаты - английский - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - lamotrigine (unii: u3h27498ks) (lamotrigine - unii:u3h27498ks) - adjunctive therapy lamotrigine tablets are 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 tablets are 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 tablets 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 tablets are indicated for the maintenance treatment of bipolar i disorder to delay the time to occurrence of mood episodes (depression, mania, hyp

Соединенные Штаты - английский - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - modafinil (unii: r3uk8x3u3d) (modafinil - unii:r3uk8x3u3d) - modafinil tablets are indicated to improve wakefulness in adult patients with excessive sleepiness associated with narcolepsy, obstructive sleep apnea (osa), or shift work disorder (swd). limitations of use in osa, modafinil tablets are indicated to treat excessive sleepiness and not as treatment for the underlying obstruction. if continuous positive airway pressure (cpap) is the treatment of choice for a patient, a maximal effort to treat with cpap for an adequate period of time should be made prior to initiating and during treatment with modafinil tablets for excessive sleepiness. modafinil is contraindicated in patients with known hypersensitivity to modafinil or armodafinil or its inactive ingredients [see warnings and precautions (5.1, 5.2, 5.3)] . teratogenic effects pregnancy category c there are no adequate and well-controlled studies of modafinil in pregnant women. intrauterine growth restriction and spontaneous abortion have been reported in association with modafinil (a mixture of r- and s-modaf

Соединенные Штаты - английский - NLM (National Library of Medicine)

lake erie medical & surgical supply dba quality care products llc - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - 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 sertraline hydrochloride in hos

Соединенные Штаты - английский - NLM (National Library of Medicine)

amneal pharmaceuticals of new york llc - dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi) - dextroamphetamine sulfate is indicated in: narcolepsy attention deficit disorder with hyperactivity as an integral part of a total treatment program that typically includes other measures (psychological, educational, social) for patients (ages 6 years to 16 years) with this syndrome. a diagnosis of attention deficit hyperactivity disorder (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 2 or more settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another mental disorder. for the inattentive type, at least 6 of the following symptoms must have persisted for at least 6 months: lack of attention to details/careless mistakes; lack of sustained attention; poor listener; failure to follow through on tasks; poor organization; avoids tasks requiring sustained mental effort; loses things; easily distracted; forgetful. for the hyperactive-impulsive type, at least 6 of the following symptoms must have persisted for at least 6 months: fidgeting/squirming; leaving seat; inappropriate running/climbing; difficulty with quiet activities; “on the go”; excessive talking; blurting answers; can’t wait turn; intrusive. the combined type requires both inattentive and hyperactive-impulsive criteria to be met. special diagnostic considerations specific etiology of this syndrome is unknown, and there is no single diagnostic test. adequate diagnosis requires the use of medical and special psychological, educational, and social resources. learning may or may not be impaired. the diagnosis must be based upon a complete history and evaluation of the patient and not solely on the presences of the required number of dsm-iv characteristics. need for comprehensive treatment program dextroamphetamine sulfate is indicated as an integral part of a total treatment program for adhd that may include other measures (psychological, educational, social) for patients with this syndrome. drug treatment may not be indicated for all patients with this syndrome. stimulants are not intended for use in patients who exhibit symptoms secondary to environmental factors and/or other primary psychiatric disorders, including psychosis. appropriate educational placement is essential and psychosocial intervention is often helpful. when remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician’s assessment of the chronicity and severity of the patient’s symptoms. advanced arteriosclerosis, symptomatic cardiovascular disease, moderate to severe hypertension, hyperthyroidism, known hypersensitivity or idiosyncrasy to the sympathomimetic amines, glaucoma. agitated states. patients with a history of drug abuse. known hypersensitivity or idiosyncrasy to amphetamine. in patients known to be hypersensitive to amphetamine, or other components of dextroamphetamine sulfate. hypersensitivity reactions such as angioedema and anaphylactic reactions have been reported in patients treated with other amphetamine products [see adverse reactions]. patients taking monoamine oxidase inhibitors (maois), or within 14 days of stopping maois (including maois such as linezolid or intravenous methylene blue), because of an increased risk of hypertensive crisis [see warnings and drug interactions]. dextroamphetamine sulfate is a schedule ii controlled substance. amphetamines have been extensively abused. tolerance, extreme psychological dependence and severe social disability have occurred. there are reports of patients who have increased the dosage to many times that recommended. abrupt cessation following prolonged high dosage administration results in extreme fatigue and mental depression; changes are also noted on the sleep eeg. manifestations of chronic intoxication with amphetamines include severe dermatoses, marked insomnia, irritability, hyperactivity, and personality changes. the most severe manifestation of chronic intoxication is psychosis, often clinically indistinguishable from schizophrenia. this is rare with oral amphetamines.