United States - English - NLM (National Library of Medicine)

citron pharma llc - naproxen (unii: 57y76r9atq) (naproxen - unii:57y76r9atq) - naproxen 250 mg - carefully consider the potential benefits and risks of naproxen tablets usp and other treatment options before deciding to use naproxen tablets usp. use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals (see warnings: gastrointestinal bleeding, ulceration, and perforation ) . naproxen tablets usp are indicated: - for the relief of the signs and symptoms of rheumatoid arthritis  - for the relief of the signs and symptoms of osteoarthritis  - for the relief of the signs and symptoms of ankylosing spondylitis  - for the relief of the signs and symptoms of juvenile arthritis  naproxen tablets usp are also indicated: - for relief of the signs and symptoms of tendonitis  - for relief of the signs and symptoms of bursitis  - for relief of the signs and symptoms of acute gout  - for the management of pain  - for the management of primary dysmenorrhea naproxen tablets are contraindicated in the following patients: - known hypersensitivity (e.g., anaphylactic

United States - English - NLM (National Library of Medicine)

citron pharma llc - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets 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 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)] . topiramate tablets are indicated for adults for the prophylaxis of migraine headache [see clinical studies (14.3)]. the usefulness of topiramate tablets in the acute treatment of migraine headache has not been studied. additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (t

United States - English - NLM (National Library of Medicine)

citron pharma llc - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram 10 mg in 5 ml - citalopram oral solution, usp is indicated for the treatment of depression. the efficacy of citalopram oral solution, usp in the treatment of depression was established in 4 to 6 week, controlled trials of outpatients whose diagnosis corresponded most closely to the dsm-iii and dsm-iii-r category of major depressive disorder (see clinical pharmacology ). a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest 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 concentration, a suicide attempt or suicidal ideation. the antidepressant action of citalopram oral solution, usp in hospitalized depressed patients has no

United States - English - NLM (National Library of Medicine)

citron pharma llc - lisinopril (unii: e7199s1ywr) (lisinopril anhydrous - unii:7q3p4bs2fd), hydrochlorothiazide (unii: 0j48lph2th) (hydrochlorothiazide - unii:0j48lph2th) - lisinopril 10 mg - lisinopril and hydrochlorothiazide tablets, usp are indicated for the treatment of hypertension, to lower blood pressure. lowering blood pressure lowers the risk of fatal and non-fatal 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 lisinopril and hydrochlorothiazide. 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 1 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

United States - English - NLM (National Library of Medicine)

citron pharma llc - quetiapine fumarate (unii: 2s3pl1b6uj) (quetiapine - unii:bgl0jsy5si) - quetiapine 25 mg - quetiapine fumarate 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 to 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 fumarate 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 fumarate tablets are indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder. efficacy was established in two 8-week mo

United States - English - NLM (National Library of Medicine)

citron pharma llc - clopidogrel bisulfate (unii: 08i79htp27) (clopidogrel - unii:a74586sno7) - clopidogrel 75 mg - - for patients with non-st-segment elevation acs [unstable angina (ua)/non-st-elevation myocardial infarction (nstemi)], including patients who are to be managed medically and those who are to be managed with coronary revascularization, clopidogrel tablets, usp have been shown to decrease the rate of a combined endpoint of cardiovascular death, myocardial infarction (mi), or stroke as well as the rate of a combined endpoint of cardiovascular death, mi, stroke, or refractory ischemia. - for patients with st-elevation myocardial infarction (stemi), clopidogrel tablets, usp have been shown to reduce the rate of death from any cause and the rate of a combined endpoint of death, re-infarction, or stroke. the benefit for patients who undergo primary percutaneous coronary intervention is unknown. the optimal duration of clopidogrel tablets, usp therapy in acs is unknown. for patients with a history of recent myocardial infarction (mi), recent stroke, or established peripheral arterial disease, clopidogrel tablets, u

United States - English - NLM (National Library of Medicine)

citron pharma llc - stavudine (unii: bo9le4qfzf) (stavudine - unii:bo9le4qfzf) - stavudine 15 mg - stavudine capsules, usp in combination with other antiretroviral agents, are indicated for the treatment of human immunodeficiency virus (hiv)-1 infection [see clinical studies (14) ] . stavudine capsules are contraindicated in patients with clinically significant hypersensitivity to stavudine or to any of the components contained in the formulation. teratogenic effects pregnancy category c reproduction studies have been performed in rats and rabbits with exposures (based on cmax ) up to 399 and 183 times, respectively, of that seen at a clinical dosage of 1 mg/kg/day and have revealed no evidence of teratogenicity. the incidence in fetuses of a common skeletal variation, unossified or incomplete ossification of sternebra, was increased in rats at 399 times human exposure, while no effect was observed at 216 times human exposure. a slight post-implantation loss was noted at 216 times the human exposure with no effect noted at approximately 135 times the human exposure. an increase in early rat ne

United States - English - NLM (National Library of Medicine)

citron pharma llc - levofloxacin (unii: 6gnt3y5lmf) (levofloxacin anhydrous - unii:rix4e89y14) - levofloxacin anhydrous 250 mg - to reduce the development of drug-resistant bacteria and maintain the effectiveness of levofloxacin tablets and other antibacterial drugs, levofloxacin tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. levofloxacin tablets are indicated for the treatment of adults (≥18 years of age) with mild, moderate, and severe infections caused by susceptible isolates of the designated microorganisms in the conditions listed in this section. levofloxacin injection is indicated when intravenous administration offers a route of administration advantageous to the patient (e.g., patient cannot tolerate an oral dosage form). culture and susceptibility testing appropriate

United States - English - NLM (National Library of Medicine)

citron pharma llc - escitalopram oxalate (unii: 5u85dbw7lo) (escitalopram - unii:4o4s742any) - escitalopram 5 mg in 5 ml - escitalopram oral solution usp is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see clinical studies (14.1)] . a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest 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 concentration, a suicide attempt or suicidal ideation. escitalopram oral solution usp is indicated for the acute treatment of generalized anxiety disorder (gad) in adults [see clinical studies (14.2)] . generalized anxiety disorder (dsm-iv) is characterized by excessive anxiety and worry (apprehensive expectation) t

United States - English - NLM (National Library of Medicine)

citron pharma llc - escitalopram oxalate (unii: 5u85dbw7lo) (escitalopram - unii:4o4s742any) - escitalopram 5 mg - escitalopram tablets are indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [see clinical studies (14.1)] . a major depressive episode (dsm-iv) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest 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 concentration, a suicide attempt or suicidal ideation. escitalopram tablets are indicated for the acute treatment of generalized anxiety disorder (gad) in adults [see clinical studies (14.2)] . generalized anxiety disorder (dsm-iv) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent