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

exelan pharmaceuticals, inc - celecoxib (unii: jcx84q7j1l) (celecoxib - unii:jcx84q7j1l) - celecoxib capsules are indicated for the management of the signs and symptoms of oa [see clinical studies (14.1) ] for the management of the signs and symptoms of ra [see clinical studies (14.2) ] for the management of the signs and symptoms of jra in patients 2 years and older [see clinical studies (14.3) ] for the management of the signs and symptoms of as [see clinical studies (14.4) ] for the management of acute pain in adults [see clinical studies (14.5) ] for the management of primary dysmenorrhea [see clinical studies (14.5) ] celecoxib capsules are contraindicated in the following patients: -   known hypersensitivity (e.g., anaphylactic reactions and serious skin reactions) to celecoxib, any components of the drug product [see warnings and precautions (5.7, 5.9) ]. -   history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other nsaids. severe, sometimes fatal, anaphylactic reactions to nsaids, have been reported in such patients [see warnings and precautions (5.7, 5.8

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

exelan pharmaceuticals, inc. - gabapentin (unii: 6cw7f3g59x) (gabapentin - unii:6cw7f3g59x) - gabapentin tablets 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 tablets are contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as gabapentin, during pregnancy. encourage women who are taking gabapentin during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling the toll free number 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org/ . risk summary there are no adequate data on the developmental risks associated with the use of gabapentin in pregnant women. in nonclinical studies in mice, rats, and rabbits, gabapentin was developmentally toxic (increase

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

exelan pharmaceuticals inc. - lurasidone hydrochloride (unii: o0p4i5851i) (lurasidone - unii:22ic88528t) - lurasidone hydrochloride tablets are indicated for: - treatment of adult and adolescent patients (13 to 17 years) with schizophrenia [see clinical studies (14.1)] . - monotherapy treatment of adult and pediatric patients (10 to 17 years) with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies (14.2)] . - adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar i disorder (bipolar depression) [see clinical studies (14.2)] . - known hypersensitivity to lurasidone hcl or any components in the formulation. angioedema has been observed with lurasidone [see adverse reactions (6.1)] . - strong cyp3a4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) [see drug interactions (7.1)]. - strong cyp3a4 inducers (e.g., rifampin, avasimibe, st. john's wort, phenytoin, carbamazepine, etc.) [see drug interactions (7.1)]. pregnancy exposure registry there is a pregnancy expo

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

medical purchasing solutions, llc - verapamil hydrochloride (unii: v3888oey5r) (verapamil - unii:cj0o37ku29) - verapamil hydrochloride 2.5 mg in 1 ml - verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including: - rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (wolff-parkinson-white [wpw] and lown-ganong-levine [lgl] syndromes). when clinically advisable, appropriate vagal maneuvers (e.g., valsalva maneuver) should be attempted prior to verapamil administration. - temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation, except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (wolff-parkinson-white [wpw] and lown-ganong-levine [lgl] syndromes). in controlled studies in the u.s., about 60% of patients with supraventricular tachycardia converted to normal sinus rhythm within 10 minutes after intravenous verapamil hydrochloride. uncontrolled studies reported in the world literature describe a conversion rate of about 80%. about 70% of patients with atrial f

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

x-gen pharmaceuticals, inc. - magnesium sulfate heptahydrate (unii: sk47b8698t) (magnesium cation - unii:t6v3lhy838) - magnesium sulfate heptahydrate 500 mg in 1 ml

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

aphena pharma solutions - tennessee, llc - alfuzosin hydrochloride (unii: 75046a1xtn) (alfuzosin - unii:90347ytw5f) - alfuzosin hydrochloride 10 mg - alfuzosin hydrochloride is indicated for the treatment of signs and symptoms of benign prostatic hyperplasia. alfuzosin hydrochloride is not indicated for the treatment of hypertension. alfuzosin hydrochloride is not indicated for use in the pediatric population. alfuzosin hydrochloride is contraindicated for use: - in patients with moderate or severe hepatic impairment (childs-pugh categories b and c), since alfuzosin blood levels are increased in these patients [see use in specific populations (8.7) and clinical pharmacology (12.3)] . - with potent cyp3a4 inhibitors such as ketoconazole, itraconazole, and ritonavir, since alfuzosin blood levels are increased [see drug interactions (7.1) and clinical  pharmacology (12.3)] . - in patients with known hypersensitivity, such as urticaria and angioedema, to alfuzosin hydrochloride or any component of alfuzosin hydrochloride tablets [see adverse reactions (6.2)] . pregnancy category b. alfuzosin hydrochloride is not indicated for use in women, and there are no s

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

aphena pharma solutions - tennessee, llc - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine besylate tablets, usp are indicated for the treatment of hypertension, to lower blood pressure. 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 amlodipine besylate 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 pharmaco

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

aphena pharma solutions - tennessee, llc - amlodipine besylate (unii: 864v2q084h) (amlodipine - unii:1j444qc288) - amlodipine besylate tablets, usp are indicated for the treatment of hypertension, to lower blood pressure. 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 amlodipine besylate 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 pharmaco

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

exelan pharmaceuticals inc. - bupropion hydrochloride (unii: zg7e5poy8o) (bupropion - unii:01zg3tpx31) - bupropion hydrochloride 300 mg - bupropion hydrochloride extended-release tablets, (xl) is 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, (xl) is 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-controlled trials

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

exelan pharmaceuticals, inc. - zonisamide (unii: 459384h98v) (zonisamide - unii:459384h98v) - zonisamide 100 mg - zonisamide capsules are indicated as adjunctive therapy in the treatment of partial seizures in adults with epilepsy. zonisamide capsules are contraindicated in patients who have demonstrated hypersensitivity to sulfonamides or zonisamide. the abuse and dependence potential of zonisamide has not been evaluated in human studies (see warnings, cognitive/neuropsychiatric adverse events subsection). in a series of animal studies, zonisamide did not demonstrate abuse liability and dependence potential. monkeys did not self-administer zonisamide in a standard reinforcing paradigm. rats exposed to zonisamide did not exhibit signs of physical dependence of the cns-depressant type. rats did not generalize the effects of diazepam to zonisamide in a standard discrimination paradigm after training, suggesting that zonisamide does not have abuse potential of the benzodiazepine-cns depressant type.