Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, 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: products contraindicated with the use of tranylcypromine sulfate - other monoamine oxidase inhibitors (maois) - selective se

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - clomiphene citrate (unii: 1b8447e7yi) (clomiphene - unii:1hrs458qu2) - clomiphene citrate is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiphene citrate therapy. those patients most likely to achieve success with clomiphene therapy include patients with polycystic ovary syndrome (see warnings : ovarian hyperstimulation syndrome ), amenorrhea-galactorrhea syndrome, psychogenic amenorrhea, post-oral-contraceptive amenorrhea, and certain cases of secondary amenorrhea of undetermined etiology. properly timed coitus in relationship to ovulation is important. a basal body temperature graph or other appropriate tests may help the patient and her physician determine if ovulation occurred. once ovulation has been established, each course of clomiphene citrate should be started on or about the 5th day of the cycle. long-term cyclic therapy is not recommended beyond a total of about six cycles (including three ovulatory cycles). (see dosage and administration

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - everolimus (unii: 9hw64q8g6g) (everolimus - unii:9hw64q8g6g) - everolimus tablets are indicated for the prophylaxis of organ rejection in adult patients at low-moderate immunologic risk receiving a kidney transplant [see clinical studies (14.1) ] everolimus is to be administered in combination with basiliximab induction and concurrently with reduced doses of cyclosporine and with corticosteroids. tdm of everolimus and cyclosporine is recommended for all patients receiving these products. [see dosage and administration (2.2, 2.3) ] everolimus is indicated for the prophylaxis of allograft rejection in adult patients receiving a liver transplant. everolimus is to be administered no earlier than 30 days post-transplant concurrently in combination with reduced doses of tacrolimus and with corticosteroids [see warnings and precautions (5.5) and clinical studies (14.2) ]. therapeutic drug monitoring (tdm) of everolimus and tacrolimus is recommended for all patients receiving these products. [see dosage and administration (2.3, 2.5) ] the safety and efficacy of everolimus has no

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - itraconazole (unii: 304nug5gf4) (itraconazole - unii:304nug5gf4) - itraconazole 100 mg - itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. blastomycosis, pulmonary and extrapulmonary 2. histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3. aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin b therapy. specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. therapy may be instituted before the results of the cultures and other laboratory studies are known; however, once these results become available, antiinfective therapy should be adjusted accordingly. itraconazole capsules are also indicated for the treatment of the following fungal infections in non-immunocompromised patients: 1. onychomycosis of the toenail, with or without fingernail involve

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - dextroamphetamine saccharate (unii: g83415v073) (dextroamphetamine - unii:tz47u051fi), amphetamine aspartate (unii: h527kap6l5) (amphetamine aspartate - unii:h527kap6l5), dextroamphetamine sulfate (unii: jj768o327n) (dextroamphetamine - unii:tz47u051fi), amphetamine sulfate (unii: 6dpv8nk46s) (amphetamine - unii:ck833kgx7e) - dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release is indicated for the treatment of attention deficit hyperactivity disorder (adhd). the efficacy of dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended-release 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 settings, e.g., school (or work) and at home. the symptoms must not be better accounted for by another me

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - alvimopan (unii: 677c126aet) (alvimopan anhydrous - unii:q153v49p3z) - alvimopan capsules are indicated to accelerate the time to upper and lower gastrointestinal recovery following surgeries that include partial bowel resection with primary anastomosis. alvimopan capsules are contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking alvimopan capsules [see warnings and precautions (5.3)]. risk summary available data regarding use of alvimopan in pregnant women are limited, and are insufficient to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. no fetal harm was observed in animal reproduction studies with oral administration of alvimopan during organogenesis to pregnant rats at doses 68 to 136 times the recommended human oral dose, or with intravenous administration during organogenesis to pregnant rats and pregnant rabbits at doses 3.4 to 6.8 times, and 5 to 10 times, respectively, the recommended human oral dose (see data). the estimated backgrou

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical inc. - levothyroxine sodium anhydrous (unii: 054i36cpmn) (levothyroxine - unii:q51bo43mg4) - levothyroxine sodium anhydrous 200 ug in 5 ml - levothyroxine sodium for injection is indicated for the treatment of myxedema coma. important limitations of use: the relative bioavailability between levothyroxine sodium for injection and oral levothyroxine products has not been established.  caution should be used when switching patients from oral levothyroxine products to levothyroxine sodium for injection as accurate dosing conversion has not been studied. none. pregnancy category a – there are no reported cases of levothyroxine sodium for injection used to treat myxedema coma in patients who were pregnant or lactating.  studies in pregnant women treated with oral levothyroxine to maintain a euthyroid state have not shown an increased risk of fetal abnormalities.  therefore, pregnant patients who develop myxedema should be treated with levothyroxine sodium for injection as the risk of nontreatment is associated with a high probability of significant morbidity or mortality to the maternal patient and the fetus. patients in labor who develop myxedema have

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - diphenoxylate hydrochloride (unii: w24od7yw48) (diphenoxylate - unii:73312p173g), atropine sulfate (unii: 03j5ze7ka5) (atropine - unii:7c0697dr9i) - diphenoxylate hydrochloride 2.5 mg - diphenoxylate hydrochloride and atropine sulfate tablets are effective as adjunctive therapy in the management of diarrhea. diphenoxylate hydrochloride and atropine sulfate tablets are contraindicated in patients with: diphenoxylate hydrochloride and atropine sulfate tablets are classified as a schedule v controlled substance by federal regulation. diphenoxylate hydrochloride is chemically related to the narcotic analgesic meperidine. in doses used for the treatment of diarrhea, whether acute or chronic, diphenoxylate has not produced addiction. diphenoxylate hydrochloride is devoid of morphine-like subjective effects at therapeutic doses. at high doses it exhibits codeine-like subjective effects. the dose which produces antidiarrheal action is widely separated from the dose which causes central nervous system effects. the insolubility of diphenoxylate hydrochloride in commonly available aqueous media precludes intravenous self-administration. a dose of 100 to 300 mg/day, which is equivalent to 40 to 120 tabl

Yhdysvallat - englanti - NLM (National Library of Medicine)

par pharmaceutical, inc. - midodrine hydrochloride (unii: 59jv96ytxv) (midodrine - unii:6ye7pbm15h) - midodrine hydrochloride tablets, usp are indicated for the treatment of symptomatic orthostatic hypotension (oh). because midodrine hydrochloride tablets, usp can cause marked elevation of supine blood pressure (bp > 200 mmhg systolic), it should be used in patients whose lives are considerably impaired despite standard clinical care, including non-pharmacologic treatment (such as support stockings), fluid expansion, and lifestyle alterations. the indication is based on midodrine hydrochloride tablets, usp effect on increases in 1-minute standing systolic blood pressure, a surrogate marker considered likely to correspond to a clinical benefit. at present, however, clinical benefits of midodrine hydrochloride tablets, usp principally improved ability to perform life activities, have not been established. further clinical trials are underway to verify and describe the clinical benefits of midodrine hydrochloride tablets, usp. after initiation of treatment, midodrine hydrochloride tablets, usp should be continue

Yhdysvallat - englanti - NLM (National Library of Medicine)

baxalta us inc. - pegaspargase (unii: 7d96ir0ppm) (pegaspargase - unii:7d96ir0ppm) - pegaspargase 750 [iu] in 1 ml - oncaspar® is indicated as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of pediatric and adult patients with all. oncaspar is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with all and hypersensitivity to native forms of l-asparaginase. oncaspar is contraindicated in patients with a: - history of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients [see warnings and precautions (5.1)] . - history of serious thrombosis with prior l-asparaginase therapy [see warnings and precautions (5.2)] . - history of pancreatitis, including pancreatitis related to prior l-asparaginase therapy [see warnings and precautions (5.3)] . - history of serious hemorrhagic events with prior l-asparaginase therapy [see warnings and precautions (5.5)] . - severe hepatic impairment [see warnings and precautions (5.6)] . risk summary there are no available data on the use of oncaspar i