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northstar rx llc - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9), sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - omeprazole 20 mg - omprazole and sodium bicarbonate capsules are indicated in adults for the: - short-term treatment of active duodenal ulcer. most patients heal within four weeks. some patients may require an additional four weeks of therapy. - short-term treatment (4 to 8 weeks) of active benign gastric ulcer. - treatment of heartburn and other symptoms associated with gerd for up to 4 weeks. - short-term treatment (4 to 8 weeks) of ee due to acid-mediated gerd which has been diagnosed by endoscopy in adults. the efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with ee has not been established. if a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. if there is recurrence of ee or gerd symptoms (e.g., heartburn), additional 4 to 8 week courses of omeprazole and sodium bicarbonate capsules may be considered. - the efficacy of omeprazole and sodium bicarbonate capsules used for longer than 8 weeks in patients with ee has not been esta

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pd-rx pharmaceuticals, inc. - nelfinavir mesylate (unii: 98d603vp8v) (nelfinavir - unii:ho3ogh5d7i) - nelfinavir 250 mg - viracept in combination with other antiretroviral agents is indicated for the treatment of hiv-1 infection. coadministration of viracept is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of nelfinavir) are listed in table 3 ]. coadministration of viracept is contraindicated with drugs that are highly dependent on cyp3a for clearance and for which elevated plasma concentrations are associated with serious and/or life-threatening events. these drugs and other contraindicated drugs (which may lead to reduced efficacy of nelfinavir) are listed in table 3 [also see drug interactions (7), table 6 ]. pregnancy category b viracept should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. there are no adequate and well-controlled studies in pregnant women taki

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rebel distributors corp - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - lopinavir 200 mg - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. the following points should be considered when initiating therapy with kaletra: - the use of other active agents with kaletra is associated with a greater likelihood of treatment response [see clinical pharmacology (12.4) and clinical studies (14)] . - genotypic or phenotypic testing and/or treatment history should guide the use of kaletra [see clinical pharmacology (12.4)] . the number of baseline lopinavir resistance-associated substitutions affects the virologic response to kaletra [see clinical pharmacology (12.4)] . - once daily administration of kaletra is not recommended for any pediatric patients. ● kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir. ●  co-administration of kaletra is contraindicated with drugs th

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

hhs/program support center/supply service center - lopinavir (unii: 2494g1jf75) (lopinavir - unii:2494g1jf75), ritonavir (unii: o3j8g9o825) (ritonavir - unii:o3j8g9o825) - lopinavir 200 mg - kaletra is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection. the following points should be considered when initiating therapy with kaletra: - the use of other active agents with kaletra is associated with a greater likelihood of treatment response [see clinical pharmacology (12.4) and clinical studies (14)] . - genotypic or phenotypic testing and/or treatment history should guide the use of kaletra [see clinical pharmacology (12.4)] . the number of baseline lopinavir resistance-associated substitutions affects the virologic response to kaletra [see clinical pharmacology (12.4)] . - once daily administration of kaletra is not recommended for any pediatric patients. - kaletra is contraindicated in patients with previously demonstrated clinically significant hypersensitivity (e.g., toxic epidermal necrolysis, stevens-johnson syndrome, erythema multiforme) to any of its ingredients, including ritonavir. - co-administration of kaletra is contraindicated with drugs th

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eisai inc. - perampanel (unii: h821664npk) (perampanel - unii:h821664npk) - perampanel 2 mg - fycompa is indicated for the treatment of partial-onset seizures with or without secondarily generalized seizures in patients with epilepsy 4 years of age and older. fycompa is indicated as adjunctive therapy for the treatment of primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older.  none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antiepileptic drugs (aeds), such as fycompa, during pregnancy. encourage women who are taking fycompa during pregnancy to enroll in the north american antiepileptic drug (naaed) pregnancy registry by calling 1-888-233-2334 or visiting http://www.aedpregnancyregistry.org. risk summary there are no adequate data on the developmental risk associated with use in pregnant women.  in animal studies, perampanel induced developmental toxicity in pregnant rat and rabbit at clinically relevant doses [ see data ] . in the u.s. general population the estimated background risk

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ascend laboratories, llc - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 500 mg - mycophenolate mofetil (mmf) is indicated for the prophylaxis of organ rejection, in adult and pediatric recipients 3 months of age and older of allogeneic kidney [see clinical studies (14.1)], heart [see clinical studies (14.2)] or liver transplants [see clinical studies (14.3)] , in combination with other immunosuppressants. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil (mmf), mycophenolic acid (mpa) or any component of the drug product. mycophenolate mofetil intravenous is contraindicated in patients who are allergic to polysorbate 80 (tween). pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to mycophenolate during pregnancy and those becoming pregnant within 6 weeks of discontinuing mycophenolate mofetil treatment. to report a pregnancy or obtain information about the registry, visit www.mycophenolaterems.com

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american health packaging - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 500 mg - mycophenolate mofetil tablet, usp is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. mycophenolate mofetil tablets, usp should be used concomitantly with cyclosporine and corticosteroids. mycophenolate mofetil intravenous is an alternative dosage form to mycophenolate mofetil capsules, tablets and oral suspension. mycophenolate mofetil intravenous should be administered within 24 hours following transplantation. mycophenolate mofetil intravenous can be administered for up to 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. mycophenolate mofetil intravenous is contraindicated in patients who are allergic to polysorbate 80 (tween).

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

american health packaging - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 250 mg - mycophenolate mofetil capsule, usp is indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. mycophenolate mofetil capsules, usp should be used concomitantly with cyclosporine and corticosteroids. mycophenolate mofetil intravenous is an alternative dosage form to mycophenolate mofetil capsules, tablets and oral suspension. mycophenolate mofetil intravenous should be administered within 24 hours following transplantation. mycophenolate mofetil intravenous can be administered for up to 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication. allergic reactions to mycophenolate mofetil have been observed; therefore, mycophenolate mofetil is contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any component of the drug product. mycophenolate mofetil intravenous is contraindicated in patients who are allergic to polysorbate 80 (tween).

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

zydus pharmaceuticals (usa) inc. - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 250 mg - mycophenolate mofetil capsules and mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. mycophenolate mofetil capsules and/or tablets should be used concomitantly with cyclosporine and corticosteroids. mycophenolate mofetil intravenous is an alternative dosage form to mycophenolate mofetil capsules, mycophenolate mofetil tablets and oral suspension. mycophenolate mofetil intravenous should be administered within 24 hours following transplantation. mycophenolate mofetil intravenous can be administered for up to 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication. allergic reactions to mycophenolate mofetil capsules and mycophenolate mofetil tablets have been observed; therefore, mycophenolate mofetil capsules and mycophenolate mofetil tablets are contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any com

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

cadila healthcare limited - mycophenolate mofetil (unii: 9242ecw6r0) (mycophenolic acid - unii:hu9dx48n0t) - mycophenolate mofetil 250 mg - mycophenolate mofetil capsules and mycophenolate mofetil tablets are indicated for the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants. mycophenolate mofetil capsules and/or tablets should be used concomitantly with cyclosporine and corticosteroids. mycophenolate mofetil intravenous is an alternative dosage form to mycophenolate mofetil capsules, mycophenolate mofetil tablets and oral suspension. mycophenolate mofetil intravenous should be administered within 24 hours following transplantation. mycophenolate mofetil intravenous can be administered for up to 14 days; patients should be switched to oral mycophenolate mofetil as soon as they can tolerate oral medication. allergic reactions to mycophenolate mofetil capsules and mycophenolate mofetil tablets have been observed; therefore, mycophenolate mofetil capsules and mycophenolate mofetil tablets are contraindicated in patients with a hypersensitivity to mycophenolate mofetil, mycophenolic acid or any com