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

quinn pharmaceuticals - glycopyrrolate (unii: v92so9wp2i) (glycopyrronium - unii:a14fb57v1d) - for use as adjunctive therapy in the treatment of peptic ulcer. glaucoma; obstructive uropathy (for example, bladder neck obstruction due to prostatic hypertrophy); obstructive disease of the gastrointestinal tract (as in achalasia, pyloroduodenal stenosis, etc.); paralytic ileus; intestinal atony of the elderly or debilitated patient; unstable cardiovascular status in acute hemorrhage; severe ulcerative colitis; toxic megacolon complicating ulcerative colitis; myasthenia gravis. glycopyrrolate tablets, usp are contraindicated in those patients with a hypersensitivity to glycopyrrolate.

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

quinnova pharmaceuticals, inc. - benzoyl peroxide (unii: w9wzn9a0gm) (benzoyl peroxide - unii:w9wzn9a0gm), selenium sulfide (unii: z69d9e381q) (selenium - unii:h6241uj22b) - cleanse & treat is indicated for the topical treatment of acne vulgaris. cleanse & treat is contraindicated in patients with a history of hypersensitivity to any of its ingredients.

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

quinnova pharmaceuticals, inc. - selenium sulfide (unii: z69d9e381q) (selenium - unii:h6241uj22b) - selenium sulfide has the following chemical structure:

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

quinnova pharmaceuticals, llc - hydrocodone bitartrate (unii: no70w886kk) (hydrocodone - unii:6yks4y3wq7) - hydrocodone bitartrate 2.5 mg

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

quinn pharmaceuticals - acyclovir (unii: x4hes1o11f) (acyclovir - unii:x4hes1o11f) - acyclovir 200 mg - acyclovir is contraindicated for patients who develop hypersensitivity to acyclovir or valacyclovir.

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

quinn pharmaceuticals - mercaptopurine (unii: e7wed276i5) (mercaptopurine anhydrous - unii:pkk6muz20g) - mercaptopurine 50 mg - mercaptopurine tablets is indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (all) as part of a combination chemotherapy maintenance regimen. mercaptopurine tablets is indicated for treatment of adult and pediatric patients with acute lymphoblastic leukemia (all) as part of a combination chemotherapy maintenance regimen. none. risk summary mercaptopurine tablets can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)]. pregnant women who receive mercaptopurine have an increased incidence of miscarriage and stillbirth (see data) . advise pregnant women of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. data human data women receiving mercaptopurine in the first trimester of pregnancy have an increased incidence of miscarriage; the risk of malformation in offspring surviving first trimester exposure is not known. in a series of 28 women receiving mercaptopurine after the first trimester of pregnancy, 3 mothers died prior to delivery, 1 delivered a stillborn child, and 1 aborted; there were no cases of macroscopically abnormal fetuses. animal data mercaptopurine was embryo-lethal and teratogenic in several animal species (rat, mouse, rabbit, and hamster) at doses less than the recommended human dose. risk summary there are no data on the presence of mercaptopurine or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with mercaptopurine tablets and for 1 week after the last dose. mercaptopurine tablets can cause fetal harm when administered to pregnant women [see use in specific populations (8.1)]. pregnancy testing verify the pregnancy status in females of reproductive potential prior to initiating mercaptopurine tablets [see use in specific populations (8.1)]. contraception females advise females of reproductive potential to use effective contraception during treatment with mercaptopurine tablets and for 6 months after the last dose. males based on genotoxicity findings, advise males with female partners of reproductive potential to use effective contraception during treatment with mercaptopurine tablets and for 3 months after the last dose [see nonclinical toxicology (13.1)]. infertility females and males based on findings from animal studies, mercaptopurine tablets can impair female and male fertility [see nonclinical toxicology (13.1)]. the long-term effects of mercaptopurine on female and male fertility, including the reversibility have not been studied. safety and effectiveness of mercaptopurine tablets has been established in pediatric patients. use of mercaptopurine tablets in pediatrics is supported by evidence from the published literature and clinical experience. symptomatic hypoglycemia has been reported in pediatric patients with all receiving mercaptopurine. reported cases were in pediatrics less than 6 years of age or with a low body mass index. clinical studies of mercaptopurine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or another drug therapy. use the lowest recommended starting dosage for mercaptopurine tablets or increase the dosing interval to every 36- 48 hours in patients with renal impairment (clcr less than 50 ml/min). adjust the dose to maintain absolute neutrophil count (anc) at a desirable level and for adverse reactions [see dosage and administration (2.3)]. use the lowest recommended starting dosage for mercaptopurine tablets in patients with hepatic impairment. adjust the dose to maintain absolute neutrophil count (anc) at a desirable level and for adverse reactions [see dosage and administration (2.3)].

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

quinn pharmaceuticals, llc - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole tablets, usp is indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions (6.1)] . there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, women should be advised of a possible risk to the fetus associ

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

quinn pharmaceuticals - tenofovir disoproxil fumarate (unii: ott9j7900i) (tenofovir anhydrous - unii:w4hfe001u5) - tenofovir disoproxil fumarate is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (hiv-1) infection in adults and pediatric patients 2 years of age and older weighing at least 35 kg. tenofovir disoproxil fumarate is indicated for the treatment of chronic hepatitis b virus (hbv) in adults and pediatric patients 2 years of age and older weighing at least 35 kg. none. pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to tenofovir disoproxil fumarate during pregnancy. healthcare providers are encouraged to register patients by calling the antiretroviral pregnancy registry (apr) at 1-800-258-4263. risk summary available data from the apr show no increase in the overall risk of major birth defects with first trimester exposure for tenofovir disoproxil fumarate (tdf) (2.1%) compared with the background rate for major birth defects of 2.7% in a u.s. reference population of the metropoli

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

quinn pharmaceuticals - riluzole (unii: 7lj087rs6f) (riluzole - unii:7lj087rs6f) - riluzole tablets is indicated for the treatment of amyotrophic lateral sclerosis (als). riluzole tablets is contraindicated in patients with a history of severe hypersensitivity reactions to riluzole or to any of its components (anaphylaxis has occurred) [see adverse reactions ( 6.1)] . risk summary there are no studies of riluzole in pregnant women, and case reports have been inadequate to inform the drug-associated risk. the background risk for major birth defects and miscarriage in patients with amyotrophic lateral sclerosis is unknown. in the u.s. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. in studies in which riluzole was administered orally to pregnant animals, developmental toxicity (decreased embryofetal/offspring viability, growth, and functional development) was observed at clinically relevant doses [see data] . based on these results, wome

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

quinn pharmaceuticals, llc - pitavastatin calcium (unii: iyd54xeg3w) (pitavastatin - unii:m5681q5f9p) - drug therapy should be one component of multiple-risk-factor intervention in individuals who require modifications of their lipid profile. lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol only when the response to diet and other nonpharmacological measures has been inadequate. pitavastatin tablets is indicated as an adjunctive therapy to diet to reduce elevated total cholesterol (tc), low-density lipoprotein cholesterol (ldl-c), apolipoprotein b (apo b), triglycerides (tg), and to increase hdl-c in adult patients with primary hyperlipidemia or mixed dyslipidemia. doses of pitavastatin tablets greater than 4 mg once daily were associated with an increased risk for severe myopathy in premarketing clinical studies. do not exceed 4 mg once daily dosing of pitavastatin tablets. the effect of pitavastatin tablets on cardiovascular morbidity and mortality has not been determined. pitavastatin tablets has not been studied in fredrickson type i, iii, and v dyslipid