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rebel distributors corp - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 10 mg - omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. omeprazole delayed-release capsules, in combination with clarithromycin is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.1) and dosage and administration (2) ]. among patients who fail therapy, omeprazole delayed-release capsules with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in pa

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rebel distributors corp. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9) - omeprazole 10 mg - omeprazole delayed-release capsules are a proton pump inhibitor indicated for: the safety and effectiveness of omeprazole delayed-release capsules in pediatric patients < 1 year of age have not been established. (8.4 ) omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. most patients heal within four weeks. some patients may require an additional four weeks of therapy. omeprazole delayed-release capsules in combination with clarithromycin and amoxicillin, are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease (active or up to 1-year history) to eradicate h. pylori in adults. omeprazole delayed-release capsules, in combination with clarithromycin are indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies   (14.1) and dosage and admini

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contract pharmacy services-pa - venlafaxine hydrochloride (unii: 7d7rx5a8mo) (venlafaxine - unii:grz5rcb1qg) - venlafaxine 75 mg - venlafaxine tablets, usp is indicated for the treatment of major depressive disorder. the efficacy of venlafaxine tablets usp in the treatment of major depressive disorder was established in 6 week controlled trials of adult outpatients whose diagnoses corresponded most closely to the dsm-iii or dsm-iii-r category of major depression and in a 4 week controlled trial of inpatients meeting diagnostic criteria for major depression with melancholia (see clinical trials ). a major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks);it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ide

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zydus lifesciences limited - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14) ]. tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. reactions have included skin rash, urticaria, pruritus, angioedema and respiratory symptoms [see adverse reactions (6.2) ]. teratogenic effects , pregnancy category b. administration of tamsulosin hydrochloride to pregnant female rats at dose levels up to approximately 50 times the human therapeutic auc exposure (300 mg/kg/day) revealed no evidence of harm to the fetus. administration of tamsulosin hydrochloride to pregnant rabbits at dose levels up to 50 mg/kg/day produced no evidence of fetal harm. tamsulosin hydrochloride capsules are not indicated for use in women. tamsulosin hydrochloride

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zydus pharmaceuticals usa inc. - tamsulosin hydrochloride (unii: 11sv1951mr) (tamsulosin - unii:g3p28oml5i) - tamsulosin hydrochloride 0.4 mg - tamsulosin hydrochloride capsules, usp are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (bph) [see clinical studies (14)] . tamsulosin hydrochloride capsules are not indicated for the treatment of hypertension. tamsulosin hydrochloride capsules are contraindicated in patients known to be hypersensitive to tamsulosin hydrochloride or any component of tamsulosin hydrochloride capsules. reactions have included skin rash, urticaria, pruritus, angioedema, and respiratory symptoms [see adverse reactions (6.2)]. risk summary tamsulosin hydrochloride capsules are not indicated for use in women. there are no adequate data on the developmental risk associated with the use of tamsulosin hydrochloride capsules in pregnant women. no adverse developmental effects were observed in animal studies in which tamsulosin hydrochloride was administered to rats or rabbits during the period of organogenesis (gd 7 to 17 in the rat and gd 6 to 18 in the rabbit) [see data] . in the u.s. general

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allergan, inc. - vilazodone hydrochloride (unii: u8htx2gk8j) (vilazodone - unii:s239o2oov3) - vilazodone hydrochloride 10 mg - viibryd®  is indicated for the treatment of major depressive disorder (mdd) in adults [see clinical studies ( 14 )]. viibryd is contraindicated in: - patients taking, or within 14 days of stopping, monoamine oxidase inhibitors (maois), including maois such as linezolid or intravenous methylene blue, because of an increased risk of serotonin syndrome [see warnings and precautions ( 5.2 ) , drug interactions ( 7 ) ] . pregnancy exposure registry there is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. healthcare providers are encouraged to advise patients to register by calling the national pregnancy registry for antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants. risk summary based on data from published observational studies, exposure to ssris, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartu

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denton pharma, inc. dba northwind pharmaceuticals - meloxicam (unii: vg2qf83cgl) (meloxicam - unii:vg2qf83cgl) - meloxicam 15 mg - meloxicam tablets, usp is indicated for relief of the signs and symptoms of osteoarthritis [ see clinical studies ( 14.1) ]. meloxicam tablets, usp is indicated for relief of the signs and symptoms of rheumatoid arthritis [ see clinical studies ( 14.1) ]. meloxicam tablets, usp is indicated for relief of the signs and symptoms of pauciarticular or polyarticular course juvenile rheumatoid arthritis in patients 2 years of age and older [ see clinical studies ( 14.2) ]. meloxicam is contraindicated in patients with known hypersensitivity (e.g., anaphylactoid reactions and serious skin reactions

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contract pharmacy services-pa - citalopram hydrobromide (unii: i1e9d14f36) (citalopram - unii:0dhu5b8d6v) - citalopram 10 mg - citalopram tablets (citalopram hydrobromide) are indicated for the treatment of depression. the efficacy of citalopram tablets 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 tablets in hospitalized depressed patients has not b

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romark laboratories, l.c. - nitazoxanide (unii: soa12p041n) (nitazoxanide - unii:soa12p041n) - nitazoxanide 500 mg - diarrhea caused by giardia lamblia or cryptosporidium parvum: alinia for oral suspension (patients 1 year of age and older) and alinia tablets (patients 12 years and older) are indicated for the treatment of diarrhea caused by giardia lamblia or cryptosporidium parvum . limitations of use alinia for oral suspension and alinia tablets have not been shown to be effective for the treatment of diarrhea caused by cryptosporidium parvum in hiv-infected or immunodeficient patients [ see clinical studies (14.2)] alinia tablets and alinia for oral suspension are contraindicated in patients with a prior hypersensitivity to nitazoxanide or any other ingredient in the formulations. risk summary there are no data with alinia in pregnant women to inform a drug-associated risk. no teratogenicity or fetotoxicity was observed in animal reproduction studies with administration of nitazoxanide to pregnant rats and rabbits during organogenesis at exposure 30 and 2 times, respectively, the exposure at the maximum recommended human dose of 500 mg twice daily based on body surface area (bsa). 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 animal data nitazoxanide was administered orally to pregnant rats at doses of 0, 200, 800 or 3200 mg/kg/day on gestation days 6 to 15. nitazoxanide produced no evidence of systemic maternal toxicity when administer once daily via oral gavage to pregnant female rats at levels up to 3200 mg/kg/day during the period of organogenesis . in rabbits, nitazoxanide was administered at doses of 0, 25, 50, or 100 mg/kg/day on gestation days 7 to 20. oral treatment of pregnant rabbits with nitazoxanide during organogenesis resulted in minimal maternal toxicity and no external fetal anomalies. risk summary no information regarding the presence of nitazoxanide in human milk, the effects on the breastfed infant, or the effects on milk production is available. the development and health benefits of breastfeeding should be considered along with the mother’s clinical need for alinia and any potential adverse effects on the breastfed infant from alinia or from the underlying maternal condition. the safety and efficacy of alinia for oral suspension for the treatment of diarrhea caused by g. lamblia or c. parvum in pediatric patients 1 to 11 years of age has been established based on three (3) randomized, controlled studies with 104 pediatric subjects treated with alinia for oral suspension 100 mg/5 ml. furthermore, the safety and efficacy of alinia for oral suspension for the treatment of diarrhea caused by g. lamblia or c. parvum in pediatric patients 12 to 17 years of age has been established based on two (2) randomized controlled studies with 44 pediatric subjects treated with alinia for oral suspension 100 mg/5 ml. [ see clinical studies (14.1)] the safety and efficacy of alinia tablets for the treatment of diarrhea caused by g. lamblia or c. parvum in pediatric patients 12 to 17 years of age has been established based on three (3) randomized controlled studies with 47 pediatric subjects treated with alinia tablets 500 mg. a single alinia tablet contains a greater amount of nitazoxanide than is recommended for use in pediatric patients 11 years or younger. [ see dosage and administration (2.1)]. safety and efficacy of alinia for oral suspension in pediatric patients less than one year of age has not been studied. clinical studies of alinia tablets and alinia for oral suspension did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. in general, the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients should be considered when prescribing alinia tablets and alinia for oral suspension. the pharmacokinetics of nitzoxanide in patients with compromised renal or hepatic function has not been studied. alinia tablets and alinia for oral suspension have not been studied for the treatment of diarrhea caused by g. lamblia in hiv-infected or immunodeficient patients. alinia tablets and alinia for oral suspension have not been shown to be superior to placebo for the treatment of diarrhea caused by c. parvum in hiv-infected or immunodeficient patients [ see clinical studies (14)]

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zydus pharmaceuticals (usa) inc. - sertraline hydrochloride (unii: uti8907y6x) (sertraline - unii:quc7nx6wmb) - sertraline 25 mg - sertraline hydrochloride tablets are indicated for the treatment of the following [see clinical studies (14)] : -   major depressive disorder (mdd) -   obsessive-compulsive disorder (ocd) -   panic disorder (pd) -   posttraumatic stress disorder (ptsd) -   social anxiety disorder (sad) -   premenstrual dysphoric disorder (pmdd) sertraline hydrochloride is contraindicated in patients: -   taking, or within 14 days of stopping, maois, (including the maois linezolid and intravenous methylene blue) because of an increased risk of serotonin syndrome [see warnings and precautions (5.2), drug interactions (7.1)] . -   taking pimozide [see drug interactions (7.1)] . -   with known hypersensitivity to sertraline (e.g., anaphylaxis, angioedema) [see adverse reactions (6.1, 6.2)]. risk summary overall, available published epidemiologic studies of pregnant women exposed to sertraline in the first trimester suggest no difference in major birth defect risk compared to the background rate for major birth defects in compar