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

astrazeneca pharmaceuticals lp - omeprazole magnesium (unii: 426qfe7xlk) (omeprazole - unii:kg60484qx9) - omeprazole 10 mg - prilosec is 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. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy prilosec 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. dual therapy prilosec in combination with clarithromycin is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, prilosec with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in patients who fail therapy, susceptibility testing should be done. if resistance to clarithromycin is demonstrated or susceptibility testing is not pos

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

covis pharma us, inc - omeprazole magnesium (unii: 426qfe7xlk) (omeprazole - unii:kg60484qx9) - omeprazole 2.5 mg - prilosec is 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. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence. triple therapy prilosec 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. dual therapy prilosec in combination with clarithromycin is indicated for treatment of patients with h. pylori infection and duodenal ulcer disease to eradicate h. pylori in adults. among patients who fail therapy, prilosec with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in patients who fail therapy, susceptibility testing should be done. if resistance to clarithromycin is demonstrated or susceptibility testing is not possible, alternative antimicrobial therapy should be instituted [see clinical pharmacology (12.4) and the clarithromycin prescribing information, microbiology section] . prilosec is indicated for short-term treatment (4 to 8 weeks) of active benign gastric ulcer in adults. prilosec is indicated for the treatment of heartburn and other symptoms associated with gerd for up to 4 weeks in patients 1 year of age and older. pediatric patients 1 year of age to adults prilosec is indicated for the short-term treatment (4 to 8 weeks) of ee due to acid-mediated gerd that has been diagnosed by endoscopy in patients 1 year of age and older. the efficacy of prilosec 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 prilosec may be considered. pediatric patients 1 month to less than 1 year of age prilosec is indicated for the short-term treatment (up to 6 weeks) of ee due to acid-mediated gerd in pediatric patients 1 month to less than 1 year of age. prilosec is indicated for the maintenance healing of ee due to acid-mediated gerd in patients 1 year of age and older. controlled studies do not extend beyond 12 months. prilosec is indicated for the long-term treatment of pathological hypersecretory conditions (e.g., zollinger-ellison syndrome, multiple endocrine adenomas and systemic mastocytosis) in adults. there are no adequate and well-controlled studies with omeprazole in pregnant women. available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole (based on body surface area for a 60 kg person). changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole. when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age [see data] . the estimated background risks of major birth defects and miscarriage for the indicated population are unknown. all pregnancies have a background risk of birth defect, loss or other adverse outcomes. in the us 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. human data four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to h2 -receptor antagonists or other controls. a population-based retrospective cohort epidemiological study from the swedish medical birth registry, covering approximately 99% of pregnancies, from 1995 to 99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. the number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low apgar score, or hospitalization was similar to the number observed in this population. the number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. a population-based retrospective cohort study covering all live births in denmark from 1996 to 2009, reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any proton pump inhibitor. the overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any proton pump inhibitor during the first trimester. a retrospective cohort study reported on 689 pregnant women exposed to either h2 -blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimester. the overall malformation rate in offspring born to mothers with first trimester exposure to omeprazole, an h2 -blocker, or were unexposed was 3.6%, 5.5%, and 4.1% respectively. a small prospective observational cohort study followed 113 women exposed to omeprazole during pregnancy (89% with first trimester exposures). the reported rate of major congenital malformations was 4% in the omeprazole group, 2% in controls exposed to non-teratogens, and 2.8% in disease-paired controls. rates of spontaneous and elective abortions, preterm deliveries, gestational age at delivery, and mean birth weight were similar among the groups. several studies have reported no apparent adverse short-term effects on the infant when single dose oral or intravenous omeprazole was administered to over 200 pregnant women as premedication for cesarean section under general anesthesia. animal data omeprazole reproductive studies conducted with omeprazole in rats at oral doses up to 138 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) and in rabbits at doses up to 69.1 mg/kg/day (about 34 times an oral human dose of 40 mg on a body surface area basis) during organogenesis did not disclose any evidence for a teratogenic potential of omeprazole. in rabbits, omeprazole in a dose range of 6.9 to 69.1 mg/kg/day (about 3.4 to 34 times an oral human dose of 40 mg on a body surface area basis) administered during organogenesis produced dose-related increases in embryo-lethality, fetal resorptions, and pregnancy disruptions. in rats, dose-related embryo/fetal toxicity and postnatal developmental toxicity were observed in offspring resulting from parents treated with omeprazole at 13.8 to 138.0 mg/kg/day (about 3.4 to 34 times an oral human doses of 40 mg on a body surface area basis), administered prior to mating through the lactation period. esomeprazole the data described below was generated from studies using esomeprazole, an enantiomer of omeprazole. the animal to human dose multiples are based on the assumption of equal systemic exposure to esomeprazole in humans following oral administration of either 40 mg esomeprazole or 40 mg omeprazole. no effects on embryo-fetal development were observed in reproduction studies with esomeprazole magnesium in rats at oral doses up to 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) or in rabbits at oral doses up to 86 mg/kg/day (about 42 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis) administered during organogenesis. a pre- and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with esomeprazole magnesium at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). neonatal/early postnatal (birth to weaning) survival was decreased at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). body weight and body weight gain were reduced and neurobehavioral or general developmental delays in the immediate post-weaning timeframe were evident at doses equal to or greater than 69 mg/kg/day (about 17 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). in addition, decreased femur length, width and thickness of cortical bone, decreased thickness of the tibial growth plate and minimal to mild bone marrow hypocellularity were noted at doses equal to or greater than 14 mg/kg/day (about 3.4 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). physeal dysplasia in the femur was observed in offspring of rats treated with oral doses of esomeprazole magnesium at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). effects on maternal bone were observed in pregnant and lactating rats in the pre- and postnatal toxicity study when esomeprazole magnesium was administered at oral doses of 14 to 280 mg/kg/day (about 3.4 to 68 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). when rats were dosed from gestational day 7 through weaning on postnatal day 21, a statistically significant decrease in maternal femur weight of up to 14% (as compared to placebo treatment) was observed at doses equal to or greater than 138 mg/kg/day (about 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). a pre- and postnatal development study in rats with esomeprazole strontium (using equimolar doses compared to esomeprazole magnesium study) produced similar results in dams and pups as described above. a follow up developmental toxicity study in rats with further time points to evaluate pup bone development from postnatal day 2 to adulthood was performed with esomeprazole magnesium at oral doses of 280 mg/kg/day (about 68 times an oral human dose of 40 mg on a body surface area basis) where esomeprazole administration was from either gestational day 7 or gestational day 16 until parturition. when maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age. limited data suggest omeprazole may be present in human milk. there are no clinical data on the effects of omeprazole on the breastfed infant or on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for prilosec and any potential adverse effects on the breastfed infant from prilosec or from the underlying maternal condition. the safety and effectiveness of prilosec have been established in pediatric patients 1 to 16 years for the treatment of symptomatic gerd, treatment of ee due to acid-mediated gerd, and maintenance of healing of ee due to acid-mediated gerd. use of prilosec in this age group is supported by adequate and well-controlled studies in adults and uncontrolled safety, efficacy, and pharmacokinetic studies performed in pediatric and adolescent patients [see clinical pharmacology (12.3), clinical studies (14.8)] . the safety and effectiveness of prilosec have been established in pediatric patients 1 month to less than 1 year of age for the treatment of ee due to acid-mediated gerd and is supported by adequate and well-controlled studies in adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients [see clinical pharmacology (12.3)] . in the pediatric population, adverse reactions of the respiratory system were frequently reported in the entire (1 month to 16 year) age group. otitis media was frequently reported in the 1 month to <1 year age group, fever was frequently reported in the 1 to <2 year age group, and accidental injuries were frequently reported in the 2 to 16 year age group [see adverse reactions (6.1)] . the safety and effectiveness of prilosec have not been established in: juvenile animal data esomeprazole, an enantiomer of omeprazole, was shown to decrease body weight, body weight gain, femur weight, femur length, and overall growth at oral doses about 34 to 68 times a daily human dose of 40 mg esomeprazole or 40 mg omeprazole based on body surface area in a juvenile rat toxicity study. the animal to human dose multiples are based on the assumption of equal systemic exposure to esomeprazole in humans following oral administration of either 40 mg esomeprazole or 40 mg omeprazole. a 28-day toxicity study with a 14-day recovery phase was conducted in juvenile rats with esomeprazole magnesium at doses of 70 to 280 mg/kg/day (about 17 to 68 times a daily oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis). an increase in the number of deaths at the high dose of 280 mg/kg/day was observed when juvenile rats were administered esomeprazole magnesium from postnatal day 7 through postnatal day 35. in addition, doses equal to or greater than 140 mg/kg/day (about 34 times a daily oral human dose of 40 mg esomeprazole or 40 mg omeprazole on a body surface area basis), produced treatment-related decreases in body weight (approximately 14%) and body weight gain, decreases in femur weight and femur length, and affected overall growth. comparable findings described above have also been observed in this study with another esomeprazole salt, esomeprazole strontium, at equimolar doses of esomeprazole. omeprazole was administered to over 2000 elderly individuals (≥ 65 years of age) in clinical trials in the u.s. and europe. there were no differences in safety and effectiveness between the elderly and younger subjects. other reported clinical experience has not identified differences in response between the elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. pharmacokinetic studies have shown the elimination rate was somewhat decreased in the elderly and bioavailability was increased. the plasma clearance of omeprazole was 250 ml/min (about half that of young volunteers) and its plasma half-life averaged one hour, about twice that of young healthy volunteers. however, no dosage adjustment is necessary in the elderly [see clinical pharmacology (12.3)] . in patients with hepatic impairment (child-pugh class a, b, or c) exposure to omeprazole substantially increased compared to healthy subjects. dosage reduction of prilosec to 10 mg once daily is recommended for patients with hepatic impairment for maintenance of healing of ee [see dosage and administration (2.1), clinical pharmacology (12.3)] . in studies of healthy subjects, asians had approximately a four-fold higher exposure than caucasians. dosage reduction of prilosec to 10 mg once daily is recommended for asian patients for maintenance of healing of ee [see dosage and administration (2.1), clinical pharmacology (12.5)] . prilosec ® (pry-lo-sec) (omeprazole magnesium) for delayed-release oral suspension taking prilosec in water: giving prilosec with water through a nasogastric (ng) tube or gastric tube: for people who have an ng tube or gastric tube that is size 6 or larger , prilosec may be given as follows:

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

ropack inc. - secnidazole (unii: r3459k699k) (secnidazole - unii:r3459k699k) - secnidazole 2 g in 4.8 g - solosec is indicated for the treatment of bacterial vaginosis in adult women [see use in specific populations ( 8.1) and clinical studies ( 14)]. to reduce the development of drug-resistant bacteria and maintain the effectiveness of solosec and other antibacterial drugs, solosec should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. hypersensitivity solosec is contraindicated in patients who have shown hypersensitivity to secnidazole, other ingredients of the formulation, or other nitroimidazole derivatives. risk summary limited available data with solosec use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. in animal reproducti

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

lupin pharmaceuticals, inc. - secnidazole (unii: r3459k699k) (secnidazole - unii:r3459k699k) - secnidazole 2 g in 4.8 g - solosec is indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older [see use in specific populations (8.1) and clinical studies (14)]. solosec is indicated for the treatment of trichomoniasis caused by trichomonas vaginalis in patients 12 years of age and older.  because trichomoniasis is a sexually transmitted disease with potentially serious sequelae, treat partners of infected patients simultaneously in order to prevent reinfection [see dosage and administration (2.2)  and  clinical studies (14.2)] . to reduce the development of drug-resistant bacteria and maintain the effectiveness of solosec and other antibacterial drugs, solosec should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. when culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. in the absence of such data, local epidemiology and susceptibility patterns may

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

stat rx usa llc - omeprazole magnesium (unii: 426qfe7xlk) (omeprazole magnesium - unii:426qfe7xlk) - omeprazole magnesium 20 mg - prilosec is 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. prilosec 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. prilosec, 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, prilosec with clarithromycin is more likely to be associated with the development of clarithromycin resistance as compared with triple therapy. in patients who fail therapy, susceptibility testing should be done. if resistance to clarithromycin

Australia - English - Department of Health (Therapeutic Goods Administration)

pharmaco australia ltd - omeprazole magnesium, quantity: 20.6 mg (equivalent: omeprazole, qty 20 mg) - tablet, enteric coated - excipient ingredients: titanium dioxide; hypromellose; triethyl citrate; crospovidone; hyprolose; purified talc; macrogol 6000; methacrylic acid copolymer; iron oxide red; magnesium stearate; glyceryl monostearate; polysorbate 80; sodium stearylfumarate; microcrystalline cellulose; sodium hydroxide; synthetic paraffin; maize starch; sucrose - gastro-oesophageal reflux disease (gord). 1. symptomatic gord. the relief of heartburn and other symptoms associated with gord. 2. erosive oesophagitis. the treatment and prevention of relapse. peptic ulcers. 1. the treatment of duodenal and gastric ulcer. 2. combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infections. 3. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be helicobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. zollinger-ellison syndrome. the treatment of zollinger-ellison syndrome.

Australia - English - Department of Health (Therapeutic Goods Administration)

pharmaco australia ltd - omeprazole magnesium, quantity: 10.3 mg (equivalent: omeprazole, qty 10 mg) - tablet, enteric coated - excipient ingredients: microcrystalline cellulose; glyceryl monostearate; titanium dioxide; hyprolose; purified talc; iron oxide yellow; macrogol 6000; sodium stearylfumarate; iron oxide red; methacrylic acid copolymer; triethyl citrate; polysorbate 80; hypromellose; magnesium stearate; crospovidone; sodium hydroxide; synthetic paraffin; maize starch; sucrose - gastro-oesophageal reflux disease (gord). 1. symptomatic gord. the relief of heartburn and other symptoms associated with gord. 2. erosive oesophagitis. the treatment and prevention of relapse. peptic ulcers. 1. the treatment of duodenal and gastric ulcer. 2. combination therapy for the treatment of peptic ulcer disease associated with helicobacter pylori infections. 3. the treatment of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs. 4. the prevention of gastric and duodenal ulcers and erosions associated with non-steroidal anti-inflammatory drugs in patients assessed as being at high risk of gastroduodenal ulcer or complications of gastroduodenal ulcer. 5. long-term prevention of relapse in gastric and duodenal ulceration, in patients proven to be helicobacter pylori negative, or in whom eradication is inappropriate, e.g. the elderly, or ineffective. zollinger-ellison syndrome. the treatment of zollinger-ellison syndrome.

Israel - English - Ministry of Health

abic ltd. - omeprazole - capsules - omeprazole 20 mg - omeprazole - omeprazole - acute duodenal ulcer. acute gastric ulcer. helicobacter pylori-associated peptic ulcer disease in combination with antibiotics. reflux esophagitis:- treatment ; - long-term management; - maintenance treatment for the prevention of relapse in patients with severe reflux esophagitis. treatment of severe reflux oesophagitis in children from one year of age and older. - maintenance treatment for the prevention of relapse in patients with poorly responsive peptic ulcer. - zollinger-ellison syndrome. - treatment and prevention of nsaid - associated duodenal and gastric ulcers or erosions in high risk patients.

Israel - English - Ministry of Health

abic ltd. - omeprazole - capsules - omeprazole 20 mg - omeprazole - omeprazole - relief of reflux-like symptoms (e.g. heartburn) with frequency of two or more days a week in sufferers aged 18 and over.

Israel - English - Ministry of Health

teva pharmaceutical industries ltd, israel - omeprazole - capsules - omeprazole 20 mg - omeprazole - relief of reflux-like symptoms (e.g. heartburn) with frequency of two or more days a week in sufferers aged 18 and over.