Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

advanced rx pharmacy of tennessee, llc - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - 1.1 treatment of active duodenal ulcer lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks ) for healing and symptom relief of active duodenal ulcer [see clinical studies ( 14.1]. 1.2 eradication of h. pylori to reduce the risk of duodenal ulcer recurrence triple therapy: lansoprazole /amoxicillin /clarithromycin lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies ( 14.2)]. please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole /amoxicillin lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated in adults for the treatment

Իսրայել - անգլերեն - Ministry of Health

teva pharmaceutical industries ltd, israel - lansoprazole - capsules - lansoprazole 15 mg - lansoprazole - lansoprazole - for the treatment of duodenal ulcer, benign gastric ulcer, reflux oesophagitis and acid related disorders of the upper gastrointestinal tract. healing, long term treatment and maintenance therapy for patients with gastro oesophageal reflux disease (gord) or duodenal ulcer. prevention of relapse in patients with gord or duodenal ulcer. eradication of h. pylori from the upper gastrointestinal tract in patients with duodenal ulcer, gastritis or benign ulcer (in combination with appropriate antibiotics). short term treatment (up to four weeks) of heartburn and/or upper epigastric pain associated with acid-related dyspepsia. long-term management of pathological hypersecretory conditions including zollinger ellison syndrome.treatment and prophylaxis of nsaid- associated benign gastric ulcers, duodenal ulcers and relief of symptoms in patients requiring continued nsaid treatment.

Իսրայել - անգլերեն - Ministry of Health

teva pharmaceutical industries ltd, israel - lansoprazole - capsules - lansoprazole 30 mg - lansoprazole - lansoprazole - for the treatment of duodenal ulcer, benign gastric ulcer, reflux oesophagitis and acid related disorders of the upper gastrointestinal tract. healing, long term treatment and maintenance therapy for patients with gastro oesophageal reflux disease (gord) or duodenal ulcer. prevention of relapse in patients with gord or duodenal ulcer. eradication of h. pylori from the upper gastrointestinal tract in patients with duodenal ulcer, gastritis or benign ulcer (in combination with appropriate antibiotics). short term treatment (up to four weeks) of heartburn and/or upper epigastric pain associated with acid-related dyspepsia. long-term management of pathological hypersecretory conditions including zollinger ellison syndrome. treatment and prophylaxis of nsaid- associated benign gastric ulcers, duodenal ulcers and relief of symptoms in patients requiring continued nsaid treatment.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

direct rx - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole 30 mg - 1.1 short-term treatment of active duodenal ulcer lansoprazole is indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14)]. 1.2 h. pylori eradication to reduce the risk of duodenal ulcer recurrence triple therapy: lansoprazole/amoxicillin/clarithromycin lansoprazole in combination with amoxicillin plus clarithromycin as triple therapy is indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14)]. please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole/amoxicillin lansoprazole in combination with amoxicillin as dual therapy is indicated for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulce

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

mylan pharmaceuticals inc. - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1)] . lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy are indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori . eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)] . please refer to the full prescribing information for amoxicillin and clarithromycin. lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy are indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin prescribing information, microbiology section). eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)] . please refer to the full prescribing information for amoxicillin. lansoprazole delayed-release orally disintegrating tablets are indicated in adults to maintain healing of duodenal ulcers. controlled studies do not extend beyond 12 months [see clinical studies (14.3)] . lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer [see clinical studies (14.4)] . lansoprazole delayed-release orally disintegrating tablets are indicated in adults for the treatment of nsaid-associated gastric ulcer in patients who continue nsaid use. controlled studies did not extend beyond eight weeks [see clinical studies (14.5)] . lansoprazole delayed-release orally disintegrating tablets are indicated in adults for reducing the risk of nsaid-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an nsaid. controlled studies did not extend beyond 12 weeks [see clinical studies (14.6)] . lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with gerd [see clinical studies (14.7)] . lansoprazole delayed-release orally disintegrating tablets are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of ee. for adults who do not heal with lansoprazole delayed-release orally disintegrating tablets for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. if there is a recurrence of erosive esophagitis an additional eight week course of lansoprazole delayed-release orally disintegrating tablets may be considered [see clinical studies (14.8)] . lansoprazole delayed-release orally disintegrating tablets are indicated in adults to maintain healing of ee. controlled studies did not extend beyond 12 months [see clinical studies (14.9)] . lansoprazole delayed-release orally disintegrating tablets are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including zollinger-ellison syndrome [see clinical studies (14.10)] . available data from published observational studies overall do not indicate an association of adverse pregnancy outcomes with lansoprazole treatment (see data) . in animal reproduction studies, oral administration of lansoprazole to rats during organogenesis through lactation at 6.4 times the maximum recommended human dose produced reductions in the offspring in femur weight, femur length, crown-rump length and growth plate thickness (males only) on postnatal day 21 (see data) . these effects were associated with reduction in body weight gain. advise pregnant women of the potential risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations are 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. if lansoprazole delayed-release orally disintegrating tablets are administered with clarithromycin, the pregnancy information for clarithromycin also applies to the combination regimen. refer to the prescribing information for clarithromycin for more information on use in pregnancy. available data from published observational studies failed to demonstrate an association of adverse pregnancy-related outcomes and lansoprazole use. methodological limitations of these observational studies cannot definitely establish or exclude any drug-associated risk during pregnancy. in a prospective study by the european network of teratology information services, outcomes from a group of 62 pregnant women administered median daily doses of 30 mg of lansoprazole were compared to a control group of 868 pregnant women who did not take any ppis. there was no difference in the rate of major malformations between women exposed to ppis and the control group, corresponding to a relative risk (rr) = 1.04, [95% confidence interval (ci) 0.25-4.21]. in a population-based retrospective cohort study covering all live births in denmark from 1996 to 2008, there was no significant increase in major birth defects during analysis of first trimester exposure to lansoprazole in 794 live births. a meta-analysis that compared 1,530 pregnant women exposed to ppis in at least the first trimester with 133,410 unexposed pregnant women showed no significant increases in risk for congenital malformations or spontaneous abortion with exposure to ppis (for major malformations odds ratio (or) = 1.12, [95% ci 0.86-1.45] and for spontaneous abortions or = 1.29, [95% ci 0.84-1.97]). no adverse effects on embryo-fetal development occurred in studies performed in pregnant rats at oral lansoprazole doses up to 150 mg/kg/day (40 times the recommended human dose [30 mg/day] based on body surface area) administered during organogenesis and pregnant rabbits at oral lansoprazole doses up to 30 mg/kg/day (16 times the recommended human dose based on body surface area) administered during organogenesis. a pre- and postnatal developmental toxicity study in rats with additional endpoints to evaluate bone development was performed with lansoprazole at oral doses of 10 to 100 mg/kg/day (0.7 to 6.4 times the maximum recommended human lansoprazole dose of 30 mg based on auc [area under the plasma concentration-time curve]) administered during organogenesis through lactation. maternal effects observed at 100 mg/kg/day (6.4 times the maximum recommended human lansoprazole dose of 30 mg based on auc) included increased gestation period, decreased body weight gain during gestation, and decreased food consumption. the number of stillbirths was increased at this dose, which may have been secondary to maternal toxicity. body weight of pups was reduced at 100 mg/kg/day starting on postnatal day 11. femur weight, femur length, and crown-rump length were reduced at 100 mg/kg/day on postnatal day 21. femur weight was still decreased in the 100 mg/kg/day group at age 17 to 18 weeks. growth plate thickness was decreased in the 100 mg/kg/day males on postnatal day 21, and was increased in the 30 and 100 mg/kg/day males at age 17 to 18 weeks. the effects on bone parameters were associated with reduction in body weight gain. there is no information regarding the presence of lansoprazole in human milk, the effects on the breastfed infant, or the effects on milk production. however, lansoprazole and its metabolites are present in rat milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for lansoprazole delayed-release orally disintegrating tablets and any potential adverse effects on the breastfed child from lansoprazole delayed-release orally disintegrating tablets or from the underlying maternal condition. the safety and effectiveness of lansoprazole delayed-release orally disintegrating tablets have been established in pediatric patients one year to 17 years of age for short-term treatment of symptomatic gerd and erosive esophagitis. in clinical studies of symptomatic gerd and erosive esophagitis, lansoprazole was not administered beyond 12 weeks in patients one year to 11 years of age. it is not known if lansoprazole delayed-release orally disintegrating tablets are safe and effective if used longer than the recommended duration. do not exceed the recommended dose and duration of use in pediatric patients (see juvenile animal toxicity data) . lansoprazole was not effective in pediatric patients with symptomatic gerd one month to less than one year of age in a multicenter, double-blind, placebo-controlled study. therefore, safety and effectiveness have not been established in patients less than one year of age. nonclinical studies in juvenile rats have demonstrated an adverse effect of heart valve thickening and bone changes at lansoprazole doses higher than the maximum recommended equivalent human dose. the pharmacokinetics of lansoprazole were studied in pediatric patients with gerd aged less than 28 days and one to 11 months. compared to healthy adults receiving 30 mg, neonates had higher exposure (mean weight-based normalized auc values 2.04- and 1.88-fold higher at doses of 0.5 and 1 mg/kg/day, respectively). infants aged ≤ 10 weeks had clearance and exposure values that were similar to neonates. infants aged greater than 10 weeks who received 1 mg/kg/day had mean auc values that were similar to adults who received a 30 mg dose. lansoprazole was not found to be effective in a u.s. and polish four week, multicenter, double-blind, placebo-controlled, parallel-group study of 162 patients between one month and less than 12 months of age with symptomatic gerd based on a medical history of crying/fussing/irritability associated with feedings who had not responded to conservative gerd management (i.e., nonpharmacologic intervention) for seven to 14 days. patients received lansoprazole as a suspension daily (0.2 to 0.3 mg/kg/day in infants ≤ 10 weeks of age or 1.0 to 1.5 mg/kg/day in infants greater than 10 weeks or placebo) for up to four weeks of double-blind treatment. the primary efficacy endpoint was assessed by greater than 50% reduction from baseline in either the percent of feedings with a crying/fussing/irritability episode or the duration (minutes) of a crying/fussing/irritability episode within one hour after feeding. there was no difference in the percentage of responders between the lansoprazole pediatric suspension group and placebo group (54% in both groups). there were no adverse events reported in pediatric clinical studies (one month to less than 12 months of age) that were not previously observed in adults. based on the results of the phase 3 efficacy study, lansoprazole was not shown to be effective. therefore, these results do not support the use of lansoprazole in treating symptomatic gerd in infants. in an uncontrolled, open-label, u.s. multicenter study, 66 pediatric patients (one year to 11 years of age) with gerd were assigned, based on body weight, to receive an initial dose of either lansoprazole 15 mg daily if ≤ 30 kg or lansoprazole 30 mg daily if greater than 30 kg administered for eight to 12 weeks. the lansoprazole dose was increased (up to 30 mg twice daily) in 24 of 66 pediatric patients after two or more weeks of treatment if they remained symptomatic. at baseline, 85% of patients had mild to moderate overall gerd symptoms (assessed by investigator interview), 58% had non-erosive gerd and 42% had erosive esophagitis (assessed by endoscopy). after eight to 12 weeks of lansoprazole treatment, the intent-to-treat analysis demonstrated an approximate 50% reduction in frequency and severity of gerd symptoms. twenty-one of 27 erosive esophagitis patients were healed at eight weeks and 100% of patients were healed at 12 weeks by endoscopy (table 4) . gerd final visit * % (n/n) symptomatic gerd     improvement in overall gerd symptoms† 76% (47/62‡) erosive esophagitis     improvement in overall gerd symptoms† 81% (22/27)     healing rate 100% (27/27) in a study of 66 pediatric patients in the age group one year to 11 years old after treatment with lansoprazole given orally in doses of 15 mg daily to 30 mg twice daily, increases in serum gastrin levels were similar to those observed in adult studies. median fasting serum gastrin levels increased 89% from 51 pg/ml at baseline to 97 pg/ml [interquartile range (25th to 75th percentile) of 71 to 130 pg/ml] at the final visit. the pediatric safety of lansoprazole delayed-release capsules has been assessed in 66 pediatric patients aged one to 11 years of age. of the 66 patients with gerd, 85% (56/66) took lansoprazole for eight weeks and 15% (10/66) took it for 12 weeks. the most frequently reported (two or more patients) treatment-related adverse reactions in patients one to 11 years of age (n = 66) were constipation (5%) and headache (3%). in an uncontrolled, open-label, u.s. multicenter study, 87 adolescent patients (12 years to 17 years of age) with symptomatic gerd were treated with lansoprazole for eight to 12 weeks. baseline upper endoscopies classified these patients into two groups: 64 (74%) non-erosive gerd and 23 (26%) erosive esophagitis (ee). the non-erosive gerd patients received lansoprazole 15 mg daily for eight weeks and the ee patients received lansoprazole 30 mg daily for eight to 12 weeks. at baseline, 89% of these patients had mild to moderate overall gerd symptoms (assessed by investigator interviews). during eight weeks of lansoprazole treatment, adolescent patients experienced a 63% reduction in frequency and a 69% reduction in severity of gerd symptoms based on diary results. twenty-one of 22 (95.5%) adolescent erosive esophagitis patients were healed after eight weeks of lansoprazole treatment. one patient remained unhealed after 12 weeks of treatment (table 5) . gerd final visit % (n/n) symptomatic gerd (all patients)     improvement in overall gerd symptoms* 73.2% (60/82)† non-erosive gerd     improvement in overall gerd symptoms* 71.2% (42/59)† erosive esophagitis     improvement in overall gerd symptoms* 78.3% (18/23)     healing rate‡ 95.5% (21/22)‡ in these 87 adolescent patients, increases in serum gastrin levels were similar to those observed in adult studies, median fasting serum gastrin levels increased 42% from 45 pg/ml at baseline to 64 pg/ml [interquartile range (25th to 75th percentile) of 44 to 88 pg/ml] at the final visit. (normal serum gastrin levels are 25 to 111 pg/ml.) the safety of lansoprazole delayed-release capsules has been assessed in these 87 adolescent patients. of the 87 adolescent patients with gerd, 6% (5/87) took lansoprazole for less than six weeks, 93% (81/87) for six to 10 weeks, and 1% (1/87) for greater than 10 weeks. the most frequently reported (at least 3%) treatment-related adverse reactions in these patients were headache (7%), abdominal pain (5%), nausea (3%) and dizziness (3%). treatment-related dizziness, reported in this prescribing information as occurring in less than 1% of adult patients, was reported in this study by three adolescent patients with non-erosive gerd, who had dizziness concurrently with other reactions (such as migraine, dyspnea, and vomiting). in two oral toxicity studies, thickening of the mitral heart valve occurred in juvenile rats treated with lansoprazole. heart valve thickening was observed primarily with oral dosing initiated on postnatal day 7 (age equivalent to neonatal humans) and postnatal day 14 (human age equivalent of approximately one year) at doses of 250 mg/kg/day and higher (at postnatal day 7 and postnatal day 14, respectively 6.2 times and 4.2 times the daily pediatric dose of 15 mg in pediatric patients age one to 11 years weighing 30 kg or less, based on auc). the treatment durations associated with heart valve thickening ranged from 5 days to 8 weeks. the findings reversed or trended towards reversibility after a 4-week drug-free recovery period. the incidence of heart valve thickening after initiation of dosing on postnatal day 21 (human age equivalent of approximately two years) was limited to a single rat (1/24) in groups given 500 mg/kg/day for 4 or 8 weeks (approximately 5.2 times the daily pediatric dose of 15 mg in pediatric patients age one to 11 years weighing 30 kg or less, based on auc). based on exposure margins, the risk of heart valve injury does not appear to be relevant to patients one year of age and older. in an eight-week oral toxicity study in juvenile rats with dosing initiated on postnatal day 7, doses equal to or greater than 100 mg/kg/day (2.5 times the daily pediatric dose of 15 mg in children age one to 11 years weighing 30 kg or less, based on auc) produced delayed growth, with impairment of weight gain observed as early as postnatal day 10 (age equivalent to neonatal humans). at the end of treatment, the signs of impaired growth at 100 mg/kg/day and higher included reductions in body weight (14 to 44% compared to controls), absolute weight of multiple organs, femur weight, femur length, and crown-rump length. femoral growth plate thickness was reduced only in males and only at the 500 mg/kg/day dose. the effects related to delayed growth persisted through the end of the four-week recovery period. longer term data were not collected. of the total number of patients (n = 21,486) in clinical studies of lansoprazole, 16% of patients were aged 65 years and over, while 4% were 75 years and over. no overall differences in safety or effectiveness were observed between these patients and younger patients and other reported clinical experience has not identified significant differences in responses between geriatric and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see clinical pharmacology (12.3)] . in patients with various degrees of chronic hepatic impairment the exposure to lansoprazole was increased compared to healthy subjects with normal hepatic function [see clinical pharmacology (12.3)] . no dosage adjustment for lansoprazole delayed-release orally disintegrating tablets is necessary for patients with mild (child-pugh class a) or moderate (child-pugh class b) hepatic impairment. the recommended dosage is 15 mg orally daily in patients with severe hepatic impairment (child-pugh class c) [see dosage and administration (2.3)] .

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole delayed-release orally disintegrating tablets are indicated for in adults short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1)] . triple therapy: lansoprazole delayed-release orally disintegrating tablets /amoxicillin/clarithromycin lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)]   please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole delayed-release orally disintegrating tablets/amoxicillin lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

ascend laboratories, llc - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1) ]. triple therapy: lansoprazole delayed-release capsules/amoxicillin/clarithromycin lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori . eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2) ]. please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole delayed-release capsules/ amoxicillin lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

lake erie medical dba quality care products llc - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1) ]. triple therapy: lansoprazole/amoxicillin/clarithromycin lansoprazole in combination with amoxicillin plus clarithromycin as triple therapy is indicated i adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2) ]. please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole/amoxicillin lansoprazole in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one-year history of a duodenal ulcer) who are either allergic or intolerant to clarithrom

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

cardinal health 107, llc - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1)] . triple therapy: lansoprazole delayed-release orally disintegrating tablets/amoxicillin/clarithromycin lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori . eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)] . please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole delayed-release orally disintegrating tablets/amoxicillin lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual therapy is

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

denton pharma, inc. dba northwind pharmaceuticals - lansoprazole (unii: 0k5c5t2qpg) (lansoprazole - unii:0k5c5t2qpg) - lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see clinical studies (14.1)]. triple therapy: lansoprazole delayed-release capsules/amoxicillin/clarithromycin lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with h. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate h. pylori. eradication of h. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see clinical studies (14.2)]. please refer to the full prescribing information for amoxicillin and clarithromycin. dual therapy: lansoprazole delayed-release capsules/amoxicillin lansoprazole delayed-release capsules in combination with amoxicillin as d