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lansoprazole dr 15 mg capsule generic prevacid 24hr, heartburn treatment 24 hour, prevacid

Out of Stock Manufacturer ZYDUS PHARMACEU 68382054306
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Uses

Lansoprazole is used orally for the short-term treatment and symptomatic relief of active duodenal and benign gastric ulcer and as maintenance therapy following healing of duodenal ulcers. Lansoprazole also is used orally in combination with amoxicillin (dual therapy) or with clarithromycin and amoxicillin (triple therapy) for the treatment of Helicobacter pylori infection and duodenal ulcer disease. Lansoprazole also has been used in other multiple-drug regimens for the treatment of H. pylori infection associated with peptic ulcer disease. Lansoprazole also is used orally for the treatment of nonsteroidal anti-inflammatory agent (NSAIA)-induced gastric ulcers in patients who continue NSAIA use, and for the prevention of NSAIA-induced gastric ulcers in patients with a documented history of gastric ulcer who require the use of an NSAIA. Oral lansoprazole also is used for short-term treatment and symptomatic relief of gastroesophageal reflux disease (e.g., erosive esophagitis), as maintenance therapy following healing of erosive esophagitis to reduce its recurrence and in the long-term treatment of pathologic GI hypersecretory conditions. Lansoprazole is used orally as self-medication for short-term treatment of frequent heartburn.

Gastroesophageal Reflux

Acute Therapy

Lansoprazole is used orally to provide short-term (up to 8 weeks) treatment and symptomatic relief of all grades of erosive esophagitis in patients with gastroesophageal reflux disease (GERD). Oral lansoprazole also is used for the short-term (up to 8 weeks) treatment of symptomatic GERD (e.g., heartburn). Potential benefits of lansoprazole in gastroesophageal reflux and esophagitis result principally from reduced acidity of gastric contents induced by the drug and resultant reduced irritation of esophageal mucosa; the drug can effectively relieve symptoms of esophagitis (e.g., heartburn) and promote healing of ulcerative and erosive lesions.

Suppression of gastric acid secretion is considered by the American College of Gastroenterology (ACG) to be the mainstay of treatment for GERD, and a proton-pump inhibitor or histamine H2-receptor antagonist is used to achieve acid suppression, control symptoms, and prevent complications of the disease. The ACG states that proton-pump inhibitors are more effective (i.e., provide more frequent and more rapid symptomatic relief and healing of esophagitis) than histamine H2-receptor antagonists in the treatment of GERD. Proton-pump inhibitors also provide greater control of acid reflux than do prokinetic agents (e.g., cisapride [no longer commercially available in the US], metoclopramide) without the risk of severe adverse effects associated with these agents.

In a controlled study in patients with manifestations of GERD (e.g., heartburn) and the absence of erosive esophageal lesions, symptomatic improvement (reduction in frequency and severity of heartburn) with lansoprazole was greater than that with placebo. In this study in patients with endoscopically confirmed GERD, the median percentage of days without heartburn was 84, 82, or 13% at week 8 of therapy with lansoprazole 15 mg daily, lansoprazole 30 mg daily, or placebo, respectively; the median percentage of nights without heartburn in these respective treatment groups was 92, 80, or 36% at week 8. Administration of 30 mg of lansoprazole daily did not provide improved relief compared with 15 mg daily in this study.

In controlled studies in patients with endoscopically evaluated GERD, reported rates of healing with lansoprazole were higher than those with placebo or an H2-receptor antagonist and at least as high as those with omeprazole. Generally, antacids were used concomitantly for pain relief. In a controlled study in patients with esophagitis, reported rates of healing were 91, 95, 94, or 53% at 8 weeks in patients receiving lansoprazole 15 mg daily, 30 mg daily, 60 mg daily, or placebo, respectively. Healing rates from controlled studies were 80-84 or 39-52% at 4 weeks and 91-92 or 53-70% at 8 weeks for lansoprazole 30 mg daily or ranitidine 150 mg twice daily, respectively. Patients receiving lansoprazole reported faster relief of daytime and nocturnal heartburn and self-administered less antacid than those receiving placebo or an H2-receptor antagonist; however, since the recommended dosage of ranitidine for esophagitis is 150 mg four times daily and patients treated with ranitidine received only 150 mg twice daily, further study is needed to evaluate relative efficacy. Lansoprazole also has been shown to be effective in promoting healing and providing symptomatic relief in a substantial proportion of patients failing to respond to usual or relatively high dosages of H2-receptor antagonists.

Although lansoprazole has been used IV for short-term (up to 7 days) treatment of erosive esophagitis in patients who are unable to take the drug orally, a parenteral dosage form no longer is commercially available in the US. In one controlled study in patients with erosive esophagitis receiving oral lansoprazole, the degree of inhibition of gastric acid secretion following IV administration of lansoprazole 30 mg daily for 7 days was similar to that achieved following repeated oral administration of the drug.

Short-term lansoprazole therapy for the treatment of erosive esophagitis will not prevent recurrence of the disease following discontinuance of the drug. Most patients with erosive esophagitis respond to lansoprazole during an initial 8-week course of therapy; however, an additional 8 weeks of therapy may contribute to healing and symptomatic improvement in some patients (i.e., patients experiencing a recurrence of erosive esophagitis or patients who fail to heal after the initial course of therapy). If symptomatic GERD or severe esophagitis recur, the manufacturer states that additional 8-week courses of lansoprazole may be given. However, the ACG states that chronic, even lifelong, therapy with a proton-pump inhibitor is appropriate in many patients with GERD.

Maintenance Therapy

Lansoprazole is used as maintenance therapy following healing of erosive esophagitis to reduce recurrence of the disease. In a multicenter, double-blind study, endoscopically documented remission of esophagitis was maintained at 6 months in 81, 93, or 27% of patients receiving lansoprazole 15 mg daily, 30 mg daily, or placebo, respectively, and such remission was maintained at 12 months in 79, 90, or 24% of patients, respectively. In another multicenter, double-blind study in patients with endoscopically confirmed healed esophagitis, remission of esophagitis was maintained at 6 months in 72, 72, or 13% of patients receiving lansoprazole 15 mg daily, 30 mg daily, or placebo, respectively, and at 12 months in 67, 55, or 13% of patients, respectively. Remission rates of esophagitis were independent of the patient's initial grade of erosive esophagitis and the daily dosage of lansoprazole (15 or 30 mg).

Because GERD is a chronic condition, the ACG states that continuous therapy to control symptoms and prevent complications is appropriate, and chronic, even lifelong, use of a proton-pump inhibitor is effective and appropriate as maintenance therapy in many patients with GERD. The frequent marked improvement in symptoms associated with full dosage of a proton-pump inhibitor generally is followed by rapid recurrence of symptoms once the drug is discontinued, and reduced-dosage regimens (e.g., every other day, ''weekend'' dosage) have not been shown to be consistently effective for maintenance therapy.

For further information on the treatment of GERD, .

Self-medication

Lansoprazole is used orally in adults 18 years of age or older as self-medication for short-term (14 days) treatment of frequent (2 or more days per week) heartburn. Because 1-4 days may be required for complete relief of symptoms, lansoprazole for self-medication is not intended for the immediate relief of heartburn. However, some individuals may experience complete relief of symptoms within 24 hours of taking the first dose of lansoprazole. In 2 controlled studies in adults with frequent (2 or more days per week) heartburn, the percentage of days (24-hour periods) without heartburn during 14 days of treatment was greater with lansoprazole 15 mg daily than with placebo (59.9-64.7 versus 45-45.7%). The percentage of heartburn-free nights during the 14-day treatment period was 79.5-81.6% with lansoprazole therapy compared with 76.3-77% with placebo. On day 1 of treatment, 50.4-50.7% of lansoprazole-treated patients experienced no heartburn compared with 33-37.9% of those receiving placebo. In a controlled study in adults with frequent nocturnal heartburn, the percentage of heartburn-free nights during 14 days of treatment was greater with lansoprazole 15 or 30 mg (61.3-61.7%) compared with placebo (47.8%). The percentage of days (24-hour periods) without heartburn and the percentage of patients without heartburn on day 1 of treatment also were greater with lansoprazole therapy than with placebo.

Gastric Ulcer

Acute Therapy

Lansoprazole is used for the short-term treatment and symptomatic relief of active benign gastric ulcer. Antacids may be used concomitantly as needed for pain relief. In controlled studies in patients with endoscopically confirmed gastric ulcers, reported rates of ulcer healing for lansoprazole were substantially higher than those for placebo. In a multicenter, double-blind study in patients with endoscopically confirmed gastric ulcer, reported rates of ulcer healing in patients receiving lansoprazole 15 or 30 mg each morning or placebo were 65, 58, or 38%, respectively, at 4 weeks and 92, 97, or 77%, respectively, at 8 weeks. Lansoprazole also produced greater reductions in daytime and nocturnal pain and antacid consumption than did placebo.

Current epidemiologic and clinical evidence supports a strong association between gastric infection with H. pylori and the pathogenesis of gastric ulcers, and the ACG, NIH, and most clinicians currently recommend that all patients with initial or recurrent gastric ulcer and documented H. pylori infection receive anti-infective therapy for treatment of the infection. The choice of a particular regimen should be based on current data on optimal therapy, including consideration of the patient's prior exposure to anti-infective agents, the local prevalence of resistance, patient compliance, and costs of therapy.(See Duodenal Ulcer: Acute Therapy, in Uses.) For a more complete discussion of H. pylori infection, including details about the efficacy of various regimens and rationale for drug selection, .

NSAIA-induced Ulcers

Treatment

Lansoprazole is used for the treatment of NSAIA-induced gastric ulcers in patients who continue NSAIA use. In 2 controlled studies in patients with endoscopically confirmed NSAIA-associated gastric ulcer who continued their NSAIA use, substantially more patients receiving lansoprazole 30 mg daily experienced ulcer healing at 8 weeks compared with those receiving an active control drug. In one study, healing of gastric ulcers occurred in 60 and 79% of patients receiving lansoprazole, compared with 28 and 55% of those receiving an active control drug at 4 and 8 weeks, respectively. In the second study, ulcer healing occurred in 77% of patients receiving lansoprazole or in 50% of those receiving an active control drug at 4 and 8 weeks. However, there was no substantial difference in the number of patients experiencing symptomatic (e.g., abdominal pain) relief between those receiving lansoprazole and those receiving the active control.

For treatment of NSAIA-induced ulcers, it is preferable to discontinue NSAIA therapy and initiate therapy with a drug (e.g., proton-pump inhibitor, histamine H2-receptor antagonist) indicated for the treatment of ulcers. When NSAIA therapy must be continued, a proton-pump inhibitor is considered the drug of choice for treatment of ulcers since the efficacy of H2-receptor antagonists is substantially decreased by continued use of NSAIAs. Treatment of H. pylori infection is recommended in patients receiving NSAIAs who have ulcers and are infected with this organism. For further information on H. pylori infection, including details about the efficacy of various regimens and rationale for drug selection,

Prevention

Lansoprazole is used for the prevention of NSAIA-induced gastric ulcers in patients with a documented history of gastric ulcer who require the use of an NSAIA. In a controlled study in patients with a history of gastric ulcer who required NSAIA therapy, lansoprazole 15 or 30 mg daily was more effective than placebo but less effective than misoprostol 200 mcg 4 times daily in preventing gastric ulcer recurrence at 4, 8, and 12 weeks of therapy. About one-half of the patients also had a history of duodenal ulcer. About 51, 93, 80, or 82% of those receiving placebo, misoprostol, or lansoprazole 15 or 30 mg, respectively, remained free of gastric ulcers at 12 weeks. In a subsequent subset analysis of patients receiving only naproxen or naproxen and aspirin (up to 325 mg daily), lansoprazole 15 or 30 mg daily was more effective than placebo and as effective as misoprostol in preventing gastric ulcer recurrence at 4, 8, and 12 weeks of therapy; about 33, 83, 89, or 83% of those receiving placebo, misoprostol, or lansoprazole 15 or 30 mg, respectively, remained free of gastric ulcers at 12 weeks. Serious NSAIA-related GI complications (e.g., bleeding, perforation, obstruction) were not reported during the study; however, the study was not designed to assess the effect of lansoprazole on the risk of such complications or on the risk of duodenal ulcers.

Serious adverse GI effects (e.g., bleeding, ulceration, perforation) can occur at any time in patients receiving chronic NSAIA therapy, and such effects may not be preceded by warning signs or symptoms. Results of studies to date are inconclusive concerning the relative risk of various NSAIAs in causing serious GI effects. In patients receiving prototypical NSAIAs and observed in clinical studies of several months' to 2-years' duration, symptomatic upper GI ulcers, gross bleeding, or perforation appeared to occur in approximately 1% of patients treated for 3-6 months and in about 2-4% of those treated for 1 year. These trends continue with long-term therapy and increase the likelihood of a serious GI event occurring at some time during the course of therapy. Studies have shown that patients with a history of peptic ulcer disease and/or GI bleeding who are receiving NSAIAs have a greater than tenfold higher risk for developing GI bleeding than patients without these risk factors. In addition to a history of ulcer disease, pharmacoepidemiologic studies have identified several comorbid conditions and concomitant therapies that may increase the risk for GI bleeding, including concomitant use of oral corticosteroids or anticoagulants, longer duration of NSAIA therapy, high NSAIA dosage, smoking, alcoholism, older age, and poor general health status. In addition, geriatric or debilitated patients appear to tolerate GI ulceration and bleeding less well than other individuals, and most spontaneous reports of fatal NSAIA-induced GI effects have been in such patients.

For patients at high risk for complications from NSAIA-induced GI ulceration (e.g., bleeding, perforation), concomitant use of misoprostol can be considered for preventive therapy. Alternatively, use of a proton-pump inhibitor (e.g., lansoprazole) may be used concomitantly to decrease the incidence of serious GI toxicity associated with NSAIA therapy. Another approach in high-risk patients who would benefit from NSAIA therapy is use of an NSAIA that is a selective inhibitor of cyclooxygenase-2 (COX-2), since these agents are associated with a lower incidence of serious GI bleeding than are prototypical NSAIAs. However, while celecoxib (200 mg twice daily) was comparably effective to diclofenac sodium (75 mg twice daily) plus omeprazole (20 mg daily) in preventing recurrent ulcer bleeding (recurrent ulcer bleeding probabilities of 4.9 versus 6.4%, respectively, during the 6-month study) in H. pylori-negative arthritis (principally osteoarthritis) patients with a recent history of ulcer bleeding, the protective efficacy was unexpectedly low for both regimens and it appeared that neither could completely protect patients at high risk. Additional study is necessary to elucidate optimal therapy for preventing GI complications associated with NSAIA therapy in high-risk patients.

Duodenal Ulcer

Acute Therapy

Lansoprazole is used for the short-term treatment of endoscopically or radiographically confirmed active duodenal ulcer. Antacids may be used concomitantly as needed for pain relief. In controlled studies in patients with endoscopically confirmed duodenal ulcers, reported rates of ulcer healing for lansoprazole were substantially higher than those for placebo. In a multicenter, double-blind study in patients with endoscopically confirmed duodenal ulcer, reported rates of ulcer healing for an oral lansoprazole dosage of 15 mg daily or placebo were 42 or 11%, respectively, at 2 weeks and 89 or 46%, respectively, at 4 weeks. A similar response was observed in patients receiving 30 or 60 mg of lansoprazole daily. Lansoprazole also produced greater reductions in daytime and nocturnal abdominal pain and antacid consumption than did placebo. Clinically important differences in the rates of ulcer healing between men and women receiving lansoprazole therapy do not appear to exist.

Lansoprazole appears to be at least as effective as H2-receptor antagonists or other proton-pump inhibitors (e.g., omeprazole) for short-term treatment of active duodenal ulcer. In a multicenter, controlled study in patients with endoscopically confirmed duodenal ulcers, 35 or 31% of ulcers were healed following 2 weeks of oral therapy with lansoprazole 20 mg daily or ranitidine 300 mg twice daily, respectively, and 92 or 71%, respectively, were healed after 4 weeks of therapy. A lansoprazole dosage of 30 mg daily was similarly effective. In another multicenter, controlled study in patients with endoscopically confirmed duodenal ulcers, 88 or 82% of ulcers were healed following 2 weeks of oral therapy with lansoprazole 30 mg daily or omeprazole 20 mg daily, respectively, and 98 or 97%, respectively, were healed after 4 weeks of therapy.

Most patients with duodenal ulcer respond to lansoprazole therapy during the usual 4-week course of therapy. However, short-term lansoprazole therapy for the treatment of active duodenal disease will not prevent recurrence of the disease following acute healing and discontinuance of the drug.

Lansoprazole is used in combination with amoxicillin and clarithromycin for the treatment of H. pylori infection and duodenal ulcer disease. Lansoprazole also is used in combination with amoxicillin for the treatment of H. pylori infection and duodenal ulcer disease in patients who are either allergic to or intolerant of clarithromycin or in whom clarithromycin resistance is known or suspected. Lansoprazole also has been used in other multiple-drug regimens for the treatment of H. pylori infection and peptic ulcer disease. Current epidemiologic and clinical evidence supports a strong association between gastric infection with H. pylori and the pathogenesis of duodenal and gastric ulcers; long-term H. pylori infection also has been implicated as a risk factor for gastric cancer. For additional information on the association of this infection with these and other GI conditions, . Conventional antiulcer therapy with H2-receptor antagonists, proton-pump inhibitors, sucralfate, and/or antacids heals ulcers but generally is ineffective in eradicating H. pylori, and such therapy is associated with a high rate of ulcer recurrence (e.g., 60-100% per year). The American College of Gastroenterology (ACG), the National Institutes of Health (NIH), and most clinicians currently recommend that all patients with initial or recurrent duodenal or gastric ulcer and documented H. pylori infection receive anti-infective therapy for treatment of the infection. Although 3-drug regimens consisting of a bismuth salt (e.g., bismuth subsalicylate) and 2 anti-infective agents (e.g., tetracycline or amoxicillin plus metronidazole) administered for 10-14 days have been effective in eradicating the infection, resolving associated gastritis, healing peptic ulcer, and preventing ulcer recurrence in many patients with H. pylori-associated peptic ulcer disease, current evidence principally from studies in Europe suggests that 1 week of such therapy provides comparable H. pylori eradication rates. Other regimens that combine one or more anti-infective agents (e.g., clarithromycin, amoxicillin) with a bismuth salt and/or an antisecretory agent (e.g., omeprazole, lansoprazole, H2-receptor antagonist) also have been used successfully for H. pylori eradication, and the choice of a particular regimen should be based on current data on optimal therapy, including consideration of the patient's prior exposure to anti-infective agents, the local prevalence of resistance, patient compliance, and costs of therapy.

Current evidence suggests that inclusion of a proton-pump inhibitor (e.g., lansoprazole, omeprazole) in anti-H. pylori regimens containing 2 anti-infectives enhances effectiveness, and limited data suggest that such regimens retain good efficacy despite imidazole (e.g., metronidazole) resistance. Therefore, the ACG and many clinicians currently recommend 1 week of therapy with a proton-pump inhibitor and 2 anti-infective agents (usually clarithromycin and amoxicillin or metronidazole), or a 3-drug, bismuth-based regimen (e.g., bismuth-metronidazole-tetracycline) concomitantly with a proton-pump inhibitor, for treatment of H. pylori infection.

Therapy with an antisecretory drug and a single anti-infective agent (i.e., ''dual therapy'') also has been used successfully for treatment of H. pylori infection. However, while some studies demonstrate that certain 2-drug anti-H. pylori regimens (e.g., clarithromycin-omeprazole, ranitidine bismuth citrate-omeprazole, amoxicillin-omeprazole) can successfully eradicate H. pylori infection and prevent recurrence of duodenal ulcer at least in the short term (e.g., at 6 months following completion of anti-H. pylori therapy), the ACG and some clinicians currently state that anti-H. pylori regimens consisting of at least 3 drugs (e.g., 2 anti-infective agents plus a proton-pump inhibitor) are recommended because of enhanced H. pylori eradication rates, decreased failures due to resistance, and shorter treatment periods compared with those apparently required with 2-drug regimens. Additional randomized, controlled studies comparing various anti-H. pylori regimens are needed to clarify optimum drug combinations, dosages, and durations of treatment for H. pylori infection. For a more complete discussion of H. pylori infection, including details about the efficacy of various regimens and rationale for drug selection,.

Maintenance Therapy

Lansoprazole is used as maintenance therapy following healing of duodenal ulcers to reduce ulcer recurrence. In 2 controlled studies of patients with endoscopically documented healed duodenal ulcers, those receiving lansoprazole 15 or 30 mg daily remained healed substantially longer, and experienced substantially fewer recurrences than those receiving placebo over a 12 month period. In one study, 90, 87, and 84% of patients receiving lansoprazole 15 mg daily, and 49, 41, and 39% of patients receiving placebo, remained in endoscopically documented remission over 3, 6, and 12 months, respectively. In another study, 94, 94, and 85% of patients receiving lansoprazole 30 mg daily and 87, 79, and 70% of those receiving lansoprazole 15 mg daily were still in endoscopically documented remission at 3, 6, and 12 months, respectively. In comparison, only 33% of those receiving placebo remained in endoscopically documented remission over 3 months, and none were in remission at 6 or 12 months. There was no substantial difference between lansoprazole 15 or 30 mg daily in maintaining remission.

Pathologic GI Hypersecretory Conditions

Lansoprazole is used for the long-term treatment of pathologic GI hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis). The drug reduces gastric acid secretion and associated symptoms (including diarrhea, anorexia, and pain) in patients with these conditions. In dosages ranging from 15 mg every other day to 180 mg daily, lansoprazole can maintain basal acid secretion below 5 or 10 mEq/hour in patients who have or have not undergone gastric surgery, respectively. Lansoprazole therapy has been continued in some patients for longer than 4 years.

Crohn's Disease-associated Ulcers

Although evidence currently is limited, proton-pump inhibitors have been used for gastric acid-suppressive therapy as an adjunct in the symptomatic treatment of upper GI Crohn's disease, including esophageal, gastroduodenal, and jejunoileal disease. Most evidence of efficacy to date has been from case studies in patients with Crohn's-associated peptic ulcer disease unresponsive to other therapies (e.g., H2-receptor antagonists, cytoprotective agents, antacids, and/or sucralfate).

For further information on the management of Crohn's Disease,

Dosage and Administration

Administration

Lansoprazole is administered orally. Lansoprazole also has been administered by IV infusion; however, a parenteral dosage form no longer is commercially available in the US.

If a dose of lansoprazole is missed, the dose should be taken as soon as possible. However, if the next scheduled dose is due, the missed dose should be omitted, and the next dose taken at the regularly scheduled time. A double dose should not be administered to make up for a missed dose.

Oral Administration

Lansoprazole is administered orally as capsules or orally disintegrating tablets. To avoid decomposition of lansoprazole in the acidic pH of the stomach, the commercially available delayed-release capsules contain enteric-coated granules of the drug, and the orally disintegrating tablets contain enteric-coated microgranules of the drug. The contents of the capsules should not be chewed or crushed, nor should the orally disintegrating tablets be broken, cut, or chewed.

Lansoprazole usually is administered once daily, generally in the morning; however, the manufacturer states that administration of the drug in 2 equally divided doses in the morning and evening may improve efficacy in patients receiving more than 120 mg daily. When lansoprazole is used in combination with amoxicillin or with clarithromycin and amoxicillin for the treatment of Helicobacter pylori infection associated with duodenal ulcer, lansoprazole is given in 2 or 3 divided doses daily.

Following administration of lansoprazole with meals, the rate and extent of GI absorption are reduced. Therefore, lansoprazole should be taken before meals. Since an acidic environment in the parietal cell canaliculi is required for conversion of proton-pump inhibitors (e.g., lansoprazole) to their active sulfenamide metabolites, the American College of Gastroenterology suggests that proton-pump inhibitors are most effective when given about 30 minutes prior to meals and that effectiveness may be compromised if these drugs are administered during the basal state (e.g., to fasting patients at bedtime) or concomitantly with other antisecretory agents (e.g., anticholinergics, histamine H2-receptor antagonists, somatostatin analogs, misoprostol). Lansoprazole may be administered concomitantly with antacids but should be administered at least 30 minutes before sucralfate (see Drug Interactions).

Oral Capsules

Lansoprazole capsules may be swallowed whole. Alternatively, the contents of a capsule may be sprinkled on a tablespoonful of a suitable soft food and swallowed without chewing; mixed with apple, orange, or tomato juice and consumed; or mixed with apple juice and given via a nasogastric tube.

In patients who have difficulty swallowing capsules, the contents of a capsule may be sprinkled on a tablespoonful of applesauce, liquid dietary supplement (e.g., Ensure) pudding, cottage cheese, yogurt, or strained pears and ingested immediately without a clinically important effect on the drug's bioavailability. The granules should not be chewed or crushed. The manufacturer states that administration of lansoprazole mixed in other foods has not been evaluated clinically and is not recommended.

Alternatively, the contents of a capsule may be emptied into a small volume (i.e., 60 mL, about 2 ounces) of apple, orange, or tomato juice, mixed briefly, and swallowed immediately. To ensure complete consumption of the dose, the glass should be rinsed with 120 mL or more of juice, and the contents swallowed immediately. The manufacturer states that administration of lansoprazole mixed in other beverages has not been evaluated clinically and is not recommended.

For patients with a nasogastric tube, the contents of a capsule can be mixed with 40 mL of apple juice in a syringe and administered immediately (i.e., within 3-5 minutes) without any clinically important effect on the drug's bioavailability; the manufacturer states that other liquids should not be used. To facilitate delivery of the entire dose and to maintain patency of the nasogastric tube, the syringe and tube should be flushed with additional apple juice.

The manufacturer states that lansoprazole capsules for self-medication should be swallowed whole with a glass of water; the capsules should not be crushed or chewed.

Orally Disintegrating Tablets

Lansoprazole orally disintegrating tablets containing enteric-coated microgranules of the drug may be allowed to disintegrate on the tongue and then swallowed without chewing; alternatively, a tablet may be dispersed in a compatible liquid and administered orally using an oral syringe or given via a nasogastric tube. The orally disintegrating tablets should not be broken or cut.

For oral administration, the orally disintegrating tablet should be placed on the tongue and allowed to disintegrate (usually in less than 1 minute) with or without water, and the particles swallowed without chewing.

For administration using an oral syringe, a 15- or 30-mg orally disintegrating tablet should be placed in an oral syringe, about 4 or 10 mL, respectively, of water should be drawn into the syringe, and the syringe should be shaken gently to ensure rapid dispersal of the particles. The contents of the syringe should be administered within 15 minutes of preparation. An additional 2 mL (for a 15-mg dose) or 5 mL (for a 30-mg dose) of water should be drawn into the syringe, mixed gently, and the entire contents ingested to ensure complete consumption of the dose.

For administration via a nasogastric tube, a 15- or 30-mg orally disintegrating tablet should be placed in a syringe, about 4 or 10 mL, respectively, of water should be drawn into the syringe, and the syringe should be shaken gently to ensure rapid dispersal of the particles. The contents of the syringe should be administered through a nasogastric tube (8 French or larger) within 15 minutes of preparation. An additional 5 mL of water should be drawn into the syringe, mixed gently, and used to flush the nasogastric tube.

Dosage

Adult Dosage

Gastroesophageal Reflux

For the short-term treatment of symptomatic gastroesophageal reflux disease (GERD), the usual adult dosage of lansoprazole is 15 mg once daily for up to 8 weeks.

For the short-term symptomatic treatment of all grades of erosive esophagitis, the usual adult dosage of lansoprazole is 30 mg once daily. Therapy is continued until healing occurs, usually within 8 weeks; an additional 8 weeks of therapy (up to 16 weeks for a single course) may contribute to healing and symptomatic improvement in some patients. If the erosive esophagitis recurs, the manufacturer states that an additional 8-week course of lansoprazole may be given. However, the American College of Gastroenterology (ACG) states that chronic, even lifelong, therapy with a proton-pump inhibitor is appropriate in many patients with GERD.

For maintenance therapy following healing of erosive esophagitis to reduce recurrence, the usual adult dosage of lansoprazole is 15 mg daily. Safety and efficacy of lansoprazole maintenance therapy for longer than 1 year have not been established.

For self-medication to relieve symptoms of frequent heartburn in adults 18 years of age or older, a lansoprazole dosage of 15 mg once daily in the morning for 14 days is recommended. For self-medication, the manufacturer recommends that the dosage of lansoprazole not exceed 15 mg in 24 hours. In addition, the drug should not be used for self-medication for longer than 14 days of continuous use and individuals should not exceed one course of therapy every 4 months unless otherwise directed by a clinician.

Gastric Ulcer

For the short-term treatment of active benign gastric ulcer, the usual adult dosage of lansoprazole is 30 mg daily for up to 8 weeks.

Nonsteroidal Anti-inflammatory Agent (NSAIA)-induced Ulcers

For the treatment of nonsteroidal anti-inflammatory agent (NSAIA)-associated gastric ulcers in patients continuing NSAIA use, the usual adult dosage of lansoprazole is 30 mg once daily for 8 weeks.

For prevention of NSAIA-associated gastric ulcers in patients with a documented history of gastric ulcer who require the use of an NSAIA, the usual adult dosage of lansoprazole is 15 mg once daily for up to 12 weeks. Efficacy of lansoprazole for periods exceeding 12 weeks in preventing of NSAIA-induced gastric ulcers has not been studied.

Duodenal Ulcer

For the short-term treatment of active duodenal ulcer, the usual adult dosage of lansoprazole is 15 mg once daily. Although an oral dosage of 30 mg daily often was administered in clinical studies, the manufacturer states that dosages of 30 or even 60 mg daily were no more effective at healing active duodenal ulcers than 15 mg daily. Therapy should be continued up to 4 weeks or until healing occurs.

When lansoprazole is used in combination with amoxicillin and clarithromycin (triple therapy) for the treatment of H. pylori infection in patients with active duodenal ulcer, the usual adult dosage is 30 mg every 12 hours (morning and evening) for 10 or 14 days. When lansoprazole is used in combination with amoxicillin (dual therapy) for the treatment of H. pylori infection in patients with active duodenal ulcer, the usual adult dosage is 30 mg every 8 hours for 14 days.

For maintenance therapy following healing of duodenal ulcer to reduce recurrence, the usual adult dosage of lansoprazole is 15 mg daily. Safety and efficacy of lansoprazole maintenance therapy for longer than 1 year have not been established.

Pathologic GI Hypersecretory Conditions

For the long-term treatment of pathologic GI hypersecretory conditions (e.g., Zollinger-Ellison syndrome, multiple endocrine adenomas, systemic mastocytosis), dosages of lansoprazole should be individualized according to patient response and tolerance. The usual initial adult dosage is 60 mg once daily. Subsequent lansoprazole dosage should be adjusted as tolerated and necessary to adequately suppress gastric acid secretion, and therapy continued as long as clinically necessary.

Oral dosages ranging from 15 mg every other day to 180 mg daily have been necessary to maintain basal gastric acid secretion at less than 10 mEq/hour in patients without a history of gastric surgery and less than 5 mEq/hour in those who have undergone gastric surgery; generally, determination of gastric acid secretion during the hour prior to a dose is useful in establishing optimum dosage. The manufacturer recommends that daily dosages exceeding 120 mg be administered in 2 equally divided doses in the morning and evening. Lansoprazole has been given continuously for longer than 4 years in some patients with Zollinger-Ellison syndrome.

Pediatric Dosage

Gastroesophageal Reflux

For the short-term treatment of symptomatic GERD or erosive esophagitis in children 1-11 years of age, the usual oral dosage of lansoprazole for children weighing 30 kg or less is 15 mg once daily for up to 12 weeks; dosage for children weighing more than 30 kg is 30 mg once daily for up to 12 weeks. Dosage in children 1-11 years of age has been increased to up to 30 mg twice daily in patients remaining symptomatic after 2 or more weeks of treatment.

For children 12-17 years of age, the usual oral dosage of lansoprazole for treatment of nonerosive GERD is 15 mg daily for up to 8 weeks, and that for erosive esophagitis is 30 mg daily for up to 8 weeks.

Special Populations

The manufacturer states that lansoprazole dosage adjustment is not necessary in geriatric patients. Although pharmacokinetics of lansoprazole may be altered slightly in patients with renal impairment, dosage adjustment is not necessary. However, the commercially available daily administration pack containing lansoprazole, amoxicillin, and clarithromycin (Prevpac)is not recommended for use in patients with creatinine clearance values less than 30 mL/minute. In patients with severe hepatic impairment, lansoprazole dosage reduction should be considered.(See Specific Populations under Cautions: Warnings/Precautions.)

Cautions

Contraindications

Known severe hypersensitivity to lansoprazole or any ingredient in the formulation.

Warnings/Precautions

Gastric Malignancy

Symptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy.

Clostridium difficile Infection

Available data suggest a possible association between use of proton-pump inhibitors and risk of Clostridium difficile infection, including C. difficile-associated diarrhea and colitis (CDAD; also known as antibiotic-associated diarrhea and colitis or pseudomembranous colitis). In most observational studies to date, the risk of C. difficile infection in patients exposed to proton-pump inhibitors has ranged from 1.4-2.75 times that in patients not exposed to proton-pump inhibitors; however, some observational studies have found no increase in risk. Although many of the cases occurred in patients who had other risk factors for CDAD, including advanced age, comorbid conditions, and/or use of broad-spectrum anti-infectives, the US Food and Drug Administration (FDA) concluded that a contributory role for proton-pump inhibitors could not be definitively ruled out. The mechanism by which proton-pump inhibitors might increase the risk of CDAD has not been elucidated. Although it has been suggested that reduction of gastric acidity by gastric antisecretory agents might facilitate colonization with C. difficile, some studies have raised questions about this proposed mechanism or have suggested that the observed association is the result of confounding with other risk factors for CDAD. FDA also is reviewing the risk of CDAD in patients exposed to histamine H2-receptor antagonists.

CDAD can be serious in patients who have one or more risk factors for C. difficile infection and are receiving concomitant therapy with a proton-pump inhibitor; colectomy and, rarely, death have been reported. FDA recommends that patients receive proton-pump inhibitors at the lowest effective dosage and for the shortest possible time appropriate for their clinical condition. Patients experiencing persistent diarrhea should be evaluated for CDAD and should be managed with appropriate supportive therapy (e.g., fluid and electrolyte management), anti-infective therapy directed against C. difficile (e.g., metronidazole, vancomycin), and surgical evaluation as clinically indicated.

Respiratory Effects

Administration of proton-pump inhibitors has been associated with an increased risk for developing certain infections (e.g., community-acquired pneumonia). For further precautionary information about this adverse effect,

Musculoskeletal Effects

Findings from several observational studies suggest that therapy with proton-pump inhibitors, particularly in high dosages (i.e., multiple daily doses) and/or for prolonged periods of time (i.e., one year or longer), may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. The magnitude of risk is unclear; causality has not been established. FDA is continuing to evaluate this safety concern. Although controlled studies are required to confirm these findings, patients should receive proton-pump inhibitors at the lowest effective dosage and for the shortest possible time appropriate for their clinical condition. Individuals who are at risk for osteoporosis-related fractures should receive an adequate intake of calcium and vitamin D and should have their bone health assessed and managed according to current standards of care.

Hypomagnesemia

Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients receiving long-term therapy (for at least 3 months or, in most cases, for longer than one year) with proton-pump inhibitors, including lansoprazole. Clinically serious adverse effects associated with hypomagnesemia, which are similar to manifestations of hypocalcemia, include tetany, seizures, tremors, carpopedal spasm, arrhythmias (e.g., atrial fibrillation, supraventricular tachycardia), and abnormal QT interval. Other reported adverse effects include paresthesia, muscle weakness, muscle cramps, lethargy, fatigue, and unsteadiness. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuance of the proton-pump inhibitor. Following discontinuance of the proton-pump inhibitor, hypomagnesemia resolved within a median of one week; upon rechallenge, hypomagnesemia recurred within a median of 2 weeks.

In patients expected to receive long-term therapy with a proton-pump inhibitor or in those receiving a proton-pump inhibitor concomitantly with digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), clinicians should consider measurement of serum magnesium concentrations prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter. (.)

Phenylketonuria

Individuals with phenylketonuria (i.e., homozygous genetic deficiency of phenylalanine hydroxylase) and other individuals who must restrict their intake of phenylalanine should be warned that each 15- or 30-mg Prevacid SoluTab orally disintegrating tablet contains aspartame (NutraSweet), which is metabolized in the GI tract to provide about 2.5 or 5.1 mg, respectively, of phenylalanine following oral administration.

Specific Populations

Pregnancy

Category B.

Lactation

Lansoprazole or its metabolites are distributed into milk in rats; it is not known whether lansoprazole is distributed into human milk. The manufacturer states that a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

Pediatric Use

Safety and efficacy of oral lansoprazole in pediatric patients 1-17 years of age have been established for short-term treatment of symptomatic gastroesophageal reflux disease (GERD) and erosive esophagitis. In an open-label study in children 1-11 years of age, symptomatic improvement occurred following 8-12 weeks of lansoprazole therapy in 76% of children with symptomatic GERD; in a limited subset of children with endoscopically documented erosive esophagitis, rates of symptomatic improvement and healing were 81 and 100%, respectively. Lansoprazole was initiated at a dosage of 15 mg daily in children weighing 30 kg or less and a dosage of 30 mg daily in those weighing more than 30 kg; dosage could be increased up to 30 mg twice daily in children who continued to experience symptoms 2 or more weeks after initiating therapy with the drug. In an open-label study in adolescents 12-17 years of age with GERD, symptomatic improvement occurred following 8 weeks of therapy with lansoprazole 15 mg daily in 71% of those with nonerosive disease; in a smaller group of adolescents with erosive esophagitis, rates of symptomatic improvement and healing were 78 and 96%, respectively, following 8-12 weeks of therapy with lansoprazole 30 mg daily. The most commonly reported adverse effects in pediatric patients receiving lansoprazole include headache, abdominal pain, constipation, nausea, and dizziness.

Efficacy of oral lansoprazole has not been established in infants younger than 1 year of age. In a controlled study in infants 1 month to younger than 1 year of age with symptomatic GERD, lansoprazole was no more effective than placebo in reducing feeding-associated episodes of crying, fussing, or irritability; in both the placebo and lansoprazole groups, the response rate was 54%.

Safety and efficacy of lansoprazole for self-medication of frequent heartburn have not been established in children younger than 18 years of age.

Geriatric Use

The frequency of adverse effects in geriatric patients appears to be similar to that in younger patients. Clearance of lansoprazole may be decreased in geriatric patients, but accumulation of the drug does not occur with once-daily dosing and dosage adjustment is not necessary.

Hepatic Impairment

Systemic exposure to lansoprazole, as measured by area under the serum concentration-time curve (AUC), may be increased by up to 500% in patients with chronic hepatic impairment. Dosage reduction should be considered in patients with severe hepatic impairment.

Renal Impairment

Although the pharmacokinetics of lansoprazole may be altered slightly in patients with renal impairment, dosage adjustment is not necessary.

Common Adverse Effects

Adverse effects occurring in 1% or more of patients receiving oral lansoprazole and more frequently than with placebo include abdominal pain, diarrhea, nausea, and constipation.

Drug Interactions

Drugs Metabolized by Hepatic Microsomal Enzymes

Lansoprazole is metabolized by cytochrome P-450 (CYP) isoenzymes 2C19 and 3A. In studies in healthy individuals, clinically important interactions were not observed between lansoprazole and other drugs (e.g., antipyrine, clarithromycin, diazepam, ibuprofen, indomethacin, phenytoin, prednisone, propranolol, warfarin) metabolized by CYP isoenzymes, including the 1A2, 2C9, 2C19, 2D6, and 3A isoenzymes.

Drugs that Cause Hypomagnesemia

Potential pharmacologic interaction (possible increased risk of hypomagnesemia). In patients receiving diuretics (i.e., loop or thiazide diuretics) or other drugs that may cause hypomagnesemia, monitoring of magnesium concentrations should be considered prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.(See Hypomagnesemia under Cautions: Warnings/Precautions.)

Gastric pH-dependent Drugs

Pharmacokinetic interaction is theoretically possible when lansoprazole is used concomitantly with gastric pH-dependent drugs (e.g., ampicillin esters, digoxin, iron salts, ketoconazole); altered drug absorption at increased gastric pH values.

Amoxicillin

Clinically important interaction is unlikely.

Antacids

Efficacy of lansoprazole is not altered by concomitant administration of antacids.

Antiretroviral Agents

Atazanavir

Potential pharmacokinetic interaction with atazanavir (possible altered oral absorption of atazanavir at increased gastric pH, resulting in decreased plasma atazanavir concentrations). Concomitant use of omeprazole 40 mg once daily and atazanavir (with or without low-dose ritonavir) results in a substantial decrease in plasma concentrations of atazanavir and possible loss of the therapeutic effect of the antiretroviral agent. The manufacturer of lansoprazole states that concomitant administration with atazanavir is not recommended. If atazanavir is administered in an antiretroviral treatment-naive patient receiving a proton-pump inhibitor, a ritonavir-boosted regimen of 300 mg of atazanavir once daily with ritonavir 100 mg once daily with food is recommended. The dose of the proton-pump inhibitor should be administered approximately 12 hours before ritonavir-boosted atazanavir; the dose of the proton-pump inhibitor should not exceed omeprazole 20 mg daily (or equivalent). Concomitant use of proton-pump inhibitors with atazanavir is not recommended in antiretroviral treatment-experienced patients.

Fosamprenavir

Concomitant use of esomeprazole with fosamprenavir (with or without ritonavir) did not substantially affect concentrations of amprenavir (active metabolite of fosamprenavir). No dosage adjustment is required when proton-pump inhibitors are used concomitantly with fosamprenavir (with or without ritonavir).

Lopinavir

Concomitant use of omeprazole with the fixed combination of lopinavir and ritonavir (lopinavir/ritonavir) did not have a clinically important effect on plasma concentrations or area under the concentration-time curve (AUC) of lopinavir. No dosage adjustment is required when proton-pump inhibitors are used concomitantly with lopinavir/ritonavir.

Raltegravir

Pharmacokinetic interaction with omeprazole (substantially increased peak plasma concentration and AUC of raltegravir); however, no dosage adjustment is recommended when proton-pump inhibitors are used concomitantly with raltegravir.

Rilpivirine

Pharmacokinetic interaction with omeprazole (decreased plasma concentrations and AUC of rilpivirine). Concomitant use of other proton-pump inhibitors also may result in decreased plasma concentrations of rilpivirine. Concomitant use of rilpivirine and proton-pump inhibitors is contraindicated.

Saquinavir

Potential pharmacokinetic interaction (increased peak plasma concentration and AUC of saquinavir). Concomitant use of omeprazole 40 mg once daily and ritonavir-boosted saquinavir (saquinavir 1 g twice daily and ritonavir 100 mg twice daily) increased the peak plasma concentration and AUC of saquinavir by 75 and 82%, respectively. Caution is advised if proton-pump inhibitors are used concomitantly with ritonavir-boosted saquinavir, and patients should be monitored for saquinavir toxicity.

Clopidogrel

Potential pharmacokinetic interaction (decreased plasma concentration of the active metabolite of clopidogrel) and pharmacodynamic interaction (reduced antiplatelet effects) between proton-pump inhibitors and clopidogrel. Clopidogrel is metabolized to its active metabolite by CYP2C19. Concurrent use of omeprazole or esomeprazole, which inhibit CYP2C19, with clopidogrel reduces exposure to the active metabolite of clopidogrel and decreases platelet inhibitory effects. Although the clinical importance has not been fully elucidated, a reduction in the effectiveness of clopidogrel in preventing cardiovascular events is possible. Proton-pump inhibitors vary in their potency for inhibiting CYP2C19. The change in inhibition of adenosine diphosphate (ADP)-induced platelet aggregation associated with concomitant use of proton-pump inhibitors is related to the change in exposure to the active metabolite of clopidogrel. In pharmacokinetic and pharmacodynamic studies in healthy individuals, concomitant use of dexlansoprazole, lansoprazole, or pantoprazole had less effect on the antiplatelet activity of clopidogrel than did concomitant use of omeprazole or esomeprazole. In individuals who were extensive metabolizers of CYP2C19 substrates, use of lansoprazole (30 mg once daily) concomitantly with clopidogrel (75 mg once daily) for 9 days reduced exposure to the active metabolite of clopidogrel by about 14% compared with use of clopidogrel alone. The observed effects of lansoprazole on metabolite exposure and clopidogrel-induced platelet inhibition were not considered clinically important, and the manufacturer of lansoprazole states that no adjustment of clopidogrel dosage is necessary if clopidogrel is used concomitantly with recommended dosages of lansoprazole.

The decision to use a proton-pump inhibitor concomitantly with clopidogrel should be based on the assessed risks and benefits in individual patients. The American College of Cardiology Foundation/American College of Gastroenterology/American Heart Association (ACCF/ACG/AHA) states that the reduction in GI bleeding risk with proton-pump inhibitors is substantial in patients with risk factors for GI bleeding (e.g., advanced age; concomitant use of warfarin, corticosteroids, or nonsteroidal anti-inflammatory agents [NSAIAs]; H. pylori infection) and may outweigh any potential reduction in the cardiovascular efficacy of antiplatelet treatment associated with a drug-drug interaction. In contrast, ACCF/ACG/AHA states that patients without such risk factors receive little if any absolute risk reduction from proton-pump inhibitor therapy, and the risk/benefit balance may favor use of antiplatelet therapy without a proton-pump inhibitor in these patients.

If concomitant therapy with a proton-pump inhibitor and clopidogrel is considered necessary, use of an agent with little or no CYP2C19-inhibitory activity should be considered. Alternatively, treatment with a histamine H2-receptor antagonist (ranitidine, famotidine, nizatidine) may be considered, although such agents may not be as effective as a proton-pump inhibitor in providing gastric protection; cimetidine should not be used since it also is a potent CYP2C19 inhibitor. There currently is no evidence that histamine H2-receptor antagonists (other than cimetidine) or other drugs that reduce gastric acid (e.g., antacids) interfere with the antiplatelet effects of clopidogrel. For further information on interactions between proton-pump inhibitors and clopidogrel,

Digoxin

Hypomagnesemia (e.g., resulting from long-term use of proton-pump inhibitors) sensitizes the myocardium to digoxin and, thus, may increase the risk of digoxin-induced cardiotoxic effects. In patients receiving digoxin, monitoring of magnesium concentrations should be considered prior to initiation of prescription proton-pump inhibitor therapy and periodically thereafter.

Methotrexate

Potential pharmacokinetic interaction (increased serum methotrexate concentrations, possibly resulting in toxicity) when proton-pump inhibitors, including lansoprazole, are used concomitantly with methotrexate. Increased serum concentrations and delayed clearance of methotrexate and/or its metabolite hydroxymethotrexate, with or without symptoms of methotrexate toxicity, have been reported in patients receiving methotrexate (usually at doses of 300 mg/m to 12 g/m) concomitantly with a proton-pump inhibitor. Although most of the reported cases occurred in patients receiving high doses of methotrexate, toxicity also has been reported in patients receiving low dosages of methotrexate (e.g., 15 mg per week) concomitantly with a proton-pump inhibitor. In patients with rheumatoid arthritis receiving low-dose methotrexate (7.5-15 mg weekly), concomitant use of lansoprazole (30 mg daily) and naproxen (500 mg twice daily) for 7 days had no effect on the pharmacokinetics of methotrexate or 7-hydroxymethotrexate. However, no formal studies of interactions between high-dose methotrexate and proton-pump inhibitors have been conducted to date.

The manufacturer of lansoprazole states that temporary discontinuance of proton-pump inhibitor therapy may be considered in some patients receiving high-dose methotrexate therapy. Some clinicians recommend either withholding proton-pump inhibitor therapy for several days before and after methotrexate administration or substituting a histamine H2-receptor antagonist for the proton-pump inhibitor when acid suppressive therapy is indicated during methotrexate therapy. Pending further evaluation, some clinicians state that these recommendations should extend to patients receiving low-dose methotrexate.

Sucralfate

Potential pharmacokinetic interaction. Concomitant administration of lansoprazole with sucralfate resulted in delayed absorption and decreased (by 17%) bioavailability of lansoprazole. Lansoprazole should be administered at least 30 minutes before sucralfate.

Tacrolimus

Potential pharmacokinetic interaction (increased whole blood concentrations of tacrolimus), particularly in transplant patients who are intermediate or poor metabolizers of CYP2C19 substrates.

Theophylline

Potential pharmacokinetic interaction. Concomitant administration of theophylline and lansoprazole may result in a slight (10%) increase in theophylline clearance. The interaction is unlikely to be clinically important, although some patients may require adjustment of theophylline dosage when lansoprazole therapy is initiated or discontinued.

Warfarin

When warfarin was administered concomitantly with single or multiple doses of lansoprazole 60 mg in healthy individuals, the pharmacokinetics of warfarin and the prothrombin time were not altered; however, increased international normalized ratio (INR) and prothrombin time have been reported in patients receiving warfarin concomitantly with proton-pump inhibitors, including lansoprazole. The INR and prothrombin time may need to be monitored when lansoprazole is used concomitantly with warfarin.

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