Lansoprazole is a proton pump inhibitor (PPI). Refer to DOSAGE AND ADMINISTRATION table (below) for indications and usage. ( 1 )
1.1Short-Term Treatment of Active Duodenal Ulcer
Lansoprazole delayed-release capsules USP are 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 delayed-release capsules USP/amoxicillin/clarithromycin Lansoprazole delayed-release capsules USP 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 delayed-release capsules USP/amoxicillin Lansoprazole delayed-release capsules USP 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 ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin package insert, MICROBIOLOGY section).
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.
1.3Maintenance of Healed Duodenal Ulcers
Lansoprazole delayed-release capsules USP are indicated to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months [ see Clinical Studies ( 14 ) ].
1.4Short-Term Treatment of Active Benign Gastric Ulcer
Lansoprazole delayed-release capsules USP are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of active benign gastric ulcer [ see Clinical Studies ( 14 ) ].
1.5Healing of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release capsules USP are indicated for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond 8 weeks [ see Clinical Studies ( 14 ) ].
1.6Risk Reduction of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release capsules USP are indicated 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 ) ].
1.7Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD
Lansoprazole delayed-release capsules USP are indicated for the treatment of heartburn and other symptoms associated with GERD [ see Clinical Studies ( 14 ) ]. Short-Term Treatment of Erosive Esophagitis Lansoprazole delayed-release capsules USP are indicated for short-term treatment (up to 8 weeks) for healing and symptom relief of all grades of erosive esophagitis. For patients who do not heal with lansoprazole delayed-release capsules USP for 8 weeks (5 to 10%), it may be helpful to give an additional 8 weeks of treatment.
If there is a recurrence of erosive esophagitis an additional 8 week course of lansoprazole delayed-release capsules USP may be considered [ see Clinical Studies ( 14 ) ].
1.8Maintenance of Healing of Erosive Esophagitis (EE)
Lansoprazole delayed-release capsules USP are indicated to maintain healing of erosive esophagitis. Controlled studies did not extend beyond 12 months [ see Clinical Studies ( 14 ) ].
1.9Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)
Lansoprazole delayed-release capsules USP are indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [ see Clinical Studies ( 14 ) ].
Contraindications
Lansoprazole delayed-release capsules are contraindicated in patients with known severe hypersensitivity to any component of the formulation of lansoprazole delayed-release capsules. For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole delayed-release capsules, refer to the CONTRAINDICATIONS section of their package inserts. Contraindicated in patients with known severe hypersensitivity to any component of the lansoprazole delayed-release capsule formulation.
( 4 )
Warnings and precautions
Symptomatic response with lansoprazole does not preclude the presence of gastric malignancy. ( 5.1 )
PPI therapy may be associated with increased risk of ClostridiumDifficile associated diarrhea. ( 5.2 )
Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. ( 5.3 )
Hypomagnesemia has been reported rarely with prolonged treatment with PPIs. ( 5.4 )
5.1Gastric Malignancy
Symptomatic response to therapy with lansoprazole does not preclude the presence of gastric malignancy.
5.2Clostridium Difficile Associated Diarrhea
Published observational studies suggest that proton pump inhibitor (PPI) therapy like lansoprazole delayed-release capsules may be associated with an increased risk of Clostridium Difficile associated diarrhea (CDAD), especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions ( 6.2 )]. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.
CDAD has been reported with use of nearly all antibacterial agents. For more information specific to antibacterial agents (clarithromycin and amoxicillin) indicated for use in combination with lansoprazole delayed-release capsules, refer to WARNINGS and PRECAUTIONS sections of those package inserts.
5.3Bone Fracture
Several published observational studies suggest that PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the conditions being treated.
Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines [ see Dosage and Administration ( 2 ) and Adverse Reactions ( 6.2 ) ].
5.4Hypomagnesemia
Hypomagnesemia, symptomatic and asymptomatic, has been reported rarely in patients treated with PPIs for at least three months, in most cases after a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. In most patients, treatment of hypomagnesemia required magnesium replacement and discontinuation of the PPI. For patients expected to be on prolonged treatment or who take PPIs with medications such as digoxin or drugs that may cause hypomagnesemia (e.g., diuretics), healthcare professionals may consider monitoring magnesium levels prior to initiation of PPI treatment and periodically [ see Adverse Reactions ( 6.2 ) ].
5.5Concomitant Use of Lansoprazole With Methotrexate
Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients [ see Drug Interactions ( 7.6 ) and Clinical Pharmacology ( 12.3 ) ].
Interactions
Atazanavir: Do not coadminister with atazanavir. ( 7.1 )
Drugs With pH-Dependent Absorption: May interfere with the absorption of drugs where gastric pH is important for bioavailability. ( 7.1 )
Warfarin: Concomitant warfarin use may require monitoring for increases in INR and prothrombin time. ( 7.2 )
Tacrolimus: Concomitant tacrolimus use may increase tacrolimus whole blood concentrations. ( 7.3 )
Theophylline: Titration of theophylline dosage may be required when concomitant lansoprazole use is started or stopped. ( 7.4 )
Methotrexate: Lansoprazole may increase serum levels of methotrexate. ( 7.6 )
7.1Drugs
With pH-Dependent Absorption Kinetics Lansoprazole causes long-lasting inhibition of gastric acid secretion. Lansoprazole and other PPIs are likely to substantially decrease the systemic concentrations of the HIV protease inhibitor atazanavir, which is dependent upon the presence of gastric acid for absorption, and may result in a loss of therapeutic effect of atazanavir and the development of HIV resistance. Therefore, lansoprazole and other PPIs should not be coadministered with atazanavir [ see Clinical Pharmacology ( 12.3 ) ].
Lansoprazole and other PPIs may interfere with the absorption of other drugs where gastric pH is an important determinant of oral bioavailability (e.g., ampicillin esters, digoxin, iron salts, ketoconazole) [ see Clinical Pharmacology ( 12.3 ) ].
7.2 Warfarin In a study of healthy subjects, coadministration of single or multiple 60 mg doses of lansoprazole and warfarin did not affect the pharmacokinetics of warfarin nor prothrombin time [ see Clinical Pharmacology ( 12.3 ) ]. However, there have been reports of increased INR and prothrombin time in patients receiving PPIs and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death.
Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time [ see Clinical Pharmacology ( 12.3 ) ].
7.3Tacrolimus
Concomitant administration of lansoprazole and tacrolimus may increase whole blood levels of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19.
7.4Theophylline
A minor increase (10%) in the clearance of theophylline was observed following the administration of lansoprazole concomitantly with theophylline. Although the magnitude of the effect on theophylline clearance is small, individual patients may require additional titration of their theophylline dosage when lansoprazole is started or stopped to ensure clinically effective blood levels [ see Clinical Pharmacology ( 12.3 ) ].
7.5Clopidogrel
Concomitant administration of lansoprazole and clopidogrel in healthy subjects had no clinically important effect on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition [ see Clinical Pharmacology ( 12.3 ) ]. No dose adjustment of clopidogrel is necessary when administered with an approved dose of lansoprazole.
7.6Methotrexate
Case reports, published population pharmacokinetic studies, and retrospective analyses suggest that concomitant administration of PPIs and methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite hydroxymethotrexate. However, no formal drug interaction studies of high dose methotrexate with PPIs have been conducted [ see Warnings and Precautions ( 5.5 ) ].
In a study of rheumatoid arthritis patients receiving low-dose methotrexate, lansoprazole and naproxen, no effect on pharmacokinetics of methotrexate was observed [ see Clinical Pharmacology ( 12.3 ) ].
7.7Combination Therapy With Clarithromycin
Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions due to drug interactions [see Warnings and Precautions in prescribing information for clarithromycin]. Because of these drug interactions, clarithromycin is contraindicated for co-administration with certain drugs [see Contraindications in prescribing information for clarithromycin]. For information about drug interactions of antibacterial agents (amoxicillin and clarithromycin) indicated in combination with lansoprazole, refer to the DRUG INTERACTIONS section of their package inserts.
Pregnancy and breastfeeding
8.1Pregnancy Teratogenic Effects Pregnancy Category B
Reproduction studies have been performed in pregnant rats at oral doses up to 40 times the recommended human dose and in pregnant rabbits at oral doses up to 16 times the recommended human dose and have revealed no evidence of impaired fertility or harm to the fetus due to lansoprazole. There are, however, no adequate or well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed [ see Nonclinical Toxicology ( 13.2 ) ].
See full prescribing information for clarithromycin before using in pregnant women.
Adverse reactions
Most commonly reported adverse reactions (≥ 1%): diarrhea, abdominal pain, nausea and constipation. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact TEVA USA, PHARMACOVIGILANCE at 1-866-832-8537 or drug.safety@tevapharm.com; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1Clinical
Worldwide, over 10,000 patients have been treated with lansoprazole in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, lansoprazole treatment has been well-tolerated in both short-term and long-term trials. Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of lansoprazole-treated patients and occurred at a greater rate in lansoprazole-treated patients than placebo-treated patients in Table 1 . Table 1: Incidence of Possibly or Probably Treatment-Related Adverse Reactions in Short-Term, Placebo-Controlled Lansoprazole Studies Body System/Adverse Event Lansoprazole Placebo (N = 2768) (N = 1023) % % Body as a Whole Abdominal Pain 2.1
1.2 Digestive System Constipation 1
0.4 Diarrhea 3.8
2.3 Nausea 1.3
1.2 Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of lansoprazole, but higher in the patients who received 60 mg of lansoprazole (2.9%, 1.4%, 4.2%, and 7.4%, respectively). The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.
In the risk reduction study of lansoprazole for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with lansoprazole, misoprostol, and placebo was 5%, 22%, and 3%, respectively. Another study for the same indication, where patients took either a COX-2 inhibitor or lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with lansoprazole included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.
Additional adverse experiences have been reported since lansoprazole has been marketed. The majority of these cases are foreign-sourced and a relationship to lansoprazole has not been established. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system. Body as a Whole - anaphylactic/anaphylactoid reactions; Digestive System - hepatotoxicity, pancreatitis, vomiting; Hemic and Lymphatic System - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Infections and Infestations – Clostridium Difficile associated diarrhea; Metabolism and Nutritional Disorders - hypomagnesemia; Musculoskeletal System - bone fracture, myositis; Skin and Appendages - severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal); Special Senses - speech disorder; Urogenital System - interstitial nephritis, urinary retention.
6.3Combination Therapy With Amoxicillin and Clarithromycin
In clinical trials using combination therapy with lansoprazole plus amoxicillin and clarithromycin, and lansoprazole plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with lansoprazole, amoxicillin, or clarithromycin. Triple Therapy: Lansoprazole/amoxicillin/clarithromycin The most frequently reported adverse reactions for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%).
There were no statistically significant differences in the frequency of reported adverse reactions between the 10 and 14 day triple therapy regimens. No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen. Dual Therapy: Lansoprazole/amoxicillin The most frequently reported adverse reactions
Our copy of this section ends here. The full text is in the official label at the FDA. Open Drugs@FDA
Composition
Active ingredients
LANSOPRAZOLE 30MG
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.
