HIGHLIGHTS OF PRESCRIBING INFORMATION • Patients receiving rilpivirine-containing products. (4, 7) Dual Therapy: Lansoprazole delayed-release orally disintegrating tablets/amoxicillin Administration with Water in an Oral Syringe 6.1 Clinical Trials Experience In clinical trials using combination therapy with lansoprazole plus amoxicillin and clarithromycin, women. Because animal reproduction studies are not always predictive of human response, this 8.6 Hepatic Impairment These highlights do not include all the information WARNINGS AND PRECAUTIONS Lansoprazole delayed-release orally disintegrating tablets in combination with amoxicillin as dual 1. Place a 15 mg tablet in oral syringe and draw up 4 mL of water, or place a 30 mg tablet Because clinical trials are conducted under widely varying conditions, adverse reaction rates and lansoprazole plus amoxicillin, no increased laboratory abnormalities particular to these drug drug should be used during pregnancy only if clearly needed [see Nonclinical Toxicology (13.2)]. In patients with various degrees of chronic hepatic impairment the exposure to lansoprazole was needed to use LANSOPRAZOLE DELAYED- • Gastric Malignancy: In adults, symptomatic therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal in oral syringe and draw up 10 mL of water. observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of combinations were observed. See full prescribing information for clarithromycin before using in pregnant women. increased compared to healthy subjects with normal hepatic function [see Clinical Pharmacology RELEASE ORALLY DISINTEGRATING TABLETS response with lansoprazole does not preclude ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant 2. Shake gently to allow for a quick dispersal. another drug and may not reflect the rates observed in clinical practice. For information about laboratory value changes with antibacterial agents (amoxicillin and (12.3)]. No dosage adjustment for lansoprazole delayed-release orally disintegrating tablets is to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the 8.3 Nursing Mothers necessary for patients with mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic safely and effectively. See full prescribing the presence of gastric malignancy. Consider 3. After the tablet has dispersed, administer the contents within 15 minutes of mixing into Worldwide, over 10,000 patients have been treated with lansoprazole in Phase 2 or Phase 3 clinical clarithromycin) indicated in combination with lansoprazole, refer to the Adverse Reactions section Lansoprazole or its metabolites are excreted in the milk of rats. It is not known whether lansoprazole information for LANSOPRAZOLE DELAYED- additional follow-up and diagnostic testing. (5.1) clarithromycin prescribing information, Microbiology section). Eradication of H. pylori has been trials involving various dosages and durations of treatment. In general, lansoprazole treatment has of their prescribing information. impairment. The recommended dosage is 15 mg orally daily in patients with severe hepatic shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.2)]. the mouth. Do not save the water and microgranule mixture for later use. is excreted in human milk. Because many drugs are excreted in human milk, because of the potential impairment (Child-Pugh Class C) [see Dosage and Administration (2.3)]. RELEASE ORALLY DISINTEGRATING TABLETS. • Acute Interstitial Nephritis: Acute interstitial nephritis been well-tolerated in both short-term and long-term trials. 7 DRUG INTERACTIONS for serious adverse reactions in nursing infants from lansoprazole, and because of the potential for Please refer to the full prescribing information for amoxicillin. 4. Refill the syringe with approximately 2 mL (5 mL for the 30 mg tablet) of water, shake 10 OVERDOSAGE LANSOPRAZOLE delayed-release orally has been observed in patients taking PPIs. (5.2) gently, and administer any remaining contents. The following adverse reactions were reported by the treating physician to have a possible or Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics tumorigenicity shown for lansoprazole in rat carcinogenicity studies, a decision should be made disintegrating tablets, for oral use 1.3 Maintenance of Healed Duodenal Ulcers probable relationship to drug in 1% or more of lansoprazole-treated patients and occurred at a when administered concomitantly with lansoprazole and instructions for preventing or managing them. whether to discontinue nursing or to discontinue lansoprazole, taking into account the importance Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient • Clostridium difficile-Associated Diarrhea: PPI Administration with Water via a NG Tube (≥ 8 French) consumed 600 mg of lansoprazole with no adverse reaction. Oral lansoprazole doses up to 5000 mg/kg Initial U.S. Approval: 1995 therapy may be associated with increased risk Lansoprazole delayed-release orally disintegrating tablets are indicated in adults to maintain healing greater rate in lansoprazole-treated patients than placebo-treated patients in Table 1. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. of lansoprazole to the mother. of duodenal ulcers. Controlled studies do not extend beyond 12 months [see Clinical Studies (14.3)]. 1. Place a 15 mg tablet in a catheter-tip syringe and draw up 4 mL of water, or place a in rats [approximately 1300 times the 30 mg human dose based on body surface area (BSA)] and in mice RECENT MAJOR CHANGES of Clostridium difficile-associated diarrhea. (5.3) 30 mg tablet in a catheter-tip syringe and draw up 10 mL of water. Table 1. Incidence of Possibly or Probably Treatment-Related Adverse Reactions in Short-Term, Table 2. Clinically Relevant Interactions Affecting Drugs Coadministered with Lansoprazole and 8.4 Pediatric Use (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs. 1.4 Treatment of Active Benign Gastric Ulcer Placebo-Controlled Lansoprazole Studies The safety and effectiveness of lansoprazole have been established in pediatric patients one to 17 Contraindications (4) 07/2017 • Bone Fracture: Long-term and multiple daily dose 2. Shake gently to allow for a quick dispersal. Interactions with Diagnostics In the event of over-exposure, treatment should be symptomatic and supportive. PPI therapy may be associated with an increased Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for short-term treatment (up Body System/ Lansoprazole Placebo years of age for short-term treatment of symptomatic GERD and erosive esophagitis, however, Warnings and Precautions to eight weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies (14.4)]. 3. After the tablet has dispersed, shake the catheter-tip syringe gently in order to keep the Antiretrovirals lansoprazole was not effective in patients with symptomatic GERD one month to less than one year If over-exposure occurs, call your poison control center at 1-800-222-1222 for current information Interactions with Investigations for risk for osteoporosis-related fractures of the hip, Adverse Reaction (N = 2768) (N = 1023) wrist or spine. (5.4) 1.5 Healing of NSAID-Associated Gastric Ulcer microgranules from settling, and immediately inject the mixture through the NG tube % % The effect of PPIs on antiretroviral drugs is variable. The clinical importance and of age in a multi-center, double-blind, placebo controlled study. on the management of poisoning or over-exposure. Neuroendocrine Tumors (5.8) 07/2017 into the stomach within 15 minutes of mixing. Do not save the water and microgranule the mechanisms behind these interactions are not always known. • Cutaneous and Systemic Lupus Erythematosus: Lansoprazole delayed-release orally disintegrating tablets are indicated in adults for the treatment Body as a Whole Neonate to less than one year of age 11 DESCRIPTION Patients with Phenylketonuria (5.10) 07/2017 of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not mixture for later use. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, The pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged less than The active ingredient in lansoprazole delayed-release orally disintegrating tablets is lansoprazole, Mostly cutaneous; new onset or exacerbation of Abdominal Pain 2.1 1.2 INDICATIONS AND USAGE extend beyond eight weeks [see Clinical Studies (14.5)]. 4. Refill the catheter-tip syringe with approximately 5 mL of water, shake gently, and flush the tube. and nelfinavir) when used concomitantly with lansoprazole may reduce 28 days and one to 11 months. Compared to healthy adults receiving 30 mg, neonates had higher USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] existing disease; discontinue lansoprazole and Digestive System antiviral effect and promote the development of drug resistance. Lansoprazole delayed-release orally disintegrating refer to specialist for evaluation. (5.5) 1.6 Risk Reduction of NSAID-Associated Gastric Ulcer 3 DOSAGE FORMS AND STRENGTHS Clinical Impact: exposure