Complete SPL Sections
1 INDICATIONS AND USAGE
INDICATIONS & USAGE SECTION
2 DOSAGE AND ADMINISTRATION
DOSAGE & ADMINISTRATION SECTION
3 DOSAGE FORMS AND STRENGTHS
DOSAGE FORMS & STRENGTHS SECTION
Lansoprazole Delayed-Release Orally Disintegrating Tablets: • 15 mg tablets are white to off-white, flat, beveled round, unscored tablet with off-white to grayish speckles, debossed with "15" on one side of the tablet and plain on the other side. • 30 mg tablets are white to off-white, flat, beveled round, unscored tablet with off-white to grayish speckles, debossed with "30" on one side of the tablet and plain on the other side.
4 CONTRAINDICATIONS
CONTRAINDICATIONS SECTION
• Lansoprazole delayed-release orally disintegrating tablets are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions ( 5.2 ), Adverse Reactions ( 6 )] . • Proton Pump Inhibitors (PPIs), including lansoprazole delayed-release orally disintegrating tablets, are contraindicated with rilpivirine-containing products [see Drug Interactions ( 7 )] . • For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole delayed-release orally disintegrating tablets, refer to the Contraindications section of their prescribing information.
5 WARNINGS AND PRECAUTIONS
WARNINGS AND PRECAUTIONS SECTION
6 ADVERSE REACTIONS
ADVERSE REACTIONS SECTION
The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis [see Warnings and Precautions ( 5.2 )] • Clostridium difficile -Associated Diarrhea [see Warnings and Precautions ( 5.3 )] • Bone Fracture [see Warnings and Precautions ( 5.4 )] • Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5.5 )] • Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions ( 5.6 )] • Cyanocobalamin (Vitamin B12) Deficiency [see Warnings and Precautions ( 5.7 )] • Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions ( 5.8 )] • Fundic Gland Polyps [see Warnings and Precautions ( 5.12 )]
7 DRUG INTERACTIONS
DRUG INTERACTIONS SECTION
Tables 2 and 3 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with lansoprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 2. Clinically Relevant Interactions Affecting Drugs Coadministered with Lansoprazole and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. • Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir, and nelfinavir) when used concomitantly with lansoprazole may reduce antiviral effect and promote the development of drug resistance. • Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with lansoprazole may increase toxicity of the antiretroviral drugs. • There are other antiretroviral drugs which do not result in clinically relevant interactions with lansoprazole. Intervention: Rilpivirine-containing products: Concomitant use with lansoprazole is contraindicated [see Contraindications ( 4 )] . See prescribing information. Atazanavir : See prescribing information for atazanavir for dosing information. Nelfinavir : Avoid concomitant use with lansoprazole. See prescribing information for nelfinavir. Saquinavir : See the prescribing information for saquinavir and monitor for potential saquinavir toxicities. Other antiretrovirals : See prescribing information. Warfarin Clinical Impact: 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. Intervention: Monitor INR and prothrombin time. Dose adjustment of warfarin may be needed to maintain target INR range. See prescribing information for warfarin. Methotrexate Clinical Impact: Concomitant use of PPIs with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions ( 5.10 )] . Intervention: A temporary withdrawal of lansoprazole may be considered in some patients receiving high-dose methotrexate. Digoxin Clinical Impact: Potential for increased exposure of digoxin. Intervention: Monitor digoxin concentrations. Dose adjustment of digoxin may be needed to maintain therapeutic drug concentrations. See prescribing information for digoxin. Theophylline Clinical Impact: Increased clearance of theophylline [see Clinical Pharmacology ( 12.3 )] . Intervention: Individual patients may require additional titration of their theophylline dosage when lansoprazole is started or stopped to ensure clinically effective blood concentrations. Drugs Dependent on Gastric pH for Absorption (e.g., iron salts, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole) Clinical Impact: Lansoprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Coadministration of PPIs in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. The clinical relevance of reduced MPA exposure on organ rejection has not been established in transplant patients receiving lansoprazole and MMF. Use lansoprazole with caution in transplant patients receiving MMF. See the prescribing information for other drugs dependent on gastric pH for absorption. Combination Therapy with Clarithromycin and Amoxicillin Clinical Impact: Concomitant administration of clarithromycin with other drugs can lead to serious adverse reactions, including potentially fatal arrhythmias, and are contraindicated. Amoxicillin also has drug interactions. Intervention: • See Contraindications and Warnings and Precautions in prescribing information for clarithromycin. • See Drug Interactions in prescribing information for amoxicillin. Tacrolimus Clinical Impact: Potentially increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. Intervention: Monitor tacrolimus whole blood trough concentrations. Dose adjustment of tacrolimus may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus. Interactions with Investigations of Neuroendocrine Tumors Clinical Impact: CgA levels increase secondary to PPI-induced decreases in gastric acidity. The increased CgA level may cause false positive results in diagnostic investigations for neuroendocrine tumors [see Warnings and Precautions ( 5.9 ), Clinical Pharmacology ( 12.2 )] . Intervention: Temporarily stop lansoprazole treatment at least 14 days before assessing CgA levels and consider repeating the test if initial CgA levels are high. If serial tests are performed (e.g., for monitoring), the same commercial laboratory should be used for testing, as reference ranges between tests may vary. Interaction with Secretin Stimulation Test Clinical Impact: Hyper-response in gastrin secretion in response to secretin stimulation test, falsely suggesting gastrinoma. Intervention: Temporarily stop lansoprazole treatment at least 28 days before assessing to allow gastrin levels to return to baseline [see Clinical Pharmacology ( 12.2 )] . False Positive Urine Tests for THC Clinical Impact: There have been reports of false positive urine screening tests for tetrahydrocannabinol (THC) in patients receiving PPIs. Intervention: An alternative confirmatory method should be considered to verify positive results. Table 3. Clinically Relevant Interactions Affecting Lansoprazole When Coadministered with Other Drugs CYP2C19 OR CYP3A4 Inducers Clinical Impact: Decreased exposure of lansoprazole when used concomitantly with strong inducers [see Clinical Pharmacology ( 12.3 )] . Intervention: St. John’s Wort, rifampin: Avoid concomitant use with lansoprazole. Ritonavir-containing products : See prescribing information. CYP2C19 or CYP3A4 Inhibitors Clinical Impact: Increased exposure of lansoprazole is expected when used concomitantly with strong inhibitors [see Clinical Pharmacology ( 12.3 )] . Intervention: Voriconazole: See prescribing information. Sucralfate Clinical Impact: Decreased and delayed absorption of lansoprazole [see Clinical Pharmacology ( 12.3 )] . Intervention: Take lansoprazole at least 30 minutes prior to sucralfate [see Dosage and Administration ( 2.4 )] .
8 USE IN SPECIFIC POPULATIONS
USE IN SPECIFIC POPULATIONS SECTION
10 OVERDOSAGE
OVERDOSAGE SECTION
Lansoprazole is not removed from the circulation by hemodialysis. In one reported overdose, a patient consumed 600 mg of lansoprazole with no adverse reaction. Oral lansoprazole doses up to 5000 mg/kg in rats [approximately 1300 times the 30 mg human dose based on body surface area (BSA)] and in mice (about 675.7 times the 30 mg human dose based on BSA) did not produce deaths or any clinical signs. In the event of over-exposure, treatment should be symptomatic and supportive. If over-exposure occurs, call your poison control center at 1-800-222-1222 for current information on the management of poisoning or over-exposure.
11 DESCRIPTION
DESCRIPTION SECTION
The active ingredient in Lansoprazole Delayed-Release Orally Disintegrating Tablets is lansoprazole USP, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl] methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its molecular formula is C 16 H 14 F 3 N 3 O 2 S with a molecular weight of 369.36. Lansoprazole, USP has the following structure: Lansoprazole, USP is a white to brownish crystalline powder which melts with decomposition at approximately 166°C. Lansoprazole, USP is freely soluble in dimethylformamide; soluble in methanol; sparingly soluble in ethanol; slightly soluble in ethyl acetate, dichloromethane and acetonitrile; very slightly soluble in ether; and practically insoluble in hexane and water. Lansoprazole, USP is stable when exposed to light for up to two months. The rate of degradation of the compound in aqueous solution increases with decreasing pH. The degradation half-life of the drug substance in aqueous solution at 25°C is approximately 0.5 hour at pH 5.0 and approximately 18 hours at pH 7.0. Lansoprazole, USP is supplied in a Delayed-Release Orally Disintegrating Tablet for oral administration. Lansoprazole Delayed-Release Orally Disintegrating Tablets are available in two dosage strengths: 15 mg and 30 mg of lansoprazole, USP per tablet. Each delayed-release orally disintegrating tablet contains enteric-coated pellets consisting of 15 mg or 30 mg of lansoprazole, USP (active ingredient) and the following inactive ingredients: aspartame*, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose monohydrate, low-substituted hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, maize starch, methacrylic acid copolymer type c, microcrystalline cellulose, strawberry flavor (cis-3-hexan-1-ol, cis-3-hexen-1-yl acetate, cis-3-hexenyl butyrate, cis-3-hexenyl hexanoate, ethyl butyrate, ethyl isovalerate, ethyl valerate, ethyl-2-methylbutyrate, gamma-decalactone, hexyl hexanoate, gum arabic, lactose, maltodextrin, methyl cinnamate, triethyl citrate), talc, titanium dioxide, and triethyl citrate. * Phenylketonurics: Contains Phenylalanine 4.05 mg per 15 mg Tablet and 8.11 mg per 30 mg Tablet.
12 CLINICAL PHARMACOLOGY
CLINICAL PHARMACOLOGY SECTION
13 NONCLINICAL TOXICOLOGY
NONCLINICAL TOXICOLOGY SECTION
14 CLINICAL STUDIES
CLINICAL STUDIES SECTION
16 HOW SUPPLIED/STORAGE AND HANDLING
HOW SUPPLIED SECTION
Lansoprazole Delayed-Release Orally Disintegrating Tablets are available as follows: 30 mg – white to off-white, flat, beveled round, unscored tablet with off-white to grayish speckles, debossed with "30" on one side of the tablet and plain on the other side. Packaged in Overbagged with 10 delayed-release orally disintegrating tablets per bag, NDC 55154-4848-0 WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
17 PATIENT COUNSELING INFORMATION
INFORMATION FOR PATIENTS SECTION
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Advise patients to: Acute Tubulointerstitial Nephritis To call their healthcare provider if they experience signs and/or symptoms associated with acute tubulointerstitial nephritis [see Warnings and Precautions ( 5.2) ] . Clostridium difficile -Associated Diarrhea To immediately call their healthcare provider if they experience diarrhea that does not improve [see Warnings and Precautions ( 5.3 )] . Bone Fracture To report any fractures, especially of the hip, wrist or spine, to their healthcare provider [see Warnings and Precautions ( 5.4 )] . Severe Cutaneous Adverse Reactions To discontinue lansoprazole delayed-release orally disintegrating tablets and immediately call their healthcare provider for further evaluation [see Warnings and Precautions ( 5.5 )]. Cutaneous and Systemic Lupus Erythematosus To immediately call their healthcare provider for any new or worsening of symptoms associated with cutaneous or systemic lupus erythematosus [see Warnings and Precautions ( 5.6 )] . Cyanocobalamin (Vitamin B12) Deficiency To report any clinical symptoms that may be associated with cyanocobalamin deficiency to their healthcare provider, if they have been receiving lansoprazole for longer than three years [see Warnings and Precautions ( 5.7 )] . Hypomagnesemia and Mineral Metabolism To report any clinical symptoms that may be associated with hypomagnesemia, hypocalcemia, and/or hypokalemia to their healthcare provider, if they have been receiving lansoprazole for at least three months [see Warnings and Precautions ( 5.8 )] . Drug Interactions Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products [see Contraindications ( 4 )] or high-dose methotrexate [see Warnings and Precautions ( 5.10 )] . Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Use in Specific Populations ( 8.1 )] . Administration • Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose. • Lansoprazole delayed-release orally disintegrating tablets should be taken before eating. • Do not crush or chew lansoprazole delayed-release orally disintegrating tablets. • Take lansoprazole delayed-release orally disintegrating tablets at least 30 minutes prior to sucralfate. • Phenylketonurics: Contains Phenylalanine 4.05 mg per 15 mg tablet and 8.11 mg per 30 mg tablet. Lansoprazole delayed-release orally disintegrating tablets • Do not break or cut. • Place the tablet on the tongue; allow it to disintegrate, with or without water, until the particles can be swallowed. Do not chew the particles. • The tablet typically disintegrates in less than one minute. • Alternatively, for children or other patients who have difficulty swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be administered with water via oral syringe or NG tube, as described in the Instructions for Use. Dispense with Medication Guide available at: www.tevausa.com/medguides Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Kfar Saba, 4410202, Israel Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Distributed By: Cardinal Health Dublin, OH 43017 L55199390324 Rev. H 4/2022
SPL MEDGUIDE SECTION
SPL MEDGUIDE SECTION
Dispense with Medication Guide available at: www.tevausa.com/medguides MEDICATION GUIDE Lansoprazole (lan-soe'-pra-zole) Delayed-Release Orally Disintegrating Tablets What is the most important information that I should know about lansoprazole delayed-release orally disintegrating tablets? You should take lansoprazole delayed-release orally disintegrating tablets exactly as prescribed, at the lowest dose possible and for the shortest time needed. Lansoprazole delayed-release orally disintegrating tablets may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Lansoprazole delayed-release orally disintegrating tablets can cause serious side effects, including: • A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including lansoprazole delayed-release orally disintegrating tablets, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PPI medicines including lansoprazole delayed-release orally disintegrating tablets. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. • Diarrhea caused by an infection ( Clostridium difficile ) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. • Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist, or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). Tell your doctor if you have a bone fracture, especially in the hip, wrist, or spine. • Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body). Some people who take PPI medicines, including lansoprazole delayed-release orally disintegrating tablets, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Talk to your doctor about your risk of these serious side effects. Lansoprazole delayed-release orally disintegrating tablets can have other serious side effects. See “What are the possible side effects of lansoprazole delayed-release orally disintegrating tablets?” What are lansoprazole delayed-release orally disintegrating tablets? A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach. In adults, lansoprazole delayed-release orally disintegrating tablets are used for: • 4 weeks for the healing and symptom relief of duodenal ulcers. • 10 to 14 days with certain antibiotics to treat an infection caused by bacteria called H. pylori . • maintaining healing of duodenal ulcers. Lansoprazole delayed-release orally disintegrating tablets have not been studied beyond 12 months for this purpose. • up to 8 weeks for the healing and symptom relief of stomach ulcers. • up to 8 weeks for the healing of stomach ulcers in people taking pain medicines called nonsteroidal anti-inflammatory drugs (NSAIDs). Lansoprazole delayed-release orally disintegrating tablets have not been studied beyond 8 weeks for this purpose. • reducing the risk of stomach ulcers in people who are at risk of developing stomach ulcers with NSAIDs. Lansoprazole delayed-release orally disintegrating tablets have not been studied beyond 12 weeks for this purpose. • up to 8 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD). GERD happens when acid in your stomach backs up into the tube (esophagus) that connects your mouth to your stomach. This may cause a burning feeling in your chest or throat, sour taste or burping. • up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 8 to 16 weeks of lansoprazole delayed-release orally disintegrating tablets for patients whose EE does not improve or whose symptoms return. • maintaining healing of EE. Lansoprazole delayed-release orally disintegrating tablets have not been studied beyond 12 months for this purpose. • the long-term treatment of conditions where your stomach makes too much acid. This includes a rare condition called Zollinger-Ellison syndrome. Children: Give lansoprazole delayed-release orally disintegrating tablets exactly as prescribed by your child’s doctor. Do not increase the dose of lansoprazole delayed-release orally disintegrating tablets or give your child lansoprazole delayed-release orally disintegrating tablets longer than the amount of time your doctor tells you to. In children 1 to 11 years of age , lansoprazole delayed-release orally disintegrating tablets are used for: • up to 12 weeks to treat heartburn and other symptoms that can happen with GERD. • up to 12 weeks for the healing and symptom relief of EE. In children 12 to 17 years of age , lansoprazole delayed-release orally disintegrating tablets are used for: • up to 8 weeks to treat heartburn and other symptoms that can happen with GERD. • up to 8 weeks for the healing and symptom relief of EE. Lansoprazole delayed-release orally disintegrating tablets are not recommended for treating the symptoms of GERD in children less than 1 year of age and may harm them. Do not take lansoprazole delayed-release orally disintegrating tablets if you are: • allergic to lansoprazole, any other PPI medicine, or any of the ingredients in lansoprazole delayed-release orally disintegrating tablets. See the end of this Medication Guide for a complete list of ingredients in lansoprazole delayed-release orally disintegrating tablets. • taking a medicine that contains rilpivirine (EDURANT ® , COMPLERA ® , ODEFSEY ® , JULUCA ® ) used to treat HIV-1 (Human Immunodeficiency Virus). Before you take lansoprazole delayed-release orally disintegrating tablets, tell your doctor about all of your medical conditions, including if you: • have low magnesium, calcium, potassium or sodium levels in your blood or you are taking a diuretic. • have liver problems. • have phenylketonuria. Lansoprazole delayed-release orally disintegrating tablets contain aspartame. • are pregnant, think you may be pregnant or plan to become pregnant. Lansoprazole delayed-release orally disintegrating tablets may harm your unborn baby. Talk to your doctor about the possible risks to an unborn baby if lansoprazole delayed-release orally disintegrating tablets are taken during pregnancy. • are breastfeeding or plan to breastfeed. It is not known if lansoprazole passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take lansoprazole delayed-release orally disintegrating tablets. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your doctor if you take methotrexate (OTREXUP ® , RASUVO ® , TREXALL ® , REDITREX ® , XATMEP ® ). How should I take lansoprazole delayed-release orally disintegrating tablets? • Take lansoprazole delayed-release orally disintegrating tablets exactly as prescribed by your doctor. • Do not change your dose or stop taking lansoprazole delayed-release orally disintegrating tablets without talking to your doctor. • Take lansoprazole delayed-release orally disintegrating tablets before meals. Lansoprazole delayed-release orally disintegrating tablets: o Lansoprazole delayed-release orally disintegrating tablets are tablets that melt in your mouth with or without water. o Do not break, cut, crush or chew the tablets. o See the “Instructions for Use” at the end of this Medication Guide for instructions on how to mix and give lansoprazole delayed-release orally disintegr...
INSTRUCTIONS FOR USE
INSTRUCTIONS FOR USE SECTION
Lansoprazole (lan-soe'-pra-zole) Delayed-Release Orally Disintegrating Tablets Important: • Take lansoprazole delayed-release orally disintegrating tablets before meals. • Do not crush or chew lansoprazole delayed-release orally disintegrating tablets. • Lansoprazole delayed-release orally disintegrating tablets should only be used with the foods and juices listed below. Lansoprazole delayed-release orally disintegrating tablets 1. Do not chew, crush, cut or break the tablets. 2. Put the tablet on the tongue and let it dissolve, with or without water. 3. Swallow after the tablet dissolves. 4. The tablet usually dissolves in less than 1 minute. For patients who have trouble swallowing tablets, lansoprazole delayed-release orally disintegrating tablets can be given as follows: Giving lansoprazole delayed-release orally disintegrating tablets with water using an oral syringe: 1. Put a 15 mg tablet in an oral syringe and draw up 4 mL of water into the oral syringe, or put a 30 mg tablet in an oral syringe and draw up 10 mL of water into the oral syringe. 2. Gently shake the oral syringe to mix the tablet and the water. 3. After the tablet is mixed in the water, place the tip of the oral syringe in the mouth. Give the medicine within 15 minutes of mixing. Do not save the tablet and water mixture for later use. 4. Refill the oral syringe with about 2 mL of water for the 15 mg tablet or 5 mL of water for the 30 mg tablet, and shake gently. Place the tip of the oral syringe in the mouth and give the medicine that is left in the syringe. Giving lansoprazole delayed-release orally disintegrating tablets with water through a nasogastric tube (NG tube) size 8 French or larger: 1. Put a 15 mg tablet in a catheter-tip syringe and draw up 4 mL of water, or put a 30 mg tablet in a catheter-tip syringe and draw up 10 mL of water. 2. Gently shake the catheter-tip syringe to mix the tablet and the water. 3. Connect the catheter-tip syringe to the NG tube. 4. Give the mixture right away through the NG tube that goes into the stomach. Give the medicine within 15 minutes of mixing. Do not save the granule and water mixture for later use. 5. Refill the catheter-tip syringe with about 5 mL of water and shake gently. Flush the NG tube with the water. How should I store lansoprazole delayed-release orally disintegrating tablets? • Store lansoprazole delayed-release orally disintegrating tablets at room temperature between 68°F to 77°F (20°C to 25°C). Keep lansoprazole delayed-release orally disintegrating tablets and all medicines out of the reach of children. This Instruction for Use has been approved by the U.S. Food and Drug Administration. Manufactured In Israel By: Teva Pharmaceutical Ind. Ltd. Kfar Saba, 4410202, Israel Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Distributed By: Cardinal Health Dublin, OH 43017 L55199390324 Rev. E 1/2022
Package/Label Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 55154-4848-0 LANSOPRAZOLE 30 mg DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS 10 TABLETS