2 DOSAGE AND ADMINISTRATION Recommended Dosage: See full prescribing information for complete dosing information for lansoprazole delayed-release capsules by indication and age group and dosage adjustment in patients with severe hepatic impairment. ( 2.1 , 2.2 , 2.3 ) Administration Instructions ( 2.4 ) Lansoprazole delayed-release capsules Should be swallowed whole. See full prescribing information for alternative administration options 2.1 Recommended Adult Dosage by Indication Indication Recommended Dose Frequency Duodenal Ulcers Short-Term Treatment 15 mg Once daily for 4 weeks Maintenance of Healed 15 mg Once daily Eradication of H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence* Triple Therapy: Lansoprazole 30 mg Twice daily for 10 or 14 days Amoxicillin 1 gram Twice daily for 10 or 14 days Clarithromycin 500 mg Twice daily for 10 or 14 days Dual Therapy: Lansoprazole 30 mg Three times daily for 14 days Amoxicillin 1 gram Three times daily for 14 days Benign Gastric Ulcer Short-Term Treatment 30 mg Once daily for up to 8 weeks NSAID-associated Gastric Ulcer Healing 30 mg Once daily for 8 weeks † Risk Reduction 15 mg Once daily for up to 12 weeks † Gastroesophageal Reflux Disease (GERD) Short-Term Treatment of Symptomatic GERD 15 mg Once daily for up to 8 weeks Short-Term Treatment of Erosive Esophagitis 30 mg Once daily for up to 8 weeks ‡ Maintenance of Healing of Erosive Esophagitis 15 mg Once daily # Pathological Hypersecretory Conditions including Zollinger-Ellison Syndrome 60 mg Once daily ¶ * Please refer to the amoxicillin and clarithromycin full prescribing information CONTRAINDICATIONS and WARNINGS and PRECAUTIONS sections, and for information regarding dosing in elderly and renally-impaired patients. † Controlled studies did not extend beyond indicated duration. ‡ For patients who do not heal with lansoprazole for eight weeks (5 to 10%), it may be helpful to give an additional eight weeks of treatment. If there is a recurrence of erosive esophagitis, an additional eight week course of lansoprazole may be considered. ¶ Varies with individual patient. Recommended adult starting dose is 60 mg once daily. Doses should be adjusted to individual patient needs and should continue for as long as clinically indicated. Dosages up to 90 mg twice daily have been administered. Daily dose of greater than 120 mg should be administered in divided doses. Some patients with Zollinger-Ellison syndrome have been treated continuously with lansoprazole for more than four years. # Controlled studies did not extend beyond 12 months 2.2 Recommended Pediatric Dosage by Indication Pediatric Patients 1 to 11 Years of Age In clinical studies, Lansoprazole delayed-release capsules was not administered beyond 12 weeks in 1 to 11 year olds. It is not known if Lansoprazole delayed-release capsules are safe and effective if used longer than the recommended duration. Do not exceed the recommended dose and duration of use in pediatric patients as outlined below [see Use in Specific Populations ( 8.4 )]. Indication Recommended Dose Frequency Short-Term Treatment of Symptomatic GERD and Short-Term Treatment of Erosive Esophagitis ≤ 30 kg 15 mg Once daily for up to 12 weeks > 30 kg 30 mg Once daily for up to 12 weeks Pediatric Patients 12 to 17 Years of Age Indication Recommended Dose Frequency Short-Term Treatment of Symptomatic GERD Non-erosive GERD 15 mg Once daily for up to 8 weeks Erosive Esophagitis 30 mg Once daily for up to 8 weeks 2.3 Hepatic Impairment The recommended dosage is 15 mg orally daily in patients with severe liver impairment (Child-Pugh C) [see Use in Specific Populations ( 8.6 )] 2.4 Important Administration Information Take Lansoprazole delayed-release capsules before meals. Do not crush or chew Lansoprazole delayed-release capsules Take Lansoprazole delayed-release capsules at least 30 minutes prior to sucralfate [ see Drug Interactions ( 7 ) ]. Antacids may be used concomitantly with Lansoprazole delayed-release capsules. 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 Capsules Swallow whole; do not chew. For patients who have difficulty swallowing capsules, Lansoprazole delayed-release capsules can be opened and administered orally or via a nasogastric tube in the soft foods or liquids specified below. Administration of Lansoprazole delayed-release capsules in foods or liquids other than those discussed below have not been studied clinically and therefore are not recommended. Administration in Soft Foods (applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears): 1.Open capsule. 2.Sprinkle intact granules on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears. 3.Swallow immediately. Administration in Liquids (apple juice, orange juice or tomato juice): 1.Open capsule. 2.Sprinkle intact granules into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately two ounces). 3.Mix briefly. 4.Swallow immediately. 5.To ensure complete delivery of the dose, rinse the glass with two or more volumes of juice and swallow the contents immediately. Administration with Apple Juice Through a Nasogastric Tube (≥16 French) 1.Open capsule. 2.Sprinkle intact granules into 40 mL of apple juice. 3.Mix briefly 4.Using a catheter tipped syringe, draw up the mixture 5.Inject through the nasogastric tube into the stomach. 6.Flush with additional apple juice to clear the tube.