Lansoprazole (Page 12 of 14)

14.9 Maintenance of Healing of Erosive Esophagitis

Two independent, double-blind, multicenter, controlled trials were conducted in patients with endoscopically confirmed healed esophagitis. Patients remained in remission significantly longer and the number of recurrences of erosive esophagitis was significantly less in patients treated with lansoprazole than in patients treated with placebo over a 12 month period ( Table 21).

Table 21. Endoscopic Remission Rates
Percent in Endoscopic Remission
Trial Drug No. of Pts. 0-3 mo. 0-6 mo. 0-12 mo.
#1 Lansoprazole 15 mg daily 59 83%* 81%* 79% ⃰
Lansoprazole 30 mg daily 56 93%* 93%* 90%*
Placebo 55 31% 27% 24%
#2 Lansoprazole 15 mg daily 50 74%* 72%* 67%*
Lansoprazole 30 mg daily 49 75%* 72%* 55%*
Placebo 47 16% 13% 13%

%=Life Table Estimate

*(p≤0.001) vs placebo.

Regardless of initial grade of erosive esophagitis, lansoprazole 15 and 30 mg were similar in maintaining remission.

In a

[see Indications and Usage ( 1.9)]

14.10 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

In open studies of 57 patients with pathological hypersecretory conditions, such as Zollinger-Ellison syndrome (ZES) with or without multiple endocrine adenomas, lansoprazole significantly inhibited gastric acid secretion and controlled associated symptoms of diarrhea, anorexia and pain. Doses ranging from 15 mg every other day to 180 mg per day maintained basal acid secretion below 10 mEq/hr in patients without prior gastric surgery and below 5 mEq/hr in patients with prior gastric surgery. Initial doses were titrated to the individual patient need, and adjustments were necessary with time in some patients [see Dosage and Administration ( 2.1)] . Lansoprazole was well tolerated at these high dose levels for prolonged periods (greater than four years in some patients). In most ZES patients, serum gastrin levels were not modified by lansoprazole. However, in some patients, serum gastrin increased to levels greater than those present prior to initiation of lansoprazole therapy [see Indications and Usage ( 1.10)] .

16 HOW SUPPLIED/STORAGE AND HANDLING

Lansoprazole delayed-release capsules USP, 30 mg are pink/black colored size ‘1’ hard gelatin capsules imprinted with ‘H’ on cap and ‘167’ on body filled with white to off white pellets. They are available as follows:

Bottles of 500 capsules NDC 82009-039-05

17 PATIENT COUNSELING INFORMATION

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 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 capsules should be taken before eating.
• Do not crush or chew lansoprazole delayed-release capsules.
• Take lansoprazole delayed-release capsule at least 30 minutes prior to sucralfate.
Lansoprazole Delayed-Release Capsules
• Swallow whole; do not chew.
• For patients who have difficulty swallowing capsules:
o Lansoprazole delayed-release capsules can be opened and sprinkled on applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears
o Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice
o Alternatively, lansoprazole delayed-release capsules can be administered with apple juice via nasogastric tube
o See the Instructions for Use for a description of all preparation and administration instructions

Manufactured for:
Quallent Pharmaceuticals Health LLC
20 Genesis Close
Grand Cayman KY1-1208
Cayman Islands

by: HETERO TM
Hetero Labs Limited
Jeedimetla, Hyderabad — 500 055, India

Revised: 04/2022

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