Lansoprazole: Package Insert and Label Information (Page 8 of 9)

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

MEDICATION GUIDE


Lansoprazole (lan-SOH-pra zohl)
Delayed-Release Capsules, USP
What is the most important information that I should know about lansoprazole delayed-release capsules?
You should take lansoprazole delayed-release capsules exactly as prescribed, at the lowest dose possible and for the shortest time needed.
Lansoprazole delayed-release capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor.
Lansoprazole delayed-release capsules 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 capsules, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with PPI medicines including lansoprazole delayed-release capsules. 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 capsules, 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 capsules can have other serious side effects. See “What are the possible side effects of lansoprazole delayed-release capsules?”.
What are lansoprazole delayed-release capsules?
A prescription medicine called a proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.
In adults , lansoprazole delayed-release capsules 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 capsules 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 capsules 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 capsules 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 capsules for patients whose EE does not improve or whose symptoms return.
• maintaining healing of EE. Lansoprazole delayed-release capsules 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 capsules exactly as prescribed by your child’s doctor. Do not increase the dose of lansoprazole delayed-release capsules or give your child lansoprazole delayed-release capsules longer than the amount of time your doctor tells you to.
In children 1 to 11 years of age, lansoprazole delayed-release capsules 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 capsules 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 capsules 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 capsules if you are:

• allergic to lansoprazole, any other PPI medicine, or any of the ingredients in lansoprazole delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in lansoprazole delayed-release capsules.
• taking a medicine that contains rilpivirine (EDURANT, COMPLERA, ODEFSEY, JULUCA) used to treat HIV-1 (Human Immunodeficiency Virus).
Before you take lansoprazole delayed-release capsules, 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.
• are pregnant, think you may be pregnant or plan to become pregnant. Lansoprazole delayed-release capsules may harm your unborn baby. Talk to your doctor about the possible risks to an unborn baby if lansoprazole delayed-release capsules 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 capsules.
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 capsules?
• Take lansoprazole delayed-release capsules exactly as prescribed by your doctor.
• Do not change your dose or stop taking lansoprazole delayed-release capsules without talking to your doctor.
• Take lansoprazole delayed-release capsules before meals.
Lansoprazole delayed-release capsules:
o Swallow lansoprazole delayed-release capsules whole.
o Do not crush or chew lansoprazole delayed-release capsules.
o If you have trouble swallowing a whole capsule, you can open the capsule and take the contents with certain foods or juices. See the “Instructions for Use” at the end of this Medication Guide for instructions on how to take lansoprazole delayed-release capsules with certain foods or juices.
o See the “Instructions for Use” at the end of this Medication Guide for instructions on how to mix and give lansoprazole delayed-release capsules through a nasogastric tube (NG tube).
• If you miss a dose of lansoprazole delayed-release capsules, take it as soon as you remember. If it is almost time for your next dose, do not take the missed dose. Take your next dose at your regular time. Do not take 2 doses at the same time.
• If you take too much lansoprazole delayed-release capsules, call your doctor or your poison control center at 1-800-222-1222 right away or go to the nearest hospital emergency room.
What are the possible side effects of lansoprazole delayed-release capsules?
Lansoprazole delayed-release capsules can cause serious side effects, including:
• See “What is the most important information that I should know about lansoprazole delayed-release capsules?”.
• Low vitamin B12 levels in the body can happen in people who have taken lansoprazole delayed-release capsules for a long time (more than 3 years). Tell your doctor if you have symptoms of low vitamin B12 levels, including shortness of breath, lightheadedness, irregular heartbeat, muscle weakness, pale skin, feeling tired, mood changes, and tingling or numbness in the arms and legs.
Stomach growths (fundic gland polyps). People who take PPI medicines for a long time have an increased risk of developing a certain type of stomach growth called fundic gland polyps, especially after taking PPI medicines for more than 1 year.
Low magnesium levels in the body can happen in people who have taken lansoprazole delayed-release capsules for at least 3 months. Tell your doctor right away if you have symptoms of low magnesium levels, including seizures, dizziness, irregular heartbeat, jitteriness, muscle aches or weakness, and spasms of hands, feet or voice.
Severe skin reactions. Lansoprazole delayed-release capsules can cause rare but severe skin reactions that may affect any part of your body. These serious skin reactions may need to be treated in a hospital and may be life threatening:
• Skin rash which may have blistering, peeling or bleeding on any part of your skin (including your lips, eyes, mouth, nose, genitals, hands or feet).
• You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.
Stop taking lansoprazole delayed-release capsules and call your doctor right away. These symptoms may be the first sign of a severe skin reaction.
The most common side effects of lansoprazole delayed-release capsules include: diarrhea, stomach-area (abdomen) pain, nausea and constipation.
These are not all the possible side effects of lansoprazole delayed-release capsules.
Call your doctor for medical advice about side effects.
You may report side effects to FDA at 1-800-FDA-1088.
How should I store lansoprazole delayed-release capsules?
Store lansoprazole delayed-release capsules at room temperature between 68°F to 77°F (20°C to 25°C).
Keep lansoprazole delayed-release capsules and all medicines out of the reach of children.
General information about the safe and effective use of lansoprazole delayed-release capsules.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lansoprazole delayed-release capsules for conditions for which it was not prescribed. Do not give lansoprazole delayed-release capsules to other people, even if they have the same symptoms that you have. It may harm them. You can ask your doctor or pharmacist for information about lansoprazole delayed-release capsules that is written for health professionals.
For more information, call 1-866-495-1995.
What are the ingredients in lansoprazole delayed-release capsules?
Active ingredient: lansoprazole USP.
Inactive ingredients in lansoprazole delayed-release capsules: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer dispersion, polysorbate 80, sucrose, sugar spheres (contains sucrose and starch (maize)), talc, titanium dioxide and triethyl citrate. The hard gelatin capsule shell consists of gelatin, FD&C Blue No. 1, D&C Red No. 28, FD&C Red No. 40 and titanium dioxide. In addition 15 mg capsule contains FD&C Green No. 3.
The imprinting ink contains polysorbate 80, propylene glycol, shellac and titanium dioxide.

Medication Guide available at https://www.quallentpharmaceuticals.com

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

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 04/2022

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