Lansoprazole: Package Insert and Label Information (Page 10 of 11)

16 HOW SUPPLIED/STORAGE AND HANDLING

Lansoprazole Delayed-Release Orally Disintegrating Tablets are available containing 15 mg or 30 mg of lansoprazole, USP.

The 15 mg tablets are pale yellow, round, flat-faced, speckled, unscored tablets debossed with M on one side of the tablet and LP1 on the other side. They are available as follows:

NDC 0378-6981-88
cartons of 100 unit-dose tablets (10 x 10)

The 30 mg tablets are pale yellow, round, flat-faced, speckled, unscored tablets debossed with M on one side of the tablet and LP2 on the other side. They are available as follows:

NDC 0378-6982-88cartons of 100 unit-dose tablets (10 x 10)

Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]

Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

PHARMACIST: Dispense a Medication Guide with each prescription.

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 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 delayed-release orally disintegrating tablets 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 delayed-release orally disintegrating tablets 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 3.37 mg per 15 mg lansoprazole delayed-release orally disintegrating tablet and 6.74 mg per 30 mg lansoprazole delayed-release orally disintegrating 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 pellets can be swallowed. Do not chew the pellets.
•
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.

Medication Guide

Lansoprazole Delayed-Release Orally Disintegrating Tablets(lan soe′ pra zole)

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 has 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 has 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 has 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 has 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
The lansoprazole delayed-release orally disintegrating tablet is a tablet that melts 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 disintegrating tablets through a syringe and NG tube.
•
If you miss a dose of lansoprazole delayed-release orally disintegrating tablets, 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 many lansoprazole delayed-release orally disintegrating tablets, 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 orally disintegrating tablets?

Lansoprazole delayed-release orally disintegrating tablets can cause serious side effects, including:

•
See “What is the most important information that I should know about lansoprazole delayed-release orally disintegrating tablets?”.
•
Low vitamin B12 levels in the body can happen in people who have taken lansoprazole delayed-release orally disintegrating tablets 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 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 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:
o
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).
o
You may also have fever, chills, body aches, shortness of breath, or enlarged lymph nodes.
Stop taking lansoprazole delayed-release orally disintegrating tablets 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 orally disintegrating tablets include: diarrhea, stomach-area (abdomen) pain, nausea and constipation.

These are not all the possible side effects of lansoprazole delayed-release orally disintegrating tablets.

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 orally disintegrating tablets?

Store lansoprazole delayed-release orally disintegrating tablets at room temperature between 20° to 25°C (68° to 77°F).

Keep lansoprazole delayed-release orally disintegrating tablets and all medicines out of the reach of children.

General information about the safe and effective use of lansoprazole delayed-release orally disintegrating tablets.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use lansoprazole delayed-release orally disintegrating tablets for conditions for which they were not prescribed. Do not give lansoprazole delayed-release orally disintegrating tablets to other people, even if they have the same symptoms that you have. They may harm them. You can ask your doctor or pharmacist for information about lansoprazole delayed-release orally disintegrating tablets that is written for health professionals.

What are the ingredients in lansoprazole delayed-release orally disintegrating tablets?

Active ingredient: lansoprazole.

Inactive ingredients in lansoprazole delayed-release orally disintegrating tablets: artificial strawberry flavor, aspartame, citric acid monohydrate, crospovidone, hydroxypropyl cellulose, magnesium carbonate, magnesium stearate, mannitol, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium bicarbonate, sodium hydroxide, sodium lauryl sulfate, sodium starch glycolate (potato), sugar spheres (corn starch and sucrose), talc, triethyl citrate and yellow iron oxide.

Lansoprazole delayed-release orally disintegrating tablets contain 3.37 mg of phenylalanine in each 15 mg tablet and 6.74 mg of phenylalanine in each 30 mg tablet.

Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A.

Manufactured by: Mylan Laboratories Limited, Hyderabad — 500 096, India

For more information, call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

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

Instructions for Use
Lansoprazole Delayed-Release Orally Disintegrating Tablets
(lan soe′ pra zole)

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 water as 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 pellets 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 20° to 25°C (68° to 77°F).

Keep lansoprazole delayed-release orally disintegrating tablets and all medicines out of the reach of children.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

The brand names listed are trademarks of their respective owners.

Manufactured for:
Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Manufactured by:
Mylan Laboratories Limited
Hyderabad — 500 096, India

75090146

Revised: 4/2022
MX:LANSOD:R7Umh/MX:MG:LANSOD:R7mh

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