LANSOPRAZOLE - lansoprazole capsule, delayed release 
Ascend Laboratories, LLC

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MEDICATION GUIDE


Lansoprazole [lan soe' pra zole] Delayed-Release Capsules, for oral use

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:

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 is 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 is used for: 

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 is used for:

In children 12 to 17 years of age, lansoprazole delayed-release capsules  is used for: 

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: 

Before you take lansoprazole delayed-release capsules, tell your doctor about all of your medical conditions, including if you: 

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? 

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).


What are the possible side effects of lansoprazole delayed-release capsules

Lansoprazole delayed-release capsules can cause serious side effects, including: 

Stop taking lansoprazole 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 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. 


What are the ingredients in lansoprazole delayed-release capsules?

Active ingredient: Lansoprazole USP

Inactive ingredients in lansoprazole delayed-release capsules:

colloidal silicon dioxide, D&C Red No. 28, FD&C Blue No.1, FD&C Red No. 40, gelatin, hypromellose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol 6000, polysorbate-80, sodium lauryl sulphate, sucrose, sugar spheres, talc and titanium dioxide. The printing ink contains potassium hydroxide, propylene glycol, shellac, strong ammonia, titanium dioxide. In addition to this, the 15 mg capsule also contains FD&C Green No.3.


For more information contact at Ascend Laboratories, LLC at 1-877-272-7901.


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


Revised: April 2024

 


Revised: 5/2024
Ascend Laboratories, LLC