FDA Label for Lansoprazole DR
View Indications, Usage & Precautions
Lansoprazole DR Product Label
The following document was submitted to the FDA by the labeler of this product Advanced Rx Pharmacy Of Tennessee, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Medication Guide Section
MEDICATION GUIDE
Lansoprazole Delayed-Release Capsules, USP
(lan soe' pra zole)
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: 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.
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 levels in your blood.
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.
· 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.
• 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 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.
• 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.
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 20° to 25° C (68° to 77° F)
Keep lansoprazole delayed-release capsules and all medicines out of the reach of children.
General information about 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 you have. It may harm them.
You can ask your doctor or pharmacist for information about lansoprazole delayed-release capsules that is written for healthcare professionals.
What are the ingredients in lansoprazole delayed-release capsules? Active ingredient: lansoprazole.
Inactive ingredients in lansoprazole delayed-release capsules
Ammonium hydroxide, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, propylene glycol, shellac, simethicone, starch, sucrose, sugar spheres, talc, and titanium dioxide.
Components of the gelatin capsule include gelatin, iron oxide red, iron oxide yellow, FD&C Blue 2, sodium lauryl sulphate and titanium dioxide for 15 mg capsules and gelatin, iron oxide black, iron oxide red, iron oxide yellow, sodium lauryl sulphate and titanium dioxide for 30 mg capsules.
All other trademark names are the property of their respective owners.
For more information, call 1-888-375-3784.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
INSTRUCTIONS FOR USE
Lansoprazole Delayed-Release Capsules, USP(lan soe' pra zole)
Important: ·
Take lansoprazole delayed-release capsules before meals.
Do not crush or chew lansoprazole delayed-release capsules.
Lansoprazole delayed-release capsules should only be used with the foods and juices listed below.
Lansoprazole delayed-release capsules
Taking lansoprazole delayed-release capsules with certain food:
You can only use applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
1. Open the capsule.
2. Sprinkle the granules on 1 tablespoon of applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
3. Swallow right away.
Taking lansoprazole delayed-release capsules with certain juices:You can only use apple juice, orange juice or tomato juice.
1 Open the capsule.
2 Sprinkle the granules into 60 mL (about ¼ cup) of apple juice, orange juice or tomato juice. 3 Stir.
4 Swallow right away.
5 To make sure that the entire dose is taken, add 1/2 cup or more of juice to the glass, stir and swallow right away
Giving lansoprazole delayed-release capsules through a nasogastric tube (NG tube) size 16 French or larger:
You can only use apple juice.
1. Place 40 mL of apple juice into a clean container.
2. Open the capsule and empty the granules into the container of apple juice.
3. Use a catheter-tip syringe to draw up the apple juice and granule mixture.
4. Gently mix the catheter-tip syringe to keep the granules from settling.
5. Attach the catheter-tip syringe to the NG tube.
6. Give the mixture right away through the NG tube that goes into the stomach. Do not save the apple juice and granule mixture for later use.
7. Refill the catheter-tip syringe with 40 mL of apple juice and mix gently. Flush the NG tube with apple juice.
How should I store lansoprazole delayed-release capsules?
• Store lansoprazole delayed-release capsules at room temperature between 20° to 25°C (68° to 77°F)
Keep lansoprazole delayed-release capsules and all medicines out of the reach of children.
This Instruction for Use has been approved by the U.S. Food and Drug Administration.
All other trademark names are the property of their respective owners.
Rx only
Manufactured by:
Dr. Reddy’s Laboratories Limited
Bachupally – 500 090 INDIA
Revised: 1220
Dispense with Medication Guide available at:
www.drreddys.com/medguide/lansoprazoledrcaps.pdf
Dosage And Administration Section
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Adult Dosage by Indication
Indication Recommended Dose Frequency
Duodenal Ulcers
Short-Term Treatment
Maintenance of Healed 15 mg
15 mg Once daily for 4 weeks
Once daily
Eradicationof H. pylori to Reduce the Risk of Duodenal Ulcer Recurrence*
Triple Therapy:
Lansoprazole delayed-release orally disintegrating tablets
Amoxicillin
Clarithromycin
Dual Therapy: Lansoprazole delayed-release capsules
Amoxicillin
30 mg
1gram
500 mg
30 mg
1 gram Twice daily for 10 or 14 days
Twice daily for 10 or 14 days
Twice daily for 10 or 14 days
Three times daily for 14 days
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
Risk Reduction 30 mg
15 mg Once daily for 8 weeks†
Once daily for up to 12 weeks†
Gastroesophageal Reflux Disease (GERD)
Short-Term Treatment of Symptomatic GERD
Short -Term Treatment of Erosive Esophagitis 15 mg
30 mg Once daily for up to 8 weeks
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 for 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 delayed-release capsules 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 delayed-release capsules 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 delayed-release capsules 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 was not administered beyond 12 weeks in 1 to 11 year olds. It is not known if lansoprazole is 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.
Indications And Usage Section
1 INDICATIONS AND USAGE
1.1 Treatment of Active Duodenal Ulcer
Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (for four weeks) for healing and symptom relief of active duodenal ulcer [see Clinical Studies (14.1)].
1.2 Eradication of H.pylori to Reduce the Risk of Duodenal Ulcer Recurrence
Triple Therapy: Lansoprazole delayed-release capsules/amoxicillin/clarithromycin
Lansoprazole delayed-release capsules in combination with amoxicillin plus clarithromycin as triple therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.2)].
Please refer to the full prescribing information for amoxicillin and clarithromycin.
Dual Therapy: Lansoprazole delayed-release capsules /amoxicillin
Lansoprazole delayed-release capsules in combination with amoxicillin as dual therapy is indicated in adults for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or one year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected (see the clarithromycin prescribing information, Microbiology section). Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence [see Clinical Studies (14.2)].
Please refer to the full prescribing information for amoxicillin.
1.3 Maintenance of Healed Duodenal Ulcers
Lansoprazole delayed-release capsules are indicated in adults to maintain healing of duodenal ulcers. Controlled studies do not extend beyond 12 months. [see Clinical Studies (14.3)].
1.4 Treatment of Active Benign Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for short-term treatment (up to eight weeks) for healing and symptom relief of active benign gastric ulcer [see Clinical Studies (14.4)].
1.5 Healing of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for the treatment of NSAID-associated gastric ulcer in patients who continue NSAID use. Controlled studies did not extend beyond eight weeks [see Clinical Studies (14.5)].
1.6 Risk Reduction of NSAID-Associated Gastric Ulcer
Lansoprazole delayed-release capsules are indicated in adults for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID. Controlled studies did not extend beyond 12 weeks [see Clinical Studies (14.6)].
1.7 Treatment of Symptomatic Gastroesophageal Reflux Disease (GERD)
Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for the treatment of heartburn and other symptoms associated with GERD [see Clinical Studies (14.7)].
1.8 Treatment of Erosive Esophagitis (EE)
Lansoprazole delayed-release capsules are indicated for short-term treatment in adults and pediatric patients 12 to 17 years of age (up to eight weeks) and pediatric patients one to 11 years of age (up to 12 weeks) for healing and symptom relief of all grades of EE.
For adults who do not heal with lansoprazole delayed-release capsules 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 delayed-release capsules may be considered [see Clinical Studies (14.8)].
1.9 Maintenance of Healing of EE
Lansoprazole delayed-release capsules are indicated in adults to maintain healing of EE. Controlled studies did not extend beyond 12 months [see Clinical Studies (14.9)].
1.10 Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome (ZES)
Lansoprazole delayed-release capsules are indicated in adults for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome [see Clinical Studies (14.10)].
Contraindications Section
4 CONTRAINDICATIONS
Lansoprazole delayed-release capsules are contraindicated in patients with known severe hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2),Adverse Reactions (6)].
Proton Pump Inhibitors (PPIs), including lansoprazole delayed-release capsules are contraindicated with rilpivirine-containing products [see Drug Interactions (7)].
For information about contraindications of antibacterial agents (clarithromycin and amoxicillin) indicated in combination with lansoprazole delayed-release capsules, refer to the Contraindications section of their prescribing information.
* Please review the disclaimer below.