Lansoprazole

CYP2C19 is an enzyme in the blood that is responsible for breaking down lansoprazole and other drugs in the body. Some patients have less of this protein in their bodies, affecting how much of the drug gets eliminated. Levels of CYP2C19 can vary greatly between individuals, and those having less of this protein are known as "poor metabolizers." 

CYP2C19 testing is done to determine whether you are a poor metabolizer. If you are a poor metabolizer, the levels of lansoprazole in your blood can become too high. As a result you may be at an increased risk of having more side effects from lansoprazole. 

Your doctor may adjust your dose of lansoprazole if you are a poor metabolizer.

Before you take lansoprazole, tell your doctor if you:

• have been told that you have low magnesium levels in your blood.
• have liver problems
• have phenylketonuria. Lansoprazole Oral DisintegratingTablet contains aspartame.
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if lansoprazole will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.
• are breast-feeding or planning to breast-feed. You and your doctor should decide if you will take lansoprazole or breast-feed. You should not do both without first talking with your doctor.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if lansoprazole will harm your unborn baby.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Usual Adult Dose for Erosive Esophagitis:

Treatment: 30 mg orally once a day
-Duration of therapy: Up to 8 weeks

Maintenance: 15 mg orally once a day

Comments:
-Controlled studies did not extend beyond 12 months.
-If patients are not healed after 8 weeks or erosive esophagitis recurs, treatment for another 8 weeks may be considered.

Uses:
-Short-term treatment for healing and symptom relief of all grades of erosive esophagitis
-Maintain healing of erosive esophagitis

Usual Adult Dose for Duodenal Ulcer:

Treatment: 15 mg orally once a day
-Duration of therapy: Up to 4 weeks

Maintenance: 15 mg orally once a day

Comment: Controlled studies did not extend beyond 12 months.

Uses:
-Short-term treatment for healing and symptom relief of active duodenal ulcers
-Maintain healing of duodenal ulcers

Usual Adult Dose for Duodenal Ulcer Prophylaxis:

Treatment: 15 mg orally once a day
-Duration of therapy: Up to 4 weeks

Maintenance: 15 mg orally once a day

Comment: Controlled studies did not extend beyond 12 months.

Uses:
-Short-term treatment for healing and symptom relief of active duodenal ulcers
-Maintain healing of duodenal ulcers

Usual Adult Dose for Duodenal Ulcer Maintenance:

Treatment: 15 mg orally once a day
-Duration of therapy: Up to 4 weeks

Maintenance: 15 mg orally once a day

Comment: Controlled studies did not extend beyond 12 months.

Uses:
-Short-term treatment for healing and symptom relief of active duodenal ulcers
-Maintain healing of duodenal ulcers

Usual Adult Dose for Gastroesophageal Reflux Disease:

15 mg orally once a day
-Duration of therapy: Up to 8 weeks

Use: Short-term treatment of heartburn and other symptoms associated with gastroesophageal reflux disease (GERD)

Usual Adult Dose for Gastric Ulcer:

30 mg orally once a day
-Duration of therapy: Up to 8 weeks

Use: Short-term treatment for healing and symptom relief of active benign gastric ulcers

Usual Adult Dose for Multiple Endocrine Adenomas:

Initial dose: 60 mg orally once a day
Maintenance dose: 60 to 180 mg/day

Comments:
-A daily dose higher than 120 mg should be given as divided doses.
-Dosage should be patient-specific and should continue as long as clinically necessary. Some patients with Zollinger-Ellison syndrome (ZES) have been on treatment for longer than 4 years.

Use: Long-term treatment of pathological hypersecretory conditions, including ZES

Usual Adult Dose for Systemic Mastocytosis:

Initial dose: 60 mg orally once a day
Maintenance dose: 60 to 180 mg/day

Comments:
-A daily dose higher than 120 mg should be given as divided doses.
-Dosage should be patient-specific and should continue as long as clinically necessary. Some patients with Zollinger-Ellison syndrome (ZES) have been on treatment for longer than 4 years.

Use: Long-term treatment of pathological hypersecretory conditions, including ZES

Usual Adult Dose for Zollinger-Ellison Syndrome:

Initial dose: 60 mg orally once a day
Maintenance dose: 60 to 180 mg/day

Comments:
-A daily dose higher than 120 mg should be given as divided doses.
-Dosage should be patient-specific and should continue as long as clinically necessary. Some patients with Zollinger-Ellison syndrome (ZES) have been on treatment for longer than 4 years.

Use: Long-term treatment of pathological hypersecretory conditions, including ZES

Usual Adult Dose for Helicobacter pylori Infection:

Triple Therapy: 30 mg orally 2 times a day, taken concomitantly with amoxicillin and clarithromycin
-Duration of therapy: 10 to 14 days

Dual Therapy: 30 mg orally 3 times a day, taken concomitantly with amoxicillin
-Duration of therapy: 14 days

Comments:
-Refer to the manufacturer product information for dosing for amoxicillin and clarithromycin.
-Eradication of Helicobacter pylori has been shown to reduce duodenal ulcer recurrence, and may result in duodenal/gastric ulcer healing without the need for continued therapy.

Uses:
-Triple therapy: Treatment of patients with H pylori infection and duodenal ulcer disease (active/1 year history of a duodenal ulcer) to eradicate H pylori
-Dual therapy: Treatment of patients with H pylori infection and duodenal ulcer disease (active/1 year history of a duodenal ulcer) who is either allergic/intolerant to clarithromycin or in whom resistance to clarithromycin is known/suspected

Usual Adult Dose for NSAID-Induced Gastric Ulcer:

30 mg orally once a day
-Duration of therapy: Up to 8 weeks

Comment: Studies did not extend beyond 8 weeks.

Use: Treatment of NSAID-associated gastric ulcer in patients who continue NSAID use

Usual Adult Dose for NSAID-Induced Ulcer Prophylaxis:

15 mg orally once a day
-Duration of therapy: Up to 12 weeks

Comment: Studies did not extend beyond 12 weeks.

Use: Reduce the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer who require the use of an NSAID

Usual Pediatric Dose for Gastroesophageal Reflux Disease:

1 to 11 years:
-Less than or equal to 30 kg: 15 mg orally once a day
-Greater than 30 kg: 30 mg orally once a day
-Duration of therapy: Up to 12 weeks

12 years and older: 15 mg orally once a day
-Duration of therapy: Up to 8 weeks

Comment: The dose was increased (up to 30 mg 2 times a day) in some patients who remained symptomatic after at least 2 weeks of treatment.

Use: Short-term treatment of GERD and other symptoms associated with GERD

Usual Pediatric Dose for Erosive Esophagitis:

1 to 11 years:
-Less than or equal to 30 kg: 15 mg orally once a day
-Greater than 30 kg: 30 mg orally once a day
-Duration of therapy: Up to 12 weeks

12 to 17 years: 30 mg orally once a day
-Duration of therapy: Up to 8 weeks

17 years and older: See adult dosing.

Comment: The dose was increased (up to 30 mg 2 times a day) in some patients who remained symptomatic after at least 2 weeks of treatment.

Use: Short-term treatment for healing and symptom relief of all grades of erosive esophagitis

Ask a doctor or pharmacist if it is safe for you to use lansoprazole if you are also using any of the following drugs:

• digoxin;

• erlotinib;

• ketoconazole;

• methotrexate;

• mycophenolate mofetil;

• tacrolimus;

• theophylline;

• warfarin (Coumadin, Jantoven);

• an antibiotic--ampicillin, clarithromycin;

• HIV medicine--atazanavir, nelfinavir; or

• iron-containing medicines--ferrous fumarate, ferrous gluconate, ferrous sulfate, and others.

This list is not complete. Other drugs may interact with lansoprazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Gastroesophageal Reflux (GERD)

Short-term treatment of symptomatic GERD (e.g., heartburn).1

Short-term treatment of erosive esophagitis (endoscopically diagnosed) in patients with GERD.1 2 3 5 18 19 20 22 23

Maintain healing and decrease recurrence of erosive esophagitis.1 126

Short-term self-medication for symptomatic relief of frequent (e.g., ≥2 days per week) heartburn in adults ≥18 years of age.191 192 194

Duodenal Ulcer

Short-term treatment of active duodenal ulcer (endoscopically or radiographically confirmed).1 2 3 4 5 6 7 12 13 14

Treatment of Helicobacter pylori infection and duodenal ulcer disease.1 134 Used in conjunction with amoxicillin and clarithromycin (triple therapy) or clarithromycin (dual therapy);1 134 has been used in other multidrug regimens†.126 129 131 135

Maintenance therapy following duodenal ulcer healing.1

Gastric Ulcer

Short-term treatment and symptomatic relief of active benign gastric ulcer.1

NSAIA-induced Gastric Ulcer

Short-term treatment of NSAIA-induced gastric ulcer in patients continuing NSAIA use.1 151 153 169

Risk reduction in patients with history of gastric ulcer who require NSAIA treatment.1

Pathologic GI Hypersecretory Conditions

Long-term treatment of pathologic hypersecretory conditions (e.g., Zollinger-Ellison syndrome with or without multiple endocrine adenoma).1

Crohn’s Disease-associated Ulcers

Some evidence for use of proton-pump inhibitors (e.g., omeprazole) for gastric acid suppressive therapy as an adjunct in the management of upper GI Crohn’s disease†, including esophageal, gastroduodenal, and jejunoileal disease.162 163 164 166 167

Storage

Oral

25°C (may be exposed to 15–30°C).1

20–25°C; protect from high heat, humidity, and moisture.191

20–25°C.134 Protect from light and moisture.134

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Oral

Immediately use extemporaneous mixtures of capsule contents and food or juice.1 (See Oral Administration under Dosage and Administration.)

It is important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it. Blood, urine, and other laboratory tests may be needed to check for unwanted effects. If your or your child's condition does not improve, or if it becomes worse, discuss this with your doctor.

Check with your doctor right away if you have a fever, joint pain, skin rash, swelling of the body, feet, or ankles, or unusual weight gain after receiving lansoprazole. These could be symptoms of acute interstitial nephritis.

Taking lansoprazole for a long time may make it harder for your body to absorb vitamin B12. Tell your doctor if you have concerns about vitamin B12 deficiency.

Check with your doctor right away if you have watery stool that does not go away, stomach pain, and fever while taking lansoprazole.

Lansoprazole may increase your risk of having fractures of the hip, wrist, and spine. This is more likely if you have osteoporosis, if you are 50 years of age and older, if you receive high doses of lansoprazole, or use it for one year or more.

Cutaneous or systemic lupus erythematosus may occur or get worse in patients receiving a PPI. Call your doctor right away if you have joint pain or a skin rash on your cheeks or arms that gets worse when exposed to the sun.

lansoprazole may cause hypomagnesemia (low magnesium in the blood). This is more likely to occur if you are taking lansoprazole for more than one year, or if you are taking lansoprazole together with digoxin (Lanoxin®) or certain diuretics or "water pills". Check with your doctor right away if you have convulsions (seizures), fast, racing, or uneven heartbeat, muscle spasms (tetany), tremors, or unusual tiredness or weakness.

Do not stop taking lansoprazole without first checking with your doctor, or unless told to do so by your doctor.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking lansoprazole. The results of some tests may be affected by lansoprazole.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription (eg, atazanavir, Reyataz®) or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Clinical

Worldwide, over 10,000 patients have been treated with Lansoprazole in Phase 2 or Phase 3 clinical trials involving various dosages and durations of treatment. In general, Lansoprazole treatment has been well-tolerated in both short-term and long-term trials.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The following adverse reactions were reported by the treating physician to have a possible or probable relationship to drug in 1% or more of Lansoprazole -treated patients and occurred at a greater rate in Lansoprazole-treated patients than placebo-treated patients in Table 1.

Headache was also seen at greater than 1% incidence but was more common on placebo. The incidence of diarrhea was similar between patients who received placebo and patients who received 15 mg and 30 mg of Lansoprazole, but higher in the patients who received 60 mg of Lansoprazole (2.9%, 1.4%, 4.2%, and 7.4%, respectively).

The most commonly reported possibly or probably treatment-related adverse event during maintenance therapy was diarrhea.

In the risk reduction study of Lansoprazole for NSAID-associated gastric ulcers, the incidence of diarrhea for patients treated with Lansoprazole, misoprostol, and placebo was 5%, 22%, and 3%, respectively.

Another study for the same indication, where patients took either a COX-2 inhibitor or Lansoprazole and naproxen, demonstrated that the safety profile was similar to the prior study. Additional reactions from this study not previously observed in other clinical trials with Lansoprazole included contusion, duodenitis, epigastric discomfort, esophageal disorder, fatigue, hunger, hiatal hernia, hoarseness, impaired gastric emptying, metaplasia, and renal impairment.

Additional adverse experiences occurring in less than 1% of patients or subjects who received Lansoprazole in domestic trials are shown below:

Body as a Whole – abdomen enlarged, allergic reaction, asthenia, back pain, candidiasis, carcinoma, chest pain (not otherwise specified), chills, edema, fever, flu syndrome, halitosis, infection (not otherwise specified), malaise, neck pain, neck rigidity, pain, pelvic pain

Cardiovascular System -angina, arrhythmia, bradycardia, cerebrovascular accident/ cerebral infarction, hypertension/hypotension, migraine, myocardial infarction, palpitations, shock (circulatory failure), syncope, tachycardia, vasodilation

Digestive System – abnormal stools, anorexia, bezoar, cardiospasm, cholelithiasis, colitis, dry mouth, dyspepsia, dysphagia, enteritis, eructation, esophageal stenosis, esophageal ulcer, esophagitis, fecal discoloration, flatulence, gastric nodules/fundic gland polyps, gastritis, gastroenteritis, gastrointestinal anomaly, gastrointestinal disorder, gastrointestinal hemorrhage, glossitis, gum hemorrhage, hematemesis, increased appetite, increased salivation, melena, mouth ulceration, nausea and vomiting, nausea and vomiting and diarrhea, gastrointestinal moniliasis, rectal disorder, rectal hemorrhage, stomatitis, tenesmus, thirst, tongue disorder, ulcerative colitis, ulcerative stomatitis

Endocrine System -diabetes mellitus, goiter, hypothyroidism

Hemic and Lymphatic System -anemia, hemolysis, lymphadenopathy

Metabolism and Nutritional Disorders –avitaminosis, gout, dehydration, hyperglycemia/ hypoglycemia, peripheral edema, weight gain/loss

Musculoskeletal System -arthralgia, arthritis, bone disorder, joint disorder, leg cramps, musculoskeletal pain, myalgia, myasthenia, ptosis, synovitis

Nervous System – abnormal dreams, agitation, amnesia, anxiety, apathy, confusion, convulsion, dementia, depersonalization, depression, diplopia, dizziness, emotional lability, hallucinations, hemiplegia, hostility aggravated, hyperkinesia, hypertonia, hypesthesia, insomnia, libido decreased/increased, nervousness, neurosis, paresthesia, sleep disorder, somnolence, thinking abnormality, tremor, vertigo

Respiratory System -asthma, bronchitis, cough increased, dyspnea, epistaxis, hemoptysis, hiccup, laryngeal neoplasia, lung fibrosis, pharyngitis, pleural disorder, pneumonia, respiratory disorder, upper respiratory inflammation/infection, rhinitis, sinusitis, stridor

Skin and Appendages -acne, alopecia, contact dermatitis, dry skin, fixed eruption, hair disorder, maculopapular rash, nail disorder, pruritus, rash, skin carcinoma, skin disorder, sweating, urticaria

Special Senses – abnormal vision, amblyopia, blepharitis, blurred vision, cataract, conjunctivitis, deafness, dry eyes, ear/eye disorder, eye pain, glaucoma, otitis media, parosmia, photophobia, retinal degeneration/disorder, taste loss, taste perversion, tinnitus, visual field defect

Urogenital System -abnormal menses, breast enlargement, breast pain, breast tenderness, dysmenorrhea, dysuria, gynecomastia, impotence, kidney calculus, kidney pain, leukorrhea, menorrhagia, menstrual disorder, penis disorder, polyuria, testis disorder, urethral pain, urinary frequency, urinary  retention, urinary tract infection, urinary urgency, urination impaired, vaginitis.

Postmarketing Experience

Additional adverse experiences have been reported since Lansoprazole has been marketed. The majority of these cases are foreign-sourced and a relationship to Lansoprazole has not been established. Because these reactions were reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These events are listed below by COSTART body system.

Body as a Whole – anaphylactic/anaphylactoid reactions; Digestive System – hepatotoxicity, pancreatitis, vomiting; Hemic and Lymphatic System – agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, neutropenia, pancytopenia, thrombocytopenia, and thrombotic thrombocytopenic purpura; Infections and Infestations – Clostridium difficile associated diarrhea; Metabolism and Nutritional Disorders – hypomagnesemia; Musculoskeletal System – bone fracture, myositis; Skin and Appendages – severe dermatologic reactions including erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis (some fatal); Special Senses – speech disorder; Urogenital System – interstitial nephritis, urinary retention.

Combination Therapy with Amoxicillin and Clarithromycin

In clinical trials using combination therapy with Lansoprazole plus amoxicillin and clarithromycin, and Lansoprazole plus amoxicillin, no adverse reactions peculiar to these drug combinations were observed. Adverse reactions that have occurred have been limited to those that had been previously reported with Lansoprazole, amoxicillin, or clarithromycin.

Triple Therapy: Lansoprazole/amoxicillin/ clarithromycin

The most frequently reported adverse reactions for patients who received triple therapy for 14 days were diarrhea (7%), headache (6%), and taste perversion (5%). There were no statistically significant differences in the frequency of reported adverse reactions between the 10-and 14-day triple therapy regimens. No treatment-emergent adverse reactions were observed at significantly higher rates with triple therapy than with any dual therapy regimen.

Dual Therapy: Lansoprazole/ amoxicillin

The most frequently reported adverse reactions for patients who received Lansoprazole three times daily plus amoxicillin three times daily dual therapy were diarrhea (8%) and headache (7%). No treatment-emergent adverse reactions were observed at significantly higher rates with Lansoprazole three times daily plus amoxicillin three times daily dual therapy than with Lansoprazole alone.

For information about adverse reactions with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with Lansoprazole, refer to the ADVERSE REACTIONS section of their package inserts.

Laboratory Values

The following changes in laboratory parameters in patients who received Lansoprazole were reported as adverse reactions:

Abnormal liver function tests, increased SGOT (AST), increased SGPT (ALT), increased creatinine, increased alkaline phosphatase, increased globulins, increased GGTP, increased/decreased/abnormal WBC, abnormal AG ratio, abnormal RBC, bilirubinemia, blood potassium increased, blood urea increased, crystal urine present, eosinophilia, hemoglobin decreased, hyperlipemia, increased/decreased electrolytes, increased/ decreased cholesterol, increased glucocorticoids, increased LDH, increased/decreased /abnormal platelets, increased gastrin levels and positive fecal occult blood. Urine abnormalities such as albuminuria, glycosuria, and hematuria were also reported. Additional isolated laboratory abnormalities were reported.

In the placebo controlled studies, when SGOT (AST) and SGPT (ALT) were evaluated, 0.4% (4/978) and 0.4% (11/2677) patients, who received placebo and Lansoprazole, respectively, had enzyme elevations greater than three times the upper limit of normal range at the final treatment visit. None of these patients who received Lansoprazole reported jaundice at any time during the study.

In clinical trials using combination therapy with Lansoprazole plus amoxicillin and clarithromycin, and Lansoprazole plus amoxicillin, no increased laboratory abnormalities particular to these drug combinations were observed.

For information about laboratory value changes with antibacterial agents (amoxicillin and clarithromycin) indicated in combination with Lansoprazole, refer to the ADVERSE REACTIONS section of their package inserts.

1.National Committee for Clinical Laboratory Standards. Summary Minutes, Subcommittee on Antimicrobial Susceptibility Testing, Tampa, FL, January 11-13, 1998.

[See FDA-Approved Medication Guide and Patient Instructions for Use]

Patient should be informed of the following:

• Advise patients to immediately report and seek care for diarrhea that does not improve. This may be a sign of Clostridium difficile associated diarrhea [see Warnings and Precautions(5.4)].
• Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia [see Warnings and Precautions (5.6)].

Information for Patients

Lansoprazole is available as a capsule in 15 mg and 30 mg strengths. Directions for use specific to the route and available methods of administration for each of these dosage forms is presented below [see Dosage and Administration (2.3)].

• Lansoprazole should be taken before eating.
• Lansoprazole products SHOULD NOT BE CRUSHED OR CHEWED.

Administration Options

1 Lansoprazole delayed-release capsules - Oral Administration

   •  Lansoprazole delayed-release capsules should be swallowed whole.

   •  Alternatively, for patients who have difficulty swallowing capsules, Lansoprazole delayed-release capsules can be opened and administered as follows:

      ○  Open capsule.

      ○  Sprinkle intact pellets on one tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.

      ○  Swallow immediately.

   •  Lansoprazole delayed-release capsules may also be emptied into a small volume of either apple juice, orange juice or tomato juice and administered as follows:

      ○  Open capsule.

      ○  Sprinkle intact pellets into a small volume of either apple juice, orange juice or tomato juice (60 mL – approximately 2 ounces).

      ○  Mix briefly.

      ○  Swallow immediately.

      ○  To ensure complete delivery of the dose, the glass should be rinsed with two or more volumes of juice and the contents swallowed immediately.

Lansoprazole delayed-release capsules – Nasogastric Tube (≥16 French) Administration

   •  For patients who have a nasogastric tube in place, Lansoprazole delayed-release capsules can be administered as follows:

      ○  Open capsule.

      ○  Mix intact pellets into 40 mL of apple juice. DO NOT USE OTHER LIQUIDS.

      ○  Inject through the nasogastric tube into the stomach.

      ○  Flush with additional apple juice to clear the tube.

USE IN OTHER FOODS AND LIQUIDS HAS NOT BEEN STUDIED CLINICALLY AND IS THEREFORE NOT RECOMMENDED.

Manufactured By:

Inventia Healthcare Private Limited

Plot No.F1 & F-1/1, Additional Ambernath M.I.D.C.,

Ambernath (East)-421506,

Dist. Thane, Maharashtra, India

Marketed by:

Lifestar Pharma LLC.

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Revised: September 2017

                                                                                                  MEDICATION GUIDE

                                                                           Lansoprazole Delayed-Release Capsules, USP

                                                                                                      (lan-SO-pruh-zole)

Read this Medication Guide before you start taking Lansoprazole delayed-release capsules and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information that I should know about Lansoprazole delayed-release capsules?

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:

• Diarrhea. Lansoprazole delayed-release capsules may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile ) in your intestines.
  Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.
• Bone fractures. People who take multiple daily doses of proton pump inhibitor medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist or spine. You should take Lansoprazole delayed-release capsules exactly as prescribed, at the lowest dose   possible for your treatment and for the shortest time needed. Talk to your doctor about your risk of bone fracture if you take Lansoprazole   delayed-release capsules.

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?

Lansoprazole delayed-release capsules are a prescription medicine called a proton pump inhibitor (PPI). Lansoprazole delayed-release capsules reduces the amount of acid in your stomach.

Lansoprazole delayed-release capsules are used in adults:

• for 4 weeks for the healing and symptom relief of duodenal ulcers. The duodenal area is the area where food passes when it leaves the stomach.
• with certain antibiotics to treat an infection called H. pylori. Sometimes H. pylori bacteria can cause duodenal ulcers. The infection needs to be treated to prevent ulcers from coming back.
• for continued healing of duodenal ulcers.
• for up to 8 weeks to heal stomach ulcers.
• for up to 8 weeks to heal stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).
• for reducing the risk of stomach ulcers in some people taking NSAIDs.
• for up to 8 weeks for the relief of heartburn and other symptoms of 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.

• for 8 weeks to heal the acid-related damage to the lining of the esophagus (called erosive esophagitis) and to relieve symptoms. If needed, your doctor may prescribe another 8 weeks of Lansoprazole delayed-release capsules .
• for continued healing of erosive esophagitis.
• for the long-term treatment of conditions where your stomach makes too much acid. This includes a condition called Zollinger-Ellison syndrome.

Lansoprazole is used in children and adolescents (ages 1 to 17):

• for up to 12 weeks to treat GERD and erosive esophagitis in children 1 to 11 years old.
• for up to 8 weeks to treat GERD and erosive esophagitis in adolescents 12 to 17 years old.

Lansoprazole delayed-release capsules are not effective for symptoms of GERD in children under the age of 1 year.

Who should not take Lansoprazole delayed-release capsules?

• Do not take Lansoprazole delayed-release capsules if you are allergic to Lansoprazole or any of the other ingredients in Lansoprazole delayed-release capsules. See the end of this Medication Guide for a complete list of ingredients in Lansoprazole delayed-release capsules.

What should I tell my doctor before taking Lansoprazole delayed-release capsules?

Before you take Lansoprazole delayed-release capsules , tell your doctor if you:

• have been told that you have low magnesium levels in your blood.
• have liver problems
• have phenylketonuria.
• have any other medical conditions
• are pregnant or plan to become pregnant. It is not known if Lansoprazole delayed-release capsules will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Lansoprazole passes into your breast milk. You and your doctor should decide if you will take Lansoprazole delayed-release capsules or breastfeed. You should not do both. 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 non-prescription drugs, vitamins, and herbal supplements. Lansoprazole delayed-release capsules may affect how other medicines work, and other medicines may affect how Lansoprazole delayed-release capsules works.

Especially tell your doctor if you take:

• atazanavir (Reyataz)
• nelfinavir (Viracept)
• erlotinib (Tarceva)
• digoxin (Lanoxin)
• a product that contains iron
• ketoconazole (Nizoral)
• warfarin (Coumadin, Jantoven)
• tacrolimus (Prograf)
• theophylline (Theo-24, Elixophyllin, Theochron, Theolair)
• an antibiotic that contains ampicillin or clarithromycin
• methotrexate
• mycophenolate mofetil (Cellcept)

Ask your doctor or pharmacist for a list of these medicines if you are not sure.

Know the medicines that you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

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.
• You should take Lansoprazole delayed-release capsules before eating.
• Lansoprazole delayed-release capsules :

      ○   You should swallow Lansoprazole delayed-release capsules whole.

      ○   Do not crush or chew Lansoprazole delayed-release capsules.

      ○   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 and 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.

• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Just take the 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 right away.

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?"
• Vitamin B12 deficiency. Lansoprazole delayed-release capsules reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B12 properly. Talk with your doctor about the possibility of vitamin B12 deficiency if you have been on Lansoprazole delayed-release capsules , USP for a long time (more than 3 years).
• Low magnesium levels in your body. This problem can be serious. Low magnesium can happen in some people who take a proton pump inhibitor medicine for at least 3 months. If low magnesium levels happen, it is usually after a year of treatment. You may or may not have symptoms of low magnesium.

Tell your doctor right away if you develop any of these symptoms:

• seizures
• dizziness
• abnormal or fast heartbeat
• jitteriness
• jerking movements or shaking (tremors)
• muscle weakness
• spasms of the hands and feet
• cramps or muscle aches
• spasm of the voice box

Your doctor may check the level of magnesium in your body before you start taking Lansoprazole, or during treatment; if you will be taking Lansoprazole delayed-release capsules for a long period of time.

The most common side effects of Lansoprazole in adults and children include:

• diarrhea
• stomach pain
• nausea
• constipation
• headache

Other side effects:

• Serious allergic reactions. Tell your doctor if you get any of the following symptoms with Lansoprazole delayed-release capsules.

• rash
• face swelling
• throat tightness
• difficulty breathing

Your doctor may stop Lansoprazole if these symptoms happen.

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Lansoprazole delayed-release capsules. For more information, ask your doctor or pharmacist. 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 Lansoprazole delayed-release capsules

Medicines are sometimes prescribed for conditions other than those listed in a Medication Guide. Do not use Lansoprazole delayed-release capsules, USP 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.

This Medication Guide summarizes the most important information about Lansoprazole delayed-release capsules. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Lansoprazole delayed-release capsules that is written for healthcare professionals.

Please address medical inquiries to, Inventia Healthcare Pvt. Ltd. at 1-855-642-2594.

What are the ingredients in Lansoprazole Delayed-Release capsules?

Active ingredient: Lansoprazole 

Inactive ingredients in Lansoprazole delayed-release capsules : corn starch, gelatin, hydroxypropyl cellulose, magnesium carbonate,methacrylic acid and ethyl acrylate copolymer dispersion, polyethylene glycol, polysorbate 80, sucrose, sugar spheres, talc, titanium dioxide.

In addition Lansoprazole 15 mg delayed-release capsules only: FD&C Blue 2, Iron oxide yellow.

Lansoprazole 30 mg delayed-release capsules only: Iron oxide black

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

                                                                                                  Instructions for Use

                                                                          Lansoprazole Delayed-Release Capsules, USP

                                                                                                  (lan-SO-pruh-zole)

Lansoprazole delayed-release capsules

• Swallow Lansoprazole delayed-release capsules whole. Do not crush or chew them.
• You should take Lansoprazole delayed-release capsules before eating.

• 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 pellets on 1 tablespoon of either applesauce, ENSURE pudding, cottage cheese, yogurt or strained pears.
3 Swallow right away.

• 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 pellets into 60 mL (about ¼ cup) of either apple juice, orange juice or tomato juice.

3 Stir.

4 Swallow right away.

5 To make sure that the entire dose is taken, rinse the glass with 1/2 cup or more of juice to get out any leftover pellets. Swallow the juice right away.

Lansoprazole delayed-release capsules through a nasogastric tube (NG tube) 16 French or larger, as prescribed by your doctor:

You can only use apple juice.

1 Open the capsule and empty the pellets into a syringe.

2 Do not break or crush the pellets.

3 Mix with 40 mL of apple juice. Do not use other liquids.

4 Attach the syringe to the NG tube and give the medicine in the syringe through the NG tube into the stomach.

5 After giving the pellets, flush the NG tube with more apple juice to clear the tube.

Lansoprazole delayed-release capsules should not be used in foods or liquids not listed above.

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.

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

Manufactured By:

Inventia Healthcare Private Limited

Plot No.F1 & F-1/1, Additional Ambernath M.I.D.C.,

Ambernath (East)-421506,

Dist. Thane, Maharashtra, India

Marketed by:

Lifestar Pharma LLC.

1200 MacArthur Blvd.

Mahwah, NJ 07430 USA

Revised: September 2017

All other trademarks names are the property of their respective owners.

Refer to adult dosing.

A 3 mg/mL oral solution (Simplified Lansoprazole Solution [SLS]) may be made with capsules and sodium bicarbonate. Empty the contents of ten lansoprazole 30 mg capsules into a beaker. Add 100 mL sodium bicarbonate 8.4% and gently stir until dissolved (about 15 minutes). Transfer solution to an amber-colored syringe or bottle. A prior study showed that SLS was stable for 8 hours at room temperature or for 14 days refrigerated (DiGiancinto, 2000). However, a more recent study, demonstrated SLS to be stable for 48 hours at room temperature in oral syringes and for only 7 days when refrigerated (Morrison, 2013).

Note: A more palatable lansoprazole (3 mg/mL) suspension is commercially available as a compounding kit (First-Lansoprazole).

Oral: Administer before food; best if taken before breakfast. The intact granules should not be chewed or crushed; however, several options are available for those patients unable to swallow capsules:

Capsules may be opened and the intact granules sprinkled on 1 tablespoon of applesauce, Ensure pudding, cottage cheese, yogurt, or strained pears. The granules should then be swallowed immediately.

Capsules may be opened and emptied into ~60 mL orange juice, apple juice, or tomato juice; mix and swallow immediately. Rinse the glass with 2 or more volumes of juice and swallow immediately to assure complete delivery of the dose.

Orally disintegrating tablets: Should not be swallowed whole, broken, cut, or chewed. Place tablet on tongue; allow to dissolve (with or without water) until particles can be swallowed. Orally-disintegrating tablets may also be administered via an oral syringe: Place the 15 mg tablet in an oral syringe and draw up ~4 mL water, or place the 30 mg tablet in an oral syringe and draw up ~10 mL water. After tablet has dispersed, administer within 15 minutes. Refill the syringe with water (2 mL for the 15 mg tablet; 5 mL for the 30 mg tablet), shake gently, then administer any remaining contents.

Nasogastric tube administration:

Capsule: Capsule can be opened, the granules mixed (not crushed) with 40 mL of apple juice and then administered through the NG tube into the stomach, then flush tube with additional apple juice. Do not mix with other liquids. Thirty milligrams has also been suspended in 10 mL of 8.4% sodium bicarbonate solution (or apple juice) or divided into 4 equal parts and flushed with water and administered via NG tube (Brophy 2010; Tsai 2000).

Orally-disintegrating tablet: Nasogastric tube ≥8 French: Place a 15 mg tablet in a syringe and draw up ~4 mL water, or place the 30 mg tablet in a syringe and draw up ~10 mL water. After tablet has dispersed, administer within 15 minutes. Refill the syringe with ~5 mL water, shake gently, and then flush the nasogastric tube.