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Lansoprazole - The Long-Term and Well Tolerated Therapy for GERD

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Lansoprazole treats symptoms of gastroesophageal reflux disease (GERD). Continue reading to learn more about its uses, dosage, effects, contraindications, and precautions.

Medically reviewed by

Dr. Mohammad Rajja

Published At November 29, 2022
Reviewed AtNovember 30, 2022

Overview:

Lansoprazole is a proton pump inhibitor that reduces the amount of acid produced by the stomach. The drug is used to treat ulcers in the stomach lining or intestine. The drug is used alone or may be combined with other medicines to treat heartburn caused due to backflow of acid from the stomach. It helps to prevent ulcer formation in adults who have already had ulcers or have had an injury of the esophagus and also decreases the risk of developing ulcers in people taking anti-inflammatory drugs. Lansoprazole is available only on a doctor’s prescription and is a delayed-release medication to prevent its breakdown by stomach acid and release in the intestine. The proton pump inhibitor is Food and Drug Administration (FDA) approved to treat active ulcers (gastric and duodenal). It also treats erosive reflux esophagitis and gastroesophageal disease.

How Does Lansoprazole Work?

Lansoprazole is a prodrug, meaning that these proton pump inhibitors require gastric acid secretion to be converted to sulfenamide or sulfenic acid. Once activated, it reacts with cysteine residues on the parietal H+ and K+ ATPase enzymes. This ability to bind covalently to their targets provides a prolonged inhibition of acid secretion. Therefore, the drug is taken before a meal to control daytime gastric acidity.

Uses:

Lansoprazole is indicated for the following:

  • The proton pump inhibitor is Food and Drug Administration (FDA) approved for short-term treatment of active gastric ulcers and duodenal ulcers (soreness that occurs inside the stomach lining or the first part of the small intestine).

  • The drug relieves symptoms of heartburn (burning in the center of the chest that may involve the neck and throat and worsens on lying down) and indigestion.

  • It is used to treat symptoms of erosive reflux esophagitis (inflammation of the esophageal mucosa) and gastroesophageal reflux disease (GERD), a state in which the acid flows back from the stomach causing heartburn (burning feeling in the chest) and may injury the esophagus in adults and children above one year of age.

  • The proton pump inhibitor helps to treat ulcers on the lining of the stomach and intestine and decreases ulcer formation in people taking non-steroidal anti-inflammatory drugs.

  • Lansoprazole is prescribed to treat Zollinger-Ellison syndrome (a digestive disorder or condition that causes the stomach to produce too much gastric acid resulting in tumor growth in the pancreas or the upper part of the small intestine).

  • Lansoprazole effectively eradicates H. pylori infection when combined with other medications, such as Amoxicillin and Clarithromycin, in triple therapy or with Amoxicillin alone in dual therapy.

Limitations:

  • Long-term therapy with Lansoprazole can increase the risk of developing stomach cancer.

  • Taking Lansoprazole for more than one year can increase the chances of specific side effects, such as bone fractures, especially in people with osteoporosis and vitamin B12 deficiency.

Dosage Restrictions:

1. Route of Administration - Oral.

2. Dosage Strengths -

  • Delayed-release capsules.

  • 15 milligrams.

  • 30 milligrams.

  • Oral-disintegrating tablets.

  • 15 milligrams.

  • 30 milligrams.

  • Oral suspension.

  • 3 millimole / milliliter.

3. Dosage Forms -

  • Fifteen milligrams of Lansoprazole capsules are opaque, hard gelatin, pink and green colored with “15” imprinted.

  • Thirty milligrams Lansoprazole capsules are opaque hard gelatin, pink and black colored with “30” imprinted.

  • Fifteen milligrams of Lansoprazole tablets are uncoated, orange to dark brown colored with a “15” imprint.

  • Thirty milligrams Lansoprazole tablets are uncoated, orange to dark brown colored with “30” imprinted.

The recommended dose is 30 milligrams, taken once daily for four to eight weeks.

Special Considerations

  • Pregnancy - Lansoprazole should be avoided during pregnancy, especially during the third trimester, as it may be associated with congenital disabilities.

  • Lactation - There are no adequate studies to determine infant risk while using Lansoprazole during breastfeeding.

  • Pediatric Patients - Lansoprazole is not recommended for children younger than one year of age. The drug may be given to toddlers only if the benefits outweigh the risks.

  • Geriatric Patients - Long-term therapy with proton pump inhibitors such as Lansoprazole is related to an increased risk of hip, spine, or wrist fractures in adults over 65.

  • Renal Impairment - People with renal impairment are more likely to develop kidney damage or failure when given Lansoprazole in the long term.

  • Hepatic Impairment - The use of Lansoprazole in patients with hepatic impairment is associated with high mortality and increased risk of hepatic decompensation that may require hospitalization. It is recommended to reduce the dose by 50% when given to patients with moderate to severe hepatic impairment.

Warnings and Contraindications:

Contraindications

Lansoprazole is contraindicated in the following cases:

  • Pregnancy - Recent studies suggest that using Lansoprazole in pregnancy can increase the risk of congenital disabilities, and the therapy should be stopped if contemplating pregnancy.

  • Hypersensitivity - Lansoprazole is contraindicated in people who have known allergic reactions to the drug or its constituents. It is likely to exacerbate the condition.

  • Colitis - Rarely have patients reported colitis (colon inflammation) in patients taking this drug. Hence, the drug must be discontinued for severe or persistent diarrhea symptoms.

Warnings and Precautions

  • Clostridium Difficile-Associated Diarrhea (CDAD) - Studies suggest that using proton pump inhibitors such as Lansoprazole may be linked with an increased risk of Clostridium difficile-associated diarrhea. It is usually observed in hospitalized patients. Close monitoring is recommended in patients with diarrhea and those taking antibacterial therapy.

  • Liver Disease - The liver primarily metabolizes Lansoprazole. Adjustment in the dose must be considered in patients with severe hepatic impairment.

  • Bone Fractures - Observational studies have shown that long-term use of Lansoprazole may be associated with an increased risk of osteoporosis-related hip, spine, or wrist fractures. These patients should be given low doses of Lansoprazole and treated for a short duration.

  • Hypomagnesemia - Treatment with proton pump inhibitors for more than three months can cause symptomatic and asymptomatic hypomagnesemia (an electrolyte disturbance caused when serum magnesium levels are lower than 1.46 mg/dl in the blood). Therefore, these patients should be monitored for severe events such as tetany, seizures, and arrhythmias.

  • Vitamin B12 Deficiency - Long-term treatment with Lansoprazole may lead to malabsorption of cyanocobalamin and vitamin B 12 deficiency. Taking large amounts of Proton pump inhibitors such as Lansoprazole is associated with vitamin B12 deficiency. This should be considered if clinical symptoms are observed.

For Patients

What Is Gastroesophageal Reflux Disease (GERD)?

Gastroesophageal reflux is a severe and long-lasting condition in which the stomach contents move up into the esophagus (a muscular tube that carries food and liquid from the throat to the stomach). It is associated with symptoms such as

  • Chest pain, usually in the middle of the chest and radiating to the back.

  • Difficulty in swallowing (dysphagia).

  • Coughing.

  • Sore throat.

  • Shortness of breath.

Long-lasting and untreated GERD can permanently damage the esophagus and Barrett’s esophagus (a condition in which the lower portion of the esophagus is damaged due to overexposure to stomach acid).

Why Is Lansoprazole Prescribed for Gastroesophageal Reflux Disease?

Lansoprazole is a proton pump inhibitor that helps lower the stomach's amount of acid. Proton pumps are enzymes found in the stomach lining and help make acid to digest food. Proton pump inhibitors such as Lansoprazole prevent the proton pumps from working properly and reduce acid production. The drug is effective within two to three days and may take up to four weeks to work properly.

Facts One Should Know About Lansoprazole:

  • Lansoprazole is to be given once, preferably in the morning, and may be taken twice a day in cases of severe illness.

  • The drug is available both over-the-counter and with a doctor’s prescription.

  • Lansoprazole works best at least 30 minutes before a meal or snack.

  • Long-term therapy with Lansoprazole may be associated with an increased risk of osteoporosis-related fractures (osteoporosis occurs when the new bone is not created after the loss of old bone).

  • Lansoprazole may increase the risk of severe diarrhea associated with symptoms such as stomach pain, fever, and watery diarrhea.

How Should One Take Lansoprazole?

  • Lansoprazole is available as a tablet and capsule to be taken by mouth.

  • It is taken once a day, usually in the morning, and works best when taken before meals.

  • The drug should be taken at the same time each day.

  • Lansoprazole is usually started on a low dose of 15 milligrams and is gradually increased for severe cases.

  • Lansoprazole may be taken twice daily for 14 days when combined with other medications to eliminate Helicobacter pylori.

  • It may take more than two weeks to show the full benefits of the drug.

  • Only stop the medicine suddenly after talking to the doctor.

  • Do not break or chew the orally disintegrating tablets. Instead, the capsule is swallowed with a glass of water or milk.

What Should the Patient Discuss With His Doctor Before Beginning Lansoprazole Therapy?

  • Allergies - Inform the physician if one has ever had an allergic reaction to Lansoprazole or other ingredients in the formulation. Symptoms may include rash, face swelling, throat tightness, or troubled breathing.

  • Medical History - The patient must always inform the treating doctor of his illnesses, such as diabetes, bronchospastic diseases, myocardial infarction, and impaired renal or hepatic function.

  • Drug History - Always give the treating doctor a complete list of the prescription and non-prescription medications that one may be taking, including any herbal supplements, nutritional supplements, and vitamins.

  • Pregnancy - If one is pregnant or planning to get pregnant any time soon, it is essential to inform the doctor. The use of Lansoprazole may harm the fetus and the mother. Using Lansoprazole during the third trimester of pregnancy may increase the risk of developing congenital disabilities if one gets pregnant while on Lansoprazole; inform the doctor as soon as one finds out.

  • Lactation - The doctor must know if one is breastfeeding. The possibility of Lansoprazole passing into the breastmilk is unknown. However, it is likely to pass in small amounts to the baby.

  • Older Adults - Prolonged use and high doses may increase the risk of bone fractures. Therefore, the doctor may prescribe low doses of Lansoprazole for treatment and for a short time.

Safety of Lansoprazole:

  • Long-term therapy with proton pump inhibitors may be associated with an increased risk for osteoporosis-related hip, wrist, or spine fractures.

  • Prolonged use may cause hypomagnesemia (an electrolyte disturbance caused due to low levels of serum magnesium in the blood).

Effectiveness of Lansoprazole:

  • There is no significant difference in the clinical effectiveness of other proton pump inhibitors, such as Omeprazole or Pantoprazole, in relieving heartburn symptoms and regurgitation.

  • The drug starts to work within two to three days and may take up to four weeks to completely control the acid symptoms.

Side Effects Patient Can Expect With Lansoprazole:

The common side effects that occur with the use of Lansoprazole are as follows:

  • Diarrhea.

  • Constipation.

  • Abdominal pain.

  • Headache.

  • Feeling sick.

  • Itchy skin rashes.

  • Dry mouth or throat.

  • Nausea.

The severe side effects may include,

  • Chest pain.

  • Fast or irregular heart rate.

  • Watery or bloody diarrhea.

  • Jerky muscle movements.

  • Confusion.

  • Feeling jittery.

  • Seizures.

  • Patients should never stop taking Lansoprazole without first talking to their doctor. Consult the physician or visit the emergency room if one experiences any side effects that require immediate attention.

  • Do not skip the dose or stop taking Lansoprazole suddenly. This can worsen the condition or make the symptoms return. Instead, the doctor will instruct on how to taper the dose gradually.

  • Stopping proton pump inhibitors can cause rebound acid hypersecretion and lead to the appearance of symptoms such as indigestion, heartburn, or regurgitation (a condition when digestive fluids and undigested food rise from the esophagus into the mouth).

Dietary Restrictions to Consider When Taking Lansoprazole:

The patient may continue to follow the regular diet unless the doctor asks to change it. No dietary restrictions are needed. The drug is taken 30 minutes before having meals. This helps the body to absorb the drug and makes the drug more effective.

  • Caffeine-Containing Foods - Avoid taking caffeine-containing food items and beverages such as tea, coffee, and chocolates while taking Lansoprazole. Caffeine can decrease the effectiveness of the drug.

  • Fatty and Spicy Foods - Try to eat small meals at once. Eat more often and avoid eating fatty and spicy foods.

  • Acidic Foods - Foods and drinks such as apples, lemons, grapefruit, oranges, tomatoes, cola, and energy drinks can worsen the symptoms of GERD and heartburn and should be avoided.

Storage of Lansoprazole:

  • Store Lansoprazole at room temperature in a closed container, away from heat, moisture, and direct light.

  • Lansoprazole tablets should be stored in the original packaging or container with a tightly closed lid.

  • Keep this drug far from the reach of children and pets.

Disposal of Lansoprazole:

  • Lansoprazole should not be disposed of by flushing or throwing it out with regular garbage.

  • One may dispose of Lansoprazole through the local medicine take-back program, which one can access or learn more about through the local pharmacist.

  • Ask the local pharmacist about other drug disposal options if the person cannot access a medicine take-back program.

Overdose:

  • In one of the reported cases, an individual had consumed almost 600 mg of Lansoprazole for more than a year, although there were no specific side effects.

  • If a person overdoses, contact a doctor immediately and do not take another tablet until the doctor tells you what to do.

  • Contact the doctor immediately if a person experiences severe abdominal pain, constipation, diarrhea, and nausea.

  • The drug is not usually eliminated with hemodialysis. So, in case of emergency, gastric emptying is performed. It is a procedure to induce vomiting in a patient, remove all the particles in the stomach and cleanse it thoroughly. In rare cases, charcoal may be administered if recommended.

  • Overdosing may cause a rare but cutaneous severe reaction called toxic epidermal necrolysis (TENS), characterized by blistering and peeling of the skin.

For Doctor

Indications:

Lansoprazole is indicated for the following purposes:

  • It is indicated for short-term treatment for healing and symptom relief of active duodenal ulcers and active benign gastric ulcers.

  • It is used for short-term treatment to heal all grades of erosive esophagitis and helps maintain healing.

  • The drug may be prescribed for treating pathological hypersecretory conditions, including Zollinger-Ellison syndrome.

  • Lansoprazole helps to reduce the risk of non-steroidal anti-inflammatories (NSAIDs) associated with gastric ulcers in patients with documented gastric ulcers. It is also used to heal NSAID-associated ulcers.

Pharmacology of Lansoprazole:

Description:

  • Lansoprazole is a white to brownish-white odorless crystalline powder. It is freely soluble in dimethylformamide, soluble in methanol, slightly soluble in ethyl acetate, and insoluble in water.

  • It is stable when exposed to light for up to two months.

  • Lansoprazole is a member of benzimidazole with selective and irreversible proton pump inhibitor activity.

Components:

1. Active Ingredients

  • Lansoprazole.

2. Inactive Ingredients

  • Sugar sphere.

  • Sucrose.

  • Methacrylic acid copolymer.

  • Hydroxypropyl cellulose.

  • Starch.

  • Magnesium carbonate.

  • Talc.

  • Polyethylene glycol.

  • Titanium dioxide.

  • Polysorbate 80.

  • Colloidal silicon dioxide.

Clinical Pharmacology:

Mechanism of Action

Lansoprazole is an antisecretory compound called substituted benzimidazoles. These compounds suppress gastric secretion by specific inhibition of the H+ and K+ ATPase enzymes at the secretory surface of the gastric parietal cell. Lansoprazole blocks the final step of acid production. This effect is dose-dependent and inhibits the stimulated gastric acid secretion, irrespective of the stimulus.

Pharmacodynamics

After oral administration, Lansoprazole significantly decreases the basal acid output and increases the mean gastric pH.

Initial Dose - Increased gastric pH is seen within one to two hours of 30 mg of Lansoprazole and two to three hours with 15 mg of Lansoprazole.

Multiple Dose - Increased gastric pH was seen within the first hour after a dose of 30 mg Lansoprazole and within one to two hours after a dose of 15 mg Lansoprazole.

Pharmacokinetics

  • Mean Cmax- 1.7 hours after oral dosing and absolute bioavailability are over 80 %.

  • Median Tmax- The presence of food diminishes by 50 % to 70 %.

[Cmax- Maximum concentration achieved by a drug in the blood, cerebrospinal fluid, or target organ after administration of a dose]

[Tmax- Time taken for a drug to reach maximum concentration after administration of a dose]

Pharmacokinetic Changes - The dose is to be adjusted to individual requirements due to variations in the rate of metabolism.

A. Distribution

  • Steady-state Plasma Levels - 0.05 to 5.0 microgram per milliliter.

  • Time to Approach Steady-state Levels - 1.7 hours.

  • Binding to Plasma Proteins- 97 %.

B. Metabolism

The liver mainly metabolizes Lansoprazole with enzymes CYP3A4 and CYP2C19.

  • Metabolic Processes- 5-Hydroxylated sulfinyl and sulfone derivatives of Lansoprazole.

  • Active Metabolites - Cyclic sulfenamide and disulfide metabolites.

  • Inactive Metabolites - Sulphide and hydroxylated sulphone

C. Elimination

After Oral Administration -

  • 30% of the dose is excreted in the urine.

  • 70% is excreted in the feces.

  • The acid inhibitory effect lasts - 24 hours.

  • Time is taken to return to normal levels - Two weeks.

  • Mean Elimination Half-Life- Less than two hours.

Special Considerations:

  • Hepatic Impairment- Lansoprazole elimination half-life is significantly prolonged in patients with hepatic disease and may show abnormal liver function tests with Lansoprazole use. Therefore, these patients may require a dose reduction of the proton pump inhibitor.

  • Bone Fractures - Always use proton pump inhibitors such as Lansoprazole cautiously in patients with a risk of bone fractures or osteoporosis. Daily high doses of Lansoprazole increased the fracture risk in patients 50 years of age and older. Therefore, close monitoring of their bone status and adequate vitamin D and calcium supplementation must be ensured.

  • Hypokalemia -and Hypocalcemia - Caution must be observed while using Lansoprazole in patients with pre-existing risk of hypokalemia (low blood potassium levels) and hypocalcemia (low blood calcium levels). Prolonged therapy with Lansoprazole requires monitoring of calcium and potassium levels and should be discontinued if symptoms arise.

  • Infants - The safety and efficacy of Lansoprazole have not been established in neonates or infants and should be administered cautiously.

Drug Interactions:

  • Erlotinib - Lansoprazole decreases levels of Erlotinib by altering its solubility and reducing its bioavailability. Concomitant use of proton pump inhibitors such as Lansoprazole with Erlotinib should be avoided.

  • Mavacameten - Lansoprazole with Mavacantem increases the drug's effect by affecting the hepatic enzyme CYP2C19 metabolism. The CYP2C19 inhibitors increase systemic exposure to Mavantem. As a result, it may cause heart failure due to systolic dysfunction.

  • Nelfinavir - Lansoprazole with Nelfinavir is contraindicated as their combination may lead to loss of virologic response of Nelfinavir and develop resistance.

  • Cabotegravir - Concomitant use of Lansoprazole and Cabotegravir is contraindicated as it may lead to decreased absorption of the Cabotegravir (used in the treatment of the human immunodeficiency virus type-1 infection) or resistance.

  • Warfarin - Combining Lansoprazole and Warfarin has been reported to show increased INR (International normalized ratio based on the prothrombin test). This can lead to abnormal bleeding.

  • Tacrolimus - Concomitant administration of Lansoprazole and Tacrolimus may increase whole blood levels, especially in transplant patients who are poor metabolizers of CYP2C19.

What Have Clinical Trials Shown Concerning Lansoprazole?

Aim of Trial 1:

To study the safety and effectiveness of Lansoprazole in treating gastroesophageal reflux disease and dyspepsia compared with Ranitidine therapy and with a placebo.

  • 4 Two randomized, double-blind, multicenter trials of 901 patients with symptomatic reflux disease confirmed by endoscopy to be non-erosive.

  • 15 mg to 30 mg Lansoprazole was given once a day; Ranitidine 150 mg was given twice a day; or placebo for eight weeks.

  • During the first four weeks - Significantly low percentages of night and day heartburn were seen with small amounts of antacid given for a few days, compared to patients treated with Ranitidine or a placebo.

  • No statistically significant differences were noted between treatment groups.

Results - Lansoprazole therapy is more effective than standard dosages of Ranitidine or placebo in relieving the symptoms of gastroesophageal reflux disease.

Aim of Trial 2:

To evaluate the efficacy and safety of Lansoprazole in self-treating subjects with frequent nocturnal heartburn.

  • A total of 864 subjects with heartburn were randomized to double-blind treatment with Lansoprazole 15 mg or 30 mg or placebo each morning,

End Point - Percentages of night times without heartburn, percentage of 24-hour days without heartburn, and percentage of subjects without heartburn on day one were noted.

Result - Mean percentage of night times without heartburn was significantly greater with Lansoprazole 15 mg or 30 mg compared to placebo for both doses. In addition, the percentage of 24-hour days without heartburn and subjects without heartburn on day one were significantly more significant with Lansoprazole 15 mg or 30 mg compared to the placebo.

Patient Counseling Information:

Administration Instructions

  • Take Lansoprazole only as prescribed by the doctor.

  • Take the drug before food.

  • Swallow these tablets and do not crush, split, or chew them.

  • Do not stop taking Lansoprazole abruptly.

Complications or Side Effects

  • Phenylketonuria - Lansoprazole disintegrating tablets contain phenylalanine (an essential amino acid). Patients with phenylketonuria should be administered Lansoprazole cautiously as there may be build-up in the body.

  • Systemic Lupus Erythematosus - Treatment with Lansoprazole should be cautioned in patients who have had systemic lupus erythematosus in the past, as it may activate or exacerbate the condition.

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Dr. Mohammad Rajja
Dr. Mohammad Rajja

General Practitioner

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