Lansoprazole 15mg DR Capsules

Manufacturer MYLAN Active Ingredient Lansoprazole Delayed-Release Capsules(lan SOE pra zole) Pronunciation lan SOE pra zole
It is used to treat or prevent GI (gastrointestinal) ulcers caused by infection.It is used to treat or prevent nonsteroidal anti- inflammatory drugs (NSAID)-associated gastric ulcers in patients with a history of ulcers. Examples of NSAIDs include ibuprofen and naproxen. It is used to treat gastroesophageal reflux disease (GERD; acid reflux).It is used to treat heartburn. It is used to treat syndromes caused by lots of stomach acid.It is used to treat or prevent ulcers of the esophagus.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Antiulcer agents
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Pharmacologic Class
Proton Pump Inhibitor (PPI)
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Pregnancy Category
Category B
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FDA Approved
Dec 1995
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lansoprazole is a medicine that reduces the amount of acid your stomach makes. It's used to treat conditions like heartburn, acid reflux, and ulcers. It works by blocking tiny pumps in your stomach that produce acid.
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How to Use This Medicine

Taking Your Medication Correctly

To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. Take your medication before meals, as directed by your doctor or healthcare provider, even if you feel well.

If you are also taking sucralfate, take your medication at least 30 minutes before taking sucralfate. Swallow the capsule whole, without chewing or crushing it. Alternatively, you can sprinkle the contents of the capsule on a small amount of soft food, such as 1 tablespoon (15 mL) of applesauce, Ensureยฎ pudding, cottage cheese, yogurt, or strained pears. Do not chew the granules.

You can also mix the contents of the capsule with 60 mL of apple, orange, or tomato juice. Swallow the mixture immediately, without chewing the granules. After mixing, take your dose right away and do not store it for future use.

If you have a feeding tube, you can use this medication as directed by your healthcare provider. Flush the feeding tube after administering the medication.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. Protect it from heat and keep the lid tightly closed.

What to Do If You Miss a Dose

If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or take extra doses.
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Lifestyle & Tips

  • Take the capsule whole, do not crush or chew it. If you have trouble swallowing, the capsule can be opened and the granules sprinkled on a tablespoon of applesauce, pudding, cottage cheese, or yogurt, and swallowed immediately.
  • Take about 30-60 minutes before a meal, preferably in the morning.
  • Avoid trigger foods that worsen acid reflux (e.g., spicy foods, fatty foods, caffeine, chocolate, peppermint, citrus, tomatoes).
  • Eat smaller, more frequent meals.
  • Avoid lying down immediately after eating (wait at least 2-3 hours).
  • Elevate the head of your bed if you experience nighttime reflux.
  • Avoid smoking and excessive alcohol consumption.
  • Maintain a healthy weight.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For GERD/Erosive Esophagitis: 15 mg or 30 mg once daily.
Dose Range: 15 - 120 mg

Condition-Specific Dosing:

Erosive Esophagitis (Treatment): 30 mg once daily for up to 8 weeks.
Erosive Esophagitis (Maintenance): 15 mg once daily.
GERD (Non-erosive): 15 mg once daily for up to 8 weeks.
Duodenal Ulcer (Treatment): 15 mg once daily for 4 weeks.
Gastric Ulcer (Treatment): 30 mg once daily for 8 weeks.
H. pylori Eradication: 30 mg twice daily for 10-14 days (as part of triple therapy).
Zollinger-Ellison Syndrome: Initial 60 mg once daily; adjust based on acid output, doses up to 90 mg BID have been used.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for infants <1 year. For 1-11 years (GERD/EE): <30 kg: 15 mg once daily; โ‰ฅ30 kg: 30 mg once daily.
Child: 1-11 years (GERD/EE): <30 kg: 15 mg once daily; โ‰ฅ30 kg: 30 mg once daily. For 12-17 years (GERD/EE): 15 mg or 30 mg once daily.
Adolescent: 12-17 years (GERD/EE): 15 mg or 30 mg once daily.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed.
Moderate: No adjustment needed.
Severe: No adjustment needed.
Dialysis: Not significantly removed by hemodialysis; no specific adjustment needed, but monitor clinical response.

Hepatic Impairment:

Mild: No adjustment needed.
Moderate: Consider dose reduction, e.g., maximum 30 mg/day.
Severe: Significant dose reduction recommended, e.g., maximum 30 mg/day. Monitor closely.

Pharmacology

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Mechanism of Action

Lansoprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specific inhibition of the H+/K+-ATPase (proton pump) at the secretory surface of the gastric parietal cell. It is a weak base that is concentrated in the acidic secretory canaliculi of the parietal cell, where it is converted to the active sulfenamide form. This active form then irreversibly binds to and inactivates the proton pump, leading to a profound and long-lasting inhibition of acid secretion.
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Pharmacokinetics

Absorption:

Bioavailability: 80-95%
Tmax: 1.5-2.2 hours
FoodEffect: Food delays absorption and reduces peak concentration (Cmax) but does not significantly affect the extent of absorption (AUC).

Distribution:

Vd: Approximately 0.3 L/kg
ProteinBinding: >97%
CnssPenetration: Limited

Elimination:

HalfLife: 1.5 hours (terminal elimination half-life, but duration of action is much longer due to irreversible binding)
Clearance: Not available (variable)
ExcretionRoute: Biliary/fecal (approximately 66%), Renal (approximately 33%)
Unchanged: <1% in urine
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Pharmacodynamics

OnsetOfAction: 1-2 hours
PeakEffect: 2-4 hours
DurationOfAction: >24 hours (due to irreversible binding to the proton pump)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of electrolyte problems, including:
+ Mood changes
+ Confusion
+ Muscle pain, cramps, or spasms
+ Weakness
+ Shakiness
+ Changes in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Dizziness or fainting
Numbness or tingling in the hands or feet
Pale skin
Bone pain

This medication may increase the risk of a severe form of diarrhea called C. diff-associated diarrhea (CDAD). If you experience any of the following symptoms, contact your doctor right away:
Stomach pain or cramps
Very loose or watery stools
Bloody stools
Do not attempt to treat diarrhea without consulting your doctor first.

Severe skin reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions, may occur with this medication. These reactions can be life-threatening and may affect other organs. Seek medical help immediately if you notice:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever
Chills
Body aches
Shortness of breath
Swollen glands

Other Possible Side Effects

Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Headache
Constipation
Stomach pain or diarrhea
Upset stomach

This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe or persistent diarrhea (especially if watery or bloody, as it could be a sign of C. difficile infection)
  • Unexplained weight loss
  • Difficulty or pain swallowing (dysphagia, odynophagia)
  • Black, tarry stools or vomit that looks like coffee grounds (signs of bleeding)
  • New or worsening abdominal pain
  • Muscle cramps, spasms, or weakness; irregular heartbeat; dizziness; seizures (signs of low magnesium)
  • New bone pain or fractures
  • Rash, especially on sun-exposed areas, with joint pain (possible subacute cutaneous lupus erythematosus)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
Certain health issues, including:
+ Black or bloody stools
+ Heartburn accompanied by lightheadedness, sweating, dizziness, or wheezing
+ Chest pain
+ Shoulder pain with shortness of breath
+ Pain that radiates to the arms, neck, or shoulders
+ Lightheadedness
+ Excessive sweating
+ Vomiting blood
+ Difficulty or pain when swallowing food
Medications you are currently taking, particularly:
+ Atazanavir
+ Methotrexate
+ Nelfinavir
+ Rilpivirine
+ Warfarin
Concurrent use of:
+ Rifampin
+ St. John's wort

Please note that this list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. This will help ensure your safety while taking this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

Important Warnings and Cautions for Patients Taking This Medication

If you are taking this medication, it is essential to inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.

Risk of Fractures
This medication may increase the risk of hip, spine, and wrist fractures in individuals with weak bones (osteoporosis). The risk may be higher if you take high doses of this medication, use it for longer than a year, or are over 50 years old. If you have risk factors for osteoporosis, such as drinking alcohol, smoking, taking steroids, or having a family history of osteoporosis, exercise caution and discuss your risks with your doctor.

Low Magnesium Levels
In rare cases, people taking this medication for at least 3 months may experience low magnesium levels, which can lead to other electrolyte problems. This typically occurs after 1 year of treatment. Your doctor may recommend regular blood tests to monitor your magnesium levels.

Low Vitamin B-12 Levels
Long-term treatment with this medication (typically longer than 3 years) may cause low vitamin B-12 levels. Be aware of the signs of low vitamin B-12 levels, including shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs. If you experience any of these symptoms, contact your doctor immediately.

Lupus
This medication has been associated with the development of lupus, as well as worsening of existing lupus. If you have lupus, inform your doctor. Be vigilant for signs of lupus, such as a rash on the cheeks or other body parts, changes in skin color, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs. If you notice any of these symptoms, contact your doctor right away.

Stomach Growths
Taking this medication for more than 1 year may increase the risk of stomach growths called fundic gland polyps. If you have questions or concerns, discuss them with your doctor.

Lab Tests
This medication may affect certain lab tests. Inform all of your healthcare providers and lab workers that you are taking this medication.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks of this medication to you and your baby.

Children
This medication is not recommended for children under 1 year of age, as it may harm them. However, your doctor may decide that the benefits outweigh the risks. If your child has been prescribed this medication, ask your doctor about the benefits and risks, and discuss any questions or concerns you may have.
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Overdose Information

Overdose Symptoms:

  • No specific symptoms of overdose are known, but high doses may lead to exaggerated adverse effects such as drowsiness, blurred vision, tachycardia, or abdominal pain.

What to Do:

In case of suspected overdose, contact a poison control center immediately. Call 1-800-222-1222. Treatment is symptomatic and supportive.

Drug Interactions

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Contraindicated Interactions

  • Rilpivirine (concurrent use with PPIs is contraindicated due to significant reduction in rilpivirine plasma concentrations)
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Major Interactions

  • Clopidogrel (reduced antiplatelet effect due to CYP2C19 inhibition)
  • Methotrexate (increased and prolonged methotrexate and/or its metabolite serum levels, potentially leading to toxicity)
  • Atazanavir, Nelfinavir (reduced absorption and plasma concentrations of antiretrovirals)
  • Erlotinib, Dasatinib, Nilotinib (reduced absorption and plasma concentrations of tyrosine kinase inhibitors)
  • Mycophenolate Mofetil (reduced exposure of mycophenolic acid)
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Moderate Interactions

  • Digoxin (increased absorption and plasma concentrations of digoxin)
  • Tacrolimus (increased tacrolimus plasma concentrations)
  • Iron salts (reduced absorption of iron)
  • Ketoconazole, Itraconazole, Posaconazole (reduced absorption of antifungals)
  • Warfarin (potential for increased INR; monitor closely)
  • Theophylline (potential for increased theophylline levels, though generally minor)
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Minor Interactions

  • Phenytoin (potential for altered phenytoin levels; monitor if co-administered)
  • Sucralfate (delays absorption of lansoprazole; administer lansoprazole at least 30 minutes before sucralfate)

Monitoring

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Baseline Monitoring

Symptom assessment (e.g., heartburn, regurgitation)

Rationale: To establish baseline severity and guide treatment goals.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Symptom resolution/control

Frequency: Periodically, as clinically indicated (e.g., at follow-up visits)

Target: Significant reduction or elimination of symptoms.

Action Threshold: Persistent or worsening symptoms may require dose adjustment, further diagnostic workup, or alternative therapy.

Serum Magnesium (Mg)

Frequency: Periodically, especially with prolonged use (>3 months) or in patients taking other drugs that can cause hypomagnesemia (e.g., diuretics).

Target: Normal range (e.g., 1.7-2.2 mg/dL)

Action Threshold: If levels are low, consider magnesium supplementation or discontinuation of PPI if clinically appropriate.

Vitamin B12 levels

Frequency: Consider for patients on long-term therapy (>2-3 years) or those at risk for B12 deficiency.

Target: Normal range (e.g., 200-900 pg/mL)

Action Threshold: If levels are low, consider B12 supplementation.

Bone Mineral Density (BMD)

Frequency: Consider for patients on very long-term, high-dose therapy, especially those with other risk factors for osteoporosis.

Target: Maintain healthy BMD

Action Threshold: If BMD declines, consider calcium/vitamin D supplementation and evaluate need for continued PPI.

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Symptom Monitoring

  • Persistent or worsening heartburn/regurgitation
  • Dysphagia (difficulty swallowing)
  • Odynophagia (painful swallowing)
  • Unexplained weight loss
  • Recurrent vomiting
  • Gastrointestinal bleeding (black, tarry stools or coffee-ground vomit)
  • New or worsening abdominal pain
  • Signs of hypomagnesemia (e.g., muscle cramps, tremors, arrhythmias, seizures)

Special Patient Groups

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Pregnancy

Lansoprazole is Pregnancy Category B. Animal studies have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Generally considered safe for use during pregnancy when clinically indicated.

Trimester-Specific Risks:

First Trimester: No increased risk of major birth defects observed in human studies.
Second Trimester: No specific risks identified.
Third Trimester: No specific risks identified.
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Lactation

Lansoprazole is excreted into breast milk in small amounts. The American Academy of Pediatrics considers PPIs to be compatible with breastfeeding. Monitor the infant for any adverse effects (e.g., diarrhea). L3 (Moderately safe).

Infant Risk: Low risk of adverse effects to the breastfed infant. Monitor for gastrointestinal disturbances.
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Pediatric Use

Approved for short-term treatment of GERD and erosive esophagitis in children aged 1 to 17 years. Dosing is weight-based for younger children. Long-term safety and efficacy beyond 12 weeks have not been established in pediatric patients.

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Geriatric Use

No overall differences in safety or effectiveness were observed between elderly and younger patients. No specific dose adjustment is required based solely on age, but monitor for age-related comorbidities and polypharmacy that may increase risk of adverse effects (e.g., fractures, C. diff, hypomagnesemia).

Clinical Information

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Clinical Pearls

  • Instruct patients to take lansoprazole at least 30-60 minutes before the first meal of the day to maximize efficacy, as the proton pumps are most active after a period of fasting.
  • Do not crush or chew delayed-release capsules; the enteric coating is essential for drug delivery and protection from stomach acid.
  • Long-term PPI use (especially >1 year) has been associated with increased risks of bone fractures (hip, wrist, spine), Clostridium difficile-associated diarrhea, hypomagnesemia, vitamin B12 deficiency, and possibly acute interstitial nephritis and chronic kidney disease.
  • Consider the lowest effective dose and shortest duration of therapy for all patients, especially those at higher risk for adverse effects.
  • For patients on long-term therapy, periodically assess the continued need for PPI and consider attempts to taper or discontinue if appropriate.
  • Be aware of potential drug interactions, particularly with clopidogrel, methotrexate, and certain antiretrovirals, due to CYP2C19 inhibition and pH-dependent absorption.
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Alternative Therapies

  • Other Proton Pump Inhibitors (PPIs): Omeprazole, Esomeprazole, Pantoprazole, Rabeprazole, Dexlansoprazole
  • Histamine-2 Receptor Blockers (H2RAs): Famotidine, Ranitidine (withdrawn), Cimetidine, Nizatidine
  • Antacids (e.g., aluminum hydroxide/magnesium hydroxide, calcium carbonate)
  • Prokinetics (e.g., Metoclopramide, for motility disorders)
  • Sucralfate (for ulcer protection)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 for 30 capsules (generic) per 30 capsules
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (generic), Tier 3 or higher (brand) for most insurance plans.
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information for patients. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. Be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.