Lansoprazole ODT 30mg Tablets

Manufacturer AUROBINDO PHARMA Active Ingredient Lansoprazole Orally Disintegrating Tablets(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
Proton Pump Inhibitor (PPI)
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Pharmacologic Class
Gastric Acid Secretion Inhibitor
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Pregnancy Category
Category B
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FDA Approved
Mar 2003
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lansoprazole ODT is a medicine that helps reduce the amount of acid your stomach makes. It's used to treat conditions like heartburn, acid reflux, and ulcers. The ODT (Orally Disintegrating Tablet) dissolves quickly in your mouth, making it easier to take.
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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're feeling well.

If you're also taking sucralfate, take this medication at least 30 minutes before taking sucralfate. To take the medication, place the tablet on your tongue and let it dissolve. You don't need to use water, and be sure not to swallow the tablet whole or chew, break, or crush it.

Alternatively, you can dissolve the tablet in an oral syringe with water. To do this, place the tablet in the syringe and add the following amount of water: 4 mL for a 15 mg tablet or 10 mL for a 30 mg tablet. Gently shake the syringe until the tablet dissolves, then take the medication within 15 minutes of mixing. After taking the medication, refill the syringe with 2 mL of water for a 15 mg tablet or 5 mL of water for a 30 mg tablet, shake gently, and swallow.

If you have a feeding tube, you can use this medication as directed by your healthcare provider. After administering the medication through the feeding tube, be sure to flush the tube.

Storing and Disposing of Your Medication

Store your medication at room temperature in a dry place, away from the bathroom. Protect the medication 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's 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 tablet at least 30 minutes before a meal, preferably in the morning.
  • Do not chew or crush the tablet; allow it to dissolve on your tongue.
  • Avoid foods and drinks that trigger your symptoms (e.g., spicy foods, fatty foods, caffeine, alcohol, citrus, chocolate).
  • Eat smaller, more frequent meals.
  • Avoid lying down for at least 3 hours after eating.
  • Elevate the head of your bed if you experience nighttime reflux.
  • Maintain a healthy weight.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication
Dose Range: 15 - 120 mg

Condition-Specific Dosing:

Erosive Esophagitis (EE): 30 mg once daily for up to 8 weeks; maintenance 15 mg once daily
Gastroesophageal Reflux Disease (GERD): 15 mg once daily for up to 8 weeks
Duodenal Ulcer (DU): 15 mg once daily for 4 weeks
Gastric Ulcer (GU): 30 mg once daily for 8 weeks
Zollinger-Ellison Syndrome (ZES): Initial 60 mg once daily; adjust dose based on acid output (up to 120 mg BID)
H. pylori Eradication: 30 mg twice daily (in combination with antibiotics) for 10-14 days
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for infants <1 year
Child: 1-11 years: EE/GERD: <30 kg: 15 mg once daily; â‰Ĩ30 kg: 30 mg once daily. For up to 12 weeks.
Adolescent: 12-17 years: EE/GERD: 15 mg once daily for up to 8 weeks.
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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 adjustment needed

Hepatic Impairment:

Mild: No adjustment needed
Moderate: Consider dose reduction (e.g., 15 mg daily) for severe impairment, but no specific guidelines for moderate.
Severe: Consider dose reduction (e.g., 15 mg daily) due to reduced clearance and increased AUC. 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, which is concentrated in the acidic secretory canaliculi of the parietal cell, where it is converted to the active sulfenamide form. This active form then binds irreversibly to the proton pump, inhibiting the final step in acid production.
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Pharmacokinetics

Absorption:

Bioavailability: 80-90% (variable)
Tmax: 1.5-2.2 hours
FoodEffect: Food can delay absorption and reduce bioavailability. ODT should be taken before meals.

Distribution:

Vd: 15.7 L
ProteinBinding: 97%
CnssPenetration: Limited

Elimination:

HalfLife: 1.3-1.7 hours (terminal elimination half-life)
Clearance: Not available
ExcretionRoute: Approximately 33% in urine and 66% in feces
Unchanged: <1% in urine
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Pharmacodynamics

OnsetOfAction: Within 1-2 hours
PeakEffect: Within 2-6 hours (acid suppression)
DurationOfAction: Up to 24 hours (due to irreversible binding to 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 immediate medical attention:

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
+ Difficulty 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
+ Balance changes
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe nausea or vomiting
Signs of kidney problems, such as:
+ Inability to urinate
+ 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 stomach pain, cramps, very loose or watery stools, or bloody stools, contact your doctor immediately. 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 concern you, contact your doctor:

Headache
Constipation
Stomach pain or diarrhea
* Nausea

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 (may indicate C. difficile infection)
  • Unexplained weight loss
  • Difficulty swallowing or painful swallowing
  • Vomiting blood or material that looks like coffee grounds
  • Black, tarry stools
  • Chest pain (especially with shortness of breath, sweating, or pain radiating to arm/jaw - seek emergency care)
  • Signs of allergic reaction (rash, hives, swelling of face/lips/tongue, difficulty breathing)
  • Signs of low magnesium (muscle spasms, tremors, irregular heartbeat, dizziness, seizures)
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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 your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment.

Risk of Fractures
This medication may increase the risk of fractures in the hip, spine, and wrist, particularly in individuals with weak bones (osteoporosis). The risk may be higher if you take high doses or use the medication for more than a year, or if you 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
Rarely, patients 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 (more than 3 years) may cause low vitamin B-12 levels. Be aware of the signs of low vitamin B-12 levels, such as 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 may cause lupus or worsen existing lupus. If you have lupus, inform your doctor. Be aware of the 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 experience any of these symptoms, contact your doctor immediately.

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 your healthcare providers and lab workers that you are taking this medication.

Phenylketonuria (PKU)
If you have PKU, consult with your doctor, as some products contain phenylalanine.

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

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 have been identified, but high doses may cause exaggerated adverse effects such as drowsiness, blurred vision, tachycardia, nausea, headache, and sweating.

What to Do:

Call 911 or your local poison control center (1-800-222-1222). Treatment is symptomatic and supportive. Lansoprazole is not significantly removed by hemodialysis.

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

  • Atazanavir (reduced absorption, significantly decreased plasma levels)
  • Nelfinavir (reduced absorption, significantly decreased plasma levels)
  • Clopidogrel (potential reduction in antiplatelet effect via CYP2C19 inhibition)
  • Methotrexate (increased and prolonged serum levels of methotrexate and/or its metabolite, potentially leading to toxicity)
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Moderate Interactions

  • Digoxin (increased absorption, increased digoxin levels)
  • Iron salts (reduced absorption of iron)
  • Tacrolimus (increased tacrolimus levels, monitor concentrations)
  • Warfarin (potential for increased INR and bleeding, monitor INR)
  • Mycophenolate mofetil (reduced exposure to mycophenolic acid)
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Minor Interactions

  • Sucralfate (delays absorption of lansoprazole, administer lansoprazole at least 30 minutes before sucralfate)
  • Theophylline (minor increase in theophylline clearance)

Monitoring

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Baseline Monitoring

Baseline symptoms of GERD/EE

Rationale: To assess initial disease severity and track treatment response.

Timing: Prior to initiation of therapy

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Routine Monitoring

Symptom resolution/improvement

Frequency: Regularly during treatment (e.g., weekly for initial weeks, then monthly)

Target: Significant reduction or absence of symptoms

Action Threshold: Lack of improvement after 4-8 weeks may warrant re-evaluation or alternative therapy

Serum Magnesium (Mg)

Frequency: Periodically, especially with long-term use (>1 year) or concomitant diuretics

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

Action Threshold: Hypomagnesemia (Mg <1.7 mg/dL) requires supplementation and consideration of PPI discontinuation

Vitamin B12 (Cyanocobalamin)

Frequency: Periodically, especially with long-term use (>3 years)

Target: Normal range

Action Threshold: Deficiency requires supplementation

Bone Mineral Density (BMD)

Frequency: Consider baseline and periodic monitoring for patients at risk of osteoporosis with long-term use (>1 year)

Target: Maintain healthy BMD

Action Threshold: Significant bone loss may require intervention or alternative therapy

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Symptom Monitoring

  • Heartburn
  • Acid regurgitation
  • Dysphagia
  • Abdominal pain
  • Nausea
  • Diarrhea
  • Headache
  • Signs of allergic reaction (rash, itching, swelling)
  • Signs of hypomagnesemia (tetany, arrhythmias, seizures)
  • Signs of C. difficile-associated diarrhea (severe diarrhea, abdominal pain, fever)

Special Patient Groups

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Pregnancy

Lansoprazole is classified as Pregnancy Category B. Studies in animals have not shown harm to the fetus, and there are no adequate and well-controlled studies in pregnant women. Generally considered acceptable for use during pregnancy when clearly needed.

Trimester-Specific Risks:

First Trimester: Low risk, generally considered safe based on available data.
Second Trimester: Low risk.
Third Trimester: Low risk.
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Lactation

Lansoprazole is excreted into breast milk in small amounts. The amount is considered too small to cause adverse effects in breastfed infants. Generally considered compatible with breastfeeding (Lactation Risk Category L2).

Infant Risk: Low risk of adverse effects to the infant.
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Pediatric Use

Approved for use in children aged 1 year and older for certain indications (GERD, EE). Dosing is weight-based for younger children. Long-term safety data in pediatric populations is limited, and use should be carefully considered.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustment is required based on age alone. However, elderly patients may have reduced hepatic function, which could affect drug clearance, and may be at higher risk for long-term adverse effects like bone fractures or B12 deficiency.

Clinical Information

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Clinical Pearls

  • Lansoprazole ODT should be taken at least 30 minutes before a meal for optimal absorption and efficacy.
  • The ODT formulation can be taken with or without water. It dissolves rapidly on the tongue.
  • For patients with a nasogastric tube, the ODT can be dispersed in water and administered via the tube.
  • Long-term PPI use (especially >1 year) has been associated with an increased risk of hypomagnesemia, C. difficile infection, and bone fractures. Periodically assess the need for continued therapy.
  • Patients on clopidogrel should generally avoid concurrent PPI use, especially omeprazole, due to potential reduction in clopidogrel's antiplatelet effect. Lansoprazole's interaction with clopidogrel is considered less significant than omeprazole but still present.
  • PPIs can mask symptoms of gastric malignancy; consider endoscopy in patients with persistent or recurrent symptoms despite therapy.
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Alternative Therapies

  • H2-receptor antagonists (e.g., Famotidine, Ranitidine [if available], Cimetidine)
  • Antacids (e.g., Calcium carbonate, Aluminum hydroxide/Magnesium hydroxide)
  • Prokinetics (e.g., Metoclopramide - for specific motility disorders)
  • Surgery (e.g., Nissen fundoplication for severe GERD)
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Cost & Coverage

Average Cost: Varies widely, typically $10-$50 per 30 tablets (generic)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (for generic)
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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 is a comprehensive patient fact sheet. It is crucial to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for guidance.

In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the quantity, and the time it occurred.