Lansoprazole ODT 15mg 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 2002
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lansoprazole is a medicine called a proton pump inhibitor (PPI). It works by reducing the amount of acid your stomach makes. This helps to relieve symptoms like heartburn and allows ulcers and acid damage to heal.
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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 are feeling well.

If you are also taking sucralfate, take your medication at least 30 minutes before taking sucralfate. To take your medication, place the tablet on your tongue and let it dissolve. You do not need to drink water with it. Do not swallow the tablet whole, and do not 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 recommended amount of water: 4 mL for 15 mg tablets or 10 mL for 30 mg tablets. Gently shake the syringe until the tablet dissolves. Take the medication within 15 minutes of mixing. After taking the medication, refill the syringe with 2 mL of water for 15 mg tablets or 5 mL of water for 30 mg tablets, 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 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 tablet at least 30 minutes before a meal, preferably in the morning.
  • Do not crush, chew, or split the orally disintegrating tablet. Allow it to dissolve on your tongue and then swallow with or without water.
  • 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 2-3 hours after eating.
  • Elevate the head of your bed if you experience nighttime reflux.
  • Maintain a healthy weight.
  • Quit smoking.

Dosing & Administration

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Adult Dosing

Standard Dose: Varies by indication. For maintenance of healed erosive esophagitis: 15 mg orally once daily. For symptomatic GERD: 15 mg orally once daily for up to 8 weeks.
Dose Range: 15 - 30 mg

Condition-Specific Dosing:

Maintenance of Healed Erosive Esophagitis: 15 mg orally once daily
Symptomatic GERD: 15 mg orally once daily for up to 8 weeks
Duodenal Ulcer (treatment): 15 mg orally once daily for 4 weeks
Gastric Ulcer (treatment): 30 mg orally once daily for 8 weeks
H. pylori Eradication (part of triple therapy): 30 mg orally twice daily for 10-14 days (in combination with antibiotics)
Zollinger-Ellison Syndrome: Initial 60 mg orally once daily, then individualize dose based on acid output. Doses up to 90 mg twice daily have been used.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established for ODT formulation. For GERD in infants 1-11 months: 1.4 mg/kg/day (max 15 mg/day) using oral suspension.
Child: For GERD in children 1-11 years: 15 mg once daily for patients weighing ≤30 kg; 30 mg once daily for patients weighing >30 kg. For erosive esophagitis in children 12-17 years: 15 mg once daily for up to 8 weeks.
Adolescent: For erosive esophagitis in adolescents 12-17 years: 15 mg orally 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: No adjustment needed; not significantly removed by hemodialysis.

Hepatic Impairment:

Mild: No adjustment needed
Moderate: Consider dose reduction (e.g., 15 mg daily maximum) for severe impairment, as exposure may be increased.
Severe: Consider dose reduction (e.g., 15 mg daily maximum) due to significantly prolonged half-life 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 substituted benzimidazole that is activated in the acidic environment of the parietal cell canaliculus, where it binds irreversibly to the proton pump, blocking the final step in acid production.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 80-90% (after first dose, can increase with repeated dosing)
Tmax: 1.5-2.2 hours (for ODT, may be slightly faster than capsules)
FoodEffect: Food can delay absorption and reduce peak concentrations, but does not significantly affect AUC. Should be taken before meals for optimal effect.

Distribution:

Vd: 0.36 L/kg
ProteinBinding: 97%
CnssPenetration: Limited

Elimination:

HalfLife: 1.5-2 hours (terminal elimination half-life, but duration of acid suppression is much longer due to irreversible binding)
Clearance: Not readily available as a specific rate, but primarily hepatic metabolism.
ExcretionRoute: Approximately two-thirds in feces (biliary excretion) and one-third in urine (as metabolites).
Unchanged: <1% in urine
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Pharmacodynamics

OnsetOfAction: Within 1 hour
PeakEffect: Within 2-4 hours (maximal acid suppression may take several days of dosing)
DurationOfAction: Up to 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
+ Change in balance
+ Abnormal heartbeat
+ Seizures
+ Loss of appetite
+ Severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ Change 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 do not experience any side effects or only have mild ones. If you are bothered by any of the following side effects or if they do not go away, contact your doctor:
Headache
Constipation
Stomach pain or diarrhea
Upset stomach

This is not a comprehensive list of all 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 stomach pain or diarrhea that is watery or bloody (may be a sign of C. difficile infection)
  • New or worsening heartburn after stopping the medication (acid rebound)
  • Unexplained weight loss, recurrent vomiting, difficulty swallowing, or black/tarry stools (may indicate a more serious condition)
  • Muscle spasms, tremors, or irregular heartbeat (signs of low magnesium)
  • Unusual bruising or bleeding
  • Any signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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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 allergic reaction you experienced, including any symptoms that occurred.
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 is not an exhaustive list of all potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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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 alcohol consumption, smoking, steroid use, seizure medication, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor.

Low Magnesium Levels
In rare cases, 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 (more than 3 years) with this medication has been associated with low vitamin B-12 levels in rare cases. Be aware of symptoms such as shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, tiredness, mood changes, or numbness or tingling in the arms or legs, and contact your doctor immediately if you experience any of these.

Lupus
This medication has been linked to the development of lupus, as well as worsening of existing lupus. If you have lupus, inform your doctor. Seek medical attention promptly if you experience symptoms 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.

Stomach Growths
The risk of stomach growths called fundic gland polyps may be higher in individuals taking this medication for more than 1 year. If you have concerns, discuss them with your doctor.

Lab Tests and Interactions
This medication may affect certain lab tests. Inform all your healthcare providers and lab workers about your treatment. If you have phenylketonuria (PKU), consult 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 cause harm. 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 concerns you may have.
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Overdose Information

Overdose Symptoms:

  • No specific symptoms of overdose have been reported with lansoprazole. Symptoms are generally minimal and may include drowsiness, blurred vision, tachycardia, or nausea.

What to Do:

There is no specific antidote. Treatment should be symptomatic and supportive. Lansoprazole is not significantly removed by hemodialysis. Call 1-800-222-1222 (Poison Control Center) immediately if overdose is suspected.

Drug Interactions

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Contraindicated Interactions

  • Rilpivirine (concurrent use with PPIs is contraindicated due to reduced rilpivirine exposure)
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Major Interactions

  • Clopidogrel (reduced antiplatelet effect due to CYP2C19 inhibition)
  • Atazanavir (reduced absorption and efficacy of atazanavir)
  • Nelfinavir (reduced absorption and efficacy of nelfinavir)
  • Methotrexate (increased and prolonged methotrexate levels, especially with high doses)
  • Dasatinib (reduced dasatinib exposure)
  • Erlotinib (reduced erlotinib exposure)
  • Pazopanib (reduced pazopanib exposure)
  • Sunitinib (reduced sunitinib exposure)
  • Mycophenolate mofetil (reduced mycophenolic acid exposure)
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Moderate Interactions

  • Digoxin (increased digoxin levels)
  • Tacrolimus (increased tacrolimus levels)
  • Iron salts (reduced absorption of iron)
  • Ketoconazole, Itraconazole, Posaconazole (reduced absorption of these antifungals)
  • Warfarin (potential for increased INR, monitor closely)
  • Theophylline (potential for increased theophylline levels, though generally minor)
  • Sucralfate (delays lansoprazole absorption, administer lansoprazole at least 30 minutes before sucralfate)
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Minor Interactions

  • Fluvoxamine (increased lansoprazole exposure due to CYP2C19 inhibition)
  • Phenytoin (potential for altered phenytoin levels, monitor)

Monitoring

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Baseline Monitoring

Baseline symptoms of GERD/ulcer disease

Rationale: To establish a starting point for assessing treatment efficacy.

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 as needed)

Target: Significant reduction or elimination of symptoms

Action Threshold: Lack of improvement or worsening symptoms may indicate need for further diagnostic workup or alternative therapy.

Serum Magnesium (Mg)

Frequency: Periodically for patients on long-term therapy (â‰Ĩ3 months, especially â‰Ĩ1 year) or those taking other drugs that can cause hypomagnesemia (e.g., diuretics).

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

Action Threshold: Below normal range; consider supplementation or discontinuation of PPI if severe and symptomatic.

Vitamin B12 levels

Frequency: Consider for patients on very long-term therapy (e.g., >3 years) due to potential for malabsorption.

Target: Normal range

Action Threshold: Low levels; consider supplementation.

Bone Mineral Density (BMD)

Frequency: Consider for patients at high risk for osteoporosis on long-term, high-dose therapy.

Target: Maintain healthy BMD

Action Threshold: Significant bone loss; consider alternative therapy or bone-protective measures.

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Symptom Monitoring

  • Heartburn
  • Acid regurgitation
  • Dysphagia (difficulty swallowing)
  • Abdominal pain
  • Nausea
  • Vomiting
  • Black, tarry stools (melena) or blood in vomit (hematemesis) - seek immediate medical attention
  • Unexplained weight loss - seek immediate medical attention
  • Persistent diarrhea (especially watery or bloody, may indicate C. difficile infection)
  • Muscle cramps, weakness, dizziness, irregular heartbeat (signs of hypomagnesemia)

Special Patient Groups

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Pregnancy

Lansoprazole is classified as 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 clearly needed.

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 in human milk in small amounts. The amount is considered low and unlikely to cause adverse effects in breastfed infants. The American Academy of Pediatrics considers lansoprazole to be compatible with breastfeeding. Monitor infant for any signs of adverse effects like diarrhea.

Infant Risk: Low risk (L2)
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Pediatric Use

Approved for short-term treatment of GERD and erosive esophagitis in children 1-17 years of age. Dosing is weight-based for younger children. Long-term safety and efficacy beyond 8-12 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 dosage adjustment is generally necessary based solely on age, but consider potential for reduced hepatic function and polypharmacy in elderly patients.

Clinical Information

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Clinical Pearls

  • Lansoprazole ODT can be taken with or without water. Place on the tongue and allow to disintegrate, then swallow. Do not crush or chew.
  • Take lansoprazole at least 30 minutes before the first meal of the day for optimal acid suppression.
  • PPIs are generally not for 'on-demand' use; they work best when taken consistently daily.
  • Long-term PPI use (especially >1 year) has been associated with increased risk of C. difficile infection, bone fractures (hip, wrist, spine), and hypomagnesemia. Periodically assess the need for continued therapy.
  • Patients on clopidogrel should generally avoid concurrent use with lansoprazole due to reduced antiplatelet effect, unless benefits outweigh risks. Consider alternative anti-secretory agents or alternative antiplatelet therapy.
  • Rebound acid hypersecretion can occur upon discontinuation of PPIs, especially after long-term use. Tapering the dose may help mitigate this effect.
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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)
  • Lifestyle modifications (dietary changes, weight loss, elevating head of bed)
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Cost & Coverage

Average Cost: Varies, typically $10-$50 per 30 tablets
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 your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which is a crucial patient fact sheet. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, we encourage you to discuss them 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. When reporting the incident, be prepared to provide detailed information, including the substance taken, the amount, and the time it occurred.