Lansoprazole ODT 15mg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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.
Available Forms & Alternatives
Available Strengths:
- Lansoprazole 15mg DR Capsules
- Lansoprazole 30mg DR Capsules
- Lansoprazole ODT 15mg Tablets
- Lansoprazole ODT 30mg Tablets
- Lansoprazole ODT 15mg Tablets
- Lansoprazole ODT 30mg Tablets
- Lansoprazole 15mg DR Capsules (otc)
- Lansoprazole 30mg DR Caps
- Lansoprazole ODT 15mg Tablets
- Lansoprazole ODT 30mg Tablets
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
Side Effects
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.
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)
Before Using This Medicine
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.
Precautions & Cautions
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.
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
Contraindicated Interactions
- Rilpivirine (concurrent use with PPIs is contraindicated due to reduced rilpivirine exposure)
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)
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)
Minor Interactions
- Fluvoxamine (increased lansoprazole exposure due to CYP2C19 inhibition)
- Phenytoin (potential for altered phenytoin levels, monitor)
Monitoring
Baseline Monitoring
Rationale: To establish a starting point for assessing treatment efficacy.
Timing: Prior to initiation of therapy
Routine Monitoring
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.
Frequency: Periodically for patients on long-term therapy (âĨ3 months, especially âĨ1 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.
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.
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.
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
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:
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.
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.
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
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.
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)