Lansoprazole 15mg DR Capsules (otc)

Lansoprazole is a proton pump inhibitor (PPI) that irreversibly blocks the H+/K+ ATPase enzyme system (the 'proton pump') in the secretory canaliculi of the gastric parietal cells. This action inhibits the final step in gastric acid production, leading to a profound and long-lasting reduction in gastric acid secretion.

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 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 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.

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
Concurrent use of specific medications, such as:
+ Atazanavir
+ Methotrexate
+ Nelfinavir
+ Rilpivirine
+ Warfarin
Use of rifampin or St. John's wort, as these may interact with this medication

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. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.

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 this medication in high doses or for longer 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, use caution and discuss your risks with your doctor.

Low Magnesium Levels
Rarely, people taking medications like this one for at least 3 months may experience low magnesium levels, which can lead to other electrolyte problems. This usually 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 medications like this one can 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 has been associated with the development of lupus, as well as worsening of 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
The risk of stomach growths called fundic gland polyps may be higher in people who take this medication for more than 1 year. 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, inform your doctor. You will need 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.

• Rilpivirine (due to significant reduction in rilpivirine absorption)

• Methotrexate (increased and prolonged methotrexate levels, potentially leading to toxicity)
• Clopidogrel (reduced antiplatelet effect of clopidogrel, though clinical significance is debated and often considered less significant than with omeprazole)
• Tacrolimus (increased tacrolimus blood concentrations)

• Iron salts (reduced absorption of iron)
• Ketoconazole, Itraconazole, Dasatinib, Erlotinib, Nelfinavir, Atazanavir (reduced absorption due to increased gastric pH)
• Digoxin (increased absorption of digoxin)
• Warfarin (potential for increased INR/bleeding risk, monitor closely)
• Sucralfate (delays and decreases lansoprazole absorption; take lansoprazole at least 30 minutes before sucralfate)
• Mycophenolate Mofetil (reduced exposure to mycophenolic acid)

• Not typically categorized as minor for significant clinical interactions.

• Heartburn frequency and severity
• Dysphagia (difficulty swallowing)
• Odynophagia (painful swallowing)
• Unexplained weight loss
• 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)
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
• Signs of C. difficile-associated diarrhea (persistent diarrhea, abdominal pain, fever)
• Signs of hypomagnesemia (fatigue, muscle twitching, tremors, convulsions, dizziness, irregular heart rhythm)

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. Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.

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

OTC 15mg Lansoprazole is not recommended for children under 18 years of age without consulting a doctor. Prescription formulations are used for specific pediatric conditions (e.g., GERD, erosive esophagitis) in children 1 year and older, with weight-based dosing.

No specific dose adjustment is required based on age. However, elderly patients may be at increased risk for certain adverse effects with long-term PPI use, including C. difficile infection, bone fractures, and hypomagnesemia. Use the lowest effective dose for the shortest duration necessary.

• Lansoprazole 15mg DR Capsules (OTC) is specifically for frequent heartburn, defined as heartburn occurring 2 or more days a week.
• It is not for immediate relief of heartburn; it may take 1 to 4 days for full effect.
• Take the capsule whole, 30-60 minutes before the first meal of the day. Do not crush, chew, or open the capsule.
• The OTC product is intended for a 14-day course of treatment, not to be repeated within 4 months unless directed by a doctor.
• Long-term use of PPIs (beyond 14 days for OTC, or prolonged prescription use) has been associated with increased risks of C. difficile infection, hypomagnesemia, bone fractures (hip, wrist, spine), and vitamin B12 deficiency.
• Patients should be advised to seek medical attention if their heartburn persists after 14 days of treatment, or if they experience any 'alarm symptoms' such as difficulty swallowing, weight loss, or bloody stools, as these may indicate a more serious underlying condition.

• Other Proton Pump Inhibitors (e.g., Omeprazole, Esomeprazole, Pantoprazole, Rabeprazole, Dexlansoprazole)
• H2-receptor antagonists (e.g., Famotidine, Cimetidine)
• Antacids (for immediate, short-term relief)
• Alginate-based products (e.g., Gaviscon)

If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. 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 valuable resource that provides important information about your treatment. Please read this guide carefully and review it again whenever you receive a refill of your medication. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, pharmacist, or other healthcare provider for clarification.

In the event of a suspected overdose, it's crucial to seek immediate medical attention. Call your local poison control center or visit the emergency room right away. When seeking help, be prepared to provide detailed information about the overdose, including the name of the medication taken, the amount consumed, and the time it occurred.