Lansoprazole 30mg DR Capsules

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 binds irreversibly to the proton pump, inhibiting the final step in acid production. Because the binding is irreversible, new proton pumps must be synthesized for acid secretion to resume, leading to a prolonged duration of action despite a short plasma half-life.

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 immediately or seek 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
+ 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 can cause side effects. Many people may not experience any side effects or may only have 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
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.

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. Be sure to describe the allergic reaction and its symptoms.
Certain health conditions, such as:
+ 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
Current medications, including:
+ Atazanavir
+ Methotrexate
+ Nelfinavir
+ Rilpivirine
+ Warfarin
Concurrent use of:
+ Rifampin
+ St. John's wort

Please note that this is not an exhaustive list of potential interactions. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist to ensure safe use. Never start, stop, or adjust the dosage of any medication without consulting your doctor.

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 hip, spine, and wrist fractures, 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, 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 (more than 3 years) with this medication has been associated with 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 linked to 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 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.

Pregnancy and Breastfeeding
If you are pregnant, plan to become pregnant, or are breastfeeding, consult your doctor to discuss the benefits and risks 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 concerns you may have.

• Rilpivirine (due to significant reduction in rilpivirine exposure)
• Atazanavir (due to significant reduction in atazanavir exposure)

• Clopidogrel (reduced antiplatelet effect due to CYP2C19 inhibition)
• Methotrexate (increased methotrexate levels and toxicity)
• Nelfinavir (reduced nelfinavir exposure)
• Dasatinib, Erlotinib, Pazopanib, Sunitinib (reduced absorption of these tyrosine kinase inhibitors)

• Iron salts (reduced absorption of iron)
• Ketoconazole, Itraconazole, Posaconazole (reduced absorption due to increased gastric pH)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)
• Tacrolimus (increased tacrolimus levels)
• Warfarin (potential for increased INR/bleeding, monitor closely)
• Digoxin (increased digoxin absorption/levels)
• Sucralfate (delays lansoprazole absorption, administer lansoprazole at least 30 minutes before sucralfate)

• Diazepam (prolonged elimination)
• Phenytoin (potential for increased phenytoin levels)

• Resolution of GERD symptoms (heartburn, regurgitation)
• Dysphagia
• Abdominal pain
• Diarrhea (especially persistent, watery diarrhea, suggestive of C. difficile infection)
• Signs of hypomagnesemia (e.g., muscle cramps, tremors, arrhythmias)
• Signs of vitamin B12 deficiency (e.g., fatigue, paresthesias)

Lansoprazole is generally considered low risk during pregnancy. Human data from observational studies and meta-analyses have not shown an increased risk of major birth defects or adverse pregnancy outcomes. Use only if clearly needed.

Lansoprazole is present in breast milk. While the amount is likely low and adverse effects on the infant are not expected, caution is advised. Consider the benefits of breastfeeding versus the potential risks to the infant.

Approved for use in children 1 year and older for GERD/erosive esophagitis, and in children ≥3 years for H. pylori eradication. Dosing is weight-based for younger children. Long-term safety data in pediatric populations is limited, and potential risks (e.g., bone fractures, C. difficile) should be considered.

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, due to potential for decreased hepatic function in the elderly, dose adjustment may be considered in severe hepatic impairment. Elderly patients may be at higher risk for bone fractures and C. difficile infection with long-term use.

• Lansoprazole is a prodrug that requires an acidic environment for activation, hence it should be taken before a meal (typically 30-60 minutes before breakfast) to maximize its effect on active proton pumps.
• The delayed-release formulation is designed to protect the drug from stomach acid until it reaches the small intestine for absorption.
• Long-term PPI use (especially >1 year) has been associated with an increased risk of bone fractures (hip, wrist, spine), C. difficile-associated diarrhea, and hypomagnesemia. Periodically assess the need for continued therapy.
• Patients on long-term PPIs should be monitored for vitamin B12 deficiency, especially those with risk factors.
• Avoid concomitant use with clopidogrel due to reduced antiplatelet effect; consider alternative antiplatelet therapy or acid suppression if possible.
• For patients with difficulty swallowing capsules, some formulations allow for opening the capsule and sprinkling the granules on soft food or mixing with certain liquids (check product-specific instructions).

• H2 Receptor Antagonists (e.g., Famotidine, Ranitidine [if available], Cimetidine)
• Antacids (for symptomatic relief)
• Prokinetics (e.g., Metoclopramide, for motility disorders)
• Surgery (e.g., Nissen fundoplication for severe GERD)

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, 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. When reporting the incident, be prepared to provide details about the medication taken, the quantity, and the time it occurred.