Lansoprazole 30mg DR Caps

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 cells, where it is converted to the active sulfenamide form. This active form then irreversibly binds to and inactivates the proton pump, leading to a profound and long-lasting inhibition of 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 immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash or hives
+ Itching or red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing or 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 or confusion
+ Muscle pain, cramps, or spasms
+ Weakness or shakiness
+ Changes in balance
+ Abnormal heartbeat or seizures
+ Loss of appetite or severe upset stomach or vomiting
Signs of kidney problems, such as:
+ Inability to pass urine
+ 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 or 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 also affect internal organs. Seek medical help right away if you notice any of the following symptoms:
Red, swollen, blistered, or peeling skin
Red or irritated eyes
Sores in the mouth, throat, nose, eyes, genitals, or skin
Fever or chills
Body aches or 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 or seek medical attention:
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
Concurrent use of specific medications, including:
+ 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 potential interactions. To ensure your safety, it is crucial to disclose all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems, to your doctor and pharmacist. This will enable them to verify the safety of taking this medication in conjunction with your other treatments and health conditions. Never initiate, discontinue, 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 in individuals with weak bones (osteoporosis). The risk may be higher if you take high doses or use this 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 medications like this one 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 medications like this one can cause 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 associated with the development or worsening of 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 right away.

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 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, 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.

• Rilpivirine (concurrent use with PPIs can significantly reduce rilpivirine exposure, leading to loss of virologic response and possible resistance)

• Clopidogrel (reduced antiplatelet effect due to CYP2C19 inhibition, though clinical significance debated for lansoprazole compared to omeprazole)
• Methotrexate (increased methotrexate levels, especially with high-dose methotrexate, due to inhibition of renal elimination)
• Tacrolimus (increased tacrolimus levels)
• Warfarin (potential for increased INR/bleeding, monitor closely)
• Dasatinib, Erlotinib, Pazopanib, Sunitinib (reduced absorption of these pH-dependent drugs)
• Mycophenolate Mofetil (reduced mycophenolic acid exposure)

• Digoxin (increased digoxin levels)
• Iron salts (reduced absorption of iron)
• Ketoconazole, Itraconazole, Posaconazole (reduced absorption of these pH-dependent antifungals)
• Atazanavir, Nelfinavir (reduced absorption of these pH-dependent antiretrovirals)
• Sucralfate (delays lansoprazole absorption; administer lansoprazole at least 30 minutes before sucralfate)
• Theophylline (minor increase in theophylline clearance, generally not clinically significant)
• Fluvoxamine (increased lansoprazole exposure due to CYP2C19 inhibition)

• Antacids (can be taken concurrently, but separate by at least 1 hour if possible)
• Diazepam (minor increase in diazepam half-life)

• Persistent or worsening heartburn
• Difficulty swallowing (dysphagia)
• Painful swallowing (odynophagia)
• Unexplained weight loss
• Black, tarry stools (melena)
• Vomiting blood (hematemesis)
• New or worsening abdominal pain
• Muscle cramps, weakness, tremors (signs of hypomagnesemia)
• Unusual fatigue, pallor, numbness/tingling (signs of B12 deficiency)

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. It should be used during pregnancy only if clearly needed.

Lansoprazole is excreted in human milk. The amount is small, and adverse effects on the infant are unlikely. However, caution should be exercised when lansoprazole is administered to a nursing mother. The Lactation Risk Category is L3 (Moderately Safe).

Approved for use in children 1 year and older for certain indications (GERD, erosive esophagitis). Dosing is weight-based for younger children. Safety and effectiveness in infants younger than 1 year have not been established.

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 increased risk for C. difficile-associated diarrhea and bone fractures.

• Take lansoprazole before the first meal of the day for optimal acid suppression.
• For patients who have difficulty swallowing capsules, lansoprazole is available as an orally disintegrating tablet (ODT) or a delayed-release oral suspension.
• Long-term PPI use (especially >1 year) has been associated with an increased risk of hypomagnesemia, C. difficile infection, and bone fractures (hip, wrist, spine). Periodically assess the need for continued therapy.
• Rebound acid hypersecretion can occur upon discontinuation of PPIs, leading to a return of symptoms. Tapering the dose may be considered for patients on long-term therapy.
• Lansoprazole is less likely to interact with clopidogrel compared to omeprazole, but caution is still advised, especially in patients at high cardiovascular risk.

• H2 Receptor Antagonists (e.g., famotidine, ranitidine [withdrawn], cimetidine)
• Antacids (e.g., Tums, Maalox, Mylanta)
• Prokinetics (e.g., metoclopramide, domperidone [not available in US])
• Sucralfate
• Alginates (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, a patient fact sheet that provides crucial information. Please read it carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate 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. Be prepared to provide detailed information about the incident, including the medication taken, the quantity, and the time it occurred.