Dexlansoprazole 30mg DR Capsules

Dexlansoprazole 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 the R-enantiomer of lansoprazole.

Urgent Side Effects: Seek Medical Attention Immediately

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 help right away:

Allergic Reaction: 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, or swelling of the mouth, face, lips, tongue, or throat.
Electrolyte Imbalance: Mood changes, confusion, muscle pain, cramps, or spasms, weakness, shakiness, balance problems, abnormal heartbeat, seizures, loss of appetite, or severe nausea and vomiting.
Kidney Problems: Inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Dizziness or Fainting
Rapid Heartbeat
Bone Pain
Lupus: If you have lupus, inform your doctor. Be aware of symptoms like a rash on the cheeks or other body parts, skin color changes, easy sunburn, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
C. diff-associated Diarrhea (CDAD): Severe diarrhea can occur. If you experience stomach pain, cramps, very loose or watery stools, or bloody stools, contact your doctor immediately. Do not attempt to treat diarrhea without consulting your doctor.
Severe Skin Reactions: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious reactions can occur, potentially affecting internal organs. Seek medical help immediately if you notice red, swollen, blistered, or peeling skin; red or irritated eyes; sores in your mouth, throat, nose, eyes, genitals, or skin; fever; chills; body aches; shortness of breath; or swollen glands.

Other Possible Side Effects

Most people do not experience severe side effects, but some may occur. If you notice any of the following symptoms or if they persist or bother you, contact your doctor:

Stomach pain or diarrhea
Nausea and vomiting
Common cold symptoms
Gas
Headache
* Nose or throat irritation

This is not an exhaustive list of potential side effects. If you have questions or concerns, consult 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. Describe the allergic reaction you experienced, including the symptoms that occurred.
If you have liver disease, as this may affect the way your body processes the medication.
If you are currently taking any of the following medications:
+ Atazanavir
+ Methotrexate
+ Nelfinavir
+ Rilpivirine
+ Warfarin
If you are taking either of the following medications:
+ Rifampin
+ St. John's wort
If the patient is a child under 12 years of age, as this medication is not approved for use in this age group. Additionally, do not administer this medication to children under 2 years of age.

Please note that this is not an exhaustive list of all potential interactions. Therefore, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including:

Prescription medications
Over-the-counter (OTC) medications
Natural products
* Vitamins

Additionally, share any health problems you have, as this information will help your doctor determine whether it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This is crucial because it may affect the results of certain laboratory tests. Be sure to notify all your healthcare providers and laboratory personnel that you are taking this drug.

If you experience any of the following symptoms, contact your doctor immediately: throat pain, chest pain, severe abdominal pain, difficulty swallowing, or signs of a bleeding ulcer, such as black, tarry, or bloody stools, vomiting blood, or coffee ground-like vomit. These symptoms may indicate a more serious health issue.

Do not take this medication for a longer period than prescribed by your doctor. Prolonged use can increase the risk of fractures in the hip, spine, and wrist, particularly in individuals with osteoporosis (weak bones). This risk may be higher if you take high doses of this medication, use it for more than a year, or are over 50 years old.

If you have risk factors for osteoporosis, such as a history of alcohol consumption, smoking, steroid use, seizure medication, or a family history of osteoporosis, exercise caution and discuss your risks with your doctor.

Long-term use of this medication (typically more than three months) may lead to rare but potentially serious side effects. For instance, it may cause low magnesium levels, which can occur after one year of treatment and may lead to other electrolyte problems. Your doctor may recommend regular blood tests to monitor your magnesium levels.

Additionally, long-term treatment with this medication (usually more than three years) may cause low vitamin B-12 levels. Be aware of the signs of low vitamin B-12 levels, which include shortness of breath, dizziness, abnormal heartbeat, muscle weakness, pale skin, fatigue, mood changes, or numbness or tingling in the arms or legs. If you experience any of these symptoms, contact your doctor promptly.

Taking this medication for more than a year may increase the risk of developing stomach growths called fundic gland polyps. If you have concerns, discuss them with your doctor.

This medication may harm an unborn baby if taken during pregnancy. If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately.

If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.

• Rilpivirine (due to significant reduction in rilpivirine exposure)

• Clopidogrel (reduced antiplatelet effect)
• Methotrexate (increased methotrexate levels, potential toxicity)
• Atazanavir (reduced atazanavir exposure)
• Nelfinavir (reduced nelfinavir exposure)
• Erlotinib (reduced erlotinib exposure)
• Dasatinib (reduced dasatinib exposure)
• Nilotinib (reduced nilotinib exposure)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)

• Digoxin (increased digoxin absorption)
• Iron salts (reduced iron absorption)
• Ketoconazole (reduced ketoconazole absorption)
• Itraconazole (reduced itraconazole absorption)
• Tacrolimus (increased tacrolimus levels)
• Warfarin (potential for increased INR/bleeding, monitor closely)
• CYP2C19 inhibitors (e.g., fluvoxamine, voriconazole - may increase dexlansoprazole exposure)
• CYP3A4 inducers (e.g., rifampin, St. John's Wort - may decrease dexlansoprazole exposure)

• Sucralfate (may delay absorption of dexlansoprazole, administer at least 30 minutes apart)

• Persistent or worsening heartburn/acid reflux
• Difficulty swallowing (dysphagia)
• Painful swallowing (odynophagia)
• Unexplained weight loss
• Black, tarry stools (melena) or vomiting blood (hematemesis)
• New or worsening abdominal pain
• Persistent diarrhea (especially watery diarrhea, fever, abdominal cramps - C. difficile infection)
• Signs of hypomagnesemia (fatigue, muscle twitching, tremors, seizures, irregular heart beat)
• Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)

Dexlansoprazole is Pregnancy Category B. Animal studies have not shown harm to the fetus. Limited human data suggest low risk, but use only if clearly needed.

Lactation Risk L3 (Moderately Safe). It is unknown if dexlansoprazole is excreted in human milk. Animal studies show excretion in milk. Use with caution, weighing potential benefits to mother against potential risks to infant.

Approved for children aged 1 to 17 years for specific indications (EE healing, maintenance of EE healing, non-erosive GERD). Dosing is weight-based for younger children with EE. Safety and effectiveness not established in children younger than 1 year.

No overall differences in safety or effectiveness were observed between elderly and younger patients. However, elderly patients may have reduced hepatic function or concomitant diseases, increasing the risk of adverse effects (e.g., C. difficile infection, bone fractures, hypomagnesemia). Use with caution and monitor for adverse effects.

• Dexlansoprazole's unique dual delayed-release formulation allows for flexible dosing, as it can be taken with or without food, and at any time of day, unlike some other PPIs.
• The dual release mechanism may provide more consistent acid suppression over 24 hours compared to single-release PPIs.
• Less susceptible to variability due to CYP2C19 genetic polymorphisms compared to other PPIs, which can be beneficial for patients who are poor metabolizers of CYP2C19.
• For patients who have difficulty swallowing capsules, the capsule can be opened and the granules sprinkled on applesauce, which should be swallowed immediately without chewing.
• Long-term PPI use (especially >1 year) has been associated with an increased risk of bone fractures, C. difficile infection, and hypomagnesemia. Periodically re-evaluate the need for continued therapy.

• Other Proton Pump Inhibitors (PPIs): Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole
• H2 Receptor Blockers (H2RAs): Famotidine, Cimetidine, Nizatidine
• Antacids (e.g., calcium carbonate, aluminum hydroxide/magnesium hydroxide)
• Prokinetics (e.g., metoclopramide - for specific motility issues)
• Surgery (e.g., Nissen fundoplication for severe GERD refractory to medical therapy)

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 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 amount, and the time it occurred.