Dexlansoprazole 60mg 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. By acting specifically on the proton pump, dexlansoprazole blocks the final step of acid production.

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 experience 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, change in balance, abnormal heartbeat, seizures, loss of appetite, or severe upset stomach or vomiting.
Kidney Problems: Inability to pass urine, change in urine output, blood in the urine, or significant weight gain.
Dizziness or Fainting
Rapid Heartbeat
Bone Pain
Lupus: If you have a history of lupus, inform your doctor. Be aware of symptoms like a rash on the cheeks or other body parts, change in skin color, 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. Contact your doctor immediately if you experience stomach pain or cramps, very loose or watery stools, or bloody stools. 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 experience 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 experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:

Stomach pain or diarrhea
Upset stomach or vomiting
Common cold symptoms
Gas
Headache
* Nose or throat irritation

This is not an exhaustive list of possible side effects. If you have concerns or questions, 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.
If you have liver disease, as this may affect the medication's safety and efficacy.
If you are currently taking any of the following medications:
+ Atazanavir
+ Methotrexate
+ Nelfinavir
+ Rilpivirine
+ Warfarin
If you are taking Rifampin or St. John's wort, as these may interact with the medication.
* 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 potential interactions. It is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure your safety while taking this medication.

Remember, before starting, stopping, or changing the dose of any medication, you must consult with your doctor to confirm it is safe to do so in conjunction with this medication and your individual health profile.

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 vomit that resembles coffee grounds. These symptoms may indicate a more serious health issue.

Do not take this medication for a longer period than prescribed by your doctor. Long-term use of this drug may increase the risk of fractures in the hip, spine, and wrist, particularly in individuals with osteoporosis (weak bones). The risk of fractures may be higher if you take this medication in high doses or for more than a year, or if you 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 when taking this medication. Discuss your individual risk factors with your doctor to determine the best course of action.

Prolonged use of this medication (typically more than three months) may lead to rare but potentially serious side effects, including low magnesium levels. Most cases of low magnesium levels occur after one year of treatment. Low magnesium levels can cause other electrolyte imbalances, and your doctor may recommend regular blood tests to monitor your levels.

Long-term treatment with this medication (usually more than three years) may also cause low vitamin B-12 levels. Be aware of the symptoms 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 and legs. If you experience any of these symptoms, contact your doctor promptly.

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

If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby. Additionally, if you are breastfeeding, inform your doctor to discuss any potential risks to your baby.

• Clopidogrel (reduced antiplatelet effect)
• Methotrexate (increased methotrexate levels)
• Nelfinavir, Atazanavir (reduced antiviral efficacy)
• Erlotinib, Dasatinib, Nilotinib (reduced absorption)

• Warfarin (potential for increased INR)
• Digoxin (increased digoxin absorption)
• Iron salts (reduced iron absorption)
• Ketoconazole, Itraconazole (reduced antifungal absorption)
• Mycophenolate mofetil (reduced mycophenolic acid exposure)
• Tacrolimus (increased tacrolimus levels)
• Citalopram (potential for QT prolongation, though less significant than with omeprazole)

• Vitamin B12 (long-term use may lead to deficiency)
• Calcium salts (reduced absorption)

• Heartburn
• Acid regurgitation
• Dysphagia
• Chest pain (non-cardiac)
• Abdominal pain
• Nausea
• Diarrhea
• Headache
• Signs of hypomagnesemia (e.g., muscle cramps, arrhythmias, seizures)
• Signs of B12 deficiency (e.g., fatigue, paresthesias)

Limited data on dexlansoprazole use in pregnant women are insufficient to inform a drug-associated risk of major birth defects or miscarriage. Animal studies have shown no evidence of harm to the fetus. Use only if clearly needed and the potential benefit outweighs the potential risk to the fetus.

It is unknown if dexlansoprazole is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Other PPIs are considered compatible with breastfeeding.

Approved for adolescents aged 12 to 17 years for healing of erosive esophagitis and treatment of non-erosive GERD. Safety and effectiveness in pediatric patients younger than 12 years have not been established.

No overall differences in safety or effectiveness were observed between elderly and younger patients. No dosage adjustment is necessary based solely on age. However, elderly patients may be more susceptible to certain adverse effects (e.g., bone fractures, C. difficile infection) and may have comorbidities or polypharmacy requiring careful consideration.

• Dexlansoprazole's dual delayed-release formulation allows for flexible dosing, as it can be taken without regard to meals, unlike some other PPIs.
• It is the R-enantiomer of lansoprazole, offering similar efficacy with potentially improved pharmacokinetic properties for some patients.
• 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 concomitant PPIs due to potential reduction in clopidogrel's antiplatelet effect, particularly with omeprazole and esomeprazole. Dexlansoprazole's interaction with clopidogrel is considered less significant than omeprazole/esomeprazole, but caution is still advised.
• Consider vitamin B12 supplementation for patients on long-term PPI therapy (e.g., >3 years) due to potential malabsorption.
• For patients with moderate hepatic impairment (Child-Pugh Class B), a dose reduction to 30 mg once daily is recommended.

• Other Proton Pump Inhibitors (PPIs): Omeprazole, Esomeprazole, Lansoprazole, Pantoprazole, Rabeprazole
• H2 Receptor Blockers (H2RAs): Famotidine, Ranitidine (withdrawn in some regions), Cimetidine, Nizatidine
• Antacids (e.g., calcium carbonate, aluminum hydroxide/magnesium hydroxide)
• Prokinetics (e.g., Metoclopramide - for specific motility disorders)
• Sucralfate (for mucosal protection)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. This medication is accompanied by a Medication Guide, which is a crucial resource for patients. Please read this guide carefully and review it again whenever your prescription is refilled. 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 detailed information, including the substance taken, the quantity, and the time it occurred.