MedCallyLooking up the FDA label…
Looking up the FDA label…
Proton Pump Inhibitor
Also sold as Dexlansoprazole delayed release, Dexilant
Dexlansoprazole delayed-release capsules are a proton pump inhibitor (PPI) indicated in patients 12 years of age and older for: • Healing of all grades of erosive esophagitis (EE). • Maintenance of healed EE and relief of heartburn. • Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). 1.1 Healing of Erosive Esophagitis Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for healing of all grades of erosive esophagitis (EE) for up to eight weeks. 1.2 Maintenance of Healed Erosive Esophagitis and Relief of Heartburn Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older to maintain healing of EE and relief of heartburn for up to six months in adults and 16 weeks in patients 12 to 17 years of age. 1.3 Treatment of Symptomatic Non-Erosive Gastroesophageal Reflux Disease Dexlansoprazole delayed-release capsules are indicated in patients 12 years of age and older for the treatment of heartburn associated with symptomatic non-erosive gastroesophageal reflux disease (GERD) for four weeks.
Advise the patient to read the FDA-approved patient labeling (Medication Guide and Instructions for Use). Adverse Reactions Advise patients to report to their healthcare provider if they experience any signs or symptoms consistent with: • Hypersensitivity Reactions • Acute Tubulointerstitial Nephritis • Clostridium difficile -Associated Diarrhea • Bone Fracture • Severe Cutaneous Adverse Reactions • Cutaneous and Systemic Lupus Erythematosus • Cyanocobalamin (Vitamin B12) Deficiency • Hypomagnesemia and Mineral Metabolism Drug Interactions Advise patients to report to their healthcare provider if they are taking rilpivirine-containing products or high-dose methotrexate. Pregnancy Advise a pregnant woman of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy. Administration • Take without regard to food. • Missed doses: If a dose is missed, administer as soon as possible. However, if the next scheduled dose is due, do not take the missed dose, and take the next dose on time. Do not take two doses at one time to make up for a missed dose. • Swallow whole; do not chew. • Can be opened and sprinkled on applesauce for patients who have trouble swallowing the capsule. • Alternatively, the capsule can be administered with water via oral syringe or NG tube, as described in the Instructions for Use. Manufactured by: Alembic Pharmaceuticals Limited Formulations Division IV, Jarod 391510, Gujarat, India Revised: 03/2025
The following serious adverse reactions are described below and elsewhere in labeling: • Acute Tubulointerstitial Nephritis • Clostridium difficile -Associated Diarrhea • Bone Fracture • Severe Cutaneous Adverse Reactions • Cutaneous and Systemic Lupus Erythematosus • Cyanocobalamin (Vitamin B12) Deficiency • Hypomagnesemia and Mineral Metabolism • Fundic Gland Polyps • Risk of Heart Valve Thickening in Pediatric Patients Less than Two Years of Age The most common adverse reactions are: • Adults (≥2%): diarrhea, ab…
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Ask a doctor — $19.994 CONTRAINDICATIONS • Dexlansoprazole delayed-release capsules are contraindicated in patients with known hypersensitivity to any component of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis and urticaria. • PPIs, including dexlansoprazole delayed-release capsules, are contraindicated with rilpivirine-containing products. • Patients with known hypersensitivity to any component of the formulation. • Patients receivi…
Recommended dosage in patients 12 years of age and older: • See full prescribing information for complete dosing information for dexlansoprazole delayed-release capsules by indication and age group and dosage adjustment in patients with hepatic impairment. Administration Instructions: • Take without regard to food. • Swallow whole; do not chew. • See full prescribing information for alternative administration options. 2.1 Recommended Dosage in Patients 12 Years of Age and Older Table 1. Recommended Dexlansoprazole…
Tables 3 and 4 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with dexlansoprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 3. Clinically Relevant Interactions Affecting Drugs Coadministered with Dexlansoprazole and Interactions with Diagnostics Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drug…
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Interaction warnings are written per drug, not for your particular combination. A doctor can check yours.
Ask about my combinationSame medicine, sold as
Works in a similar way — proton pump inhibitors
These are different medicines in the same family, not swaps for each other. Which one suits you is a prescribing decision.