Dexilant DR Capsule 30 mg (Dexlansoprazole)

Adult dose

This medicine may be taken with or without food. Swallow this medicine whole. Patients who have difficulty swallowing the medicine may administer it by one of the following methods. 1) Open the capsule and sprinkle the granules onto 1 tablespoon (15 mL) of applesauce, then administer immediately. The granules must not be chewed. 2) Open the capsule and place the granules in a clean container. Mix with 20mL of water, draw the entire mixture into an oral syringe, and gently shake to prevent the granules from settling. Administer the mixture orally immediately. Do not save the water-and-granule mixture for later use. Then add another 10 mL of water to the syringe, gently shake, and administer orally; repeat this process 2 times. 3) Open the capsule and place the granules in a clean container. Mix with 20mL of water, draw the entire mixture into a catheter-tipped syringe, and gently shake to prevent the granules from settling. Immediately administer the mixture into the stomach through a nasogastric tube (≥16 French). Do not save the water-and-granule mixture for later use. Then add another 10 mL of water to the syringe, gently shake, and administer through the nasogastric tube; repeat this process 2 times. 1. Treatment of erosive esophagitis Administer dexlansoprazole 60mg orally once daily for up to 8 weeks. 2. Maintenance of healed erosive esophagitis For adults, administer dexlansoprazole 30mg orally once daily for up to 6 months. 3. Treatment of symptoms associated with symptomatic non-erosive gastroesophageal reflux disease (Non-Erosive Gastroesophageal Reflux Disease) Administer dexlansoprazole 30mg orally once daily for 4 weeks. Patients with hepatic impairment: No dose adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). For patients with moderate hepatic impairment (Child-Pugh Class B), 30mg of this medicine may be considered the maximum daily dose. Clinical studies have not been conducted in patients with severe hepatic impairment (Child-Pugh Class C) (see section '9. Administration to patients with hepatic impairment' under Precautions for Use).

Child dose

Adolescents aged 12 years and older: Maintenance of healed erosive esophagitis: Administer dexlansoprazole 30mg orally once daily for up to 16 weeks.

This drug should not be used in patients who have had allergic reactions to any component of this medication. Severe allergic reactions such as anaphylaxis, angioedema, and bronchospasm may occur. Patients on antiretroviral therapy should not use this drug concurrently as it may reduce the effectiveness of the medications. During treatment with this drug, gastrointestinal symptoms such as diarrhea, abdominal pain, nausea, and vomiting may occur, and rarely, serious skin rash or liver function abnormalities may develop. Long-term use may lead to mineral imbalances such as vitamin B12 deficiency or hypomagnesemia; therefore, monitoring through blood tests may be required, and supplementary treatment may be necessary. Patients with osteoporosis or those at high risk of fractures should exercise caution when taking this drug in high doses for prolonged periods, as it may increase fracture risk. Acute interstitial nephritis may develop, so if any signs of reduced kidney function or allergic symptoms occur, the medication should be discontinued immediately, and a physician consulted. This drug may interact with other medications; therefore, especially when used with digoxin, warfarin, tacrolimus, or methotrexate, monitoring blood levels with a specialist is advised. It should be used cautiously during pregnancy only when necessary, and breastfeeding should be reviewed to consider pausing either the drug or breastfeeding. It is not recommended for children, especially those under 12 years old, as safety and efficacy have not been established. Elderly patients can generally use it safely but should be monitored closely, as some may be more sensitive to the medication. Severe side effects are rare in cases of overdose, but if symptoms occur, immediate medical attention is required. Store this medication out of reach of children, do not transfer it to another container, and avoid using automatic dispensers, as oral tablets can break easily.

Anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria, diarrhea, abdominal pain, nausea, upper respiratory infection, vomiting, abdominal distension, anemia, lymphadenopathy, angina, arrhythmia, bradycardia, chest pain, edema, myocardial infarction, palpitations, tachycardia, ear pain, tinnitus, dizziness, goiter, eye irritation, eye edema, abdominal discomfort, abdominal tenderness, bowel irregularity, anal discomfort, Barrett's esophagus, gastric stones, abnormal bowel sounds, halitosis, microscopic colitis, colonic polyps, constipation, thirst, duodenitis, dyspepsia, dysphagia, enteritis, belching, esophagitis, gastric polyps, gastritis, gastroenteritis, gastrointestinal disturbance, gastrointestinal hypermotility disorder, gastroesophageal reflux disease, gastrointestinal ulcer and perforation, hematemesis, blood in stool, hemorrhoids, gastric emptying failure, irritable bowel syndrome, mucous stools, oral mucosal vesicles, pain during bowel movements, proctitis, oral sensory disturbances, rectal bleeding, nausea, adverse drug reactions, lethargy, chills, paresthesia, inflammation, mucosal inflammation, nodules, pain, fever, biliary colic, cholelithiasis, hepatomegaly, hypersensitivity, Candida infection, influenza, nasopharyngitis, oral herpes simplex, pharyngitis, sinusitis, viral infection, vulvovaginal infection, falls, fractures, joint sprains, overdose, progressive pain, sunburn, increased ALP, increased ALT, increased AST, decreased bilirubin, increased bilirubin, increased serum creatinine, increased serum gastrin, increased blood glucose, increased serum potassium, abnormal liver function tests, decreased platelet count, increased total protein, weight gain, changes in appetite, hypercalcemia, hypokalemia, arthralgia, arthritis, muscle cramps, musculoskeletal pain, myalgia, changes in taste, spasms, dizziness, headache, migraine, memory impairment, sensory disturbances, hyperkinetic behavior, tremors, trigeminal neuralgia, abnormal dreams, anxiety, depression, insomnia, changes in libido, urinary disorders, urgency, dysmenorrhea, dyspareunia, menorrhagia, menstrual disorders, aspiration, asthma, bronchitis, cough, dyspnea, hiccups, hyperventilation, airway congestion, sore throat, acne, dermatitis, erythema, pruritus, rash, skin lesions, urticaria, deep vein thrombosis, facial flushing, hypertension, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, hearing loss, blurred vision, oral edema, pancreatitis, gastric polyps, facial edema, drug-induced hepatitis, anaphylactic shock, exfoliative dermatitis, hypomagnesemia, hyponatremia, hypocalcemia, fractures, cerebrovascular accident, transient ischemic attack, acute renal failure, erectile dysfunction, pharyngeal edema, throat tightness, generalized erythema, hypersensitivity vasculitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia with systemic symptoms drug reaction, acute generalized pustular dermatosis, erythema multiforme, Clostridium difficile-associated diarrhea, systemic lupus erythematosus, cutaneous lupus erythematosus

This medication should be stored in a tightly closed container to prevent air and moisture from entering, preferably in a cool place between 15 to 30 degrees Celsius. This storage method helps maintain the medicine's effectiveness for a longer period.

Appearance

Hard capsule with light blue upper and gray lower part filled with white or light brown granules

Package unit

60 capsules (10 capsules/PTP packaging x 6)/box