Dexirazole Capsule 30 Milligrams (Dexlansoprazole)

Adult dose

This medicine may be taken without regard to meals. Swallow this medicine whole. For patients who have difficulty swallowing the medicine, administer it using one of the following methods. 1) Open the capsule, sprinkle the granules onto 1 tablespoon (15 mL) of applesauce, and administer immediately. The granules must not be chewed. 2) Open the capsule, place the granules in a clean container, and mix with 20mL of water. Draw the entire mixture into an oral syringe and gently shake to prevent the granules from settling, then administer the mixture orally immediately. Do not save the water and granule mixture for later use. Add another 10 mL of water to the syringe, gently shake, and administer orally; repeat this process 2 times. 3) Open the capsule, place the granules in a clean container, and mix with 20mL of water. Draw the entire mixture into a syringe with a catheter and gently shake to prevent the granules from settling, then administer the mixture immediately into the stomach through a nasogastric tube (≥16 French). Do not save the water and granule mixture for later use. 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 healing of erosive esophagitis 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 dosage adjustment is necessary for 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. No clinical studies have been conducted in patients with severe hepatic impairment (Child-Pugh Class C) (see Precautions for Use, section ‘9. Administration to Patients with Hepatic Impairment’).

Child dose

Adolescents aged 12 years and older, treatment of erosive esophagitis: Administer dexlansoprazole 60mg orally once daily for up to 8 weeks. Adolescents aged 12 years and older, maintenance of healing of erosive esophagitis: Administer dexlansoprazole 30mg orally once daily for up to 16 weeks. Adolescents aged 12 years and older, 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.

This medication should not be administered to patients with a history of allergic reactions or hypersensitivity to any components of this drug. Patients who have experienced acute interstitial nephritis after using proton pump inhibitors similar to this drug should exercise caution. Additionally, patients taking antiretroviral medications should not use this drug in combination. This medication contains the dye Yellow No. 5; therefore, patients with allergies or hypersensitivity to this component should use it with caution. In clinical trials, patients taking this medication reported side effects such as diarrhea, abdominal pain, nausea, upper respiratory infections, vomiting, and abdominal bloating. It is important to consult with healthcare professionals if these symptoms occur. Long-term use of this medication, especially beyond 3 months, may lead to hypomagnesemia, a condition characterized by low magnesium levels in the blood; therefore, regular blood tests may be necessary. As this drug suppresses gastric acid secretion, it may slightly increase the risk of gastrointestinal bacterial infections; if diarrhea persists or worsens, immediate consultation with healthcare professionals is advised. During pregnancy, this medication should only be used when deemed necessary, and in cases of breastfeeding, a decision should be made regarding whether to stop breastfeeding based on the benefits and risks of the medication. It is recommended not to use this medication in children, especially those under 12 years of age, as safety and efficacy have not been established. There is no need for special dosage adjustments in the elderly; however, some elderly individuals may be more sensitive to this medication, so caution is advised. Patients with impaired kidney function also do not require special dosage adjustments. Patients with moderate or severe liver dysfunction may require dosage adjustments, which should be discussed with a physician. There may be interactions with other medications while taking this drug, so it is crucial to inform healthcare professionals when taking medications such as iron supplements, antifungals, antiretrovirals, warfarin, tacrolimus, and methotrexate. If a dose is missed, take it as soon as possible; however, if the next dose is near, skip the missed dose and be careful not to double dose. Long-term or excessive use of this drug may lead to side effects; thus, it is essential to comply with the prescribed dosage and duration by a physician. Finally, store this medication out of reach of children, do not transfer it to another container, and avoid using automatic dispensers.

Hypersensitivity reaction, anaphylaxis, acute interstitial nephritis, diarrhea, abdominal pain, nausea, upper respiratory tract infection, vomiting, bloating, anemia, lymphadenopathy, angina, arrhythmia, bradycardia, chest pain, edema, myocardial infarction, palpitations, tachycardia, ear pain, tinnitus, dizziness, thyroid enlargement, eye irritation, eyelid edema, abdominal discomfort, abdominal tenderness, abnormal bowel movement, anal discomfort, Barrett's esophagus, gastric stones, abnormal bowel sounds, bad breath, microscopic colitis, colorectal polyp, constipation, dry mouth, duodenitis, dyspepsia, dysphagia, enteritis, belching, esophagitis, gastric polyp, gastritis, gastroenteritis, gastrointestinal disorder, gastrointestinal hypermotility disorder, gastroesophageal reflux disease, gastrointestinal ulcers and perforation, hematemesis, melena, hemorrhoids, gastroparesis, irritable bowel syndrome, mucous stools, oral mucosal vesicles, pain during bowel movements, proctitis, oral paresthesia, rectal bleeding, nausea, adverse drug reaction, fatigue, abnormal sensation, inflammation, mucosal inflammation, nodules, pain, fever, biliary colic, cholelithiasis, hepatomegaly, hypersensitivity, Candida infection, influenza, nasopharyngitis, oral herpes simplex, pharyngitis, sinusitis, viral infection, vulvar infection, falls, fractures, joint sprains, overdose, progressive pain, sunburn, increased ALP, increased ALT, increased AST, decreased bilirubin, increased bilirubin, increased blood creatinine, increased blood gastrin, increased blood glucose, increased blood 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, taste changes, spasms, dizziness, headache, migraine, memory impairment, sensory abnormalities, psychomotor agitation, tremors, trigeminal neuralgia, abnormal dreams, anxiety, depression, insomnia, changes in libido, urinary disorders, urgency, dysmenorrhea, dyspareunia, heavy menstrual bleeding, menstrual disorders, aspiration, asthma, bronchitis, cough, dyspnea, hiccups, hyperventilation, airway congestion, pharyngitis, acne, dermatitis, erythema, itching, rash, skin lesions, urticaria, deep vein thrombosis, facial flushing, hypertension, anaphylaxis, auditory hallucinations, B-cell lymphoma, bursitis, central obesity, acute cholecystitis, dehydration, diabetes, speech disorders, epistaxis, folliculitis, gout, herpes zoster, hyperlipidemia, hypothyroidism, neutrophilia, decreased mean corpuscular hemoglobin concentration, neutropenia, anal drooping, restless legs syndrome, drowsiness, tonsillitis, headache, nasopharyngitis, oropharyngeal pain, autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, hearing loss, blurred vision, oral edema, pancreatitis, facial edema, drug-induced hepatitis, anaphylactic shock, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, hypomagnesemia, hyponatremia, fractures, cerebrovascular accident, transient ischemic attack, acute renal failure, pharyngeal edema, throat tightness, generalized erythema, hypersensitivity vasculitis, eosinophilia with systemic symptoms drug reaction, Clostridium difficile-associated diarrhea, systemic lupus erythematosus, cutaneous lupus erythematosus

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to keep it in a cool place between 15 and 30 degrees Celsius.

Appearance

A hard capsule with a blue upper part and gray lower part filled with white to light yellow spherical granules.

Package unit

28 capsules (7 capsules/PTP packaging x 4 pieces)