Medication info
Apsito Tablet 20 mg (Fexuprazan Hydrochloride)

Apsito Tablet 20 mg (Fexuprazan Hydrochloride)

Prescription medicationTabletOral
Ingredient · strength
Fexuprazan Hydrochloride›20mg / 1 tablet
Manufacturer / importer
Hanol BioPharma Co., Ltd.
Appearance
Pale yellow rectangular film-coated tablet
Packaging
28 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle, 28 tablets/box [7 tablets/PTPx4]
Approval status
Active

MFDS item code 202501242 · Approved 2025.05.20 · Insurance code 655605680

Summary

Main use
Prevention of nonsteroidal anti-inflammatory drug-induced peptic ulcers
Who takes it
Adults
Adult dose
Prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers (gastric and duodenal ulcers) Administer 20mg orally once daily for 24 weeks. The duration of the comparative clinical trial did not exceed 24 weeks. This medicine may be administered without regard to meals.

Ingredients

Manufacturer
Hanol BioPharma Co., Ltd.

Efficacy & effects

Prevention of nonsteroidal anti-inflammatory drug-induced peptic ulcers

  • Peptic ulcers
  • gastric ulcers
  • duodenal ulcers
View approved original text

This medication helps prevent peptic ulcers such as gastric ulcers or duodenal ulcers that may occur due to the use of non-steroidal anti-inflammatory drugs (NSAIDs). It is used for patients taking NSAIDs to reduce the risk of ulcer occurrence and to protect gastrointestinal health.

How to take

Adult dose

Prevention of nonsteroidal anti-inflammatory drug (NSAID)-induced peptic ulcers (gastric and duodenal ulcers) Administer 20mg orally once daily for 24 weeks. The duration of the comparative clinical trial did not exceed 24 weeks. This medicine may be administered without regard to meals.

Precautions

This medication should not be used in patients with allergic reactions or those who have been sensitive to any of its ingredients in the past. Additionally, patients taking certain antiviral medications and pregnant or breastfeeding women should avoid this medication. Patients with genetic metabolic disorders such as lactose intolerance should also avoid this medication. Special caution is required when this medication is used in patients with poor liver or kidney function. Elderly patients should be cautious when taking this medication due to diminished bodily functions. Patients should be aware that side effects such as gastrointestinal disturbances, diarrhea, and abdominal pain may occur while taking this medication. The risk of osteoporosis may increase with long-term use, so the medication should be taken at the minimum dose for the necessary duration. Regular blood tests may be needed if magnesium levels decrease due to long-term use or use alongside certain medications. This medication reduces gastric acid, which may slightly increase the risk of bacterial infections in the stomach, so if diarrhea persists, medical consultation should be sought. It is used for the prevention of gastric ulcers in patients taking non-steroidal anti-inflammatory drugs (NSAIDs), and gastric conditions must be verified before administration. This medication may interact with other drugs, so any medications currently being taken should be disclosed. Pregnant and breastfeeding women should avoid this medication, as its safety during pregnancy has not been confirmed. Safety for children and adolescents has not been established, so its use is not recommended. This medication should be kept out of reach of children, and transferring it to another container may affect its quality.

Side effects

  • Dyspepsia
  • diarrhea
  • erosive gastritis
  • upper abdominal pain
  • nausea
  • abdominal discomfort
  • vomiting
  • abdominal distension
  • constipation
  • enteritis
Show 73 more
  • abdominal pain
  • gastroesophageal reflux disease
  • hypergastrinemia
  • esophagitis
  • dry mouth
  • bloating
  • colon polyps
  • superior mesenteric artery dissection
  • COVID-19
  • nasopharyngitis
  • shingles
  • influenza
  • cystitis
  • acute pyelonephritis
  • coronavirus infection
  • gastroenteritis
  • paronychia
  • tinea
  • upper respiratory infection
  • arthralgia
  • joint swelling
  • limb pain
  • rheumatoid arthritis
  • arthritis
  • chondropathy
  • muscle weakness
  • myofascial pain syndrome
  • osteoarthritis
  • tendinitis
  • increased blood gastrin
  • increased alanine aminotransferase
  • increased aspartate aminotransferase
  • increased blood creatine phosphokinase
  • increased blood triglycerides
  • prolonged QT on electrocardiogram
  • urticaria
  • dermoid cyst
  • eczema
  • psoriasis
  • rash
  • chest pain
  • peripheral edema
  • catheter site pain
  • inflammation
  • fever
  • foreign body sensation
  • cough
  • oropharyngeal pain
  • idiopathic pulmonary fibrosis
  • pneumothorax
  • pulmonary mass
  • laryngopharyngeal reflux
  • contusion
  • ligament sprain
  • epicondylitis
  • lower limb fracture
  • meniscus injury
  • procedure-related pain
  • chronic kidney disease
  • hypertension
  • atherosclerosis
  • hypertensive crisis
  • neutropenia
  • thrombocytopenia
  • sleep disturbances
  • allergic conjunctivitis
  • dyslipidemia
  • hypertriglyceridemia
  • autoimmune hepatitis
  • acute hepatitis
  • abnormal uterine bleeding
  • thyroid cyst
  • tinnitus

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain a storage temperature between 1 to 30 degrees Celsius at room temperature. This will help preserve the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Pale yellow rectangular film-coated tablet

Package unit

28 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle, 28 tablets/box [7 tablets/PTPx4]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.