SMFRA Tablet 40mg (Esomeprazole Magnesium Trihydrate)

Adult dosage

This medication should be swallowed with liquid such as water and must not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg administered once daily for 4 weeks - If esophagitis is not resolved or symptoms continue, continue for another 4 weeks - Maintenance therapy for prevention of recurrence in esophagitis patients: 20 mg once daily - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is required. · Once symptoms are alleviated, subsequent symptoms can be controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. For patients at high risk of developing gastric and duodenal ulcers due to the use of nonsteroidal anti-inflammatory drugs, it is not recommended to administer as needed for ongoing symptom control. 2) Antibiotic combination therapy for the eradication of Helicobacter pylori Administer 20 mg of this drug in combination with 1 g of amoxicillin and 500 mg of clarithromycin, twice a day for 7 days. 3) Short-term therapy for upper gastrointestinal symptoms (pain, discomfort, burning) associated with the use of nonsteroidal anti-inflammatory drugs (COX-2 non-selective and selective) - 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is required. Clinical trials exceeding 4 weeks have not been conducted. 4) For patients requiring continuous administration of nonsteroidal anti-inflammatory drugs - Treatment of gastric ulcer related to nonsteroidal anti-inflammatory drug use: 20 mg once daily for 4 to 8 weeks. - Prevention of gastric ulcer and duodenal ulcer associated with the use of nonsteroidal anti-inflammatory drugs: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. Subsequent doses should be adjusted based on the patient, and treatment should continue as long as clinical symptoms persist. Based on clinical data, most patients can be controlled at a dosage of 80 to 160 mg daily. Doses exceeding 80 mg should be divided and taken twice daily. 6) Maintenance therapy following intravenous induction for prevention of rebleeding from gastric or duodenal ulcers After intravenous induction for prevention of rebleeding from gastric or duodenal ulcers, administer 40 mg once daily for 4 weeks. 2. Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg administered once daily for 4 weeks. If esophagitis is not treated or symptoms persist, continue for another 4 weeks. - Symptomatic treatment for gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further medical attention is necessary. · Once symptoms are alleviated, continuous symptoms can be controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. For patients at high risk of developing gastric and duodenal ulcers due to the use of nonsteroidal anti-inflammatory drugs, it is not recommended to administer as needed for ongoing symptom control. 3. Children under 12 years There is no experience in administering this drug to children under 12 years. 4. Renal impairment No dosage adjustment is necessary. Caution should be exercised as there are not many cases in patients with severe renal failure. 5. Hepatic impairment No dosage adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the dosage should not exceed 20 mg. 6. Elderly No dosage adjustment is necessary.

Children's dosage

Adolescents aged 12 years and older 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive reflux esophagitis: 40 mg administered once daily for 4 weeks - If esophagitis is not treated or symptoms persist, continue for another 4 weeks.

This medicine should not be used in certain patients. For example, patients with allergies to this drug, its ingredients, or benzimidazole class drugs, or those who have previously had such reactions should not take this medicine. Also, it should not be administered in combination with amoxicillin or clarithromycin for Helicobacter pylori eradication therapy if there is an allergy to these antibiotics. Patients with specific heart conditions or those who are breastfeeding should not use this medication. During the use of this medication, various adverse reactions may occur, including gastrointestinal symptoms such as headache, abdominal pain, diarrhea, nausea, and vomiting, as well as skin rash, itching, and rarely severe hypersensitivity reactions or blood abnormalities. Long-term use may cause electrolyte abnormalities such as hypomagnesemia, so regular monitoring is necessary. Furthermore, this drug can interact with other medications, so if you are taking other medications, you must inform your doctor or pharmacist. Caution is especially needed when used with antiviral agents, antibiotics, or blood coagulation inhibitors. The safety of this medication during pregnancy has not been fully established, so pregnant women should consult a doctor before taking it. If breastfeeding, it is advisable not to take this medicine as it may be excreted in breast milk. In case of overdose, there is no specific antidote, so it is important to receive treatment based on symptoms, and it should be stored out of reach of children.

Serious side effects

Urticaria, angioedema, anaphylaxis, shock, hypomagnesemia (severe), hypocalcemia, hypokalemia, mental confusion, aggressiveness, hallucinations, pancreatitis, hepatitis, jaundice, liver failure, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms (DRESS syndrome), interstitial nephritis, rhabdomyolysis, severe allergic reactions, severe skin adverse reactions

Mild side effects

Headache, dizziness, paresthesia, drowsiness, taste disturbance, blurred vision, bronchospasm, abdominal pain, constipation, diarrhea, abdominal distention, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, increased liver enzymes, hepatitis, dermatitis, itching, rash, hair loss, photosensitivity, fractures, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, allergic reactions, back pain, chest pain

This medication may be sensitive to air and moisture, so it should be stored in a sealed container. Furthermore, it is important to maintain a cool room temperature between 1 to 30 degrees Celsius when storing the medication. This will help maintain the efficacy and safety of the medication for a long time.

Appearance

Pink, rectangular film-coated tablets

Package unit

14 tablets (7 tablets/ Alu-Alu x 2)