Medication info
Esomeprazole Magnesium Trihydrate 40 mg Tablet

Esomeprazole Magnesium Trihydrate 40 mg Tablet

Prescription medicationTabletOral · Intravenous injection
Ingredient · strength
Esomeprazole Magnesium Trihydrate (Micronized)›44.5mg / 1 tablet
Manufacturer / importer
Celltrion Pharmaceutical Co., Ltd.
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets x 2 PTP)
Approval status
Active

MFDS item code 201507815 · Approved 2015.11.23 · Insurance code 693901940

Summary

Main use
Treatment of gastrointestinal disorders (reflux, ulcers, etc.), Helicobacter pylori eradication, and Zollinger-Ellison syndrome
Who uses it
Adults · Children
Adult dosage
1) Gastroesophageal reflux disease (GERD). - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis is not healed or symptoms persist, continue treatment for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. · Once symptoms have resolved, subsequent recurring symptoms may be controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurring symptoms is not recommended for patients at high risk of developing gastric or duodenal ulcers due to nonsteroidal anti-inflammatory drug use. 2) Combination therapy with antibiotics for Helicobacter pylori eradication Administer this medicine 20 mg in combination with amoxicillin 1 g and clarithromycin 500 mg twice daily for 7 days. 3) Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, heartburn) associated with use of nonsteroidal anti-inflammatory drugs (nonselective or selective COX-2 inhibitors) - 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. Clinical studies lasting more than 4 weeks have not been conducted. 4) Patients requiring continued nonsteroidal anti-inflammatory drug therapy - Treatment of gastric ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. The treatment period is 4∼8 weeks. - Prevention of gastric and duodenal ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. The dose should be adjusted for each patient, and treatment should be continued while clinical symptoms are present. Clinical data indicate that most patients can be controlled with doses of 80 ∼ 160 mg per day. Doses greater than 80 mg per day should be divided and taken twice daily. 6) Maintenance therapy following induction of prevention of rebleeding from gastric or duodenal ulcers with intravenous administration Administer 40 mg once daily for 4 weeks following induction of prevention of rebleeding from gastric or duodenal ulcers with intravenous administration. 4. Renal impairment No dose adjustment is necessary. Use with caution because there is limited experience with administration to patients with severe renal impairment. 5. Hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the dose of this medicine should not exceed 20 mg. 6. Older adults No dose adjustment is necessary.
Children's dosage
Adolescents 12 years of age and older - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis is not healed or symptoms persist, continue treatment for an additional 4 weeks. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. · Once symptoms have resolved, subsequent recurring symptoms may be controlled by administering 20 mg once daily. Children under 12 years of age There is no experience with administration of this medicine to children under 12 years of age.

Ingredients

Manufacturer
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of gastrointestinal disorders (reflux, ulcers, etc.), Helicobacter pylori eradication, and Zollinger-Ellison syndrome

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • duodenal ulcer
  • peptic ulcer
  • upper gastrointestinal symptoms
  • pain
  • discomfort
  • burning sensation
  • gastric ulcer
  • duodenal ulcer
  • Zollinger-Ellison syndrome
View approved original text

This medicine is used for long-term maintenance therapy to treat gastroesophageal reflux disease, especially erosive esophagitis, and to prevent the recurrence of esophagitis. It is also effective in the treatment and prevention of recurrence of duodenal and peptic ulcers caused by Helicobacter pylori infection. It is utilized as a short-term therapy for the treatment of upper gastrointestinal symptoms (pain, discomfort, burning sensation) associated with the use of non-steroidal anti-inflammatory drugs. It helps in the treatment of gastric ulcers in patients requiring continuous use of non-steroidal anti-inflammatory drugs and prevents gastric and duodenal ulcers. It is also used for maintenance therapy to prevent rebleeding in gastric ulcers or duodenal ulcers and in the treatment of Zollinger-Ellison syndrome. Thus, it is effectively used for the treatment and prevention of various gastrointestinal diseases.

Dosage and Administration

Adult dosage

1) Gastroesophageal reflux disease (GERD). - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis is not healed or symptoms persist, continue treatment for an additional 4 weeks. - Long-term maintenance therapy to prevent recurrence in patients with esophagitis: 20 mg once daily - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. · Once symptoms have resolved, subsequent recurring symptoms may be controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurring symptoms is not recommended for patients at high risk of developing gastric or duodenal ulcers due to nonsteroidal anti-inflammatory drug use. 2) Combination therapy with antibiotics for Helicobacter pylori eradication Administer this medicine 20 mg in combination with amoxicillin 1 g and clarithromycin 500 mg twice daily for 7 days. 3) Short-term treatment of upper gastrointestinal symptoms (pain, discomfort, heartburn) associated with use of nonsteroidal anti-inflammatory drugs (nonselective or selective COX-2 inhibitors) - 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. Clinical studies lasting more than 4 weeks have not been conducted. 4) Patients requiring continued nonsteroidal anti-inflammatory drug therapy - Treatment of gastric ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. The treatment period is 4∼8 weeks. - Prevention of gastric and duodenal ulcers associated with nonsteroidal anti-inflammatory drug use: 20 mg once daily. 5) Treatment of Zollinger-Ellison syndrome The recommended initial dose is 40 mg twice daily. The dose should be adjusted for each patient, and treatment should be continued while clinical symptoms are present. Clinical data indicate that most patients can be controlled with doses of 80 ∼ 160 mg per day. Doses greater than 80 mg per day should be divided and taken twice daily. 6) Maintenance therapy following induction of prevention of rebleeding from gastric or duodenal ulcers with intravenous administration Administer 40 mg once daily for 4 weeks following induction of prevention of rebleeding from gastric or duodenal ulcers with intravenous administration. 4. Renal impairment No dose adjustment is necessary. Use with caution because there is limited experience with administration to patients with severe renal impairment. 5. Hepatic impairment No dose adjustment is necessary in patients with mild to moderate hepatic impairment. In patients with severe hepatic impairment, the dose of this medicine should not exceed 20 mg. 6. Older adults No dose adjustment is necessary.

Children's dosage

Adolescents 12 years of age and older - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis is not healed or symptoms persist, continue treatment for an additional 4 weeks. - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: · 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. · Once symptoms have resolved, subsequent recurring symptoms may be controlled by administering 20 mg once daily. Children under 12 years of age There is no experience with administration of this medicine to children under 12 years of age.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to individuals who are allergic to this drug or its constituents, or those with hypersensitivity to certain antibiotics. Additionally, patients with specific heart diseases or nursing mothers should not take this medication. This drug can cause various adverse reactions, with common symptoms including headache, abdominal pain, and diarrhea, while rare but serious allergic reactions or blood anomalies may occur. Long-term use requires regular check-ups, and a higher risk of gastrointestinal infections may increase, so if diarrhea persists, consult a doctor. Additionally, this drug may interact with several other medications, so caution is needed when administered in combination. During pregnancy or lactation, the safety of this drug has not been sufficiently confirmed, so caution is advised. In case of overdose, there is no specific antidote, and treatment should be administered according to symptoms. It is important to keep this medication out of reach of children.

Side effects

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucination, headache, dizziness, paresthesia, drowsiness, taste disorder, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal distension, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, elevated liver enzymes, hepatitis, liver failure, encephalopathy, dermatitis, itching, rash, urticaria, hair loss, photosensitivity, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, drug reaction with eosinophilia and systemic symptoms, fracture, arthralgia, myalgia, muscle weakness, interstitial nephritis, gynecomastia, asthenia, increased sweating, Clostridium difficile-associated diarrhea, abdominal bloating, allergic reaction, back pain, chest pain, sternal chest pain, facial swelling, facial flushing, fatigue, fever, influenza-like illness, generalized edema, leg edema, lethargy, pain, stiffness, peripheral edema, flushing, hypertension, tachycardia, thyroid gland enlargement, irritable bowel syndrome, worsening constipation, dyspepsia, dysphagia, gastrointestinal malformation, upper abdominal pain, burping, esophageal disorder, frequent bowel movements, gastroenteritis, gastrointestinal bleeding, hiccups, black stools, oral disorders, pharyngeal disorders, rectal disorders, gastrointestinal symptoms, increased serum gastrin, tongue disorders, tongue swelling, ulcerative stomatitis, earache, tinnitus, anemia, hypopigmented anemia, cervical lymphadenopathy, nosebleeds, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, liver function abnormalities, elevated ALT, elevated AST, diabetes, hyperuricemia, elevated ALP, dry mouth, vitamin B12 deficiency, weight gain, weight loss, worsening arthritis, arthropathy, seizures, fibromyalgia, hernia, polymyalgia rheumatica, decreased appetite, apathy, increased appetite, confusion, worsening depression, hypertonia, sensory impairment, erectile dysfunction, insomnia, migraine, worsening migraine, sleep disorder, tremors, visual field loss, dysmenorrhea, menstrual disorders, vaginitis, worsening asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythematous rash, papular rash, otitis media, olfactory disturbance, loss of taste, taste disturbance, abnormal urination, albuminuria, cystitis, dysuria, fungal infection, hematuria, urination frequency, candidiasis, genital candidiasis, polyuria, conjunctivitis, visual disturbances, duodenitis, esophagitis, esophageal stricture, esophageal ulcer, esophageal varices, gastric ulcer, gastritis, benign polyps or nodules, Barrett's esophagus, mucosal discoloration, hernia, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric gland polyps, hypocalcemia, hypokalemia, rhabdomyolysis

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

Storage

This medication is sensitive to air and moisture, so it must be stored in a sealed container. It is best to keep it at room temperature between 1°C and 30°C. Proper storage helps maintain the drug's effectiveness and safety.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets x 2 PTP)

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.

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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.