Medication info
Esomark Capsule 20mg (Esomeprazole Magnesium Trihydrate)

Esomark Capsule 20mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationHard capsuleOral · Intravenous injection
Ingredient · strength
Esomeprazole Magnesium Granules›87.55mg / 1 capsule
Manufacturer / importer
Dongkwang Pharmaceutical Co., Ltd.
Appearance
Hard gelatin capsule with light green upper and yellowish lower, containing white or gray granules
Packaging
28 capsules/bottle
Approval status
Active

MFDS item code 201503041 · Approved 2015.05.21 · Insurance code 645905840

Summary

Main use
Treatment and prevention of acid-related disorders, gastrointestinal disorders caused by anti-inflammatory analgesics, ulcers and rebleeding, and Helicobacter pylori infection
Who uses it
Adults · Children
Adult dosage
1. Adults 1) Gastroesophageal reflux disease (GERD). - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis has not healed or symptoms persist, continue treatment for another 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 recurrent symptoms are controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurrent 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 nonsteroidal anti-inflammatory drug (nonselective or selective COX-2 inhibitor) use - 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. Clinical trials lasting longer than 4 weeks have not been conducted. 4) Patients requiring continued nonsteroidal anti-inflammatory drug treatment - 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 subsequently be adjusted for each patient, and treatment should continue while clinical symptoms are present. According to clinical data, most patients can be controlled with doses of 80 ∼ 160 mg per day. Doses greater than 80 mg per day should be divided into two doses. 6) Maintenance therapy following initiation of prevention of recurrent bleeding due to gastric or duodenal ulcers by intravenous injection Administer 40 mg once daily for 4 weeks following initiation of prevention of recurrent bleeding due to gastric or duodenal ulcers by intravenous injection. 4. Renal impairment No dose adjustment is necessary. Since there is limited experience with administration to patients with severe renal impairment, use with caution. 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. Elderly patients 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 has not healed or symptoms persist, continue treatment for another 4 weeks. Adolescents 12 years of age and older - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. Adolescents 12 years of age and older - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: Once symptoms have resolved, subsequent recurrent symptoms are controlled by administering 20 mg once daily. Adolescents 12 years of age and older - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurrent symptoms is not recommended for patients at high risk of developing gastric or duodenal ulcers due to nonsteroidal anti-inflammatory drug use. Children under 12 years of age - There is no experience with administration of this medicine to children under 12 years of age.

Ingredients

Manufacturer
Dongkwang Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment and prevention of acid-related disorders, gastrointestinal disorders caused by anti-inflammatory analgesics, ulcers and rebleeding, and Helicobacter pylori infection

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

This medication is used for the treatment of gastroesophageal reflux disease and erosive esophagitis and is effective for long-term maintenance therapy to prevent recurrence in patients with esophagitis. It also helps alleviate symptoms in patients with gastroesophageal reflux disease without esophagitis. This drug is used for the treatment and prevention of recurrence in patients with duodenal ulcers and peptic ulcers in conjunction with antibiotics for the eradication of Helicobacter pylori. It aids in the treatment of upper gastrointestinal symptoms related to the use of non-steroidal anti-inflammatory drugs and in the treatment and prevention of gastric and duodenal ulcers. It is also applied for the treatment of Zollinger-Ellison syndrome and maintenance therapy to prevent gastric and duodenal ulcer rebleeding. This is a medication effective for treating and preventing various gastrointestinal diseases.

Dosage and Administration

Adult dosage

1. Adults 1) Gastroesophageal reflux disease (GERD). - Treatment of erosive reflux esophagitis: Administer 40 mg once daily for 4 weeks. If esophagitis has not healed or symptoms persist, continue treatment for another 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 recurrent symptoms are controlled by administering 20 mg once daily. · In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurrent 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 nonsteroidal anti-inflammatory drug (nonselective or selective COX-2 inhibitor) use - 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. Clinical trials lasting longer than 4 weeks have not been conducted. 4) Patients requiring continued nonsteroidal anti-inflammatory drug treatment - 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 subsequently be adjusted for each patient, and treatment should continue while clinical symptoms are present. According to clinical data, most patients can be controlled with doses of 80 ∼ 160 mg per day. Doses greater than 80 mg per day should be divided into two doses. 6) Maintenance therapy following initiation of prevention of recurrent bleeding due to gastric or duodenal ulcers by intravenous injection Administer 40 mg once daily for 4 weeks following initiation of prevention of recurrent bleeding due to gastric or duodenal ulcers by intravenous injection. 4. Renal impairment No dose adjustment is necessary. Since there is limited experience with administration to patients with severe renal impairment, use with caution. 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. Elderly patients 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 has not healed or symptoms persist, continue treatment for another 4 weeks. Adolescents 12 years of age and older - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: 20 mg once daily. If symptoms are not controlled after 4 weeks, further evaluation is required. Adolescents 12 years of age and older - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: Once symptoms have resolved, subsequent recurrent symptoms are controlled by administering 20 mg once daily. Adolescents 12 years of age and older - Symptomatic treatment of gastroesophageal reflux disease without esophagitis: In adults, 20 mg may be administered once daily as needed. As-needed administration to control recurrent symptoms is not recommended for patients at high risk of developing gastric or duodenal ulcers due to nonsteroidal anti-inflammatory drug use. 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. Patients who are allergic to this drug or its components or have had hypersensitivity reactions should not take it. Care should be taken when using it in conjunction with certain antibiotics or medications, particularly penicillins and macrolide antibiotics. It is also not safe for use in pregnant or breastfeeding women. Different adverse reactions may occur while taking this medication, so caution is necessary. Headaches, abdominal pain, diarrhea, nausea, and dizziness are frequently reported symptoms, while more serious side effects such as blood abnormalities, liver dysfunction, skin rashes, and myalgia can occur infrequently. Especially with long-term use, electrolyte imbalances such as hypomagnesemia may occur, requiring regular monitoring. Because this medication suppresses gastric acid secretion and lowers gastric acidity, the risk of gastrointestinal infections may slightly increase. Furthermore, long-term use may increase the risk of fractures, so caution is advised for patients with osteoporosis. This medication may interact with other medications, so if you are taking other drugs, you must inform your doctor or pharmacist. Because data on its safety during pregnancy is limited, pregnant patients should consult their doctor before taking it. In cases of overdose, there is no specific antidote, so appropriate treatment should be received depending on the symptoms, and observation may be necessary in a hospital if needed. Finally, this medication should be kept out of the reach of children, and care should be taken not to transfer it to other containers, as doing so can affect the quality.

Side effects

Leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, fever, angioedema, anaphylactic reaction, shock, peripheral edema, hyponatremia, hypomagnesemia, insomnia, anxiety, mental confusion, depression, aggression, hallucinations, headache, dizziness, paresthesia, drowsiness, dysgeusia, blurred vision, bronchospasm, pancreatitis, abdominal pain, constipation, diarrhea, abdominal bloating, nausea, vomiting, dry mouth, stomatitis, gastrointestinal candidiasis, microscopic colitis, increased 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, hyperhidrosis, Clostridium difficile-associated diarrhea, abdominal distension, allergic reaction, back pain, chest pain, sternal pain, facial edema, facial flushing, fatigue, influenza-like illness, generalized edema, leg edema, malaise, pain, stiffness, anemia, hypopigmented anemia, cervical lymphadenopathy, epistaxis, leukocytosis, leukopenia, thrombocytopenia, hyperbilirubinemia, abnormal liver function, increased ALT, increased AST, diabetes, hyperuricemia, increased ALP, polydipsia, vitamin B12 deficiency, weight gain, weight loss, exacerbation of arthritis, arthropathy, seizures, fibromyalgia syndrome, hernia, rheumatoid polymyalgia, loss of appetite, apathy, increased appetite, confusion, exacerbation of depression, hypertonicity, sensory impairment, erectile dysfunction, insomnia, migraine, exacerbation of migraine, sleep disturbance, tremor, visual field loss, dysmenorrhea, menstrual disorders, vaginitis, exacerbation of asthma, cough, dyspnea, laryngeal edema, pharyngitis, rhinitis, sinusitis, acne, anal itching, erythematous rash, papular rash, otitis media, abnormal olfaction, taste loss, taste distortion, urinary abnormalities, 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, skeletal muscle lysis, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric fundic polyps, hypocalcemia, hypokalemia, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms, acute generalized exanthematous pustulosis

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture and kept at room temperature between 1 and 30 degrees Celsius. This storage method helps maintain the drug's effectiveness and prevents degradation.

Appearance and packaging

Appearance

Hard gelatin capsule with light green upper and yellowish lower, containing white or gray granules

Package unit

28 capsules/bottle

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.