Medication info

Estonel Tablet 20mg (S-Pantoprazole Sodium Trihydrate)

Prescription medicationExpired
Ingredient · strength
S-Pantoprazole Sodium Trihydrate›Strength being verified
Manufacturer / importer
CMG Pharmaceutical Co., Ltd.
Appearance
Yellow rectangular enteric-coated film-coated tablet
Packaging
28 tablets/bottle
Approval status
Expired

MFDS item code 201802721 · Approved 2018.06.29

This product's status changed to Expired on 2023.06.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of moderate to severe reflux esophagitis and gastric and duodenal ulcers
Who uses it
Adults
Adult dosage
1. Gastric ulcer and moderate to severe reflux esophagitis The usual adult dose is 1 tablet once daily (equivalent to 20mg of S-pantoprazole), taken with water before breakfast without chewing or crushing. Most patients may be healed within 4 weeks, although the healing period may vary occasionally from patient to patient. If healing is not complete after the first 4 weeks of treatment, continue treatment for a further 4 weeks. If the condition has not responded to other treatments, the dose may be doubled (equivalent to 40 mg of S-pantoprazole daily). 2. Duodenal ulcer The usual adult dose is 1 tablet once daily (equivalent to 20 mg of S-pantoprazole), taken with water before breakfast without chewing or crushing. Most patients may be healed within 2 weeks, although the healing period may vary occasionally from patient to patient. If healing is not complete after the first 2 weeks of treatment, continue treatment for a further 2 weeks. If the condition has not responded to other treatments, the dose may be doubled (equivalent to 40 mg of S-pantoprazole daily). In elderly patients or patients with renal impairment, the dose should not exceed 20mg of S-pantoprazole daily. In patients with severe liver impairment, reduce the dose to 1 tablet (equivalent to 20mg of S-pantoprazole) once every other day.

Ingredients

Manufacturer
CMG Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of moderate to severe reflux esophagitis and gastric and duodenal ulcers

  • Duodenal ulcers
  • gastric ulcers
  • gastroesophageal reflux disease
View approved original text

This medication is used for the treatment of duodenal ulcers, gastric ulcers, and moderate to severe gastroesophageal reflux disease.

Dosage and Administration

Adult dosage

1. Gastric ulcer and moderate to severe reflux esophagitis The usual adult dose is 1 tablet once daily (equivalent to 20mg of S-pantoprazole), taken with water before breakfast without chewing or crushing. Most patients may be healed within 4 weeks, although the healing period may vary occasionally from patient to patient. If healing is not complete after the first 4 weeks of treatment, continue treatment for a further 4 weeks. If the condition has not responded to other treatments, the dose may be doubled (equivalent to 40 mg of S-pantoprazole daily). 2. Duodenal ulcer The usual adult dose is 1 tablet once daily (equivalent to 20 mg of S-pantoprazole), taken with water before breakfast without chewing or crushing. Most patients may be healed within 2 weeks, although the healing period may vary occasionally from patient to patient. If healing is not complete after the first 2 weeks of treatment, continue treatment for a further 2 weeks. If the condition has not responded to other treatments, the dose may be doubled (equivalent to 40 mg of S-pantoprazole daily). In elderly patients or patients with renal impairment, the dose should not exceed 20mg of S-pantoprazole daily. In patients with severe liver impairment, reduce the dose to 1 tablet (equivalent to 20mg of S-pantoprazole) once every other day.

Precautions

This medication should not be used in patients with moderate or severe impairment of liver or kidney function, as its safety and efficacy have not been adequately established. Patients with a history of allergic reactions to this drug, its ingredients, or benzimidazole class drugs may experience serious hypersensitive reactions, and thus it should not be administered. This medication cannot be used in conjunction with certain antiviral drugs. It should not be given to pregnant women in early pregnancy or women of childbearing potential, as well as nursing mothers. This medication contains tartrazine, and care should be taken in patients with hypersensitivity or an allergy history to this substance. During treatment with this drug, gastrointestinal symptoms such as constipation, diarrhea, gastritis, vomiting, as well as headache, dizziness, and itching may occur, and if any unusual symptoms arise, consult a physician or pharmacist. Long-term use may lead to side effects such as vitamin B12 deficiency, hypomagnesemia, and increased fracture risk, so regular check-ups are necessary. If there are symptoms suggestive of gastric cancer, such as weight loss, vomiting, or black stools while taking this medication, further investigations must be conducted. Patients with severe liver dysfunction should take this medication every other day and undergo periodic liver function tests, and discontinue use if liver enzyme levels increase. This medication may cause drowsiness or dizziness, so caution is needed when driving or operating machinery. There may be drug interactions with other medications, especially anticoagulants, antiviral agents, or methotrexate, so it is essential to inform the physician if taking any of these. It is safest to avoid use during pregnancy or breastfeeding unless carefully discussed with a physician. Safety and efficacy in pediatric patients have not been adequately established, so it is best not to use. There are no specific symptoms reported for overdosage, but if unusual symptoms occur, seek medical attention immediately. This medication should be swallowed whole without chewing or crushing, and stored out of reach of children.

Side effects

Anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria, constipation, diarrhea, gastritis, gastric polyp, hiatal hernia, soft stool, chest pain, dyspepsia, nausea, vomiting, abdominal bloating, enteritis, edema, fatigue, fever, sweating, hypertension, tachycardia, ear and throat disorders, dry eyes, vision disorders, cold, increased liver enzymes, insomnia, dizziness, neuropathy, drowsiness, lower back pain, limb pain, headache, stomachache, abscess, itching, rash, nosebleed, elevated creatine phosphokinase, elevated liver enzyme (AST), loss of appetite, stomatitis, nasal congestion, runny nose, sore throat, upper respiratory infection, decreased neutrophils, skin laceration, abdominal pain, numbness, increased sputum, bladder residual urine, amputation, upper abdominal pain, distention, belching, dry mouth, asthenia, malaise, elevated body temperature, fever, elevated bilirubin, liver failure, jaundice, anaphylactic shock, arthralgia, myalgia, rhabdomyolysis, bone fracture, headache, taste disorder, sleep disturbance, depression, hallucinations, confusion, spatial disorientation, interstitial nephritis, pruritus, skin flushing, urticaria, angioedema, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, increased lipids, weight changes, hyponatremia, hypomagnesemia, elevated CK, anxiety, bronchitis, chest pain, increased cough, dyspnea, flu symptoms, gastroenteritis, gastrointestinal disorders, tension, infection, migraine, neck pain, pain, pharyngitis, rectal disorders, rhinitis, elevated AST, sinusitis, upper respiratory infection, frequent urination, urinary tract infection, abscess, allergic reaction, chills, facial edema, generalized edema, heat sensation, hernia, abnormal clinical laboratory tests, lethargy, moniliasis, tumor, nonspecific drug reaction, ECG abnormalities, angina, arrhythmia, atrial fibrillation, coronary artery disease, congestive heart failure, bleeding, hypotension, myocardial infarction, myocardial ischemia, palpitations, retinal vascular disease, syncope, phlebitis, thrombosis, vasodilation, loss of appetite, aphthous stomatitis, colitis, duodenitis, swallowing disorders, esophageal bleeding, esophagitis, gastric duodenal tumor, gastric duodenal bleeding, gastric duodenal moniliasis, gingivitis, halitosis, hematemesis, increased appetite, melena, oral ulcer, oral moniliasis, periodontal abscess, periodontitis, rectal bleeding, gastric ulcer, bowel movement disorders, tongue discoloration, ulcerative colitis, diabetes, goiter, biliary colic, hyperbilirubinemia, cholecystitis, cholelithiasis, jaundice, hepatitis, elevated ALP, anemia, petechial hemorrhage, eosinophilia, iron deficiency anemia, leukocytosis, thrombocytopenia, dehydration, gout, thirst, weight gain, weight loss, arthritis, bone disease, joint disease, leg cramps, bursitis, tendinitis, abnormal dream, confusion, convulsion, dry mouth, dysphonia, hyperactivity, decreased libido, anxiety, neuralgia, neuritis, neuropathy, paresthesia, diminished reflex, abnormal perception, tremor, asthma, hiccups, laryngitis, respiratory distress, pneumonia, altered voice, acne, alopecia, contact dermatitis, eczema, fungal skin disease, hemorrhage, herpes simplex, herpes zoster, lichen planus dermatitis, papular rash, skin disease, skin ulcer, sweating, amblyopia, cataract, hearing loss, diplopia, ear pain, paralysis, glaucoma, otitis externa, tinnitus, albuminuria, balanitis, mastalgia, cystitis, menstrual irregularities, dysuria, epididymitis, hematuria, erectile dysfunction, kidney stones, renal pain, nocturia, prostate disorders, pyelonephritis, scrotal edema, urethral pain, urethral disorders, urological disorders, vaginitis, Clostridium difficile-associated diarrhea, DRESS syndrome, systemic lupus erythematosus, skin lupus erythematosus, gastric polyp

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

Storage

This medication may be sensitive to light, so it should be stored in a container that does not allow light to pass through. Additionally, it is important to store it at a temperature between 1 and 30 degrees Celsius to maintain the drug's effectiveness.

Appearance and packaging

Appearance

Yellow rectangular enteric-coated film-coated tablet

Package unit

28 tablets/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.