Medication info

Stofrazole Tablet 10 mg (S-Pantoprazole Sodium Trihydrate)

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

MFDS item code 201802761 · Approved 2018.07.02

This product's status changed to Expired on 2023.07.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of non-erosive gastroesophageal reflux disease; prevention of recurrence of reflux esophagitis
Who uses it
Adults
Adult dosage
1. Treatment of non-erosive gastroesophageal reflux disease: Administer 10 mg of S-pantoprazole orally once daily before breakfast. Symptom relief generally occurs within 2 ~ 4 weeks, and healing can usually be achieved with 4 weeks of treatment. 2. Long-term maintenance therapy to prevent recurrence of reflux esophagitis: Take 1 tablet (equivalent to 10 mg of S-pantoprazole) once daily before breakfast. If recurrence occurs, increase the dose to 20 mg of S-pantoprazole daily, then reduce it to 10 mg daily again after healing.

Ingredients

Manufacturer
Joah Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of non-erosive gastroesophageal reflux disease; prevention of recurrence of reflux esophagitis

  • Non-erosive gastroesophageal reflux disease
  • reflux esophagitis
View approved original text

This medication is used for the treatment of non-erosive gastroesophageal reflux disease and for long-term maintenance therapy to prevent the recurrence of reflux esophagitis.

Dosage and Administration

Adult dosage

1. Treatment of non-erosive gastroesophageal reflux disease: Administer 10 mg of S-pantoprazole orally once daily before breakfast. Symptom relief generally occurs within 2 ~ 4 weeks, and healing can usually be achieved with 4 weeks of treatment. 2. Long-term maintenance therapy to prevent recurrence of reflux esophagitis: Take 1 tablet (equivalent to 10 mg of S-pantoprazole) once daily before breakfast. If recurrence occurs, increase the dose to 20 mg of S-pantoprazole daily, then reduce it to 10 mg daily again after healing.

Precautions

This drug should not be administered to patients with moderate to severe impairment of liver or kidney function, as its safety and efficacy have not been adequately confirmed. Patients who are allergic to this medication, its ingredients, or benzimidazole drugs, or who have previously experienced hypersensitivity reactions, should not use it. Particularly, caution is warranted as serious allergic reactions such as anaphylaxis, angioedema, and bronchospasm may occur. This drug cannot be used in conjunction with certain antiviral drugs (atazanavir, nelfinavir), as concomitant use may diminish drug efficacy. Women who are in early pregnancy or may become pregnant, as well as nursing mothers, should not take this medication. Additionally, patients taking drugs containing rilpivirine should also not use this medication. While taking this drug, various side effects such as constipation, diarrhea, abdominal pain, headache, dizziness, and fatigue may occur, and patients should consult with healthcare professionals if symptoms arise. Long-term use requires regular health check-ups, and particularly if used for more than one year, the risk of side effects may increase. Elderly patients or those with impaired kidney function may require dosage adjustments, and in cases of severe liver impairment, dosing intervals should be extended. This medication suppresses gastric acid secretion, so it is effective for symptoms due to excess stomach acid; however, accurate diagnosis is needed if malignancy is suspected. Caution is advised as prolonged use may increase the risk of hypomagnesemia or fractures, and magnesium levels should be periodically monitored if necessary. Due to many potential drug interactions, patients taking anticoagulants, antiviral agents, or immunosuppressants should inform their healthcare provider. It is safer not to take this medication during pregnancy or breastfeeding, and safety in pediatric patients has not been established. No specific symptoms have been reported with overdose; however, if any atypical symptoms occur, immediate medical attention is required. This drug should be taken whole without chewing or crushing, and if taken for a long time, it is recommended to consult a physician to adhere to the minimum dosage and appropriate duration. Keep out of reach of children to prevent safety accidents.

Side effects

Anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria, constipation, diarrhea, gastritis, gastric polyp, hiatal hernia, loose stools, chest pain, dyspepsia, nausea, vomiting, abdominal distension, enteritis, sentinel polyp, edema, fatigue, fever, sweating, hypertension, tachycardia, eustachian tube dysfunction, dry eyes, visual disturbance, cold, elevated liver enzymes, hyperlipidemia, insomnia, dizziness, neuropathy, drowsiness, low back pain, limb pain, headache, facial pain, abscess, itching, epistaxis, elevated creatine phosphokinase, elevated liver enzymes (AST), decreased appetite, stomatitis, nasal congestion, rhinorrhea, sore throat, upper respiratory infection, neutropenia, skin laceration, black stool, atrophic vulvovaginitis, ovarian cyst, biliary stone, musculoskeletal chest pain, urticaria, increased sputum, bladder residual urine, amputation, upper abdominal pain, bloating, belching, dry mouth, asthenia, malaise, elevated body temperature, elevated bilirubin, liver failure, jaundice, anaphylactic reaction, arthralgia, myalgia, rhabdomyolysis, bone fracture, dysgeusia, sleep disorders, depression, hallucinations, confusion, spatial disorientation, interstitial nephritis, angioedema, mucocutaneous syndrome, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lille syndrome, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, lipid increase, weight change, hyponatremia, hypomagnesemia, elevated CK, anxiety, bronchitis, increased cough, dyspnea, flu-like symptoms, gastroenteritis, gastrointestinal disorders, tension, infection, migraine, cervical pain, pain, pharyngitis, rectal dysfunction, rhinitis, elevated AST, sinusitis, upper respiratory infection, increased urination, urinary tract infection, allergic reaction, chills, pustule, facial edema, general edema, heat sensation, hernia, abnormal clinical laboratory test results, malaise, moniliasis, tumor, nonspecific drug reaction, electrocardiogram 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, decreased appetite, aphthous stomatitis, colitis, duodenitis, swallowing difficulty, esophageal bleeding, esophagitis, gastric and duodenal tumor, gastric and duodenal bleeding, gastric and duodenal moniliasis, gingivitis, halitosis, hematemesis, increased appetite, melena, oral ulcer, oral moniliasis, periodontal abscess, periodontitis, rectal bleeding, gastric ulcer, bowel abnormalities, tongue discoloration, ulcerative colitis, diabetes, goiter, gallbladder pain, hyperbilirubinemia, cholecystitis, cholelithiasis, jaundice, hepatitis, elevated ALP, anemia, petechiae, 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, seizures, dry mouth, dysarthria, hyperactivity, decreased libido, agitation, neuralgia, neuritis, neurological disorder, abnormal sensation, decreased reflexes, abnormal perception, tremors, asthma, epistaxis, hiccups, laryngitis, respiratory distress, pneumonia, voice alterations, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, bleeding, herpes simplex, herpes zoster, eczema-like dermatitis, papular rash, skin disease, skin ulcers, sweating, amblyopia, cataract, hearing loss, diplopia, otalgia, paralysis, glaucoma, external ear canal inflammation, tinnitus, albuminuria, balanitis, breast pain, cystitis, menstrual irregularities, urination disorders, epididymitis, hematuria, erectile dysfunction, nephrolithiasis, renal pain, nocturia, prostate disorder, pyelonephritis, scrotal edema, urethral pain, urethral disease, urinary abnormalities, vaginitis, Clostridium difficile-associated diarrhea, DRESS syndrome, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric mucosal polyp

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

Storage

This medication should be stored in a well-sealed container to protect it from light and air. It is important to maintain the storage temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Pink rectangular enteric-coated tablet

Package unit

28 tablets/bottle

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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.