Medication info

Pantolustablets (S- Pantoprazole Sodium Trihydrate)

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

MFDS item code 201802691 · Approved 2018.06.28

This product's status changed to Expired on 2023.06.28. 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 peptic ulcers (gastric and duodenal)
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. Do not chew or crush the tablet. - Healing occurs within 4 weeks in most cases, although the time to healing may vary among patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for another 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. Do not chew or crush the tablet. - Healing occurs within 2 weeks in most cases, although the time to healing may vary among patients. If healing is not complete after the initial 2 weeks of treatment, continue treatment for another 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, do not exceed 20mg of S-pantoprazole daily. ◯ In patients with severe hepatic impairment (liver impairment), reduce the dose and take 1 tablet (equivalent to 20mg of S-pantoprazole) once every other day.

Ingredients

Manufacturer
Sama Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of moderate to severe reflux esophagitis and peptic ulcers (gastric and duodenal)

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

This medication is used for 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. Do not chew or crush the tablet. - Healing occurs within 4 weeks in most cases, although the time to healing may vary among patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for another 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. Do not chew or crush the tablet. - Healing occurs within 2 weeks in most cases, although the time to healing may vary among patients. If healing is not complete after the initial 2 weeks of treatment, continue treatment for another 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, do not exceed 20mg of S-pantoprazole daily. ◯ In patients with severe hepatic impairment (liver impairment), reduce the dose and take 1 tablet (equivalent to 20mg of S-pantoprazole) once every other day.

Precautions

This medication should not be administered to patients with moderate or severe impairment of liver or kidney function as safety and efficacy have not been sufficiently confirmed. Patients with an allergy to this medication, its components, or benzimidazole class medications may develop severe allergic reactions and should not use this medication. This medication cannot be taken with certain other medications, particularly patients taking atazanavir or rilpivirine, as it may reduce their effectiveness. It is safer not to use this medication during the first trimester of pregnancy or for women who are pregnant or breastfeeding. This medication contains a dye called Yellow No. 5, so patients with an allergy or hypersensitivity to this ingredient should use it cautiously. During the use of this medication, gastrointestinal-related symptoms such as constipation, diarrhea, gastritis, gastric polyps, dyspepsia, vomiting, and systemic symptoms such as fatigue, edema, headache, dizziness, and insomnia may occur. Rarely, serious allergic reactions, skin rash, hives, angioedema, liver function abnormalities, nephritis, mental changes, or increased fracture risk have been reported. Long-term use, especially over one year, requires regular monitoring, and if symptoms suggestive of malignant tumors such as stomach cancer arise, a consultation with a specialist for diagnosis is necessary. This medication may decrease gastric acid and increase bacterial growth in the stomach; thus, if diarrhea persists or infection symptoms appear, inform healthcare professionals immediately. Dizziness or visual disturbances may occur, requiring caution when driving or operating machinery. Do not chew or crush the tablet during use, and keep it out of reach of children in a safe place. Furthermore, the safety and efficacy of this medication in children have not been sufficiently documented, so it is recommended that it not be used in pediatric patients. No specific symptoms are known for overdose; however, if unusual symptoms appear, seek appropriate medical treatment at a hospital immediately.

Side effects

Anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, hives, constipation, diarrhea, gastritis, gastric polyp, hiatal hernia, loose stools, chest pain, dyspepsia, nausea, vomiting, abdominal distension, enteritis, edema, fatigue, fever, sweating, hypertension, tachycardia, ear and throat canal disorder, dry eye syndrome, visual disturbances, cold, elevated liver enzymes, insomnia, dizziness, neuropathy, drowsiness, back pain, limb pain, headache, gastric pain, boil, itching, rash, nosebleed, elevated creatine phosphokinase, elevated liver enzymes (AST), decreased appetite, stomatitis, nasal congestion, runny nose, sore throat, upper respiratory infection, neutropenia, skin laceration, abdominal pain, numbness, increased sputum, bladder residual urine, truncation, upper abdominal pain, abdominal distention, belching, dry mouth, asthenia, languor, elevated body temperature, fever, elevated bilirubin, liver failure, jaundice, anaphylactic reaction, arthralgia, myalgia, rhabdomyolysis, bone fracture, headache, blurred vision, taste disturbance, sleep disorder, depression, hallucination, confusion, disorientation, interstitial nephritis, pruritus, skin erythema, hives, angioedema, mucocutaneous syndrome, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, Lyell's syndrome, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, increased lipids, weight change, hyponatremia, hypomagnesemia, elevated CK, anxiety, bronchitis, increased cough, dyspnea, flu symptoms, gastroenteritis, gastrointestinal disorders, tension overload, infection, migraine, cervical pain, pain, pharyngitis, rectal disorders, rhinitis, elevated AST, sinusitis, upper respiratory infection, frequent urination, urinary tract infection, allergic reaction, chills, facial edema, general edema, heat sensation, hernia, abnormal laboratory test results, malaise, 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, venous inflammation, thrombosis, vasodilation, decreased appetite, aphthous stomatitis, colitis, duodenitis, swallowing difficulty, esophageal bleeding, esophagitis, gastric and duodenal tumors, 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 irregularities, tongue discoloration, ulcerative colitis, diabetes, goiter, gallbladder pain, hyperbilirubinemia, cholecystitis, cholelithiasis, hepatitis, elevated ALP, anemia, purpura, eosinophilia, iron deficiency anemia, leukocytosis, dehydration, gout, thirst, weight gain, weight loss, arthritis, bone disease, joint disease, leg cramps, bursitis, tendinitis, abnormal dream, confusion, seizures, dry mouth, speech disorder, hyperactivity, decreased libido, anxiety, neuralgia, neuritis, neurological disorders, abnormal sensation, reflex action reduction, abnormal perception, tremor, asthma, hiccup, laryngitis, respiratory distress, pneumonia, voice alteration, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, bleeding, herpes simplex, shingles, lichenoid dermatitis, papular rash, skin disease, skin ulcer, sweating, amblyopia, cataract, hearing loss, diplopia, otalgia, paralysis, glaucoma, external otitis, tinnitus, albuminuria, balanitis, mastalgia, cystitis, menstrual irregularities, urination disorders, epididymitis, hematuria, erectile dysfunction, kidney stones, renal pain, enuresis, prostate disorders, pyelonephritis, scrotal edema, urethral pain, urethral disorders, urinary abnormalities, vaginitis, Clostridium difficile-associated diarrhea, DRESS syndrome, systemic lupus erythematosus, erythematous lupus.

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

Storage

This medication is sensitive to light and should be stored in containers that block light. Additionally, it is best to keep the medication at room temperature between 1 to 30 degrees Celsius, avoiding excessively hot or cold places. Proper storage helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

Yellow rectangular enteric-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.