Medication info
Pantor Tablet 40 mg (Pantoprazole Sodium Sesquihydrate)

Pantor Tablet 40 mg (Pantoprazole Sodium Sesquihydrate)

Prescription medicationTabletOral
Ingredient · strength
Pantoprazole Sodium Sesquihydrate›45.1mg / 1 tablet
Manufacturer / importer
Celltrion Pharmaceutical Co., Ltd.
Appearance
Yellow, enteric-coated oval tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201706571 · Approved 2017.08.14 · Insurance code 693902600

Summary

Main use
Treatment of gastroesophageal reflux disease and gastric and duodenal ulcers, prevention of ulcer recurrence, and suppression of excessive gastric acid secretion
Who takes it
Adults
Adult dose
1. Combination therapy with antibiotics to prevent recurrence of gastroduodenal ulcers associated with Helicobacter pylori infection The usual adult dose is 40 mg of pantoprazole twice daily (before breakfast and dinner) for 1 week, in combination with the following antibiotics. Swallow without chewing or crushing. (1) Amoxicillin 1,000 mg and clarithromycin 500 mg twice daily for 1 week, or (2) Metronidazole 500 mg and clarithromycin 500 mg twice daily for 1 week, or (3) Amoxicillin 1,000 mg and metronidazole 500 mg twice daily for 1 week. The metronidazole regimens in (2) and (3) should be used only when regimen 1 is unsuitable. If additional treatment with pantoprazole is indicated to ensure ulcer healing, the recommended doses according to the regimens below for duodenal and gastric ulcers should be considered. When combination therapy is not required (e.g., when testing negative for Helicobacter pylori infection), use pantoprazole monotherapy according to the regimens below. 2. Gastric ulcer and reflux esophagitis The usual adult dose is 40 mg of pantoprazole once daily, taken with water before breakfast. Swallow without chewing or crushing. Healing usually occurs within 4 weeks, although the healing period may occasionally vary among patients. If healing is not achieved after the initial 4 weeks, continue treatment for an additional 4 weeks. If there has been no response to other treatments, the dose may be doubled to 80 mg of pantoprazole daily. 3. Duodenal ulcer The usual adult dose is 40 mg of pantoprazole once daily, taken with water before breakfast. Swallow without chewing or crushing. Healing usually occurs within 2 weeks, although the healing period may occasionally vary among patients. If healing is not achieved after the initial 2 weeks, continue treatment for an additional 2 weeks. If there has been no response to other treatments, the dose may be doubled to 80 mg of pantoprazole daily. 4. Zollinger-Ellison syndrome and other pathological hypersecretory conditions Start with an initial dose of 80 mg of pantoprazole daily, then increase or decrease the dose according to measurements of gastric acid secretion. Doses above 80 mg should be divided into two daily doses. Temporary increases to 160 mg or more are possible, but should be used only for as long as necessary to achieve adequate acid control. There is no fixed treatment duration; treatment should be adjusted according to clinical need. In patients with severe hepatic impairment, reduce the dose so that it does not exceed 20mg of pantoprazole once daily. In elderly patients or patients with renal impairment, do not exceed 40 mg of pantoprazole daily. In elderly patients, as an exception, this medicine may be taken at a dose of 40 mg twice daily (before breakfast and dinner) for 1 week in combination with the antibiotics listed above. Swallow without chewing or crushing. Combination therapy with antibiotics should not be used in patients with moderate to severe hepatic or renal impairment. There are insufficient data on the efficacy and safety of this combination therapy in these patients.

Ingredients

Manufacturer
Celltrion Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of gastroesophageal reflux disease and gastric and duodenal ulcers, prevention of ulcer recurrence, and suppression of excessive gastric acid secretion

  • Gastric ulcers infected by Helicobacter pylori
  • duodenal ulcers infected by Helicobacter pylori
  • duodenal ulcers
  • gastric ulcers
  • moderate gastroesophageal reflux disease
  • severe gastroesophageal reflux disease
  • Zollinger-Ellison syndrome
  • pathological gastric acid hypersecretion
View approved original text

This medication is used as part of a combination therapy with antibiotics to prevent the recurrence of gastric or duodenal ulcers infected by Helicobacter pylori. It is also effective for the treatment of duodenal and gastric ulcers and helps moderate to severe gastroesophageal reflux disease. It is used to relieve symptoms by controlling pathological hypersecretion of gastric acid, such as in Zollinger-Ellison syndrome. This drug is helpful in the treatment and management of various gastrointestinal-related diseases.

How to take

Adult dose

1. Combination therapy with antibiotics to prevent recurrence of gastroduodenal ulcers associated with Helicobacter pylori infection The usual adult dose is 40 mg of pantoprazole twice daily (before breakfast and dinner) for 1 week, in combination with the following antibiotics. Swallow without chewing or crushing. (1) Amoxicillin 1,000 mg and clarithromycin 500 mg twice daily for 1 week, or (2) Metronidazole 500 mg and clarithromycin 500 mg twice daily for 1 week, or (3) Amoxicillin 1,000 mg and metronidazole 500 mg twice daily for 1 week. The metronidazole regimens in (2) and (3) should be used only when regimen 1 is unsuitable. If additional treatment with pantoprazole is indicated to ensure ulcer healing, the recommended doses according to the regimens below for duodenal and gastric ulcers should be considered. When combination therapy is not required (e.g., when testing negative for Helicobacter pylori infection), use pantoprazole monotherapy according to the regimens below. 2. Gastric ulcer and reflux esophagitis The usual adult dose is 40 mg of pantoprazole once daily, taken with water before breakfast. Swallow without chewing or crushing. Healing usually occurs within 4 weeks, although the healing period may occasionally vary among patients. If healing is not achieved after the initial 4 weeks, continue treatment for an additional 4 weeks. If there has been no response to other treatments, the dose may be doubled to 80 mg of pantoprazole daily. 3. Duodenal ulcer The usual adult dose is 40 mg of pantoprazole once daily, taken with water before breakfast. Swallow without chewing or crushing. Healing usually occurs within 2 weeks, although the healing period may occasionally vary among patients. If healing is not achieved after the initial 2 weeks, continue treatment for an additional 2 weeks. If there has been no response to other treatments, the dose may be doubled to 80 mg of pantoprazole daily. 4. Zollinger-Ellison syndrome and other pathological hypersecretory conditions Start with an initial dose of 80 mg of pantoprazole daily, then increase or decrease the dose according to measurements of gastric acid secretion. Doses above 80 mg should be divided into two daily doses. Temporary increases to 160 mg or more are possible, but should be used only for as long as necessary to achieve adequate acid control. There is no fixed treatment duration; treatment should be adjusted according to clinical need. In patients with severe hepatic impairment, reduce the dose so that it does not exceed 20mg of pantoprazole once daily. In elderly patients or patients with renal impairment, do not exceed 40 mg of pantoprazole daily. In elderly patients, as an exception, this medicine may be taken at a dose of 40 mg twice daily (before breakfast and dinner) for 1 week in combination with the antibiotics listed above. Swallow without chewing or crushing. Combination therapy with antibiotics should not be used in patients with moderate to severe hepatic or renal impairment. There are insufficient data on the efficacy and safety of this combination therapy in these patients.

Precautions

This medication should not be used in patients with moderate to severe impairment of liver or kidney function, as its safety and effectiveness have not been established in these patients. Patients with known allergies to this medication, its ingredients, or related drug classes should not take it. Particular caution should be exercised in patients with allergies to penicillin or macrolide antibiotics when using this drug in combination with these antibiotics. Pregnant women in early pregnancy or those who may become pregnant, as well as nursing mothers, are advised not to take this medication. This drug may interact with other medications; therefore, if you are currently taking any other medication, be sure to consult with your doctor or pharmacist. Regular tests, such as liver function tests, are necessary during prolonged use, and any unusual symptoms should be reported to healthcare professionals immediately. This medication suppresses gastric acid secretion, which may lead to bacterial overgrowth in the gastrointestinal tract. If diarrhea or signs of infection persist, diagnosis and treatment are needed. Dizziness or visual disturbances may occur, so caution is advised when driving or operating machinery. Prolonged use at high doses may increase the risk of fractures, so patients at risk of osteoporosis should be cautious. During the course of treatment, adhere to the recommended dosage and duration, and do not arbitrarily discontinue or modify the medication. There is insufficient experience in the use of this medication in children and adolescents under 18 years of age, so it should be used cautiously in this age group. There is no specific antidote for overdose, so appropriate treatment should be administered based on symptoms. When taking this medication, do not chew or crush the tablets; swallow them whole and keep out of reach of children.

Side effects

Upper abdominal pain, constipation, bloating, diarrhea, nausea, vomiting, belching, dry mouth, fatigue, muscle weakness, lethargy, edema, elevated body temperature, fever, increased liver enzyme levels, elevated bilirubin, jaundice, anaphylactic shock, joint pain, muscle pain, rhabdomyolysis, bone fracture, headache, dizziness, visual disturbances, dysgeusia, insomnia, sleep disorders, depression, hallucinations, confusion, disorientation, interstitial nephritis, pruritus, skin erythema, hives, angioedema, skin mucosal syndrome, erythema multiforme, toxic epidermal necrolysis, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, lipid increase, weight change, hyponatremia, hypomagnesemia, elevated CK, anxiety, asthenia, lumbago, bronchitis, chest pain, increased cough, dyspepsia, dyspnea, flu-like symptoms, gastroenteritis, gastrointestinal disorders, tension headache, infection, migraine, cervical pain, pain, pharyngitis, rectal disorders, rhinitis, elevated AST, sinusitis, upper respiratory infection, increased urination, urinary tract infection, boil, allergic reaction, chills, abscess, facial edema, generalized edema, warmth, hernia, abnormalities in clinical laboratory tests, fatigue, moniliasis, tumor, nonspecific drug reactions, electrocardiogram abnormalities, angina, arrhythmia, atrial fibrillation, coronary artery disease, congestive heart failure, bleeding, hypertension, hypotension, myocardial infarction, myocardial ischemia, palpitations, retinal vascular disease, syncope, tachycardia, phlebitis, thrombosis, vasodilation, decreased appetite, aphthous stomatitis, colitis, duodenitis, dysphagia, enteritis, esophageal hemorrhage, esophagitis, gastric duodenal tumor, gastric duodenal hemorrhage, gastric duodenal moniliasis, gingivitis, halitosis, hematemesis, increased appetite, melena, oral ulcer, oral moniliasis, periodontal abscess, periodontitis, rectal bleeding, gastric ulcer, abnormal bowel movements, tongue discoloration, ulcerative colitis, diabetes, goiter, gallbladder pain, hyperbilirubinemia, cholecystitis, cholelithiasis, jaundice, hepatitis, elevated ALP, anemia, purpura, eosinophilia, iron deficiency anemia, leukocytosis, leukopenia, thrombocytopenia, dehydration, gout, thirst, weight gain, weight loss, arthritis, bone disease, joint disease, leg cramps, bursitis, tendinitis, abnormal dream, confusion, convulsion, dry mouth, speech disorder, hyperactivity, decreased libido, restlessness, neuralgia, neuritis, neuropathy, dysesthesia, diminished reflexes, drowsiness, abnormal perception, tremors, asthma, epistaxis, hiccups, laryngitis, respiratory distress, pneumonia, voice alteration, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, bleeding, herpes simplex, shingles, lichen planus dermatitis, papular rash, skin disorders, skin ulcer, sweating, amblyopia, cataract, hearing loss, diplopia, otalgia, paralysis, glaucoma, otitis externa, tinnitus, albuminuria, balanitis, mastalgia, cystitis, menstrual irregularities, micturition disorders, epididymitis, hematuria, erectile dysfunction, kidney stones, renal colic, nocturia, prostate disorders, pyelonephritis, scrotal edema, urethral pain, urethral disorders, urinary abnormalities, vaginitis, Clostridium difficile-associated diarrhea, hypocalcemia, hypokalemia, DRESS syndrome, microscopic colitis, systemic lupus erythematosus, lupus erythematosus of the skin, gastric polyp

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

Storage

This medication is sensitive to light and should be stored in a container that blocks light. It is also recommended to store it at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

Yellow, enteric-coated oval tablet

Package unit

30 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.