Medication info
Toprazole 40 mg (Pantoprazole Sodium Sesquihydrate)

Toprazole 40 mg (Pantoprazole Sodium Sesquihydrate)

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

MFDS item code 200704994 · Notified 2007.04.30 · Insurance code 665001290

Summary

Main use
Treatment of gastroesophageal reflux disease and gastric and duodenal ulcers; prevention of ulcer recurrence; suppression of gastric acid hypersecretion
Who takes it
Adults
Adult dose
1. Antibiotic combination therapy to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori Adults usually take pantoprazole 40 mg per dose twice daily (before breakfast and dinner) in combination with the following antibiotics for 1 week. Swallow without chewing or crushing. (1) Amoxicillin 1,000 mg per dose and clarithromycin 500 mg per dose twice daily for 1 week, or (2) Metronidazole 500 mg per dose and clarithromycin 500 mg per dose twice daily for 1 week, or (3) Amoxicillin 1,000 mg per dose and metronidazole 500 mg per dose twice daily for 1 week. The metronidazole regimens in (2) and (3) should be used only when regimen 1 is inappropriate. If additional treatment with pantoprazole is indicated to ensure ulcer healing, the dosage recommendations below for duodenal and gastric ulcers should be considered. If combination therapy is not required (e.g., Helicobacter pylori test negative), use pantoprazole monotherapy according to the dosage instructions below. 2. Gastric ulcer and reflux esophagitis Adults usually take pantoprazole 40 mg once daily in the morning before breakfast, with water, without chewing or crushing. Healing occurs within 4 weeks in most cases, although the healing period may vary among patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. If there has been no response to other treatments in particular, the dose may be doubled (pantoprazole 80 mg daily). 3. Duodenal ulcer Adults usually take pantoprazole 40 mg once daily in the morning before breakfast, with water, without chewing or crushing. Healing occurs within 2 weeks in most cases, although the healing period may vary among patients. If healing is not complete after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. If there has been no response to other treatments in particular, the dose may be doubled (pantoprazole 80 mg daily). 4. Zollinger-Ellison syndrome and other pathological hypersecretory conditions Start with an initial dose of pantoprazole 80 mg daily, then increase or decrease the dose according to measurements of gastric acid secretion. For doses of 80 mg or more, administer in 2 divided doses daily. The dose may be temporarily increased to 160 mg or more, but only for as long as needed to achieve adequate acid control. The duration of treatment is not limited but should be modified according to clinical need. For patients with severe hepatic impairment (liver impairment), reduce the dose so that it does not exceed pantoprazole 20mg once daily. Do not exceed pantoprazole 40 mg daily in elderly patients or patients with renal impairment. As an exception, elderly patients may take this medicine 40 mg per dose twice daily (before breakfast and dinner) in combination with the antibiotics listed above for 1 week, without chewing or crushing. Antibiotic combination therapy should not be used in patients with moderate to severe hepatic/renal impairment. There are insufficient data on the efficacy and safety of this combination therapy.

Ingredients

Manufacturer
Kyungbo Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of gastroesophageal reflux disease and gastric and duodenal ulcers; prevention of ulcer recurrence; suppression of gastric acid hypersecretion

  • Infection by Helicobacter pylori
  • gastric ulcers
  • duodenal ulcers
  • gastroesophageal reflux disease
  • conditions of excessive gastric acid secretion
View approved original text

This medication is used in combination with antibiotics to prevent the recurrence of gastric and duodenal ulcers caused by Helicobacter pylori infection. It is also effective for duodenal ulcers, gastric ulcers, and moderate to severe gastroesophageal reflux disease. It is used to treat conditions characterized by pathological excessive gastric acid secretion, such as Zollinger-Ellison syndrome. This drug reduces gastric acid secretion, alleviating symptoms of ulcers and esophagitis and reducing the risk of recurrence. Accordingly, it is used to treat gastric and duodenal ulcers, gastroesophageal reflux disease, and states of excessive gastric acid secretion.

How to take

Adult dose

1. Antibiotic combination therapy to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori Adults usually take pantoprazole 40 mg per dose twice daily (before breakfast and dinner) in combination with the following antibiotics for 1 week. Swallow without chewing or crushing. (1) Amoxicillin 1,000 mg per dose and clarithromycin 500 mg per dose twice daily for 1 week, or (2) Metronidazole 500 mg per dose and clarithromycin 500 mg per dose twice daily for 1 week, or (3) Amoxicillin 1,000 mg per dose and metronidazole 500 mg per dose twice daily for 1 week. The metronidazole regimens in (2) and (3) should be used only when regimen 1 is inappropriate. If additional treatment with pantoprazole is indicated to ensure ulcer healing, the dosage recommendations below for duodenal and gastric ulcers should be considered. If combination therapy is not required (e.g., Helicobacter pylori test negative), use pantoprazole monotherapy according to the dosage instructions below. 2. Gastric ulcer and reflux esophagitis Adults usually take pantoprazole 40 mg once daily in the morning before breakfast, with water, without chewing or crushing. Healing occurs within 4 weeks in most cases, although the healing period may vary among patients. If healing is not complete after the initial 4 weeks of treatment, continue treatment for an additional 4 weeks. If there has been no response to other treatments in particular, the dose may be doubled (pantoprazole 80 mg daily). 3. Duodenal ulcer Adults usually take pantoprazole 40 mg once daily in the morning before breakfast, with water, without chewing or crushing. Healing occurs within 2 weeks in most cases, although the healing period may vary among patients. If healing is not complete after the initial 2 weeks of treatment, continue treatment for an additional 2 weeks. If there has been no response to other treatments in particular, the dose may be doubled (pantoprazole 80 mg daily). 4. Zollinger-Ellison syndrome and other pathological hypersecretory conditions Start with an initial dose of pantoprazole 80 mg daily, then increase or decrease the dose according to measurements of gastric acid secretion. For doses of 80 mg or more, administer in 2 divided doses daily. The dose may be temporarily increased to 160 mg or more, but only for as long as needed to achieve adequate acid control. The duration of treatment is not limited but should be modified according to clinical need. For patients with severe hepatic impairment (liver impairment), reduce the dose so that it does not exceed pantoprazole 20mg once daily. Do not exceed pantoprazole 40 mg daily in elderly patients or patients with renal impairment. As an exception, elderly patients may take this medicine 40 mg per dose twice daily (before breakfast and dinner) in combination with the antibiotics listed above for 1 week, without chewing or crushing. Antibiotic combination therapy should not be used in patients with moderate to severe hepatic/renal impairment. There are insufficient data on the efficacy and safety of this combination therapy.

Precautions

This medication should not be used in patients with moderate to severe impairment of liver or kidney function. Patients who have had allergic reactions to this medication, its ingredients, or benzimidazole medications should be cautious as this drug can cause serious allergic reactions. Patients allergic to penicillin or macrolide antibiotics should avoid using this medication in conjunction with them, as problems may arise. Patients taking certain heart-related medications, pregnant women in early stages, and breastfeeding women should refrain from using this medication for safety. This medication contains lactose and should not be administered to patients with lactose intolerance or related genetic disorders. Caution should be exercised in patients with a history of allergy to the coloring agents contained in this medication. Taking this medication can result in various side effects such as abdominal pain, diarrhea, headache, dizziness, and skin rash; therefore, if any unusual symptoms occur, immediate consultation with a doctor is advised. Regular health evaluations are required for long-term use of this medication, particularly liver function tests and magnesium levels checks. Since this medication suppresses gastric acid secretion, it may slightly increase the risk of gastrointestinal bacterial infections; thus, if diarrhea symptoms persist, medical personnel should be informed. Since this medication can affect blood coagulation, patients on anticoagulants should frequently monitor their blood test results. Pregnant or nursing women should always consult with a physician before using this medication, especially avoiding use in early pregnancy. Safety in children and adolescents has not been sufficiently confirmed, so use in this age group should be cautious. This medication should be swallowed whole without chewing or crushing, and storage should be in an area out of reach of children. While there are no known specific symptoms in cases of overdose, immediate medical treatment should be sought if symptoms occur. Long-term high-dose use of this medication may result in increased fracture risk, vitamin B12 absorption issues, and hypomagnesemia, hence caution is advised. During the use of this medication, it is important to consult healthcare professionals immediately if any adverse reactions or suspicious symptoms appear for appropriate measures.

Side effects

Abdominal pain, constipation, bloating, diarrhea, nausea, vomiting, belching, dry mouth, fatigue, weakness, lethargy, edema, increased body temperature, fever, elevated liver enzymes, elevated bilirubin, jaundice, anaphylactic shock, arthralgia, myalgia, rhabdomyolysis, bone fracture, headache, dizziness, visual disturbances, taste abnormalities, insomnia, sleep disturbances, depression, hallucinations, confusion, disorientation, interstitial nephritis, itching, skin rash, urticaria, angioedema, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, lipid elevation, weight changes, hyponatremia, hypomagnesemia, elevated CK, anxiety, listlessness, lower back pain, bronchitis, chest pain, increased cough, indigestion, dyspnea, flu-like symptoms, gastroenteritis, gastrointestinal disorders, hypertonic tension, infection, migraine, cervical pain, pain, pharyngitis, rectal disorders, rhinitis, elevated AST, sinusitis, upper respiratory infection, polyuria, urinary tract infection, boil, allergic reaction, chills, abscess, facial edema, generalized edema, heat sensation, hernia, abnormal clinical laboratory tests, lethargy, moniliasis, tumor, nonspecific drug reaction, 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, swallowing difficulties, enteritis, esophageal hemorrhage, 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, abnormal bowel movements, tongue discoloration, ulcerative colitis, diabetes, goiter, gallbladder pain, hyperbilirubinemia, cholecystitis, cholelithiasis, jaundice, hepatitis, elevated ALP, anemia, petechial hemorrhage, 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, convulsions, dry mouth, dysphasia, hyperactivity, decreased libido, anxiety, neuralgia, neuritis, neuropathy, abnormal sensations, reflex activity reduction, abnormal perception, tremor, asthma, epistaxis, hiccups, laryngitis, respiratory disturbances, pneumonia, voice changes, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, bleeding, herpes simplex, shingles, lichen planus dermatitis, papular rash, skin disease, skin ulcer, sweating, amblyopia, cataract, hearing loss, diplopia, otalgia, paralysis, glaucoma, otitis externa, tinnitus, albuminuria, balanitis, breast pain, cystitis, menstrual irregularities, dysuria, epididymitis, hematuria, erectile dysfunction, kidney stones, renal colic, nocturnal enuresis, prostate disorders, pyelonephritis, scrotal edema, urethral pain, urethral disorders, urological abnormalities, vaginitis, Clostridium difficile-associated diarrhea, DRESS syndrome, microscopic colitis, systemic lupus erythematosus, cutaneous lupus erythematosus, 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, ideally at a temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, enteric-coated oval tablet

Package unit

28 tablets/bottle

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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.