Medication info
Pantolane Tablets (Pantoprazole Sodium Sesquihydrate)

Pantolane Tablets (Pantoprazole Sodium Sesquihydrate)

Prescription medicationTabletOral
Ingredient · strength
Pantoprazole Sodium Sesquihydrate›45.1mg / 1 tablet
Manufacturer / importer
Dong-A ST Co., Ltd.
Appearance
This medicine is a yellow, enteric-coated, oval tablet.
Packaging
28 tablets/bottle
Approval status
Active

MFDS item code 200400173 · Notified 2004.09.03 · Insurance code 642503560

Summary

Main use
Treatment and prevention of recurrence of ulcers, treatment of reflux esophagitis, and suppression of excessive gastric acid secretion
Who takes it
Adults
Adult dose
1. Combination antibiotic therapy to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori Usually, adults take pantoprazole 40 mg per dose twice daily (before breakfast and dinner) for 1 week, in combination with one of the following antibiotics. 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 recommended doses for duodenal and gastric ulcers according to the dosage instructions below should be considered. If combination therapy is not required (e.g., Helicobacter pylori-negative infection), use pantoprazole monotherapy according to the dosage instructions below. 2. Gastric ulcer and reflux esophagitis Usually, adults take pantoprazole 40 mg once daily in the morning before breakfast with water, without chewing or crushing. Most cases heal within 4 weeks, although the healing period may vary in some patients. If healing is not complete after the first 4 weeks of treatment, continue treatment for a further 4 weeks. If there has been no response to other treatments, the dose may be doubled (pantoprazole 80 mg per day). 3. Duodenal ulcer Usually, adults take pantoprazole 40 mg once daily in the morning before breakfast with water, without chewing or crushing. Most cases heal within 2 weeks, although the healing period may vary in some patients. If healing is not complete after the first 2 weeks of treatment, continue treatment for a further 2 weeks. If there has been no response to other treatments, the dose may be doubled (pantoprazole 80 mg per day). 4. Zollinger-Ellison syndrome and other pathological hypersecretory conditions Start with an initial dose of pantoprazole 80 mg per day, then increase or decrease the dose according to measurements of gastric acid secretion. Doses of 80 mg or more should be divided and taken twice daily. A temporary increase to 160 mg or more is possible, but should be used only for as long as necessary to adequately control acid secretion. The treatment period is not limited but should be modified according to clinical need. In patients with severe liver impairment, reduce the dose so that it does not exceed pantoprazole 20 mg once daily. In elderly patients or patients with renal impairment, the dose should not exceed pantoprazole 40 mg per day. As an exception, elderly patients may take this medicine 40 mg per dose twice daily (before breakfast and dinner) for 1 week, in combination with the antibiotics described above. Swallow 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
Dong-A ST Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of ulcers, treatment of reflux esophagitis, and suppression of excessive gastric acid secretion

  • Infection with Helicobacter pylori
  • duodenal ulcers
  • gastric ulcers
  • gastroesophageal reflux disease
  • Zollinger-Ellison syndrome
  • gastric acid hypersecretion conditions
View approved original text

This medication is used in combination therapy with antibiotics to prevent the recurrence of gastric and duodenal ulcers infected with Helicobacter pylori. It also aids in the treatment of duodenal and gastric ulcers. It is effective in alleviating symptoms of moderate to severe gastroesophageal reflux disease. It helps improve pathological conditions related to gastric acid hypersecretion, including Zollinger-Ellison syndrome. This drug maintains the health of the stomach and duodenum and effectively treats symptoms of related diseases.

How to take

Adult dose

1. Combination antibiotic therapy to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori Usually, adults take pantoprazole 40 mg per dose twice daily (before breakfast and dinner) for 1 week, in combination with one of the following antibiotics. 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 recommended doses for duodenal and gastric ulcers according to the dosage instructions below should be considered. If combination therapy is not required (e.g., Helicobacter pylori-negative infection), use pantoprazole monotherapy according to the dosage instructions below. 2. Gastric ulcer and reflux esophagitis Usually, adults take pantoprazole 40 mg once daily in the morning before breakfast with water, without chewing or crushing. Most cases heal within 4 weeks, although the healing period may vary in some patients. If healing is not complete after the first 4 weeks of treatment, continue treatment for a further 4 weeks. If there has been no response to other treatments, the dose may be doubled (pantoprazole 80 mg per day). 3. Duodenal ulcer Usually, adults take pantoprazole 40 mg once daily in the morning before breakfast with water, without chewing or crushing. Most cases heal within 2 weeks, although the healing period may vary in some patients. If healing is not complete after the first 2 weeks of treatment, continue treatment for a further 2 weeks. If there has been no response to other treatments, the dose may be doubled (pantoprazole 80 mg per day). 4. Zollinger-Ellison syndrome and other pathological hypersecretory conditions Start with an initial dose of pantoprazole 80 mg per day, then increase or decrease the dose according to measurements of gastric acid secretion. Doses of 80 mg or more should be divided and taken twice daily. A temporary increase to 160 mg or more is possible, but should be used only for as long as necessary to adequately control acid secretion. The treatment period is not limited but should be modified according to clinical need. In patients with severe liver impairment, reduce the dose so that it does not exceed pantoprazole 20 mg once daily. In elderly patients or patients with renal impairment, the dose should not exceed pantoprazole 40 mg per day. As an exception, elderly patients may take this medicine 40 mg per dose twice daily (before breakfast and dinner) for 1 week, in combination with the antibiotics described above. Swallow 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 drug should not be given to patients with moderate to severe liver or kidney dysfunction due to insufficient clinical experience regarding its safety and efficacy. Patients with hypersensitivity to this drug or any of its components or who have had allergic reactions in the past should not use it. Caution is required when co-administering this drug with penicillin or macrolide antibiotics in patients with allergies to these. Women in the first three months of pregnancy, women who may become pregnant, and breastfeeding women are advised not to use this drug. Patients taking this drug for a long time should have regular check-ups, especially to monitor liver function for abnormalities. As this drug inhibits gastric acid secretion, there may be a slight increase in the risk of gastrointestinal bacterial infections due to reduced gastric acid. If symptoms such as dizziness or visual disturbances occur, activities requiring caution, such as driving or operating machinery, should be avoided. Long-term use of this drug may lead to hypomagnesemia; thus, it is important to regularly check magnesium levels, especially if used for more than a year. This drug may interact with other medications; therefore, consult a doctor or pharmacist when taking it with anticoagulants or antiviral agents. This drug should be swallowed whole without chewing or crushing and stored out of reach of children.

Side effects

Abdominal pain, constipation, bloating, diarrhea, gastric adenomatous polyp, nausea, vomiting, belching, dry mouth, fatigue, weakness, lethargy, edema, increased body temperature, fever, elevated liver enzymes, increased bilirubin, jaundice, anaphylactic shock, joint pain, muscle pain, rhabdomyolysis, bone fracture, headache, dizziness, visual disturbances, altered taste, insomnia, sleep disorders, depression, hallucinations, confusion, spatial disorientation, interstitial nephritis, itching, skin redness, urticaria, angioedema, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, lipid elevation, weight change, hyponatremia, hypomagnesemia, elevated CK, anxiety, asthenia, low back pain, bronchitis, chest pain, increased cough, dyspepsia, dyspnea, flu-like symptoms, gastroenteritis, gastrointestinal disorders, stress, infection, migraine, cervical pain, pain, pharyngitis, rectal disorders, rhinitis, elevated AST, sinusitis, upper respiratory infection, frequent urination, urinary tract infection, abscess, allergic reaction, chills, abscess, facial edema, general edema, warming sensation, hernia, abnormal laboratory test results, malaise, moniliasis, tumor, nonspecific drug reaction, abnormal ECG, angina pectoris, 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 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 abnormalities, tongue discoloration, ulcerative colitis, diabetes, thyroid goiter, cholecystalgia, hyperbilirubinemia, cholecystitis, cholelithiasis, jaundice, hepatitis, elevated ALP, anemia, petechiae, eosinophilia, iron-deficiency anemia, leukocytosis, leukopenia, thrombocytopenia, dehydration, gout, thirst, weight gain, weight loss, arthritis, bone disorders, joint disorders, leg cramps, bursitis, tendinitis, abnormal dream, confusion, convulsions, dry mouth, speech impairment, hallucinations, hyperactivity, decreased libido, restlessness, neuralgia, neuritis, neuropathy, abnormal sensations, diminished reflexes, sleep disorders, drowsiness, perceptual disturbances, tremors, asthma, epistaxis, hiccups, laryngitis, respiratory disorders, pneumonia, voice distortion, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, bleeding, herpes simplex, herpes zoster, lichen planus dermatitis, papular eruption, skin disorders, skin ulcers, sweating, amblyopia, cataract, hearing loss, diplopia, otalgia, paralysis, glaucoma, external otitis, altered taste, tinnitus, albuminuria, balanitis, mastalgia, cystitis, menstrual irregularities, dysuria, 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, microscopic colitis, systemic lupus erythematosus, cutaneous lupus erythematosus

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

Storage

This drug should be stored in a tightly closed container that can block light, at a temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the drug's effectiveness for an extended period.

Appearance and packaging

Appearance

This medicine is a yellow, enteric-coated, oval 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.