Medication info
Pantorol Tablets 40 Milligrams (Pantoprazole Sodium Sesquihydrate)

Pantorol Tablets 40 Milligrams (Pantoprazole Sodium Sesquihydrate)

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

MFDS item code 201502710 · Approved 2015.04.30 · Insurance code 640903020

Summary

Main use
Treatment of gastric and duodenal ulcers (including in combination with eradication therapy), reflux esophagitis, and gastric acid hypersecretion
Who takes it
Adults
Adult dose
1. Antibiotic combination therapy to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori - Usually, adults take pantoprazole 40 mg 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 dosage recommendations below for duodenal and gastric ulcers should be considered. - If combination therapy is not necessary (e.g., negative for Helicobacter pylori infection), use pantoprazole monotherapy according to the regimens 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. - Healing occurs within 4 weeks in most cases, although the healing time may vary between patients. If healing is not achieved after the first 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 - Usually, adults 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 time may vary between patients. If healing is not achieved after the first 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 - The initial dose is pantoprazole 80 mg daily; the dose may then be increased or decreased according to measurements of gastric acid secretion. - Doses of 80 mg or more should be divided into 2 doses per day. - 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 adjusted 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 older adults or patients with renal impairment, do not exceed pantoprazole 40 mg daily. As an exception, older adults may take this medicine 40 mg twice daily (before breakfast and dinner) for 1 week as part of the antibiotic combination therapy described above, 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
Ilhwa Co., Ltd.

Efficacy & effects

Treatment of gastric and duodenal ulcers (including in combination with eradication therapy), reflux esophagitis, and gastric acid hypersecretion

  • Helicobacter pylori infection
  • gastric ulcer
  • duodenal ulcer
  • gastroesophageal reflux disease
  • Zollinger-Ellison syndrome
  • hypersecretion of gastric acid
View approved original text

This medication is used in combination with antibiotics to prevent the recurrence of gastric and duodenal ulcers infected by Helicobacter pylori. It is also effective in treating duodenal ulcers and gastric ulcers. It helps patients with moderate to severe gastroesophageal reflux disease. It is used in the treatment of pathological hypersecretion of gastric acid states such as Zollinger-Ellison syndrome. Overall, it is used to improve symptoms of various gastrointestinal diseases.

How to take

Adult dose

1. Antibiotic combination therapy to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori - Usually, adults take pantoprazole 40 mg 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 dosage recommendations below for duodenal and gastric ulcers should be considered. - If combination therapy is not necessary (e.g., negative for Helicobacter pylori infection), use pantoprazole monotherapy according to the regimens 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. - Healing occurs within 4 weeks in most cases, although the healing time may vary between patients. If healing is not achieved after the first 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 - Usually, adults 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 time may vary between patients. If healing is not achieved after the first 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 - The initial dose is pantoprazole 80 mg daily; the dose may then be increased or decreased according to measurements of gastric acid secretion. - Doses of 80 mg or more should be divided into 2 doses per day. - 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 adjusted 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 older adults or patients with renal impairment, do not exceed pantoprazole 40 mg daily. As an exception, older adults may take this medicine 40 mg twice daily (before breakfast and dinner) for 1 week as part of the antibiotic combination therapy described above, 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 administered to patients with moderate to severe impairment of liver or kidney function due to insufficient clinical experience regarding safety and efficacy. Patients who have had an allergic reaction to this medication or its components, or to benzimidazole-class drugs, should not use this medication as it may cause serious allergic reactions. Particularly, patients allergic to penicillins and macrolide antibiotics should exercise caution when using this medication in combination, and it should be avoided when taken with certain specific drugs. Women in the first three months of pregnancy or those who may become pregnant, as well as breastfeeding women, should not take this medication. This medication contains lactose, so it should not be given to patients with lactose intolerance or related genetic disorders. During treatment, various side effects such as stomach discomfort, fatigue, headache, dizziness, skin rash may occur, and in rare cases, severe liver damage or allergic reactions might occur. Regular check-ups are necessary during long-term use, and administration should be discontinued immediately if any liver function abnormalities arise. This medication suppresses gastric acid secretion and may increase bacterial growth in the stomach, which can raise the risk of infections. Additionally, this medication may interact with other drugs; thus, caution is needed when taking anticoagulants or certain antiviral agents or antibiotics. Those taking this medication should avoid driving or operating machinery if dizziness or visual disturbances occur. Pregnant or nursing individuals are advised not to use this medication, and safety has not been sufficiently confirmed for children and adolescents. In case of overdose, since there is no specific antidote, appropriate treatment should be administered based on symptoms. This medication should be taken whole, not chewed or crushed, and kept out of reach of children. Furthermore, transferring to another container can lead to quality deterioration or accidents, so caution is advisable. Lastly, long-term high-dose use has been associated with an increased cancer risk in some animal studies, so it is important to use the minimum dose and duration as directed by a physician.

Side effects

Upper abdominal pain, constipation, bloating, diarrhea, gastric adenomatous polyp, nausea, vomiting, belching, dry mouth, fatigue, weakness, lethargy, edema, elevated body temperature, fever, increased liver enzyme levels, elevated bilirubin, jaundice, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria, arthralgia, myalgia, rhabdomyolysis, bone fractures, headache, dizziness, visual disturbances, taste abnormalities, insomnia, sleep disturbances, depression, hallucinations, confusion, disorientation, interstitial nephritis, pruritus, skin erythema, urticaria, angioedema, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, increased lipids, weight changes, hyponatremia, hypomagnesemia, elevated CK, anxiety, asthenia, low back pain, bronchitis, chest pain, increased cough, dyspepsia, shortness of breath, flu-like symptoms, gastroenteritis, gastrointestinal disturbances, tension and anxiety, infection, migraine, cervical pain, pain, pharyngitis, rectal disturbances, rhinitis, elevated AST, sinusitis, upper respiratory infection, frequent urination, urinary tract infection, boil, allergic reaction, chills, folliculitis, facial edema, general edema, heat sensation, hernia, abnormal clinical laboratory test results, fatigue, moniliasis, tumor, non-specific drug reactions, abnormal electrocardiogram, 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 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, 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, speech disorder, hallucination, hyperactivity, decreased libido, restlessness, neuralgia, neuritis, neurological disorder, abnormal sensation, decreased reflex activity, sleep disorder, drowsiness, abnormal perception, tremor, asthma, nosebleed, hiccups, laryngitis, respiratory distress, pneumonia, voice alteration, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, bleeding, herpes simplex, shingles, lichenoid dermatitis, papular eruption, skin disease, skin ulcer, sweating, amblyopia, cataract, hearing loss, diplopia, otalgia, paralysis, glaucoma, otitis externa, taste abnormalities, tinnitus, albuminuria, balanitis, mastalgia, cystitis, menstrual irregularities, urination disorders, epididymitis, hematuria, erectile dysfunction, kidney stones, renal pain, nocturia, prostate disorders, pyelonephritis, scrotal edema, urethral pain, urethral disease, urinary disturbances, 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 medication should be stored in a tightly closed container that protects it from light, and the storage temperature should be maintained between 1°C and 30°C room temperature. Storing it this way will help maintain its effectiveness for a long time.

Appearance and packaging

Appearance

Yellow enteric-coated oval-shaped 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.