Pantoprazole Sodium Sesquihydrate 40 mg Tablets

Adult dose

1. Combination antibiotic 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) Take amoxicillin 1,000 mg and clarithromycin 500 mg twice daily for 1 week, or (2) Take metronidazole 500 mg and clarithromycin 500 mg twice daily for 1 week, or (3) Take 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 and regimens below should be considered for duodenal and gastric ulcers. If combination therapy is not required (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 can occur within 4 weeks in most patients, although the healing time may vary occasionally. 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, 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. Healing can occur within 2 weeks in most patients, although the healing time may vary occasionally. 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, 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 above 80 mg should be divided into 2 doses per day. A temporary increase to 160 mg or more is possible, but should be used only for as long as needed to achieve adequate acid control. The duration of treatment is not limited but should be changed according to clinical need. In patients with severe liver impairment, reduce the dose so that it does not exceed pantoprazole 20mg once daily. Do not exceed pantoprazole 40 mg per day in elderly patients or patients with renal impairment. As an exception, elderly patients may take this product 40 mg twice daily (before breakfast and dinner) for 1 week in combination with the antibiotics described above, without chewing or crushing. Combination antibiotic 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.

This drug should not be used in patients with moderate to severe impairment of liver or kidney function due to insufficient clinical experience regarding its safety and efficacy. Patients who have had an allergic reaction to this medication, its components, or benzimidazole derivatives should not be administered this drug, as severe allergic reactions such as anaphylactic shock or angioedema may occur. Caution is required when using this drug in conjunction with specific antibiotics in patients who have allergies to penicillin or macrolide antibiotics. Women in early pregnancy or who might become pregnant, as well as nursing mothers, are advised not to take this medication. This drug may cause various adverse reactions, with common symptoms including abdominal pain, constipation, diarrhea, nausea, fatigue, etc., and rarely, severe liver damage, anaphylactic shock, skin rashes, and muscle pain may occur. Regular testing of liver function and overall health should be performed with long-term use, especially when taking the medication for over a year, as the risk of side effects increases. This drug suppresses gastric acid secretion, which can increase the number of bacteria in the gastrointestinal tract, so if symptoms of infection such as diarrhea persist, consultation with healthcare professionals is required. Dizziness or visual disturbances may occur, so caution is warranted when driving or operating machinery. Interactions may occur with other medications; thus, it is important to inform healthcare providers, especially when taking antivirals, anticoagulants, methotrexate, etc. This medication should be swallowed whole and not chewed or crushed, and should be kept out of reach of children. In case of overdose, there is no specific antidote, so appropriate treatment should be provided based on symptoms.

Abdominal pain, constipation, abdominal distension, diarrhea, nausea, vomiting, belching, dry mouth, fatigue, asthenia, lethargy, edema, elevated body temperature, fever, elevated liver enzymes, elevated bilirubin, jaundice, anaphylactic shock, arthralgia, myalgia, rhabdomyolysis, bone fracture, headache, dizziness, visual disturbances, taste disturbances, insomnia, sleep disorders, depression, hallucinations, confusion, disorientation, interstitial nephritis, pruritus, skin erythema, urticaria, angioedema, mucocutaneous syndrome, erythema multiforme, toxic epidermal necrolysis, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, increased lipids, weight changes, hyponatremia, hypomagnesemia, increased CK, anxiety, lethargy, low back pain, bronchitis, chest pain, increased cough, dyspepsia, dyspnea, flu-like symptoms, gastroenteritis, gastrointestinal disorders, tension and anxiety, infection, migraine, cervical pain, pain, pharyngitis, rectal disorders, rhinitis, elevated AST, sinusitis, upper respiratory infection, frequent urination, urinary tract infection, boils, allergic reaction, chills, abscess, facial edema, generalized edema, heat sensation, hernia, abnormalities in laboratory tests, malaise, moniliasis, tumor, nonspecific drug reaction, ECG abnormalities, angina, arrhythmia, atrial fibrillation, coronary artery disease, congestive heart failure, bleeding, hypertension, hypotension, myocardial infarction, myocardial ischemia, palpitations, retinal vascular diseases, syncope, tachycardia, phlebitis, thrombosis, vasodilation, decreased appetite, aphthous stomatitis, colitis, duodenitis, dysphagia, enteritis, esophageal hemorrhage, esophagitis, gastric and duodenal tumors, gastric and duodenal bleeding, gastric and duodenal moniliasis, gingivitis, halitosis, hematemesis, increased appetite, melena, oral ulcers, oral moniliasis, periodontal abscess, periodontitis, rectal bleeding, gastric ulcer, bowel irregularities, tongue discoloration, ulcerative colitis, diabetes, goiter, gallbladder pain, 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 diseases, joint diseases, leg cramps, bursitis, tendinitis, abnormal dream, confusion, convulsions, dry mouth, dysarthria, hallucinations, hyperactivity, decreased libido, nervousness, neuralgia, neuritis, neurological disorders, abnormal sensations, decreased reflexes, sleep disorders, drowsiness, perceptual disturbances, tremors, asthma, nosebleeds, hiccups, laryngitis, respiratory disorders, pneumonia, voice changes, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, bleeding, herpes simplex, shingles, lichen planus dermatitis, papular rash, skin disorders, skin ulcers, sweating, amblyopia, cataract, hearing loss, diplopia, ear pain, paralysis, glaucoma, otitis externa, taste disturbances, tinnitus, albuminuria, balanitis, mastalgia, cystitis, irregular menstruation, urinary disorders, epididymitis, hematuria, erectile dysfunction, kidney stones, renal pain, nocturia, prostate disorders, pyelonephritis, scrotal edema, urethral pain, urethral disorders, urinary abnormalities, vaginitis, Clostridium difficile-associated diarrhea, DRESS syndrome, microscopic colitis, systemic lupus erythematosus, discoid lupus erythematosus, gastric polyp

This drug should be stored in a container that protects it from light as it is sensitive to light. Additionally, it should be stored safely at room temperature between 1 to 30 degrees Celsius.

Appearance

Yellow enteric-coated oval tablets

Package unit

30 tablets per bottle