Pantoprazole 40 mg Tablets (Pantoprazole Sodium Sesquihydrate)

Adult dose

1. Antibiotic combination therapy to prevent recurrence of gastroduodenal ulcers associated with Helicobacter pylori infection - Generally, adults should 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) Take amoxicillin 1,000 mg per dose and clarithromycin 500 mg per dose twice daily for 1 week, or (2) Take metronidazole 500 mg per dose and clarithromycin 500 mg per dose twice daily for 1 week, or (3) Take 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 regimens below should be considered. - If combination therapy is not necessary (e.g., a negative test for Helicobacter pylori infection), use pantoprazole monotherapy according to the regimens below. 2. Gastric ulcer and reflux esophagitis - Generally, adults should 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 cases, although the healing period may vary between patients. If the condition is not completely healed 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 - Generally, adults should 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 cases, although the healing period may vary between patients. If the condition is not completely healed 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 - Start with an initial dose of pantoprazole 80 mg daily, then increase or decrease the dose according to measured gastric acid secretion. - Doses of 80 mg or more 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 necessary to achieve adequate acid control. - The duration of treatment is not limited, but should be adjusted according to clinical need. ○ In patients with severe hepatic impairment (liver impairment), reduce the dose so that it does not exceed pantoprazole 20mg once daily. ○ In elderly patients or patients with renal impairment, do not exceed pantoprazole 40 mg daily. As an exception, elderly patients may receive this medicine at a dose of 40 mg per dose 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.

This drug should not be used in patients with moderate to severe liver or kidney impairment as its safety and efficacy have not been adequately confirmed. Patients who are hypersensitive to this drug or any of its ingredients, or who have experienced severe allergic reactions to benzimidazole derivatives, are advised against its administration. Particular caution is required when combined with this drug in patients with penicillin or macrolide antibiotic allergies. Additionally, due to potential drug interactions, patients taking certain heart-related medications or antivirals should not use this drug. It is safest for women in early pregnancy or those who may become pregnant, as well as women who are breastfeeding, to avoid this medication. Various side effects may occur while taking this drug; common ones include abdominal pain, constipation, diarrhea, nausea, and fatigue, while rare but serious side effects may include severe liver damage, allergic reactions, skin rashes, and blood disorders. Long-term use may lead to impaired vitamin B12 absorption or increased fracture risk, thus regular monitoring is necessary. Since this drug suppresses gastric acid secretion, bacterial counts in the stomach may increase, leading to potential Clostridium difficile infection if diarrhea persists. Dizziness or vision disturbances may occur; caution is needed when driving or operating machinery. This drug can interact with other medications, so it is vital for patients taking anticoagulants, antivirals, antibiotics, or immunosuppressants to consult with a healthcare provider. Pregnant or breastfeeding women should refrain from taking this drug, and its safety in pediatric or adolescent populations has not been adequately established. In case of overdose, since no specific antidote exists, it is crucial to receive symptomatic treatment. This drug should be swallowed whole without chewing or crushing, and it must be kept out of the reach of children. If prolonged usage occurs or unusual symptoms manifest, immediate consultation with a healthcare provider is recommended.

anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria, abdominal pain, constipation, bloating, diarrhea, gastric polyp, nausea, vomiting, belching, dry mouth, fatigue, weakness, lethargy, edema, increased body temperature, fever, elevated liver enzyme levels, increased bilirubin, liver failure, arthralgia, myalgia, rhabdomyolysis, bone fracture, headache, dizziness, vision disturbances, dysgeusia, insomnia, sleep disorders, depression, hallucinations, confusion, disorientation, interstitial nephritis, pruritus, skin reddening, mucocutaneous syndrome, erythema multiforme, toxic epidermal necrolysis, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, increased lipids, weight change, hyponatremia, hypomagnesemia, elevated CK, anxiety, malaise, lumbago, bronchitis, chest pain, increased coughing, dyspepsia, shortness of breath, flu-like symptoms, gastroenteritis, gastrointestinal disturbances, tension, infection, migraine, cervical pain, pain, pharyngitis, rectal disturbances, rhinitis, elevated AST, sinusitis, upper respiratory infection, frequent urination, urinary tract infection, boils, allergic reactions, chills, abscess, facial edema, general edema, warmth, hernia, abnormal clinical laboratory test results, fatigue, moniliasis, tumors, nonspecific 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 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 ulcers, bowel irregularities, tongue discoloration, ulcerative colitis, diabetes, goiter, gallbladder pain, hyperbilirubinemia, cholecystitis, cholelithiasis, jaundice, hepatitis, elevated ALP, anemia, purpura, eosinophilia, iron deficiency anemia, leukocytosis, dehydration, gout, thirst, weight gain, weight loss, arthritis, bone disorders, joint disorders, leg cramps, bursitis, tendinitis, abnormal dream, confusion, seizures, dry mouth, speech disturbance, hyperactivity, decreased libido, restlessness, neuralgia, neuritis, nerve disorders, dysesthesia, decreased reflexes, drowsiness, altered perception, tremors, asthma, nosebleed, hiccups, laryngitis, respiratory disorders, pneumonia, voice changes, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, herpes simplex, shingles, lichen planus dermatitis, papular rash, skin disorders, skin ulcers, sweating, amblyopia, cataract, hearing loss, diplopia, otalgia, paralysis, glaucoma, external otitis, tinnitus, albuminuria, balanitis, mastalgia, cystitis, menstrual irregularities, urinary disorders, epididymitis, hematuria, erectile dysfunction, kidney stones, renal pain, nocturia, prostate disorders, pyelonephritis, scrotal edema, urethral pain, urethral disorders, urogenital abnormalities, vaginitis, Clostridium difficile infection, DRESS syndrome, microscopic colitis, systemic lupus erythematosus, cutaneous lupus erythematosus

This medication is sensitive to light and should be stored in a container that does not allow light to pass through. Additionally, it is essential to store the drug at room temperature, between 1 and 30 degrees Celsius, to maintain its effectiveness.

Appearance

Yellow enteric-coated oval tablets

Package unit

30 tablets/bottle