Itax Pantoprazole Tablets (Pantoprazole Sodium Sesquihydrate)

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 inappropriate. - If additional treatment with pantoprazole is indicated to ensure ulcer healing, the recommended doses according to the 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 with water before breakfast, without chewing or crushing. - Healing may occur within 4 weeks in most patients, but the healing time may vary occasionally. If not healed after the first 4 weeks, 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 per day). 3. Duodenal ulcer - Usually, adults take pantoprazole 40 mg once daily with water before breakfast, without chewing or crushing. - Healing may occur within 2 weeks in most patients, but the healing time may vary occasionally. If not healed after the first 2 weeks, 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 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 greater than 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 hepatic impairment (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. In elderly patients, as an exception, this medicine may be taken at a dose of 40 mg twice daily (before breakfast and dinner) for 1 week in the antibiotic combination therapy described above, without chewing or crushing. ○ Do not use antibiotic combination therapy in patients with moderate to severe hepatic/renal impairment. There are insufficient data on the efficacy and safety of this combination therapy.

This medication should not be used in patients with moderate to severe impairment of liver or kidney function due to insufficient clinical experience with safety and efficacy. Patients who are allergic or have had hypersensitivity reactions to this medication or its components, or to similar classes of medication, should not take it. Particular caution should be exercised in patients allergic to penicillin or macrolide antibiotics when using this medication together with those antibiotics. Severe side effects may occur when used with certain specific medications; therefore, if currently taking terfenadine, cisapride, pimodidine, astemizole, atazanavir, nelpivirine, or rilpivirine, this medication should not be used. It is best to avoid this medication in women who are in the first trimester of pregnancy or those who may become pregnant, as well as in nursing mothers. While taking this medication, side effects may occur in various areas, including the gastrointestinal system, systemic condition, liver, immune system, muscles and bones, nervous system, mental system, kidneys, skin, endocrine system, blood, reproductive system, and metabolic system. Especially, severe skin reactions or allergic reactions such as anaphylaxis may occur; therefore, if abnormal symptoms arise, immediate consultation with medical personnel is necessary. Because this medication inhibits gastric acid secretion, long-term use may increase the risk of infections due to bacterial overgrowth in the stomach. Additionally, long-term use may lead to vitamin B12 absorption issues, hypomagnesemia, increased fracture risk, so regular examinations are needed. Dizziness or vision disturbances may occur while using this medication, hence caution is required when driving or operating machinery. Due to potential interactions with other medications, especially anticoagulants, antibiotics, antivirals, and anticancer drugs, healthcare providers should be informed of all medications being taken. This medication should not be chewed or crushed but taken whole and should be kept out of reach of children. In cases of pregnancy or nursing, careful administration should be done after consulting a physician, and there is a need for caution in administering it to children or adolescents since there is not enough experience.

Upper abdominal pain, constipation, distension, diarrhea, gastric polyp, nausea, vomiting, belching, dry mouth, fatigue, asthenia, lethargy, edema, elevated body temperature, fever, increased liver enzyme levels, elevated bilirubin, jaundice, anaphylactic shock, arthralgia, myalgia, rhabdomyolysis, bone fracture, headache, dizziness, visual disturbance, dysgeusia, insomnia, sleep disturbance, depression, hallucinations, confusion, spatial disorientation, interstitial nephritis, pruritus, skin flushing, urticaria, angioedema, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, increased lipids, weight change, hyponatremia, hypomagnesemia, elevated CK, anxiety, apathy, low back pain, bronchitis, chest pain, increased cough, dyspepsia, dyspnea, flu symptoms, gastroenteritis, gastrointestinal disturbance, tension, infection, migraine, cervical pain, pain, pharyngitis, rectal disturbance, rhinitis, elevated AST, sinusitis, upper respiratory infection, frequent urination, urinary tract infection, boil, allergic reaction, chills, abscess, facial edema, general edema, heat sensation, hernia, abnormal clinical laboratory test results, malaise, moniliasis, tumor, nonspecific drug reaction, abnormal ECG, 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 difficulty, enteritis, esophageal bleeding, esophagitis, gastric and duodenal tumor, 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, bowel irregularity, 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 disease, joint disease, leg cramps, bursitis, tendonitis, abnormal dream, confusion, convulsion, dry mouth, speech disorder, hallucinations, hyperactivity, decreased libido, restlessness, neuralgia, neuritis, neurological disorder, paresthesia, reduced reflex action, sleep disturbance, drowsiness, altered perception, tremor, asthma, epistaxis, hiccup, laryngitis, respiratory disturbance, pneumonia, altered voice, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, bleeding, herpes simplex, herpes zoster, lichen planus, papular urticaria, skin disease, skin ulcer, sweating, amblyopia, cataract, hearing loss, diplopia, ear pain, paralysis, glaucoma, external otitis, dysgeusia, tinnitus, albuminuria, balanitis, breast pain, cystitis, menstrual irregularity, urinary difficulty, epididymitis, hematuria, erectile dysfunction, nephrolithiasis, nephralgia, nocturnal enuresis, prostate disorder, pyelonephritis, scrotal edema, urethral pain, urethral disease, urological abnormality, vaginitis, Clostridium difficile-associated diarrhea, DRESS syndrome, microscopic colitis, systemic lupus erythematosus, cutaneous lupus erythematosus

This medication should be stored in a sealed container that can block light, and it is advisable to keep it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication and prevent degradation.

Appearance

Yellow enteric-coated oval tablets

Package unit

30 tablets/bottle