Tecta 40 mg (Pantoprazole Hemimagnesium Hydrate)

Adult dose

1. Antibiotic combination therapy to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori - In general, adults should take pantoprazole 40 mg per dose twice daily (before breakfast and dinner) with the following antibiotics for 1 week. 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 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), administer pantoprazole monotherapy according to the regimens below. 2. Gastric ulcer and reflux esophagitis - In general, adults should take pantoprazole 40 mg once daily in the morning before breakfast, with water, without chewing or crushing. - Most cases may heal within 4 weeks, although the healing period may vary among patients. If healing is incomplete after the initial 4 weeks of treatment, continue for a further 4 weeks. - If there has been no response to other treatments in particular, the dose may be doubled (80 mg of pantoprazole daily). 3. Duodenal ulcer - In general, adults should take pantoprazole 40 mg once daily in the morning before breakfast, with water, without chewing or crushing. - Most cases may heal within 2 weeks, although the healing period may vary among patients. If healing is incomplete after the initial 2 weeks of treatment, continue for a further 2 weeks. - If there has been no response to other treatments in particular, the dose may be doubled (80 mg of pantoprazole daily). 4. Zollinger-Ellison syndrome and other pathological hypersecretory conditions - Start with an initial dose of 80 mg of pantoprazole daily, 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. - Temporary increases to 160 mg or more are possible, but should be used only for as long as needed to control acid secretion adequately. - 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 20mg of pantoprazole once daily. ◯ In elderly patients or patients with renal impairment, do not exceed 40 mg of pantoprazole daily. As an exception, elderly patients may take 40 mg of this medicine 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 administered to patients with moderate to severe liver or kidney dysfunction due to insufficient clinical experience with its safety or efficacy. Patients with hypersensitivity to this drug or its ingredients, or to benzimidazole derivative drugs, and those with a history of hypersensitivity to concomitant antibiotics may experience serious allergic reactions, so this medication should not be used. Caution is especially necessary for patients with hypersensitivity to penicillin antibiotics or macrolide antibiotics, and for those taking certain heart-related medications when used in combination with this drug. It is safest not to use this medication during the first trimester of pregnancy or in women who may become pregnant and in lactating women. While taking this medication, various side effects such as stomach pain or discomfort, fatigue, headache, dizziness, skin rash, and liver function abnormalities may occur, and if symptoms are severe, immediate consultation with a doctor is required. For long-term use of this drug, regular liver function tests and blood tests are important, and with especially prolonged use beyond one year, caution should be taken for possible electrolyte imbalances such as hypomagnesemia. This drug inhibits gastric acid secretion and decreases the acidity inside the stomach, which may slightly increase the risk of gastric bacterial infections, so if diarrhea symptoms persist, notify healthcare professionals. Dizziness or visual disturbances may occur, so caution is required when driving or operating machinery. Due to possible interactions with other medications, particularly anticoagulants, antibiotics, antiviral drugs, etc., it is essential to inform healthcare professionals, and monitoring of drug concentrations or effects may be necessary. This drug should be taken whole without chewing or crushing and must be kept out of reach of children. In cases of pregnancy or breastfeeding and for children under 18 years of age, sufficient safety data is lacking, thus avoiding use is recommended. In cases of overdose, as there are no specific antidotes, appropriate treatment according to symptoms is necessary.

Abdominal pain, constipation, bloating, diarrhea, gastric polyp, nausea, vomiting, belching, dry mouth, fatigue, asthenia, lethargy, edema, elevated body temperature, fever, elevated liver enzyme levels, increased bilirubin, jaundice, anaphylactic shock, arthralgia, myalgia, rhabdomyolysis, bone fracture, headache, dizziness, visual disturbances, dysgeusia, insomnia, sleep disturbances, depression, hallucinations, confusion, disorientation, interstitial nephritis, pruritus, skin erythema, urticaria, angioedema, mucocutaneous symptoms, erythema multiforme, toxic epidermal necrolysis, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, increased lipids, weight change, hyponatremia, hypomagnesemia, elevated CK, anxiety, lethargy, lumbago, bronchitis, chest pain, increased cough, dyspepsia, dyspnea, flu-like symptoms, gastroenteritis, gastrointestinal disorders, tension headache, infection, migraine, cervical pain, pain, pharyngitis, rectal disorders, rhinitis, elevated AST, sinusitis, upper respiratory infection, increased urination, urinary tract infection, boil, allergic reaction, chills, abscess, facial edema, generalized edema, heat sensation, hernia, abnormal clinical laboratory findings, malaise, moniliasis, tumor, nonspecific drug reactions, ECG abnormalities, 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 hemorrhage, esophagitis, gastric and duodenal tumor, gastric and duodenal hemorrhage, 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, petechiae, 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 disability, hyperactivity, decreased libido, restlessness, neuralgia, neuritis, neuropathy, dysesthesia, decreased reflexes, drowsiness, abnormal perception, tremors, asthma, epistaxis, hiccups, laryngitis, respiratory disorders, pneumonia, voice changes, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, bleeding, herpes simplex, shingles, lichen planus, papular rash, skin disease, skin ulcer, sweating, amblyopia, cataract, hearing loss, diplopia, otalgia, paralysis, glaucoma, external ear canal inflammation, tinnitus, albuminuria, balanitis, mastalgia, cystitis, menstrual irregularities, dysuria, epididymitis, hematuria, erectile dysfunction, nephrolithiasis, renal pain, nocturia, prostate disorders, pyelonephritis, scrotal edema, urethral pain, urethral disorders, urogenital disorders, vaginitis, acute bronchitis, diarrhea, vomiting, abdominal pain, nausea, small intestinal diverticulitis, gastrointestinal infection, back pain, sciatica, vertigo, brachial plexus lesion, elevated serum creatine phosphokinase, elevated serum creatine phosphokinase MB, elevated gamma-glutamyl transferase, leukocytosis, hyperkalemia, increased serum potassium, hypertension, increased blood pressure, Clostridium difficile-associated diarrhea, hypocalcemia, hypokalemia, DRESS syndrome, acute generalized exanthematous pustulosis, microscopic colitis, systemic lupus erythematosus, cutaneous lupus erythematosus, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia with systemic symptoms due to drug reaction, acute generalized exanthematous pustulosis

This drug must be stored in a tightly sealed container to protect it from air or moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius.

Appearance

Yellow, bilaterally convex, film-coated tablet

Package unit

30 tablets (10 tablets/PTP packaging X3)