Medication info
Pantoprazole 40 mg (Pantoprazole Sodium Sesquihydrate)

Pantoprazole 40 mg (Pantoprazole Sodium Sesquihydrate)

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

MFDS item code 202002803 · Approved 2020.04.21 · Insurance code 073001020

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers, treatment of reflux esophagitis, and suppression of gastric acid hypersecretion
Who takes it
Adults
Adult dose
1. Antibiotic combination therapy to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori - The usual adult dose is 40 mg of pantoprazole twice daily (before breakfast and dinner) for 1 week, in combination with the following antibiotics. Swallow whole; do not chew or crush. (1) Take 1,000 mg of amoxicillin and 500 mg of clarithromycin twice daily for 1 week; or (2) Take 500 mg of metronidazole and 500 mg of clarithromycin twice daily for 1 week; or (3) Take 1,000 mg of amoxicillin and 500 mg of metronidazole 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 dose recommendations below for duodenal and gastric ulcers should be considered. - If combination therapy is not required (e.g., a negative test for Helicobacter pylori infection), use pantoprazole monotherapy according to the regimen below. 2. Gastric ulcer and reflux esophagitis - The usual adult dose is 40 mg of pantoprazole once daily, taken with water before breakfast; swallow whole without chewing or crushing. - Healing occurs within 4 weeks in most patients, although the healing time may vary. If the ulcer has not healed after the initial 4 weeks, continue treatment for an additional 4 weeks. - If there has been no response to other treatments, the dose may be doubled to 80 mg of pantoprazole daily. 3. Duodenal ulcer - The usual adult dose is 40 mg of pantoprazole once daily, taken with water before breakfast; swallow whole without chewing or crushing. - Healing occurs within 2 weeks in most patients, although the healing time may vary. If the ulcer has not healed after the initial 2 weeks, continue treatment for an additional 2 weeks. - If there has been no response to other treatments, the dose may be doubled to 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 two daily doses. - Temporary increases to 160 mg or more are possible, but should be used only as long as needed to achieve adequate control of acid secretion. - The duration of treatment is not limited but should be adjusted according to clinical need. ○ In patients with severe hepatic impairment, reduce the dose so that it does not exceed 20mg of pantoprazole once daily. ○ Do not exceed 40 mg of pantoprazole daily in elderly patients or patients with renal impairment. As an exception, elderly patients may receive this medicine at 40 mg twice daily (before breakfast and dinner) for 1 week as part of the antibiotic combination therapy described above. Swallow whole without chewing or crushing. ○ Do not use antibiotic combination therapy in patients with moderate to severe hepatic or renal impairment. There are insufficient data on the efficacy and safety of this combination therapy.

Ingredients

Manufacturer
Gunil Biopharm Co., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of gastric and duodenal ulcers, treatment of reflux esophagitis, and suppression of gastric acid hypersecretion

  • Gastric and duodenal ulcers
  • duodenal ulcers
  • gastric ulcers
  • gastroesophageal reflux disease
  • excessive gastric acid secretion
View approved original text

This medication is used in combination with antibiotics for the prevention of recurrence of gastric and duodenal ulcers infected with Helicobacter pylori. It is also effective in treating duodenal ulcers and gastric ulcers and helps alleviate moderate to severe gastroesophageal reflux disease. It is applied in pathological conditions of excessive gastric acid secretion such as Zollinger-Ellison syndrome. This medication controls gastric acid secretion to improve symptoms of gastrointestinal diseases and prevents recurrence, maintaining a healthy gastric condition.

How to take

Adult dose

1. Antibiotic combination therapy to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori - The usual adult dose is 40 mg of pantoprazole twice daily (before breakfast and dinner) for 1 week, in combination with the following antibiotics. Swallow whole; do not chew or crush. (1) Take 1,000 mg of amoxicillin and 500 mg of clarithromycin twice daily for 1 week; or (2) Take 500 mg of metronidazole and 500 mg of clarithromycin twice daily for 1 week; or (3) Take 1,000 mg of amoxicillin and 500 mg of metronidazole 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 dose recommendations below for duodenal and gastric ulcers should be considered. - If combination therapy is not required (e.g., a negative test for Helicobacter pylori infection), use pantoprazole monotherapy according to the regimen below. 2. Gastric ulcer and reflux esophagitis - The usual adult dose is 40 mg of pantoprazole once daily, taken with water before breakfast; swallow whole without chewing or crushing. - Healing occurs within 4 weeks in most patients, although the healing time may vary. If the ulcer has not healed after the initial 4 weeks, continue treatment for an additional 4 weeks. - If there has been no response to other treatments, the dose may be doubled to 80 mg of pantoprazole daily. 3. Duodenal ulcer - The usual adult dose is 40 mg of pantoprazole once daily, taken with water before breakfast; swallow whole without chewing or crushing. - Healing occurs within 2 weeks in most patients, although the healing time may vary. If the ulcer has not healed after the initial 2 weeks, continue treatment for an additional 2 weeks. - If there has been no response to other treatments, the dose may be doubled to 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 two daily doses. - Temporary increases to 160 mg or more are possible, but should be used only as long as needed to achieve adequate control of acid secretion. - The duration of treatment is not limited but should be adjusted according to clinical need. ○ In patients with severe hepatic impairment, reduce the dose so that it does not exceed 20mg of pantoprazole once daily. ○ Do not exceed 40 mg of pantoprazole daily in elderly patients or patients with renal impairment. As an exception, elderly patients may receive this medicine at 40 mg twice daily (before breakfast and dinner) for 1 week as part of the antibiotic combination therapy described above. Swallow whole without chewing or crushing. ○ Do not use antibiotic combination therapy in patients with moderate to severe hepatic or 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 hepatic or renal function impairment, as there is insufficient clinical experience regarding its safety and efficacy. Patients who have had allergic reactions to this medication or its ingredients, or to benzimidazole class medications, should not be treated with this medication. Allergic reactions may include anaphylaxis, angioedema, and bronchospasm. In particular, caution is required when this medication is used in combination with antibiotics in patients allergic to penicillin and macrolide-class antibiotics. Moreover, patients currently taking certain medications (terfenadine, cisapride, pimodivir, astemizole, atazanavir, nelfinavir, rilpivirine) should not use this medication concurrently. It is safer for women during the first three months of pregnancy or those who may become pregnant, as well as breastfeeding women, to avoid this medication. This medication may lead to side effects in various systems such as gastrointestinal, systemic, hepatobiliary, immune, musculoskeletal, nervous, psychiatric, skin, endocrine, and hematological systems; therefore, if any unusual symptoms occur, consulting a doctor immediately is necessary. If this medication is taken long-term, especially for more than one year, regular check-ups are necessary as metabolic abnormalities such as increased fracture risk or hypomagnesemia may occur, and caution should be exercised. Due to its action of suppressing gastric acid secretion, the risk of gastrointestinal bacterial infections may increase; therefore, any persistent diarrhea symptoms should be reported to healthcare providers. Dizziness or visual disturbances may occur, so caution is advised when driving or operating machinery. This medication may interact with other drugs, especially anticoagulants, antiviral agents, antibiotics, and immunosuppressants, so it is important to inform your doctor if you are taking them. Pregnant or nursing women are advised against using this medication, and caution is warranted due to the lack of experience in children and adolescents. No specific symptoms have been reported in the case of overdose; however, if any unusual symptoms occur, consultation with a healthcare provider should be sought. When taking this medication, it is advisable not to chew or crush the tablet but to swallow it whole, and it should be stored out of reach of children. Long-term use of this medication may result in changes in gastric tissue; therefore, it is recommended to take it only for the minimum necessary dosage and duration.

Side effects

Upper abdominal pain, constipation, distension, diarrhea, nausea, vomiting, belching, dry mouth, fatigue, weakness, lethargy, edema, elevated body temperature, fever, increased liver enzyme levels, elevated bilirubin, jaundice, anaphylactic shock, arthralgia, myalgia, rhabdomyolysis, bone fractures, headache, dizziness, visual disturbances, taste alteration, insomnia, sleep disturbances, 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, lipid increase, weight change, hyponatremia, hypomagnesemia, elevated CK, anxiety, asthenia, low back pain, bronchitis, chest pain, increased cough, dyspepsia, dyspnea, flu-like symptoms, gastroenteritis, gastrointestinal disturbances, tension, infection, migraine, cervical pain, pain, pharyngitis, rectal abnormalities, rhinitis, elevated AST, sinusitis, upper respiratory infection, frequent urination, urinary tract infection, abscess, allergic reaction, chills, tonsillitis, facial edema, generalized edema, heat sensation, hernia, abnormal clinical laboratory tests, malaise, moniliasis, tumors, nonspecific drug reactions, electrocardiogram abnormalities, angina, arrhythmia, atrial fibrillation, coronary artery disease, congestive heart failure, hemorrhage, 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 ulcer, oral moniliasis, periodontal abscess, periodontitis, rectal bleeding, gastric ulcer, abnormal bowel movements, 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, tendinitis, abnormal dream, confusion, seizures, dry mouth, speech disorder, hallucinations, hyperactivity, decreased libido, nervousness, neuralgia, neuritis, neurological disorders, abnormal sensation, decreased reflexes, sleep disturbances, drowsiness, abnormal perception, tremor, asthma, nosebleed, hiccups, laryngitis, respiratory difficulties, pneumonia, voice changes, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, hemorrhage, herpes simplex, shingles, lichen planus, papular rash, skin disorders, skin ulcers, sweating, amblyopia, cataract, hearing loss, diplopia, otalgia, paralysis, glaucoma, external otitis, taste alteration, tinnitus, albuminuria, balanitis, mastalgia, cystitis, menstrual irregularities, urination disorders, epididymitis, hematuria, erectile dysfunction, kidney stones, renal pain, enuresis, prostate disorders, pyelonephritis, scrotal edema, urethral pain, urethral disorders, urological abnormalities, vaginitis, Clostridium difficile-associated diarrhea, hypocalcemia, hypokalemia, DRESS syndrome, microscopic colitis, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric gland polyps

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light, so it should be stored in a tightly sealed container that protects it from light. It is important to maintain storage temperatures between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow, enteric-coated, oval tablet

Package unit

30 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.

Questions about this medicine

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.