Medication info
Pantoloc 40 mg (Pantoprazole Sodium Sesquihydrate)

Pantoloc 40 mg (Pantoprazole Sodium Sesquihydrate)

Prescription medicationTabletOral
Ingredient · strength
Pantoprazole Sodium Sesquihydrate›45.1mg / 1 tablet
Manufacturer / importer
Takeda Pharmaceuticals Korea CO., Ltd.
Appearance
Yellow, oval tablet with enteric coating printed with P40 on one side
Packaging
30 tablets/package
Approval status
Active

MFDS item code 201006491 · Approved 2010.10.26 · Insurance code 696300060

Summary

Main use
Treatment and prevention of recurrence of gastroesophageal reflux disease and gastric and duodenal ulcers; treatment 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 pantoprazole 40 mg per dose twice daily (before breakfast and dinner) for 1 week, in combination with the following antibiotics. 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. - Regimens using metronidazole 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 required (e.g., negative for Helicobacter pylori infection), use pantoprazole monotherapy according to the regimens below. 2. Gastric ulcer and reflux esophagitis - The usual adult dose is pantoprazole 40 mg once daily in the morning before breakfast, swallowed with water without chewing or crushing. - Most patients may be healed within 4 weeks, although healing time may vary between patients. If healing is not complete after the first 4 weeks, continue treatment for another 4 weeks. - If there has been no response to other treatments, the dose may be doubled (pantoprazole 80 mg daily). 3. Duodenal ulcer - The usual adult dose is pantoprazole 40 mg once daily in the morning before breakfast, swallowed with water without chewing or crushing. - Most patients may be healed within 2 weeks, although healing time may vary between patients. If healing is not complete after the first 2 weeks, continue treatment for another 2 weeks. - If there has been no response to other treatments, 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 measurements of gastric acid secretion. - Doses of 80 mg or more should be divided into 2 doses per day. - Temporary dose increases to 160 mg or more are possible, but should be limited to the amount needed to control acid secretion. - 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 to no more than pantoprazole 20mg once daily. ◯ Do not exceed pantoprazole 40 mg daily in elderly patients or patients with renal impairment. As an exception, elderly patients may take 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 or renal impairment. There are insufficient data on the efficacy and safety of this combination therapy.

Ingredients

Importer
Takeda Pharmaceuticals Korea CO., Ltd.

Efficacy & effects

Treatment and prevention of recurrence of gastroesophageal reflux disease and gastric and duodenal ulcers; treatment of gastric acid hypersecretion

  • Infection with Helicobacter pylori
  • duodenal ulcer
  • gastric ulcer
  • moderate gastroesophageal reflux disease
  • severe gastroesophageal reflux disease
  • Zollinger-Ellison syndrome
  • pathological gastric acid hypersecretion condition
View approved original text

This medication is used in combination with antibiotics to prevent the recurrence of gastric and duodenal ulcers caused by Helicobacter pylori infection. It is also effective for the treatment of duodenal ulcers and gastric ulcers. It can improve moderate to severe symptoms of gastroesophageal reflux disease and is applicable in conditions of pathological gastric acid hypersecretion such as Zollinger-Ellison syndrome. This treatment helps in the recovery of gastrointestinal diseases and symptom relief.

How to take

Adult dose

1. Antibiotic combination therapy to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori - The usual adult dose is pantoprazole 40 mg per dose twice daily (before breakfast and dinner) for 1 week, in combination with the following antibiotics. 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. - Regimens using metronidazole 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 required (e.g., negative for Helicobacter pylori infection), use pantoprazole monotherapy according to the regimens below. 2. Gastric ulcer and reflux esophagitis - The usual adult dose is pantoprazole 40 mg once daily in the morning before breakfast, swallowed with water without chewing or crushing. - Most patients may be healed within 4 weeks, although healing time may vary between patients. If healing is not complete after the first 4 weeks, continue treatment for another 4 weeks. - If there has been no response to other treatments, the dose may be doubled (pantoprazole 80 mg daily). 3. Duodenal ulcer - The usual adult dose is pantoprazole 40 mg once daily in the morning before breakfast, swallowed with water without chewing or crushing. - Most patients may be healed within 2 weeks, although healing time may vary between patients. If healing is not complete after the first 2 weeks, continue treatment for another 2 weeks. - If there has been no response to other treatments, 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 measurements of gastric acid secretion. - Doses of 80 mg or more should be divided into 2 doses per day. - Temporary dose increases to 160 mg or more are possible, but should be limited to the amount needed to control acid secretion. - 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 to no more than pantoprazole 20mg once daily. ◯ Do not exceed pantoprazole 40 mg daily in elderly patients or patients with renal impairment. As an exception, elderly patients may take 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 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 liver or kidney dysfunction as there is insufficient clinical experience regarding its safety and efficacy. Additionally, patients with a history of allergic reactions to this medication, its components, or benzimidazole class medications should avoid use. Patients allergic to penicillin and macrolide antibiotics should also be cautious when using this medication in combination, and patients taking certain heart-related medications should not use it concurrently. It is safest for women in their first three months of pregnancy or those who may become pregnant, as well as breastfeeding women, to avoid this medication. During the course of this medication, various side effects such as gastrointestinal symptoms, general fatigue, liver dysfunction, and allergic reactions may occur, and if any abnormal symptoms appear, medical consultation should be sought immediately. Particularly when used long-term, regular monitoring of liver function and blood status is important. This medication suppresses gastric acid secretion, which may enhance the possibility of bacterial growth in the gastrointestinal tract; therefore, if symptoms of infection such as diarrhea persist, consulting a specialist is necessary. Moreover, this medication may interact with other drugs, so any other medications being taken should be disclosed to healthcare professionals. When taking, do not chew or crush the tablet, but swallow it whole, and keep it out of reach of children. Finally, this medication has not been adequately tested for dosing in children or adolescents, so caution is required for its use.

Side effects

Upper abdominal pain, constipation, bloating, diarrhea, gastric polyps, nausea, vomiting, belching, dry mouth, fatigue, asthenia, lethargy, edema, increased 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, mucous membrane syndrome, erythema multiforme, toxic epidermal necrolysis, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, lipid increase, weight changes, hyponatremia, hypomagnesemia, elevated CK, anxiety, lethargy, low back pain, 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, frequent urination, urinary tract infection, boil, allergic reaction, chills, abscess, facial edema, general edema, heat sensation, hernia, laboratory test abnormalities, malaise, moniliasis, tumor, nonspecific drug reactions, ECG abnormalities, angina pectoris, arrhythmia, atrial fibrillation, coronary artery disease, congestive heart failure, bleeding, hypertension, hypotension, myocardial infarction, myocardial ischemia, palpitations, retinal vascular disease, syncope, tachycardia, venous inflammation, thrombosis, vasodilation, decreased appetite, aphthous stomatitis, colitis, duodenitis, swallowing disorders, 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 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, speech disorder, hallucinations, hyperactivity, decreased libido, restlessness, neuralgia, neuritis, neurological disorders, paresthesia, decreased reflexes, sleep disturbances, drowsiness, perceptual disturbances, tremor, asthma, nosebleed, hiccups, laryngitis, respiratory distress, pneumonia, voice distortion, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, bleeding, herpes simplex, shingles, lichenoid dermatitis, papular rash, skin diseases, skin ulcer, sweating, amblyopia, cataract, hearing loss, diplopia, ear pain, paralysis, glaucoma, otitis externa, taste disturbances, tinnitus, albuminuria, balanitis, breast pain, cystitis, menstrual irregularities, urination disorders, epididymitis, hematuria, erectile dysfunction, kidney stones, kidney pain, nocturnal enuresis, prostate disorders, pyelonephritis, scrotal edema, urethral pain, urethral disorders, urinary anomalies, vaginitis, clostridium difficile-associated diarrhea, hypocalcemia, hypokalemia, DRESS syndrome, acute generalized exanthematous pustulosis, microscopic colitis, systemic lupus erythematosus, discoid lupus erythematosus, gastric polyps, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, eosinophilia with systemic symptoms associated drug reactions, acute generalized exanthematous pustulosis

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

Storage

Due to its sensitivity to light, this medication should be stored in a container that blocks light. Additionally, to maintain its efficacy, it should be stored at room temperature, between 1°C and 30°C.

Appearance and packaging

Appearance

Yellow, oval tablet with enteric coating printed with P40 on one side

Package unit

30 tablets/package

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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.