Medication info
Peptazole 40 mg (Pantoprazole Sodium Sesquihydrate)

Peptazole 40 mg (Pantoprazole Sodium Sesquihydrate)

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

MFDS item code 200502900 · Notified 2005.05.04 · Insurance code 645302090

Summary

Main use
Treatment and prevention of recurrence of reflux esophagitis 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 associated with Helicobacter pylori infection In general, adults should take 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. The metronidazole regimens in (2) and (3) should be used only when the regimen in (1) is unsuitable. 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., in patients who test negative for Helicobacter pylori infection), use 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. Swallow without chewing or crushing. Healing can be achieved within 4 weeks in most cases, although the healing period may occasionally vary by patient. If the condition has not healed after the initial 4 weeks of treatment, continue taking it for a further 4 weeks. If there has been no response to other treatments, the dose may be doubled (pantoprazole 80 mg daily). 3. Duodenal ulcer In general, adults should take pantoprazole 40 mg once daily in the morning before breakfast with water. Swallow without chewing or crushing. Healing can be achieved within 2 weeks in most cases, although the healing period may occasionally vary by patient. If the condition has not healed after the initial 2 weeks of treatment, continue taking it for a further 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 greater than 80 mg should be taken in 2 divided doses daily. The dose may be temporarily increased to 160 mg or more, but 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 liver impairment, reduce the dose so that it does not exceed pantoprazole 20 mg once daily. In elderly patients or patients with renal impairment, do not exceed pantoprazole 40 mg daily. As an exception, elderly patients may take this medicine 40 mg per dose twice daily (before breakfast and dinner) for 1 week in combination with the antibiotics listed above. Swallow 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.

Ingredients

Manufacturer
Hanlim Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Infection with Helicobacter pylori
  • gastric ulcers
  • duodenal ulcers
  • gastroesophageal reflux disease
  • Zollinger-Ellison syndrome
  • conditions of increased gastric acid secretion
View approved original text

This drug is used as part of an antibacterial combination therapy to prevent 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 symptoms of gastroesophageal reflux disease. It is also used to manage conditions of increased gastric acid secretion, such as Zollinger-Ellison syndrome. Therefore, this drug is used for the treatment and relief of various diseases caused by ulcers and excess gastric acid.

How to take

Adult dose

1. Antibiotic combination therapy to prevent recurrence of gastroduodenal ulcers associated with Helicobacter pylori infection In general, adults should take 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. The metronidazole regimens in (2) and (3) should be used only when the regimen in (1) is unsuitable. 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., in patients who test negative for Helicobacter pylori infection), use 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. Swallow without chewing or crushing. Healing can be achieved within 4 weeks in most cases, although the healing period may occasionally vary by patient. If the condition has not healed after the initial 4 weeks of treatment, continue taking it for a further 4 weeks. If there has been no response to other treatments, the dose may be doubled (pantoprazole 80 mg daily). 3. Duodenal ulcer In general, adults should take pantoprazole 40 mg once daily in the morning before breakfast with water. Swallow without chewing or crushing. Healing can be achieved within 2 weeks in most cases, although the healing period may occasionally vary by patient. If the condition has not healed after the initial 2 weeks of treatment, continue taking it for a further 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 greater than 80 mg should be taken in 2 divided doses daily. The dose may be temporarily increased to 160 mg or more, but 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 liver impairment, reduce the dose so that it does not exceed pantoprazole 20 mg once daily. In elderly patients or patients with renal impairment, do not exceed pantoprazole 40 mg daily. As an exception, elderly patients may take this medicine 40 mg per dose twice daily (before breakfast and dinner) for 1 week in combination with the antibiotics listed above. Swallow 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.

Precautions

This drug should not be used in patients with moderate to severe impairment of liver or kidney function, as safety and efficacy have not been sufficiently established. Patients with a history of allergic reactions to this drug, its components, or benzimidazole derivatives should be cautious, as severe allergic reactions such as anaphylactic shock, angioedema, and bronchospasm may occur. Particularly, patients allergic to penicillins or macrolide antibiotics and those taking certain heart-related medications should avoid co-administration with this drug for safety. Pregnant women, women of childbearing potential, and lactating women are advised not to take this medication. This medication contains lactose and should not be administered to patients with lactose intolerance or certain genetic metabolic disorders. During use, various side effects such as abdominal pain, constipation, diarrhea, fatigue, headache, dizziness, rash, allergic reactions, etc., may occur, so if abnormal symptoms arise, immediate consultation with a healthcare professional is required. Patients on long-term treatment should undergo regular health checks, such as liver function tests, and discontinue the medication if liver function worsens. This drug suppresses gastric acid secretion, which may increase the risk of bacterial overgrowth in the stomach, so if diarrhea persists, specialist medical attention should be sought. Additionally, this drug may interact with other medications, so patients taking anticoagulants, antivirals, antibiotics, immunosuppressants, etc., should inform their healthcare provider and use this drug with caution. Pregnant or nursing patients should consult a specialist before using this medication, as its use may affect the fetus or newborn. The safety for children and adolescents under 18 years of age has not been sufficiently established, so caution is required. When taking this medication, do not chew or crush the tablet but swallow it whole, and store it in a safe place out of reach of children. In the event of an overdose, there is no specific antidote, so appropriate treatment should be based on the symptoms.

Side effects

Upper abdominal pain, constipation, bloating, diarrhea, nausea, vomiting, belching, dry mouth, fatigue, weakness, lethargy, edema, elevated body temperature, fever, increased liver enzyme levels, increased bilirubin, jaundice, anaphylactic shock, arthralgia, myalgia, rhabdomyolysis, bone fractures, headache, dizziness, visual disturbances, taste disturbances, insomnia, sleep disorders, depression, hallucinations, confusion, disorientation, interstitial nephritis, pruritus, skin redness, urticaria, angioedema, mucocutaneous syndrome, erythema multiforme, toxic epidermal necrolysis, photosensitivity, hyperglycemia, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, gynecomastia, hyperlipidemia, increased lipids, weight change, hyponatremia, hypomagnesemia, CK increase, anxiety, weakness, low back pain, bronchitis, chest pain, increased coughing, dyspepsia, dyspnea, flu-like symptoms, gastroenteritis, gastrointestinal disturbances, stress, infection, migraine, neck pain, pain, pharyngitis, rectal dysfunction, rhinitis, AST increase, sinusitis, upper respiratory infection, frequent urination, urinary tract infection, boil, allergic reaction, chills, inguinal hernia, abnormalities in clinical laboratory tests, malaise, moniliasis, tumor, nonspecific drug reaction, ECG abnormalities, angina, arrhythmia, atrial fibrillation, coronary artery disease, congestive heart failure, bleeding, hypertension, hypotension, myocardial infarction, myocardial ischemia, palpitations, retinal vascular diseases, syncope, tachycardia, venitis, thrombosis, vasodilation, decreased appetite, aphthous stomatitis, colitis, duodenitis, swallowing difficulties, enteritis, esophageal bleeding, esophagitis, gastric-duodenal tumors, gastric-duodenal bleeding, gastric-duodenal moniliasis, gingivitis, halitosis, hematemesis, increased appetite, melena, oral ulcers, oral moniliasis, periodontal abscess, periodontitis, rectal bleeding, gastric ulcer, bowel movement abnormalities, tongue discoloration, ulcerative colitis, diabetes, goiter, gallbladder pain, hyperbilirubinemia, cholecystitis, cholelithiasis, jaundice, hepatitis, ALP increase, 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 dreams, confusion, seizures, dry mouth, speech disturbance, hallucination, hyperactivity, decreased libido, restlessness, neuralgia, neuritis, neurological disorders, paresthesia, decreased reflexes, sleep disorders, drowsiness, altered perception, tremors, asthma, epistaxis, hiccups, laryngitis, respiratory distress, pneumonia, voice changes, acne, alopecia, contact dermatitis, eczema, fungal dermatitis, bleeding, herpes simplex, shingles, lichen planus, papular urticaria, skin diseases, skin ulcers, sweating, amblyopia, cataract, hearing loss, diplopia, otalgia, paralysis, glaucoma, otitis externa, taste disturbance, tinnitus, albuminuria, balanitis, mastalgia, cystitis, menstrual irregularities, urination disorders, epididymitis, hematuria, erectile dysfunction, kidney stones, renal pain, nocturia, prostate disorders, pyelonephritis, scrotal edema, urethral pain, urethral disorders, urinary abnormalities, vaginitis, Clostridium difficile diarrhea, DRESS syndrome, microscopic colitis, systemic lupus erythematosus, cutaneous lupus erythematosus, gastric polyp

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

Storage

This drug is sensitive to light, so it should be stored in a special container that does not allow light to enter. Additionally, the medication should be stored at room temperature between 1 and 30 degrees Celsius, not in excessively hot or cold places.

Appearance and packaging

Appearance

Yellow enteric-coated oval-shaped tablet

Package unit

28 tablets/bottle

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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.

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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.