Medication info
Pantoprazole Tablets 40 mg (Pantoprazole Sodium Sesquihydrate)

Pantoprazole Tablets 40 mg (Pantoprazole Sodium Sesquihydrate)

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

MFDS item code 200400910 · Notified 2004.09.03 · Insurance code 642401560

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of gastroesophageal reflux disease and gastric acid hypersecretion
Who takes it
Adults
Adult dose
1. Combination therapy with antibiotics to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori The usual adult dose is 40 mg of pantoprazole per dose twice daily (before breakfast and dinner), in combination with the following antibiotics, for 1 week. Swallow whole without chewing or crushing. (1) Take 1,000 mg of amoxicillin per dose and 500 mg of clarithromycin per dose twice daily for 1 week, or (2) Take 500 mg of metronidazole per dose and 500 mg of clarithromycin per dose twice daily for 1 week, or (3) Take 1,000 mg of amoxicillin per dose and 500 mg of metronidazole per dose twice daily for 1 week. The 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 dosage recommendations below for duodenal and gastric ulcers should be considered. If combination therapy is not needed (e.g., when testing negative for Helicobacter pylori infection), use pantoprazole monotherapy according to the dosage instructions below. 2. Gastric ulcers 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 can usually be achieved within 4 weeks, although the healing period may vary among patients. If the ulcer has not healed after the first 4 weeks of treatment, continue treatment for another 4 weeks. If there is no response to other treatments, the dose may be doubled (to 80 mg of pantoprazole per day). 3. Duodenal ulcers The usual adult dose is 40 mg of pantoprazole once daily, taken with water before breakfast. Swallow whole without chewing or crushing. Healing can usually be achieved within 2 weeks, although the healing period may vary among patients. If the ulcer has not healed after the first 2 weeks of treatment, continue treatment for another 2 weeks. If there is no response to other treatments, the dose may be doubled (to 80 mg of pantoprazole per day). 4. Zollinger-Ellison syndrome and other pathological hypersecretory conditions Initiate treatment with a starting dose of 80 mg of pantoprazole per day, then increase or decrease the dose according to measurements of gastric acid secretion. For doses of 80 mg or more, divide the daily dose into 2 doses. The dose may temporarily be increased to 160 mg or more, but 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 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 per day. In elderly patients, as an exception, this medicine may be taken at 40 mg per dose twice daily (before breakfast and dinner) for 1 week in the antibiotic combination therapy described above. Swallow whole 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
Youngjin Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Infection by Helicobacter pylori
  • gastric ulcer
  • duodenal ulcer
  • gastroesophageal reflux disease
  • hypersecretion of gastric acid
View approved original text

This medication is used in combination with antibiotics to prevent recurrence of gastric and duodenal ulcers caused by Helicobacter pylori infection. It is also effective in the treatment of duodenal ulcers and gastric ulcers, and helps alleviate symptoms of moderate to severe gastroesophageal reflux disease. It is used in the treatment of pathological conditions caused by Zollinger-Ellison syndrome and excessive gastric acid secretion. This drug contributes to improving symptoms and restoring health in various gastrointestinal diseases caused by excessive gastric acid.

How to take

Adult dose

1. Combination therapy with antibiotics to prevent recurrence of gastroduodenal ulcers infected with Helicobacter pylori The usual adult dose is 40 mg of pantoprazole per dose twice daily (before breakfast and dinner), in combination with the following antibiotics, for 1 week. Swallow whole without chewing or crushing. (1) Take 1,000 mg of amoxicillin per dose and 500 mg of clarithromycin per dose twice daily for 1 week, or (2) Take 500 mg of metronidazole per dose and 500 mg of clarithromycin per dose twice daily for 1 week, or (3) Take 1,000 mg of amoxicillin per dose and 500 mg of metronidazole per dose twice daily for 1 week. The 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 dosage recommendations below for duodenal and gastric ulcers should be considered. If combination therapy is not needed (e.g., when testing negative for Helicobacter pylori infection), use pantoprazole monotherapy according to the dosage instructions below. 2. Gastric ulcers 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 can usually be achieved within 4 weeks, although the healing period may vary among patients. If the ulcer has not healed after the first 4 weeks of treatment, continue treatment for another 4 weeks. If there is no response to other treatments, the dose may be doubled (to 80 mg of pantoprazole per day). 3. Duodenal ulcers The usual adult dose is 40 mg of pantoprazole once daily, taken with water before breakfast. Swallow whole without chewing or crushing. Healing can usually be achieved within 2 weeks, although the healing period may vary among patients. If the ulcer has not healed after the first 2 weeks of treatment, continue treatment for another 2 weeks. If there is no response to other treatments, the dose may be doubled (to 80 mg of pantoprazole per day). 4. Zollinger-Ellison syndrome and other pathological hypersecretory conditions Initiate treatment with a starting dose of 80 mg of pantoprazole per day, then increase or decrease the dose according to measurements of gastric acid secretion. For doses of 80 mg or more, divide the daily dose into 2 doses. The dose may temporarily be increased to 160 mg or more, but 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 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 per day. In elderly patients, as an exception, this medicine may be taken at 40 mg per dose twice daily (before breakfast and dinner) for 1 week in the antibiotic combination therapy described above. Swallow whole 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 liver or kidney dysfunction, as safety and efficacy have not been established in such cases. Serious allergic reactions may occur in patients who have had allergic reactions to this drug, its components, or benzimidazole derivatives. Caution is especially necessary for patients who are allergic to penicillin or macrolide antibiotics when used in combination. Women in early pregnancy or with a possibility of pregnancy, as well as breastfeeding women, are advised not to take this drug. Patients with genetic metabolic disorders such as lactose intolerance should avoid this medication due to lactose content. This drug contains certain coloring agents, and patients with allergies to these components should use it cautiously. Taking this drug may cause various side effects such as indigestion, headache, dizziness, skin rash, etc., and if any abnormal symptoms occur, consult a doctor immediately. Regular examinations such as liver function tests are required during long-term use, and if liver function deteriorates, the medication should be discontinued. This drug inhibits gastric acid secretion, which may increase the risk of bacterial infections in the gastrointestinal tract, so if diarrhea persists, inform medical personnel. Furthermore, caution should be exercised as prolonged high doses may increase the risk of bone fractures. There may be interactions with other medications, so it is essential to inform about any current medications. This drug should be taken as directed without chewing or crushing and kept out of reach of children. During pregnancy or breastfeeding, it is safest to avoid taking it, and if necessary, consult a doctor.

Side effects

  • Upper abdominal pain
  • constipation
  • bloating
  • diarrhea
  • gastric adenoma
  • nausea
  • vomiting
  • belching
  • dry mouth
  • fatigue
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  • weakness
  • lethargy
  • edema
  • increased body temperature
  • fever
  • elevated liver enzyme levels
  • increased bilirubin
  • jaundice
  • anaphylactic shock
  • arthralgia
  • myalgia
  • rhabdomyolysis
  • bone fracture
  • headache
  • dizziness
  • visual disturbances
  • taste disturbances
  • insomnia
  • sleep disturbances
  • depression
  • hallucinations
  • confusion
  • disorientation
  • interstitial nephritis
  • itching
  • skin redness
  • 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
  • asthenia
  • 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
  • increased urination
  • urinary tract infection
  • boil
  • allergic reaction
  • chills
  • abscess
  • facial edema
  • generalized edema
  • warm sensation
  • hernia
  • abnormal clinical laboratory tests
  • lethargy
  • moniliasis
  • tumor
  • non-specific drug reaction
  • abnormal electrocardiogram
  • angina pectoris
  • 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 bleeding
  • esophagitis
  • gastric-duodenal tumor
  • gastric-duodenal bleeding
  • gastric-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
  • dehydration
  • gout
  • thirst
  • weight gain
  • weight loss
  • arthritis
  • bone disease
  • joint disease
  • leg cramps
  • bursitis
  • tendinitis
  • abnormal dream
  • confusion
  • convulsions
  • dry mouth
  • speech disorder
  • hyperactivity
  • decreased libido
  • restlessness
  • neuralgia
  • neuritis
  • neurological disorders
  • paresthesia
  • decreased reflexes
  • abnormal perception
  • tremors
  • asthma
  • nosebleed
  • hiccups
  • laryngitis
  • respiratory distress
  • pneumonia
  • voice changes
  • acne
  • alopecia
  • contact dermatitis
  • eczema
  • fungal dermatitis
  • bleeding
  • herpes simplex
  • herpes zoster
  • lichen planus
  • papular rash
  • skin disease
  • skin ulcer
  • sweating
  • amblyopia
  • cataract
  • hearing loss
  • diplopia
  • otalgia
  • paralysis
  • glaucoma
  • otitis externa
  • tinnitus
  • albuminuria
  • balanitis
  • breast pain
  • cystitis
  • menstrual disorder
  • urination disorder
  • epididymitis
  • hematuria
  • erectile dysfunction
  • kidney stones
  • renal pain
  • nocturia
  • prostate disorder
  • pyelonephritis
  • scrotal edema
  • urethral pain
  • urethral disease
  • urological abnormalities
  • vaginitis
  • Clostridium difficile diarrhea
  • DRESS syndrome
  • microscopic colitis
  • systemic lupus erythematosus
  • cutaneous lupus erythematosus

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

Storage

This drug is sensitive to light and should be stored in a container that does not allow light in. Additionally, it is crucial to store it in a cool room temperature, between 1 to 30 degrees Celsius, to maintain its effectiveness.

Appearance and packaging

Appearance

Yellow oval enteric-coated tablet

Package unit

28 tablets/bottle/carton

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

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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.