Medication info

Pantoprazole 40 mg Tablet (Pantoprazole Sodium Sesquihydrate)

Prescription medicationTabletOralExpired
Ingredient · strength
Pantoprazole Sodium Sesquihydrate›45.1mg / 1 tablet
Manufacturer / importer
Dongwha Pharmaceutical Co., Ltd.
Appearance
Yellow oval enteric-coated tablet
Packaging
30 tablets/bottle
Approval status
Expired

MFDS item code 202002296 · Approved 2020.04.02

This product's status changed to Expired on 2025.04.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment and prevention of recurrence of gastric and duodenal ulcers; treatment of reflux esophagitis and 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 the evening meal) for 1 week, in combination with the following antibiotics. 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 recommended doses according to the regimens below should be considered for duodenal and gastric ulcers. - If combination therapy is not needed (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 40 mg of pantoprazole once daily, taken with water before breakfast. Do not chew or crush. - Healing occurs within 4 weeks in most patients, although the healing time may vary occasionally. If the ulcer has not healed after the initial 4 weeks of treatment, 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. Do not chew or crush. - Healing occurs within 2 weeks in most patients, although the healing time may vary occasionally. If the ulcer has not healed after the initial 2 weeks of treatment, 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 gastric acid secretion measurements. - Doses greater than 80 mg should be divided into two daily doses. - A temporary increase to more than 160 mg is possible, but should be used only for as long as needed 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 20mg of pantoprazole once daily. ○ In elderly patients or patients with renal impairment, the dose should not exceed 40 mg of pantoprazole daily. As an exception, elderly patients may take 40 mg of this medicine twice daily (before breakfast and the evening meal) for 1 week as part of the antibiotic combination therapy described above. Do not chew or crush. ○ 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
Dongwha Pharmaceutical Co., Ltd.

Efficacy & effects

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

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

This medication is used as part of an antibiotic combination therapy to prevent the recurrence of Helicobacter pylori-infected gastric and duodenal ulcers. It is also effective in treating duodenal ulcers and gastric ulcers, and helps alleviate symptoms of moderate to severe gastroesophageal reflux disease. It is used in pathological conditions of excessive gastric acid secretion, such as Zollinger-Ellison syndrome, and contributes to controlling gastric acid. It is effective in treating and preventing various gastrointestinal diseases, improving patient symptoms and preventing recurrence.

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 the evening meal) for 1 week, in combination with the following antibiotics. 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 recommended doses according to the regimens below should be considered for duodenal and gastric ulcers. - If combination therapy is not needed (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 40 mg of pantoprazole once daily, taken with water before breakfast. Do not chew or crush. - Healing occurs within 4 weeks in most patients, although the healing time may vary occasionally. If the ulcer has not healed after the initial 4 weeks of treatment, 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. Do not chew or crush. - Healing occurs within 2 weeks in most patients, although the healing time may vary occasionally. If the ulcer has not healed after the initial 2 weeks of treatment, 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 gastric acid secretion measurements. - Doses greater than 80 mg should be divided into two daily doses. - A temporary increase to more than 160 mg is possible, but should be used only for as long as needed 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 20mg of pantoprazole once daily. ○ In elderly patients or patients with renal impairment, the dose should not exceed 40 mg of pantoprazole daily. As an exception, elderly patients may take 40 mg of this medicine twice daily (before breakfast and the evening meal) for 1 week as part of the antibiotic combination therapy described above. Do not chew or crush. ○ 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

It is advisable to avoid using this medication in patients with moderately to severely impaired liver or kidney function. Patients with allergies or hypersensitivity to this drug, its components, or benzimidazole drugs should not take it. Care should be taken when combining this medication with penicillin or macrolide antibiotics in patients with known allergies. Women in early pregnancy, those who may become pregnant, and breastfeeding women should avoid using this drug. This medication suppresses gastric acid secretion and may increase the risk of infection due to bacterial overgrowth in the stomach with long-term use. Long-term use may lead to vitamin B12 absorption disorders or electrolyte abnormalities like hypomagnesemia, necessitating regular monitoring. This medication interacts with certain antiviral drugs or antibiotics, which may reduce its efficacy or increase the risk of side effects; therefore, it should be discussed with a healthcare professional. Dizziness or vision disturbances may occur while taking this medication, requiring caution during driving or machinery operation. When taking this medication, it should be swallowed whole, not chewed or crushed, and kept out of reach of children. There is no specific antidote for overdose; appropriate treatment should be provided based on symptoms. The safety and efficacy of this medication have not been sufficiently confirmed in children or adolescents under 18 years of age. Any unusual symptoms or suspected side effects during treatment should prompt immediate consultation with a healthcare professional.

Side effects

  • Upper abdominal pain
  • constipation
  • bloating
  • diarrhea
  • gastric polyps
  • nausea
  • vomiting
  • belching
  • dry mouth
  • fatigue
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  • asthenia
  • lethargy
  • edema
  • increased body temperature
  • fever
  • elevated liver enzyme levels
  • elevated bilirubin
  • jaundice
  • anaphylactic shock
  • joint pain
  • muscle pain
  • rhabdomyolysis
  • bone fracture
  • headache
  • dizziness
  • visual disturbance
  • taste abnormalities
  • insomnia
  • sleep disturbances
  • depression
  • hallucinations
  • confusion
  • disorientation
  • interstitial nephritis
  • itching
  • skin erythema
  • 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
  • back pain
  • bronchitis
  • chest pain
  • increased cough
  • dyspepsia
  • dyspnea
  • influenza-like symptoms
  • gastroenteritis
  • gastrointestinal disorders
  • tension
  • infection
  • migraine
  • cervical pain
  • pain
  • pharyngitis
  • rectal disorders
  • rhinitis
  • elevated AST
  • sinusitis
  • upper respiratory infection
  • frequency of urination
  • urinary tract infection
  • boil
  • allergic reaction
  • chills
  • furuncle
  • facial edema
  • generalized edema
  • warmth
  • hernia
  • abnormal laboratory test results
  • 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 disease
  • syncope
  • tachycardia
  • phlebitis
  • thrombosis
  • vasodilation
  • decreased appetite
  • aphthous stomatitis
  • colitis
  • duodenitis
  • swallowing difficulties
  • enteritis
  • esophageal hemorrhage
  • esophagitis
  • gastric-duodenal tumor
  • gastric-duodenal hemorrhage
  • gastric-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
  • cholecystalgia
  • 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 disorders
  • joint disorders
  • leg cramps
  • bursitis
  • tendinitis
  • abnormal dream
  • confusion
  • convulsion
  • dry mouth
  • dysarthria
  • hallucinations
  • hyperactivity
  • decreased libido
  • restlessness
  • neuralgia
  • neuritis
  • neurodisorder
  • dysesthesia
  • decreased reflexes
  • sleep disturbances
  • drowsiness
  • abnormal perception
  • tremor
  • asthma
  • nosebleed
  • hiccups
  • laryngitis
  • respiratory distress
  • pneumonia
  • voice modification
  • acne
  • alopecia
  • contact dermatitis
  • eczema
  • fungal dermatitis
  • bleeding
  • herpes simplex
  • shingles
  • lichenoid dermatitis
  • papular rash
  • skin disease
  • skin ulcer
  • sweating
  • amblyopia
  • cataract
  • hearing loss
  • diplopia
  • otalgia
  • paralysis
  • glaucoma
  • otitis externa
  • taste abnormalities
  • tinnitus
  • albuminuria
  • balanitis
  • breast pain
  • cystitis
  • menstrual irregularities
  • dysuria
  • epididymitis
  • hematuria
  • erectile dysfunction
  • kidney stones
  • renal pain
  • nocturia
  • prostate disorders
  • pyelonephritis
  • scrotal edema
  • urethral pain
  • urethral disease
  • urinary 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 medication is sensitive to light and should be stored in a tightly closed container that protects it from light. It is important to maintain the storage temperature between 1°C and 30°C at room temperature.

Appearance and packaging

Appearance

Yellow oval enteric-coated 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

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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.