Medication info

Pantoprazole (Pantoprazole Sodium Sesquihydrate)

Prescription medication
Ingredient · strength
Pantoprazole Sodium Sesquihydrate›42.3mg / 1 vial
Manufacturer / importer
Dongwha Pharm Co., Ltd.
Appearance
This drug is a colorless, transparent vial containing a white to almost white dry powder.
Packaging
46.1 mg/vial [1 vial (46.1 mg/vial)]
Approval status
Active

MFDS item code 200702319 · Notified 2007.02.22 · Insurance code 642703571

Summary

Main use
Treatment of moderate-to-severe reflux esophagitis, peptic ulcers, and pathological gastric acid hypersecretion
Who uses it
Adults
Adult dosage
If oral administration of pantoprazole is not appropriate, dissolve 10 mL of normal saline injection in each vial of this medicine (equivalent to 40 mg of pantoprazole) and administer by direct intravenous injection, or mix this solution with 100 mL of normal saline injection or 5 % dextrose solution and administer intravenously over 2∼15 minutes. As soon as oral administration becomes possible, discontinue intravenous pantoprazole and switch to oral pantoprazole 40 mg. 1. Duodenal ulcer, gastric ulcer, moderate to severe reflux esophagitis Administer 1 vial of this medicine (equivalent to 40 mg of pantoprazole) intravenously once daily. 2. Zollinger-Ellison syndrome and other pathological hypersecretory conditions - Start with an initial dose of 80 mg per day, then increase or decrease the dose according to measurements of gastric acid secretion. - Doses of 80 mg or more should be administered in 2 divided doses per day. - A temporary increase to 160 mg or more is possible, but should be used only for as long as necessary to achieve adequate acid control. - When rapid acid control is required, an initial dose of 2 × 80 mg reduced acid output to the target range (< 10 mEq/h) within one hour in most patients. ◯ In patients with severe hepatic impairment, the daily dose should be reduced to 20 mg of pantoprazole. ◯ In elderly patients or patients with renal impairment, the daily dose should not exceed 40 mg of pantoprazole.

Ingredients

Manufacturer
Dongwha Pharm Co., Ltd.

Efficacy & effects

Treatment of moderate-to-severe reflux esophagitis, peptic ulcers, and pathological gastric acid hypersecretion

  • Duodenal ulcers
  • gastric ulcers
  • gastroesophageal reflux disease
  • Zollinger-Ellison syndrome
  • conditions of excessive gastric acid secretion
View approved original text

This medication is used for peptic ulcers, including duodenal and gastric ulcers. It is also effective for the treatment of moderate to severe gastroesophageal reflux disease. Additionally, it helps manage conditions of excessive gastric acid secretion, such as Zollinger-Ellison syndrome. Therefore, it is used to treat various gastric-related diseases.

Dosage and Administration

Adult dosage

If oral administration of pantoprazole is not appropriate, dissolve 10 mL of normal saline injection in each vial of this medicine (equivalent to 40 mg of pantoprazole) and administer by direct intravenous injection, or mix this solution with 100 mL of normal saline injection or 5 % dextrose solution and administer intravenously over 2∼15 minutes. As soon as oral administration becomes possible, discontinue intravenous pantoprazole and switch to oral pantoprazole 40 mg. 1. Duodenal ulcer, gastric ulcer, moderate to severe reflux esophagitis Administer 1 vial of this medicine (equivalent to 40 mg of pantoprazole) intravenously once daily. 2. Zollinger-Ellison syndrome and other pathological hypersecretory conditions - Start with an initial dose of 80 mg per day, then increase or decrease the dose according to measurements of gastric acid secretion. - Doses of 80 mg or more should be administered in 2 divided doses per day. - A temporary increase to 160 mg or more is possible, but should be used only for as long as necessary to achieve adequate acid control. - When rapid acid control is required, an initial dose of 2 × 80 mg reduced acid output to the target range (< 10 mEq/h) within one hour in most patients. ◯ In patients with severe hepatic impairment, the daily dose should be reduced to 20 mg of pantoprazole. ◯ In elderly patients or patients with renal impairment, the daily dose should not exceed 40 mg of pantoprazole.

Precautions

This medication should not be used in patients with hypersensitivity to certain ingredients or those who have experienced allergic reactions such as anaphylaxis, angioedema, or bronchospasm in the past. Furthermore, patients currently on certain antiviral drugs or those being treated with antiviral agents should not receive this medication. Caution is required when using this medication, as various side effects may occur. Relatively common symptoms include dyspepsia, diarrhea, headache, dizziness, and skin rash; however, rare but serious adverse reactions have also been reported, including severe liver damage, severe allergic reactions, skin diseases, and kidney problems. Regular check-ups are needed for long-term use, especially to monitor liver function. This drug is not suitable for mild dyspepsia and may require additional testing if symptoms persist. Patients with severely impaired liver function should reduce the dose, and treatment should be discontinued if liver enzyme levels increase. Long-term use may increase the risk of fractures, so caution is necessary. Additionally, long-term use may lead to hypomagnesemia, so blood magnesium levels should be monitored periodically. This medication suppresses gastric acid secretion, which may increase the risk of bacterial infections in the gastrointestinal tract, so consult with healthcare professionals if diarrhea persists. Dizziness or visual disturbances may occur, so caution is advised when driving or operating machinery. This drug may interact with various medications, so inform your doctor if you are taking other medications. Caution is especially needed when used in conjunction with anticoagulants, methotrexate, or certain antivirals. It is advisable not to use this medication during the first three months of pregnancy, and it should only be used during pregnancy if the potential benefits outweigh the risks. It is recommended that breastfeeding women do not use this medication. There is insufficient experience to recommend use in children or adolescents under 18 years of age. Although no special safety differences exist for the elderly, caution is warranted based on their condition. No specific symptoms have been reported in cases of overdose, but if unusual symptoms occur, consult healthcare professionals immediately. This drug should be prepared and stored according to instructions before administration, and do not use if the product is discolored or contaminated. Long-term use may increase the risk of gastric polyps, so the minimum effective dose and shortest duration of use are recommended. If any abnormal reactions occur in the skin or body during the course of taking this medication, notify healthcare professionals immediately for evaluation.

Side effects

  • Anaphylaxis
  • anaphylactic shock
  • angioedema
  • bronchospasm
  • acute interstitial nephritis
  • urticaria
  • agranulocytosis
  • leukopenia
  • thrombocytopenia
  • pancytopenia
Show 72 more
  • upper abdominal pain
  • diarrhea
  • constipation
  • abdominal bloating
  • dyspepsia
  • gastric polyp
  • nausea
  • vomiting
  • dry mouth
  • rhinitis
  • injection site reaction
  • thrombophlebitis at the injection site
  • fever
  • peripheral edema
  • pyrexia
  • elevated bilirubin
  • hepatic failure
  • jaundice
  • hepatocellular damage
  • elevated liver enzymes
  • arthralgia
  • myalgia
  • rhabdomyolysis
  • bone fracture
  • headache
  • dizziness
  • visual impairment
  • taste disturbance
  • insomnia
  • sleep disorder
  • depression
  • hallucinations
  • disorientation
  • confusion
  • interstitial nephritis
  • itching
  • skin erythema
  • Stevens-Johnson syndrome
  • erythema multiforme
  • toxic epidermal necrolysis
  • photosensitivity reaction
  • gynecomastia
  • hyperlipidemia
  • increased lipids
  • weight change
  • hyponatremia
  • hypomagnesemia
  • elevated CK
  • shock
  • anterior ischemic optic neuropathy
  • elevated creatine kinase
  • severe skin reactions
  • jaundice due to hepatocellular damage
  • interstitial nephritis
  • pancreatitis
  • confusion
  • hypokinesia
  • speech impairment
  • hypersalivation
  • vertigo
  • tinnitus
  • hypocalcemia
  • hypokalemia
  • Clostridium difficile diarrhea
  • paresthesia
  • DRESS syndrome
  • microscopic colitis
  • systemic lupus erythematosus
  • discoid lupus erythematosus
  • rash of discoid lupus erythematosus
  • arthralgia
  • cytopenia.

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

Storage

This drug may be sensitive to light, so it should be stored in a tightly closed container that does not allow light to enter. Additionally, it is important to store it at a cool temperature below 25 degrees Celsius to maintain the drug's effectiveness.

Appearance and packaging

Appearance

This drug is a colorless, transparent vial containing a white to almost white dry powder.

Package unit

46.1 mg/vial [1 vial (46.1 mg/vial)]

Same-ingredient medicines

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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.