Medication info

Glopanto Prazole 40mg (Pantoprazole Sodium Sesquihydrate)

Prescription medication
Ingredient · strength
Pantoprazole Sodium Sesquihydrate›45.1mg / 1 vial
Manufacturer / importer
Keeps Biopharma Co., Ltd.
Appearance
This medication is a colorless transparent vial containing a dry powder that is white to nearly white.
Packaging
1 vial (46.1 mg/vial x 1)
Approval status
Active

MFDS item code 201206431 · Notified 2012.08.09 · Insurance code 693200761

Summary

Main use
Treatment of reflux esophagitis, gastric and duodenal ulcers, and pathological gastric acid hypersecretion
Who uses it
Adults
Adult dosage
When oral administration of pantoprazole is inappropriate, dissolve 1 vial of this product (equivalent to 40 mg of pantoprazole) in 10 mL of normal saline and administer by direct intravenous injection, or mix this solution with 100 mL of normal saline 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 product (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 daily, 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 administrations. - A temporary increase to 160 mg or more is possible, but should be used only for as long as needed 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, reduce the daily dose 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
Keeps Biopharma Co., Ltd.

Efficacy & effects

Treatment of reflux esophagitis, gastric and duodenal ulcers, and pathological gastric acid hypersecretion

  • Duodenal ulcers
  • gastric ulcers
  • gastroesophageal reflux disease
  • excessive gastric acid secretion
View approved original text

This injection is used for the treatment of duodenal ulcers, gastric ulcers, and moderate to severe gastroesophageal reflux disease. It is also effective for pathological conditions of excessive gastric acid secretion, such as Zollinger-Ellison syndrome. This medication helps alleviate symptoms and treat ulcers and inflammation by controlling gastric acid secretion. Therefore, it is used to improve the symptoms of various gastrointestinal disorders.

Dosage and Administration

Adult dosage

When oral administration of pantoprazole is inappropriate, dissolve 1 vial of this product (equivalent to 40 mg of pantoprazole) in 10 mL of normal saline and administer by direct intravenous injection, or mix this solution with 100 mL of normal saline 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 product (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 daily, 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 administrations. - A temporary increase to 160 mg or more is possible, but should be used only for as long as needed 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, reduce the daily dose 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 administered to patients with hypersensitivity to certain ingredients or those who have experienced such reactions in the past. Additionally, patients receiving certain antivirals may see reduced efficacy when used together, so its use should be avoided. Various side effects may occur such as gastrointestinal pain, diarrhea, headache, dizziness, skin rash, etc. Especially, liver dysfunction or severe allergic reactions may occur, and if abnormal symptoms appear, medical consultation should be sought immediately. Regular monitoring is required during long-term use, particularly evaluating liver function and electrolyte levels periodically is important. This medication is not to be used for mild dyspeptic symptoms; if symptoms persist, further examination should be conducted. Patients with renal or liver dysfunction may require dose adjustments, and if liver enzyme levels increase during treatment, administration should be suspended. Caution is required as the risk of fractures may increase with prolonged high doses. This medication may slightly increase the risk of bacterial infections in the stomach by inhibiting gastric acid secretion, so if diarrhea persists, inform healthcare professionals. It is advisable to avoid driving or operating machinery if dizziness or visual disturbances occur. This medication may have interactions with other drugs, so inform your healthcare provider if you are taking other medications. It should be avoided in early pregnancy, and it is safest for breastfeeding women not to take it. There is insufficient experience in using it in children and adolescents under 18 years of age, so it is not recommended. No specific symptoms have been reported in cases of overdose, but if abnormal reactions occur, visit a hospital immediately. This medication must be properly prepared before administration, and the prepared solution should be used within 12 hours while paying attention to storage temperature. If there is discoloration or turbidity before use, do not use and discard it. This medication may increase the risk of developing gastric polyps with prolonged use, so it is advisable to use it for the minimum necessary dosage and duration.

Side effects

anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute interstitial nephritis, urticaria, agranulocytosis, leukopenia, thrombocytopenia, pancytopenia, upper abdominal pain, diarrhea, constipation, abdominal distension, dyspepsia, gastric polyps, nausea, vomiting, dry mouth, rhinitis, injection site reaction, thrombophlebitis at the injection site, elevated body temperature, peripheral edema, fever, increased bilirubin, liver failure, jaundice, hepatocellular damage, elevated liver enzymes, arthralgia, myalgia, rhabdomyolysis, bone fractures, headache, dizziness, visual disturbances, taste disturbances, insomnia, sleep disorders, depression, hallucinations, disorientation, confusion, interstitial nephritis, pruritus, skin erythema, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, photosensitivity reaction, gynecomastia, hyperlipidemia, increased lipids, weight change, hyponatremia, hypomagnesemia, elevated CK, anterior ischemic optic neuropathy, pancreatitis, confusion, decreased mobility, speech disorder, increased salivation, vertigo, tinnitus, hypocalcemia, hypokalemia, Clostridium difficile-associated diarrhea, paresthesia, 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, so it should be stored in a tightly sealed container that does not allow light. Moreover, it is essential to store it at a cool temperature below 25 degrees Celsius to maintain its efficacy.

Appearance and packaging

Appearance

This medication is a colorless transparent vial containing a dry powder that is white to nearly white.

Package unit

1 vial (46.1 mg/vial x 1)

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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.