Medication info

Pantoprazole Sodium Sesquihydrate 40 mg Tablet

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

MFDS item code 201906908 · Approved 2019.09.30

This product's status changed to Expired on 2024.09.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastroesophageal reflux disease, gastric and duodenal ulcers (including prevention of recurrence), and gastric acid hypersecretion
Who takes it
Adults
Adult dose
1. Combination therapy with antibiotics to prevent recurrence of gastroduodenal ulcers associated with Helicobacter pylori infection - The usual adult dose is 40 mg of pantoprazole per dose, administered twice daily (before breakfast and dinner) in combination with the following antibiotics for 1 week. Swallow whole; do not chew or crush. (1) Take 1,000 mg of amoxicillin and 500 mg of clarithromycin per dose twice daily for 1 week, or (2) Take 500 mg of metronidazole and 500 mg of clarithromycin per dose twice daily for 1 week, or (3) Take 1,000 mg of amoxicillin and 500 mg of metronidazole per dose 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, consider the recommended doses and regimens below 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. Swallow whole; do not chew or crush. - Most cases may heal within 4 weeks, although healing time may vary among patients. If not healed after the first 4 weeks, continue treatment for another 4 weeks. - If there is no response to other treatment in particular, 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. Swallow whole; do not chew or crush. - Most cases may heal within 2 weeks, although healing time may vary among patients. If not healed after the first 2 weeks, continue treatment for another 2 weeks. - If there is no response to other treatment in particular, 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 measurements of gastric acid secretion. - Doses exceeding 80 mg should be divided into 2 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. - The duration of treatment is not limited, but should be changed according to clinical need. ○ In patients with severe hepatic impairment (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 daily. As an exception, elderly patients may take 40 mg of this medicine per dose twice daily (before breakfast and dinner) for 1 week as part of the antibiotic combination therapy described above. Swallow whole; do not chew or crush. ○ Do not use antibiotic combination therapy in patients with moderate to severe hepatic/renal impairment. There are insufficient data on the efficacy and safety of this combination therapy.

Ingredients

Manufacturer
Korea Sintex Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of gastroesophageal reflux disease, gastric and duodenal ulcers (including prevention of recurrence), and gastric acid hypersecretion

  • Infection with Helicobacter pylori
  • gastric ulcer
  • duodenal ulcer
  • reflux esophagitis
  • Zollinger-Ellison syndrome
  • excessive gastric acid secretion
View approved original text

This medication is used in combination with antibiotics to prevent the recurrence of gastric and duodenal ulcers infected with Helicobacter pylori. It is also effective in the treatment of duodenal ulcers and gastric ulcers. It can be applied to patients with moderate to severe reflux esophagitis. It is also used in Zollinger-Ellison syndrome and other pathological conditions with excessive gastric acid secretion. It helps treat and prevent various gastrointestinal-related diseases.

How to take

Adult dose

1. Combination therapy with antibiotics to prevent recurrence of gastroduodenal ulcers associated with Helicobacter pylori infection - The usual adult dose is 40 mg of pantoprazole per dose, administered twice daily (before breakfast and dinner) in combination with the following antibiotics for 1 week. Swallow whole; do not chew or crush. (1) Take 1,000 mg of amoxicillin and 500 mg of clarithromycin per dose twice daily for 1 week, or (2) Take 500 mg of metronidazole and 500 mg of clarithromycin per dose twice daily for 1 week, or (3) Take 1,000 mg of amoxicillin and 500 mg of metronidazole per dose 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, consider the recommended doses and regimens below 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. Swallow whole; do not chew or crush. - Most cases may heal within 4 weeks, although healing time may vary among patients. If not healed after the first 4 weeks, continue treatment for another 4 weeks. - If there is no response to other treatment in particular, 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. Swallow whole; do not chew or crush. - Most cases may heal within 2 weeks, although healing time may vary among patients. If not healed after the first 2 weeks, continue treatment for another 2 weeks. - If there is no response to other treatment in particular, 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 measurements of gastric acid secretion. - Doses exceeding 80 mg should be divided into 2 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. - The duration of treatment is not limited, but should be changed according to clinical need. ○ In patients with severe hepatic impairment (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 daily. As an exception, elderly patients may take 40 mg of this medicine per dose twice daily (before breakfast and dinner) for 1 week as part of the antibiotic combination therapy described above. Swallow whole; do not chew or crush. ○ Do not use antibiotic combination therapy in patients with moderate to severe hepatic/renal impairment. There are insufficient data on the efficacy and safety of this combination therapy.

Precautions

This medication should not be administered to patients with moderate to severe impairment of liver or kidney function due to insufficient clinical experience regarding safety and efficacy. Patients who have experienced hypersensitivity to this medication, its components, or benzimidazole derivatives may experience serious allergic reactions, such as anaphylaxis, angioedema, and bronchospasm, and should not use this medication. Patients with hypersensitivity to certain specific antibiotics used in combination with this medication should also avoid it, and it is recommended that pregnant women in early pregnancy, women who could become pregnant, and breastfeeding women do not use this medication. Various gastrointestinal symptoms, headache, dizziness, depression, skin rash, and other side effects may appear during treatment with this medication, so if any abnormal symptoms occur, immediate consultation with a healthcare professional is required. Long-term use may reduce the acidity in the stomach, which could increase the risk of some bacterial infections and higher fracture risk, thus regular check-ups are necessary. This medication may interact with other drugs, so it is crucial to inform the prescribing doctor or pharmacist, especially if you are taking anticoagulants, antivirals, or antibiotics. Pregnant or breastfeeding women should avoid use due to potential effects on the fetus or infant, and if necessary, sufficient consultation with a specialist is required. Safety in children and adolescents has not been thoroughly validated, so caution is required with use. In the case of overdose, there is no specific antidote, so appropriate treatment should be received based on symptoms. When taking, do not chew or crush the tablet but swallow it whole, and store it in a safe place out of reach of children.

Side effects

  • Abdominal pain
  • constipation
  • distension
  • diarrhea
  • nausea
  • vomiting
  • belching
  • dry mouth
  • fatigue
  • asthenia
Show 225 more
  • lethargy
  • edema
  • elevated body temperature
  • fever
  • elevated liver enzymes
  • increased bilirubin
  • jaundice
  • anaphylactic shock
  • arthralgia
  • myalgia
  • rhabdomyolysis
  • bone fracture
  • headache
  • dizziness
  • vision impairment
  • taste disturbance
  • insomnia
  • sleep disturbances
  • depression
  • hallucinations
  • confusion
  • spatial disorientation
  • interstitial nephritis
  • itching
  • skin redness
  • urticaria
  • angioedema
  • mucocutaneous syndrome
  • erythema multiforme
  • toxic epidermal necrolysis
  • photosensitivity
  • hyperglycemia
  • agranulocytosis
  • leukopenia
  • thrombocytopenia
  • pancytopenia
  • gynecomastia
  • hyperlipidemia
  • lipid increase
  • weight change
  • hyponatremia
  • hypomagnesemia
  • elevated CK
  • anxiety
  • weakness
  • back pain
  • bronchitis
  • chest pain
  • increased cough
  • dyspepsia
  • dyspnea
  • flu-like symptoms
  • gastroenteritis
  • gastrointestinal disorders
  • tension excess
  • infection
  • migraine
  • cervical pain
  • pain
  • pharyngitis
  • rectal disorders
  • rhinitis
  • elevated AST
  • sinusitis
  • upper respiratory infection
  • frequent urination
  • urinary tract infection
  • boil
  • allergic reaction
  • chills
  • abscess
  • facial edema
  • general edema
  • warmth
  • hernia
  • abnormal clinical laboratory tests
  • fatigue
  • moniliasis
  • tumor
  • nonspecific drug reaction
  • electrocardiogram 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
  • loss of appetite
  • aphthous stomatitis
  • colitis
  • duodenitis
  • swallowing disorders
  • 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 abnormalities
  • tongue discoloration
  • ulcerative colitis
  • diabetes
  • goiter
  • gallbladder pain
  • 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 disease
  • joint disease
  • leg cramps
  • bursitis
  • tendinitis
  • abnormal dream
  • confusion
  • seizures
  • dry mouth
  • speech disorders
  • hallucinations
  • hyperactivity
  • decreased libido
  • agitation
  • neuralgia
  • neuritis
  • neurological disorders
  • dysesthesia
  • reduced reflex
  • sleep disturbances
  • drowsiness
  • abnormal perception
  • tremors
  • asthma
  • nosebleed
  • hiccups
  • laryngitis
  • respiratory disorders
  • pneumonia
  • voice alteration
  • acne
  • alopecia
  • contact dermatitis
  • eczema
  • fungal skin disease
  • bleeding
  • herpes simplex
  • herpes zoster
  • lichen planus dermatitis
  • papular eruption
  • skin disease
  • skin ulcer
  • sweating
  • amblyopia
  • cataract
  • hearing loss
  • diplopia
  • earache
  • paralysis
  • glaucoma
  • otitis externa
  • taste disturbance
  • tinnitus
  • albuminuria
  • balanitis
  • breast pain
  • cystitis
  • menstrual irregularities
  • urinary disorders
  • epididymitis
  • hematuria
  • erectile dysfunction
  • kidney stones
  • renal pain
  • nocturia
  • prostate disorders
  • pyelonephritis
  • scrotal swelling
  • urethral pain
  • urethral disease
  • urological abnormalities
  • vaginitis
  • Clostridium difficile diarrhea
  • hypocalcemia
  • hypokalemia
  • 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

Store this medication in a closed container that can block light, safely at a temperature between 1 degree and 30 degrees Celsius. Storing it this way ensures that the ingredients do not change and that effectiveness is well maintained.

Appearance and packaging

Appearance

Yellow, enteric-coated oval 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.