Medication info

Pantoprazole 20 mg (Pantoprazole Sodium Sesquihydrate)

Prescription medicationTabletExpired
Ingredient · strength
Pantoprazole Sodium Sesquihydrate›22.55mg / 1 tablet
Manufacturer / importer
Korea Sinthec Pharmaceutical Co., Ltd.
Appearance
Yellow enteric-coated oval tablet
Packaging
30 tablets/bottle
Approval status
Expired

MFDS item code 201906909 · 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, prevention of recurrent reflux esophagitis, and prevention of NSAID-induced gastroduodenal ulcers
Who uses it
Adults
Adult dosage
1. Treatment of mild reflux esophageal disease and related symptoms: Administer 20 mg of pantoprazole once daily orally before breakfast. Symptom relief generally occurs within 2 ∼ 4 weeks, and healing may usually be achieved with 4 weeks of treatment. If healing does not occur, an additional 4 weeks of treatment may achieve healing. 2. Long-term maintenance therapy to prevent recurrence of reflux esophagitis: Administer 20 mg of pantoprazole once daily before breakfast. If recurrence occurs, increase the dose to 40 mg of pantoprazole daily, then reduce it back to 20 mg daily after healing. 3. Prevention of gastroduodenal ulcers caused by nonsteroidal anti-inflammatory drugs in patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs: Administer 20mg of pantoprazole once daily. • No dose adjustment is necessary in elderly patients or patients with renal impairment. • Patients with hepatic impairment Do not exceed 20 mg of this medicine once daily in patients with severe hepatic impairment.

Ingredients

Manufacturer
Korea Sinthec Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of gastroesophageal reflux disease, prevention of recurrent reflux esophagitis, and prevention of NSAID-induced gastroduodenal ulcers

  • Heartburn
  • acid reflux
  • dysphagia
  • gastric and duodenal ulcers
View approved original text

This medication helps treat symptoms such as heartburn, acid reflux, and dysphagia associated with mild gastroesophageal reflux disease. It is also used for long-term maintenance to prevent the recurrence of reflux esophagitis. For patients who need to continue taking non-steroidal anti-inflammatory drugs (NSAIDs), this medication is effective in preventing the development of gastric and duodenal ulcers. Thus, it is used to prevent and improve various gastrointestinal issues.

Dosage and Administration

Adult dosage

1. Treatment of mild reflux esophageal disease and related symptoms: Administer 20 mg of pantoprazole once daily orally before breakfast. Symptom relief generally occurs within 2 ∼ 4 weeks, and healing may usually be achieved with 4 weeks of treatment. If healing does not occur, an additional 4 weeks of treatment may achieve healing. 2. Long-term maintenance therapy to prevent recurrence of reflux esophagitis: Administer 20 mg of pantoprazole once daily before breakfast. If recurrence occurs, increase the dose to 40 mg of pantoprazole daily, then reduce it back to 20 mg daily after healing. 3. Prevention of gastroduodenal ulcers caused by nonsteroidal anti-inflammatory drugs in patients requiring continuous treatment with nonsteroidal anti-inflammatory drugs: Administer 20mg of pantoprazole once daily. • No dose adjustment is necessary in elderly patients or patients with renal impairment. • Patients with hepatic impairment Do not exceed 20 mg of this medicine once daily in patients with severe hepatic impairment.

Precautions

This medication should not be administered to patients with hypersensitivity to certain ingredients or benzimidazoles, as serious allergic reactions such as anaphylaxis, angioedema, and bronchospasm may occur. Additionally, this medication should not be used in patients taking certain antiviral agents such as atazanavir or nelfinavir, as the drug's effectiveness may be reduced when used together. It is also advisable that women who are in the first three months of pregnancy or who may become pregnant, as well as breastfeeding women, do not use this medication, as it may pose a risk to the fetus or newborn. Due to the inhibitory action on gastric acid secretion, long-term use of this medication may lead to vitamin B12 absorption disorders. Therefore, regular check-ups are required if taken long-term. Moreover, elderly patients over 65 or those with a history of gastric ulcers, duodenal ulcers, or gastrointestinal bleeding should be cautious, as the risk of gastrointestinal bleeding may increase with this medication. Prolonged high-dose use may increase the risk of fractures; hence, it is recommended to use the minimum dosage for the shortest duration possible. While taking this medication, hypomagnesemia may occasionally occur, which can lead to hypocalcemia or hypokalemia. It is important to monitor magnesium levels regularly, especially during long-term treatment of more than a year. This medication may slightly increase the risk of bacterial infections in the gastrointestinal tract due to the suppression of gastric acid secretion. If diarrhea persists, consult a physician. Dizziness or visual disturbances may occur; therefore, caution is needed while driving or operating machinery. Additionally, since this medication is metabolized in the liver, patients with severe liver impairment may need to adjust the dosage and undergo regular liver enzyme checks. This medication should not be used in combination with certain drugs such as atazanavir, nelfinavir, or rilpivirine due to potential interactions. Consult a physician regarding the usage of this medication if pregnant or breastfeeding, as it may pose risks to the fetus or newborn. There is insufficient experience using this medication in children under 12 years of age, and it is not recommended. Specific symptoms of overdose are not known, but if any abnormalities occur, seek medical attention immediately. It is advisable to swallow the tablet whole without chewing or crushing it. In case of long-term use, follow the physician's instructions regarding minimal dosage and appropriate duration, and monitor the treatment progress carefully. This medication should be stored out of reach of children and should not be transferred to other containers.

Side effects

  • Anaphylaxis
  • anaphylactic shock
  • angioedema
  • bronchospasm
  • acute interstitial nephritis
  • urticaria
  • upper abdominal pain
  • constipation
  • bloating
  • diarrhea
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  • gastric polyps
  • nausea
  • vomiting
  • belching
  • dry mouth
  • fatigue
  • asthenia
  • lethargy
  • edema
  • elevated body temperature
  • fever
  • elevated liver enzyme levels
  • elevated bilirubin
  • hepatic failure
  • jaundice
  • arthralgia
  • myalgia
  • rhabdomyolysis
  • bone fractures
  • headache
  • dizziness
  • visual disturbances
  • taste disturbances
  • insomnia
  • sleep disorders
  • depression
  • hallucinations
  • confusion
  • disorientation
  • interstitial nephritis
  • pruritus
  • skin erythema
  • angioedema
  • mucocutaneous syndrome
  • Stevens-Johnson syndrome
  • erythema multiforme
  • toxic epidermal necrolysis
  • Lyell syndrome
  • photosensitivity
  • hyperglycemia
  • agranulocytosis
  • leukopenia
  • thrombocytopenia
  • pancytopenia
  • gynecomastia
  • hyperlipidemia
  • increased lipids
  • weight changes
  • hyponatremia
  • hypomagnesemia
  • elevated CK
  • anxiety
  • lethargy
  • low back pain
  • bronchitis
  • chest pain
  • increased cough
  • dyspepsia
  • shortness of breath
  • flu-like symptoms
  • gastroenteritis
  • gastrointestinal disorders
  • tension headache
  • 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 swelling
  • generalized edema
  • heat sensation
  • hernia
  • abnormal clinical laboratory tests
  • malaise
  • moniliasis
  • tumor
  • nonspecific drug reactions
  • 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
  • decreased appetite
  • aphthous stomatitis
  • colitis
  • duodenitis
  • swallowing difficulties
  • enteritis
  • esophageal bleeding
  • esophagitis
  • gastric and duodenal tumor
  • gastric and duodenal bleeding
  • gastric and 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
  • convulsion
  • dry mouth
  • speech disorder
  • hyperactivity
  • reduced libido
  • restlessness
  • neuralgia
  • neuritis
  • neurological disorders
  • abnormal sensations
  • decreased reflexes
  • tremors
  • asthma
  • epistaxis
  • hiccups
  • laryngitis
  • respiratory distress
  • pneumonia
  • voice changes
  • acne
  • alopecia
  • contact dermatitis
  • eczema
  • fungal dermatitis
  • bleeding
  • herpes simplex
  • herpes zoster
  • lichen planus dermatitis
  • papular rash
  • skin disease
  • skin ulcers
  • sweating
  • amblyopia
  • cataract
  • hearing loss
  • diplopia
  • otalgia
  • paralysis
  • glaucoma
  • otitis externa
  • tinnitus
  • albuminuria
  • balanitis
  • mastalgia
  • cystitis
  • menstrual irregularities
  • dysuria
  • epididymitis
  • hematuria
  • erectile dysfunction
  • kidney stones
  • renal colic
  • nocturia
  • prostate disorders
  • pyelonephritis
  • scrotal swelling
  • urethral pain
  • urethral disorders
  • genitourinary disorders
  • vaginitis
  • Clostridium difficile diarrhea
  • hypocalcemia
  • hypokalemia
  • DRESS syndrome
  • microscopic colitis
  • systemic lupus erythematosus
  • skin 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 light-protected container. It is also important to maintain a room temperature of between 1 to 30 degrees Celsius when storing it. Proper storage will help maintain the effectiveness of the medication for a longer period.

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

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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.