Medication info

Cipra Tablet 40mg (Esomeprazole Magnesium Trihydrate)

Prescription medicationTablet경구 · 정맥Approval withdrawn
Ingredient · strength
Esomeprazole Magnesium Trihydrate›44.5mg / 1 tablet
Manufacturer / importer
(주)휴온스생명과학
Appearance
Pink round film-coated tablet
Packaging
28 tablets/PTP [14 tablets/Alu-Alu×2]
Approval status
Approval withdrawn

MFDS item code 202002254 · Approved 2020.03.31

This product's status changed to Approval withdrawn on 2024.04.02. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, prevention of rebleeding in gastric and duodenal ulcers and maintenance treatment.
Who uses it
Adults · Children
Adult dosage
This medication should be swallowed with liquids like water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 1 time over 4 weeks - If esophagitis is untreated or symptoms persist, take for an additional 4 weeks - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily for 1 time - Symptomatic treatment in gastroesophageal reflux disease without esophagitis: 1 time of 20 mg once daily.
Children's dosage
Adolescents aged 12 and older: - Treatment of erosive esophagitis: 40 mg once daily for 1 time over 4 weeks - Symptomatic treatment in gastroesophageal reflux disease without esophagitis: 20 mg once daily for 1 time - Symptoms.

Ingredients

Manufacturer
(주)휴온스생명과학

Efficacy & effects

Treatment of gastroesophageal reflux disease (including erosive esophagitis), treatment and prevention of recurrence of Helicobacter pylori positive peptic ulcers, relief of gastrointestinal symptoms related to non-steroidal anti-inflammatory drugs, treatment and prevention of gastric ulcers and duodenal ulcers, treatment of Zollinger-Ellison syndrome, prevention of rebleeding in gastric and duodenal ulcers and maintenance treatment.

  • Gastroesophageal reflux disease
  • erosive esophagitis
  • esophagitis
  • Helicobacter pylori positive duodenal ulcer
  • peptic ulcer
  • upper gastrointestinal pain
  • upper gastrointestinal discomfort
  • upper gastrointestinal burning sensation
  • gastric ulcer related to non-steroidal anti-inflammatory drug use
  • duodenal ulcer related to non-steroidal anti-inflammatory drug use
  • Zollinger-Ellison syndrome
  • gastric ulcer
View approved original text

This medication is used for the treatment of gastroesophageal reflux disease, especially for erosive esophagitis and for long-term maintenance therapy to prevent the recurrence of esophagitis. It is also effective in relieving symptoms of gastroesophageal reflux disease without esophagitis. It is utilized in combination with antibiotics for the treatment and prevention of recurrence of duodenal and peptic ulcers caused by Helicobacter pylori infection. It helps in the short-term treatment of upper gastrointestinal symptoms that may occur during the use of non-steroidal anti-inflammatory drugs and also treats gastric ulcers as well as preventing gastric and duodenal ulcers. Additionally, it is used for the treatment of Zollinger-Ellison syndrome and for maintenance therapy after preventing rebleeding due to gastric or duodenal ulcers. Overall, it effectively improves various symptoms and diseases related to gastrointestinal disorders.

Dosage and Administration

Adult dosage

This medication should be swallowed with liquids like water and should not be chewed or crushed. 1) Gastroesophageal reflux disease (GERD) - Treatment of erosive esophagitis: 40 mg once daily for 1 time over 4 weeks - If esophagitis is untreated or symptoms persist, take for an additional 4 weeks - Maintenance therapy to prevent recurrence of esophagitis: 20 mg once daily for 1 time - Symptomatic treatment in gastroesophageal reflux disease without esophagitis: 1 time of 20 mg once daily.

Children's dosage

Adolescents aged 12 and older: - Treatment of erosive esophagitis: 40 mg once daily for 1 time over 4 weeks - Symptomatic treatment in gastroesophageal reflux disease without esophagitis: 20 mg once daily for 1 time - Symptoms.

Precautions

This medication should not be administered to certain patients. It should not be used in patients who are hypersensitive to this drug, its ingredients, or benzimidazole derivatives or have a history of such reactions. Patients with hypersensitivity to antibiotics like amoxicillin or clarithromycin used in combination to eradicate Helicobacter pylori should also not take this medication. Administration is prohibited in certain patients including those on specific heart-related medications or antiviral agents, breastfeeding women, and patients with myocardial infarction. Various adverse reactions may occur when using this medication. Commonly reported side effects include headaches, abdominal pain, diarrhea, constipation, and drowsiness; less frequently, blood abnormalities, allergic reactions, liver dysfunction, skin rashes, and muscle pain may be observed. Particularly, hypomagnesemia may rarely occur, which can cause serious electrolyte imbalances, requiring caution. This medication increases the risk of bacterial infections in the stomach due to its action of suppressing gastric acid secretion. Moreover, long-term use may increase the risk of fractures, so patients at risk for osteoporosis require regular monitoring. Attention should be paid to drug interactions during medication use. In particular, when combined with digoxin, warfarin, methotrexate, antiviral agents, and certain antibiotics, there might be adverse effects due to changes in drug concentrations, so consultation with healthcare professionals is needed. There is limited safety data on this drug during pregnancy, so caution is advised when administering it to pregnant women; breastfeeding women are recommended not to take this medication. In cases of overdose, since no specific antidote exists, symptomatic treatment is required, and this medication has a high protein binding rate, which is not removed by dialysis. This medication should be kept out of reach of children, and transferring it to another container should be avoided for maintaining quality and safety.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylactic reactions, shock, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS syndrome), liver failure, encephalopathy, liver abnormalities (including hepatitis with or without jaundice), severe hypomagnesemia, rhabdomyolysis, severe allergic reactions, severe skin adverse reactions.

Mild side effects

  • Headache
  • dizziness
  • paresthesia
  • drowsiness
  • taste disturbances
  • blurred vision
  • bronchospasm
  • abdominal pain
  • constipation
  • diarrhea
Show 28 more
  • abdominal bloating
  • nausea
  • vomiting
  • dry mouth
  • stomatitis
  • gastrointestinal candidiasis
  • increased liver enzymes
  • hepatitis
  • dermatitis
  • itching
  • rashes
  • hair loss
  • photosensitivity
  • fractures
  • arthralgia
  • myalgia
  • weakness
  • increased sweating
  • insomnia
  • anxiety
  • mental confusion
  • depression
  • aggression
  • hallucinations
  • peripheral edema
  • hyponatremia
  • hypomagnesemia
  • low.

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and must be kept at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/PTP [14 tablets/Alu-Alu×2]

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.