Medication info

Zantac Tablet (Ranitidine Hydrochloride)

Prescription medicationTablet경구Expired
Ingredient · strength
Ranitidine Hydrochloride›168mg / 1 tablet
Manufacturer / importer
(주)시어스제약
Appearance
Pale yellow to yellow round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201805028 · Approved 2018.12.11

This product's status changed to Expired on 2023.12.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for improvement of gastric ulcers and gastric mucosal lesions, and alleviation of excessive gastric acid symptoms
Who takes it
Adults · Children
Adult dose
Adults should take 150 mg of ranitidine orally twice a day, in the morning and at bedtime. - Gastric/Duodenal Ulcer: 150 mg once, twice a day or 300 mg once a day (at bedtime); for duodenal ulcer patients, 300 mg can be administered twice daily. - Maintenance therapy for recurrent ulcers: 150 mg once daily at bedtime. - Gastroesophageal reflux disease
Child dose
For children, clinical studies are not established; however, for those aged 8 to 18, 150 mg (2 mg per kg body weight) can be administered once, up to twice a day.

Ingredients

Manufacturer
(주)시어스제약

Efficacy & effects

Treatment for improvement of gastric ulcers and gastric mucosal lesions, and alleviation of excessive gastric acid symptoms

  • Gastric and duodenal ulcers
  • Zollinger-Ellison syndrome
  • gastroesophageal reflux disease
  • prevention of Mendelson's syndrome
  • postoperative ulcers
  • gastric and duodenal ulcers caused by the use of non-steroidal anti-inflammatory drugs (NSAIDs)
  • gastric mucosal lesions
  • erosion
  • bleeding
  • redness
  • swelling
  • acute gastritis
View approved original text

This medication is used to treat ulcers in the stomach and duodenum, Zollinger-Ellison syndrome, and gastroesophageal reflux disease. It is also effective for preoperative dosing to prevent Mendelson's syndrome and for the treatment of ulcers due to the use of non-steroidal anti-inflammatory drugs (NSAIDs). It improves acute exacerbations of acute and chronic gastric inflammation and gastric mucosal lesions such as upper gastrointestinal bleeding, and helps alleviate symptoms of heartburn and acid regurgitation caused by excessive gastric acid. It effectively improves symptoms of various gastrointestinal diseases.

How to take

Adult dose

Adults should take 150 mg of ranitidine orally twice a day, in the morning and at bedtime. - Gastric/Duodenal Ulcer: 150 mg once, twice a day or 300 mg once a day (at bedtime); for duodenal ulcer patients, 300 mg can be administered twice daily. - Maintenance therapy for recurrent ulcers: 150 mg once daily at bedtime. - Gastroesophageal reflux disease

Child dose

For children, clinical studies are not established; however, for those aged 8 to 18, 150 mg (2 mg per kg body weight) can be administered once, up to twice a day.

Precautions

This medication should not be used in patients who have had an allergic reaction to this drug or its components. Avoid administration in patients with a history of acute porphyria, as this drug may precipitate seizures. Patients with impaired kidney function may have increased blood concentration due to renal excretion, requiring dose adjustments. Patients with liver dysfunction should also use this medication with caution. Patients with a history of drug allergy or elderly patients should administer this drug carefully. When combined with non-steroidal anti-inflammatory drugs, especially in the elderly or those with a history of peptic ulcers, regular monitoring of the condition is necessary. This medication may mask symptoms of gastric cancer, so it should be confirmed that it is not cancer if symptoms of gastric ulcer or dyspepsia arise or change in middle-aged patients or older. Patients with gastric and duodenal ulcers with Helicobacter pylori infection should undergo bacterial eradication therapy. Rarely, this medication can cause severe allergic reactions or anaphylactic shock, so if any unusual symptoms occur during administration, treatment should be discontinued immediately. If skin rashes, hives, or bronchospasm occur, use should be discontinued. Various side effects, including blood-related symptoms, liver dysfunction, cardiac arrhythmias, gastrointestinal symptoms, and neurological symptoms may rarely occur, so any unusual symptoms should be reported immediately. Patients with poor kidney function should particularly be cautious of symptoms such as mental confusion or seizures. This medication should be used at the minimum dose while confirming the therapeutic effect, and if ineffective, other treatments should be considered. Elderly patients and those with chronic lung disease, diabetes, or weakened immune systems may have an increased risk of pneumonia, which should be monitored carefully. Avoid driving or operating dangerous machinery if dizziness or drowsiness occurs. This medication may interact with other drugs, so inform your doctor or pharmacist about any concurrent medications. In particular, cautiously observe for bleeding risks when used with warfarin. Women who are pregnant or may become pregnant, as well as nursing mothers, should carefully consider the risks and benefits if this medication is necessary. Safety in pediatric patients has not been sufficiently established, so caution is needed when using. Elderly patients may require dose adjustments due to increased drug concentration from decreased kidney function. Overdose is rarely accompanied by specific toxic symptoms, but gastric lavage or symptomatic treatment should be provided if necessary. Keep out of reach of children and do not transfer to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • shock (anaphylactic shock)
  • bronchospasm
  • hypotension
  • chest pain
  • thrombocytopenia
  • leukopenia
  • bone marrow suppression
  • aplastic anemia
Show 14 more
  • agranulocytosis
  • pancytopenia
  • acquired immune hemolytic anemia
  • liver dysfunction (including jaundice)
  • hepatitis
  • vasculitis
  • acute pancreatitis
  • seizures
  • altered consciousness
  • myoclonus
  • rhabdomyolysis
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • heart block

Mild side effects

  • Rash
  • fever
  • elevated serum creatinine levels
  • bradycardia
  • atrioventricular block
  • tachycardia
  • constipation
  • nausea
  • vomiting
  • abdominal fullness
Show 27 more
  • abdominal pain
  • loss of appetite
  • diarrhea
  • dizziness
  • drowsiness
  • headache
  • heaviness in the head
  • insomnia
  • agitation
  • anxiety
  • mental confusion
  • depression
  • hallucinations
  • blurred vision
  • involuntary movements
  • gynecomastia
  • excessive lactation
  • erectile dysfunction
  • decreased libido
  • joint pain
  • muscle pain
  • skin rash
  • mild erythema multiforme
  • hair loss
  • glossitis
  • itching skin
  • blood-related symptoms

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

Storage

This medication should be stored in a tightly sealed container that protects from light, at a temperature between 1 to 30 degrees Celsius. Storing it this way will help safely maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Pale yellow to yellow round film-coated tablets

Package unit

30 tablets/bottle, 100 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.