Medication info

Aprogen Ranitidine Tablet 150 mg (Ranitidine Hydrochloride)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Ranitidine Hydrochloride›168mg / 1 tablet
Manufacturer / importer
(주)에이프로젠바이오로직스
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 199500687 · Notified 1995.05.24

This product's status changed to Approval withdrawn on 2024.01.11. 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 relief of excessive gastric acid symptoms
Who takes it
Adults · Children
Adult dose
As ranitidine, take 150 mg by mouth twice a day, in the morning and at bedtime. For gastric and duodenal ulcers: take 150 mg by mouth twice a day or 300 mg once a day at bedtime. In particular, for duodenal ulcer patients, take 300 mg twice a day, in the morning and at bedtime. The regimen and dose for preventing ulcers related to NSAID use is the same. Re
Child dose
For children aged 8 to 18 years, a single dose of 150 mg (2 mg per kg of body weight) can be administered up to 2 times per day.

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

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

  • Gastric and duodenal ulcers
  • Zollinger-Ellison syndrome
  • gastroesophageal reflux disease
  • prevention of Mendelson syndrome
  • post-operative ulcers
  • gastric and duodenal ulcers due to NSAID use
  • gastric mucosal erosion
  • gastric mucosal bleeding
  • gastric mucosal redness
  • gastric mucosal swelling
  • acute gastritis
  • exacerbation of chronic gastritis
View approved original text

This medication is used for gastrointestinal diseases such as gastric and duodenal ulcers, Zollinger-Ellison syndrome, and gastroesophageal reflux disease. It is also effective in preventing Mendelson syndrome before anesthesia and treating post-operative ulcers, as well as preventing ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). It helps improve gastric mucosal lesions due to acute and chronic gastritis exacerbation, as well as upper gastrointestinal bleeding. It is also used to relieve symptoms of heartburn and acid regurgitation caused by excess gastric acid. This drug improves symptoms by protecting the gastric mucosa and inhibiting gastric acid secretion.

How to take

Adult dose

As ranitidine, take 150 mg by mouth twice a day, in the morning and at bedtime. For gastric and duodenal ulcers: take 150 mg by mouth twice a day or 300 mg once a day at bedtime. In particular, for duodenal ulcer patients, take 300 mg twice a day, in the morning and at bedtime. The regimen and dose for preventing ulcers related to NSAID use is the same. Re

Child dose

For children aged 8 to 18 years, a single dose of 150 mg (2 mg per kg of body weight) can be administered up to 2 times per day.

Precautions

This medication should not be used by those who have had an allergic reaction to this drug or its components. Additionally, it should not be administered to patients with a history of acute porphyria, as it may worsen their symptoms. Since this drug contains lactose, it cannot be used in patients with genetic disorders that prevent lactose digestion. Patients with poor kidney function should use this medication cautiously, as the rate of clearance may be slowed, and dosage should be reduced or the dosing interval increased. Patients with impaired liver function should also use it carefully, and those with a previous drug allergy should use it cautiously. Elderly patients may have a higher risk of side effects; therefore, special caution is required. Those taking NSAIDs may encounter gastrointestinal problems, so regular check-ups are necessary. This drug may mask symptoms of stomach cancer; therefore, if gastric ulcer patients or those over middle age develop new or changed dyspeptic symptoms, malignancy should be ruled out before use. Helicobacter pylori-positive gastric and duodenal ulcer patients should undergo treatment to eliminate this bacterium. Severe allergic reactions or shock may rarely occur when taking this medication, so if any unusual symptoms appear, discontinue immediately and consult a healthcare professional. Hypersensitivity reactions such as urticaria, rash, or difficulty breathing may occur; if such symptoms arise, stop taking the drug. Blood-related issues may lead to decreased white blood cell or platelet counts, and if fatigue or bleeding occurs, immediate testing is necessary. Liver function may transiently deteriorate, so if jaundice or fatigue appears, treatment should be stopped. Cardiovascular abnormalities such as arrhythmias or vasculitis have also been reported rarely, so caution is advised. Gastrointestinal symptoms may include constipation, nausea, abdominal pain, among others, and acute pancreatitis may occur rarely. Neurological side effects such as dizziness, drowsiness, confusion, or depression may appear; thus, close observation is necessary if unusual symptoms occur. This drug may interact with other medications, so if you're taking other medicines, you must inform your healthcare provider. In particular, when used with drugs affecting blood clotting, frequent blood tests are necessary to monitor the condition. The effect of some drugs taken with this medication may change, so it may be necessary to adjust the dosing interval or dosage. Women who are pregnant or may become pregnant should use this drug cautiously, as its safety is not established; use should be reserved for necessary situations. If breastfeeding, this drug can pass into breast milk, so it should only be given if necessary. There is little experience using this drug in children, so safety has not been established. Elderly patients should use this drug carefully, as reduced kidney function may allow the medication to remain in the body longer; thus, adjusting the dose and interval is recommended. Dizziness or drowsiness may occur when taking this drug; therefore, it is advisable to avoid driving or operating hazardous machinery. No serious issues have been reported with overdose; however, proper treatment such as vomiting or gastric lavage may be necessary. Keep this drug out of the reach of children, and avoid transferring it to other containers as it may alter its quality. This drug may reduce gastric acid secretion, promoting bacterial growth in the stomach; therefore, regular check-ups, including eye examinations, are necessary when used for long periods.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, shock (anaphylactic shock), difficulty breathing (bronchospasm), severe allergic reactions, severe skin adverse reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis), jaundice, hepatitis (hepatocellular, cholestatic, or mixed), consciousness disturbances, seizures (tonic-clonic, etc.), myoclonus, agranulocytosis, pancytopenia, aplastic anemia, acute interstitial nephritis, severe edema with elevated blood pressure

Mild side effects

Rash, fever, angioedema, hypotension, chest pain, granulocytopenia, elevated serum creatinine levels, leukopenia, thrombocytopenia, myelosuppression, aplastic anemia, agranulocytosis, pancytopenia, eosinophilia, hepatic dysfunction (elevated AST, ALT, γ-GTP, ALP), bradycardia, heart block, tachycardia, vasculitis, constipation, nausea, vomiting, abdominal distention, abdominal pain, loss of appetite, diarrhea, acute pancreatitis

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

Storage

Store this medication in a tightly sealed container that blocks light, maintaining a temperature between 1 and 30 degrees Celsius (room temperature). This is an important storage method to preserve the effectiveness of the medication and prevent deterioration.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 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.