Medication info

Ranisen Tablet (Ranitidine Hydrochloride)

Prescription medicationExpired
Ingredient · strength
Ranitidine Hydrochloride›Strength being verified
Manufacturer / importer
(주)퍼슨
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 500 tablets/bottle
Approval status
Expired

MFDS item code 201308716 · Approved 2013.08.07

This product's status changed to Expired on 2023.08.07. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of gastric ulcers and gastric mucosal lesions, alleviation of excessive gastric acid effects
Who uses it
Adults · Children
Adult dosage
For adults, as ranitidine: 150 mg orally, twice a day in the morning and at bedtime. For the treatment of gastric and duodenal ulcers: 150 mg orally, twice a day or 300 mg once a day at bedtime; duodenal ulcer patients may take 300 mg twice a day. For gastroesophageal reflux disease: take 150 mg orally, twice a day for 8 weeks or 300 mg once before bedtime.
Children's dosage
For children aged 8 to 18 years, the dosage may be 150 mg (2 mg per kg of body weight) per dose, up to twice a day.

Ingredients

Manufacturer
(주)퍼슨

Efficacy & effects

Improvement of gastric ulcers and gastric mucosal lesions, alleviation of excessive gastric acid effects

  • Gastric and duodenal ulcers
  • Zollinger-Ellison syndrome
  • gastroesophageal reflux disease
  • Mendelson's syndrome
  • postoperative ulcers
  • gastric and duodenal ulcers due to NSAID administration
  • acute gastritis
  • acute exacerbation of chronic gastritis
  • upper gastrointestinal bleeding
  • peptic ulcer
  • acute stress ulcer
  • acute gastric mucosal lesions
View approved original text

This drug is used for gastric and duodenal ulcers, Zollinger-Ellison syndrome, and gastroesophageal reflux disease. It is also administered to prevent Mendelson's syndrome before anesthesia and is effective in treating postoperative ulcers and preventing ulcers caused by non-steroidal anti-inflammatory drugs (NSAIDs). It improves gastric mucosal lesions during exacerbation of acute and chronic gastritis and helps in treating upper gastrointestinal bleeding due to peptic ulcers or acute stress ulcers. Additionally, it is used to relieve symptoms such as heartburn and acid reflux caused by excessive gastric acid. Overall, this drug is used to improve and treat symptoms of various gastrointestinal disorders.

Dosage and Administration

Adult dosage

For adults, as ranitidine: 150 mg orally, twice a day in the morning and at bedtime. For the treatment of gastric and duodenal ulcers: 150 mg orally, twice a day or 300 mg once a day at bedtime; duodenal ulcer patients may take 300 mg twice a day. For gastroesophageal reflux disease: take 150 mg orally, twice a day for 8 weeks or 300 mg once before bedtime.

Children's dosage

For children aged 8 to 18 years, the dosage may be 150 mg (2 mg per kg of body weight) per dose, up to twice a day.

Precautions

This drug should not be used in patients with a history of allergic reactions to any of the components of this drug. It is also safe to avoid in patients with a rare blood disorder called acute porphyria. For patients with impaired kidney function, the dosage should be adjusted by reducing the dose or extending the interval between doses, as this drug can remain in the body for a long time. Caution is also advised in patients with poor liver function. Patients with a history of drug allergic reactions, the elderly, and those taking NSAIDs should exercise special caution. In particular, patients who are experiencing new digestive symptoms or have a history of gastric ulcers and are over middle age should use this drug only after ruling out the possibility of stomach cancer. Patients with gastric or duodenal ulcers associated with Helicobacter pylori should also undergo eradication therapy. While taking this drug, severe allergic reactions such as shock, hives, and difficulty breathing may rarely occur, so if any abnormal symptoms develop, the drug should be discontinued immediately and treatment sought. Blood tests may show decreased white blood cells or platelets; if systemic fatigue, bleeding, or fever occurs, it is important to see a doctor for testing. If symptoms of liver dysfunction or jaundice develop, the drug should be stopped immediately and consultation with a doctor is advised. Patients with a history of heart disease should be cautious, as heart rate may slow or become irregular. Gastrointestinal symptoms such as constipation, nausea, and abdominal pain may also occur. Neurological symptoms such as dizziness, drowsiness, headaches, insomnia, and mental confusion may happen, and if symptoms are severe, discontinuation should be considered. Muscle pain or joint pain may occur, and rare cases of muscle damage have been reported; any unusual symptoms should be communicated to a physician. Skin rashes or hair loss may occur infrequently. During treatment, regular blood tests, liver function tests, and kidney function tests should be conducted, and caution should be exercised as the risk of pneumonia may increase in the elderly or those with chronic illnesses. Patients should avoid driving or operating dangerous machinery if dizziness or drowsiness occur while taking this medication. There may be interactions with other drugs, so it is essential to inform a doctor or pharmacist if other medications are being taken. Particular caution should be observed when taken with anticoagulants or certain heart medications, as monitoring of blood coagulation status is necessary. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of taking this drug, and caution is also recommended for nursing mothers. For children, safety has not been fully established, so use should be cautious. In case of overdose, severe adverse effects are rare, but emergency measures such as vomiting or gastric lavage may be necessary. This drug should be kept out of reach of children and should not be transferred to another container.

Side effects and when to seek care immediately

Serious side effects

  • Anaphylactic shock
  • hives
  • angioedema
  • bronchospasm
  • low blood pressure
  • chest pain
  • vascular edema
  • shock
  • leukopenia
  • thrombocytopenia
Show 10 more
  • aplastic anemia
  • pure red cell aplasia
  • aplastic anemia
  • hypoplastic anemia
  • autoimmune hemolytic anemia
  • hepatitis
  • jaundice
  • consciousness disturbances
  • seizures
  • myoclonus

Mild side effects

Hives, angioedema, rash, fever, low blood pressure, chest pain, granulocytopenia, elevated serum creatinine level, leukopenia, thrombocytopenia, transient liver dysfunction (elevated AST, ALT, γ-GTP, ALP), bradycardia, heart block, tachycardia, vasculitis, constipation, nausea, vomiting, abdominal bloating, abdominal pain, loss of appetite, diarrhea, dizziness, drowsiness, headache, feeling heavy-headed, insomnia, agitation, anxiety, mental confusion, depression, hallucination,

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

Storage

This drug is sensitive to light, so it should be stored in a container that blocks light and kept at a temperature between 1 to 30 degrees Celsius. Therefore, it is important to avoid direct sunlight and maintain it in an appropriate temperature environment until it is used.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 500 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.