Medication info

Samchundang Ranitidine Injection (Ranitidine Hydrochloride)

Prescription medication경구 · 근육 · 정맥Expired
Ingredient · strength
Ranitidine Hydrochloride›28mg / 1mL
Manufacturer / importer
삼천당제약(주)
Appearance
Brown ampoule filled with a colorless to pale yellow transparent liquid
Packaging
2mL×1 ampoule, 50 ampoules
Approval status
Expired

MFDS item code 199100973 · Notified 1991.11.14

This product's status changed to Expired on 2025.04.01. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of stomach (ulcer, gastroesophageal reflux) and upper gastrointestinal diseases
Who uses it
Adults · Children
Adult dosage
As ranitidine, administer 50mg intravenously or intramuscularly 3-4 times a day. For intravenous administration, dilute this drug 50mg in 20ml of normal saline or dextrose solution and administer slowly over at least 2 minutes or mix with an infusion at a rate of 25mg/hr over 2 hours. For upper gastrointestinal bleeding, effects typically appear within a week, and once oral administration is feasible, it should be switched.
Children's dosage
Clinical studies for pediatric use have not been established.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Treatment of stomach (ulcer, gastroesophageal reflux) and upper gastrointestinal diseases

  • Stomach ulcer
  • duodenal ulcer
  • Zollinger-Ellison syndrome
  • gastroesophageal reflux disease
  • Mendelson's syndrome
  • postoperative ulcer
  • upper gastrointestinal bleeding
  • peptic ulcer
  • acute stress ulcer
  • acute gastric mucosal lesion
View approved original text

This medication is used to treat ulcers in the stomach and duodenum, Zollinger-Ellison syndrome, and gastroesophageal reflux disease. It also helps prevent Mendelson's syndrome during preoperative anesthesia and prevents postoperative ulcers. It is effective in treating upper gastrointestinal bleeding caused by acute stress ulcers or acute gastric mucosal lesions. It is used to improve various symptoms related to gastrointestinal diseases.

Dosage and Administration

Adult dosage

As ranitidine, administer 50mg intravenously or intramuscularly 3-4 times a day. For intravenous administration, dilute this drug 50mg in 20ml of normal saline or dextrose solution and administer slowly over at least 2 minutes or mix with an infusion at a rate of 25mg/hr over 2 hours. For upper gastrointestinal bleeding, effects typically appear within a week, and once oral administration is feasible, it should be switched.

Children's dosage

Clinical studies for pediatric use have not been established.

Precautions

This medication should be cut carefully when using glass ampoules to avoid glass fragments. Extra caution is needed when used in children or the elderly. This medication should not be administered to patients who have had an allergic reaction to this drug or its components. Patients with impaired kidney function may require dose adjustment as this drug is excreted through the kidneys, which can lead to elevated plasma concentrations. Caution should be exercised when administering to patients with liver dysfunction, a history of hypersensitivity, elderly patients, and those with a history of acute porphyria. This medication may rarely cause serious allergic reactions or anaphylactic shock; thus, if any unusual symptoms occur during administration, it should be discontinued immediately and appropriate treatment should be received. Watch for hypersensitivity reactions such as hives, rash, and bronchospasms. Blood abnormalities may include leukopenia, thrombocytopenia, aplastic anemia, and so it is essential to get tested immediately if symptoms such as systemic fatigue, bleeding, or fever occur. Liver dysfunction may occur; if elevated liver enzymes or jaundice symptoms arise, treatment should be discontinued. Rare cardiovascular issues may include arrhythmia, bradycardia, and heart block, so caution is advised for patients with heart disease. Gastrointestinal side effects may include constipation, nausea, vomiting, and abdominal pain. There may be neurologic symptoms such as dizziness, drowsiness, seizures, and mental confusion; consult with healthcare professionals if any unusual symptoms arise. Endocrine disorders such as gynecomastia and erectile dysfunction have been reported rarely. Musculoskeletal problems like myalgia or rhabdomyolysis may also occur, so be cautious. Skin rashes or hair loss symptoms may rarely occur. This medication should be administered at the minimum effective dose with close observation of therapeutic effects; if ineffective, alternative treatments should be considered. Elderly patients or those with chronic illnesses may have an increased risk of pneumonia. Routine blood tests of liver function may be advisable with long-term high-dose treatment. Use only when oral administration is not feasible or in emergency situations, and switch back to oral administration as soon as possible. This medication may interact with other drugs, so inform healthcare providers of any medications being taken. Women who are pregnant or may become pregnant should carefully weigh the risks and benefits before use, and similar caution should be exercised during breastfeeding. Safety for pediatric use has not been fully established. This medication may cause false-positive results in certain tests, so care should be taken with testing procedures. Overdose is rare, but may require treatment such as vomiting or gastric lavage, and in severe cases, dialysis may be needed. Intramuscular injection may cause pain or induration at the injection site, so caution is needed. For patients with a risk of abnormal heart rate, the infusion rate should be slow, and the recommended rate should not be exceeded. This medication may mask symptoms of gastric cancer; thus, patients over middle age with newly developed indigestion or those with gastric ulcers should ascertain malignancy before using it. Prolonged use may bind to ocular melanins, necessitating ophthalmologic examinations.

Side effects and when to seek care immediately

Serious side effects

  • Anaphylactic shock, hives, angioedema, chest pain, vascular edema → severe allergic reactions
  • Severe rash, blisters, skin peeling, pain in oral/ocular mucosa → severe skin reactions
  • Bronchospasm, asthma attack, difficulty breathing → respiratory issues
  • Skin or eyes turning yellow (jaundice), severe lethargy → liver issues (jaundice)
  • Severe headache, mental confusion, seizures, generalized muscle spasms in severe and elderly patients →

Mild side effects

Hives, angioedema, rash, fever, bronchospasm, hypotension, chest pain, vascular edema, granulocytopenia, elevated serum creatinine levels, leukopenia, thrombocytopenia, aplastic anemia, agranulocytosis, pancytopenia, eosinophilia, temporary liver dysfunction (elevated AST, ALT, γ-GTP, ALP), bradycardia, heart block, tachycardia, vasculitis, constipation, nausea, vomiting, abdominal pain

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 container that can block light. Additionally, it is best stored at room temperature between 1°C and 30°C. This storage method helps maintain the medication's effectiveness for a prolonged period.

Appearance and packaging

Appearance

Brown ampoule filled with a colorless to pale yellow transparent liquid

Package unit

2mL×1 ampoule, 50 ampoules

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.