Medication info

Ranitac Injection (Ranitidine Hydrochloride)

Prescription medicationSolution경구 · 근육 · 정맥Expired
Ingredient · strength
Ranitidine Hydrochloride›28mg / 1mL
Manufacturer / importer
하나제약(주)
Appearance
Brown ampoule containing a colorless to light yellow transparent solution
Packaging
2mL x 50 ampoules
Approval status
Expired

MFDS item code 199702396 · Notified 1997.05.26

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 gastrointestinal diseases such as gastric and duodenal ulcers and gastroesophageal reflux disease
Who uses it
Adults · Children
Adult dosage
As ranitidine, administer 50mg 3 to 4 times a day by intravenous or intramuscular injection. For intravenous injection, dilute 50mg of this drug in 20ml of normal saline or dextrose solution and inject slowly over at least 2 minutes, or mix in the infusion to administer at a rate of 25mg/hr over 2 hours. For pre-anesthesia dosing (to prevent Mendelson’s syndrome), inject 50mg intramuscularly or slowly intravenously over 1 minute, 45 to 60 minutes before induction.
Children's dosage
Clinical studies for pediatric patients have not been established.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Treatment of gastrointestinal diseases such as gastric and duodenal ulcers and gastroesophageal reflux disease

  • Gastric and duodenal ulcers
  • Zollinger-Ellison syndrome
  • gastroesophageal reflux disease
  • Mendelson's syndrome
  • post-surgical ulcers
  • upper gastrointestinal bleeding
  • peptic ulcers
  • acute stress ulcers
  • acute gastric mucosal lesions
View approved original text

This medication treats gastric and duodenal ulcers, and is also effective for Zollinger-Ellison syndrome and gastroesophageal reflux disease. Additionally, it is administered pre-anesthesia to prevent Mendelson’s syndrome and is used post-surgery for the treatment of ulcers and upper gastrointestinal bleeding. It also helps with acute stress ulcers and acute gastric mucosal lesions. It is effective for the treatment and prevention of various digestive-related diseases.

Dosage and Administration

Adult dosage

As ranitidine, administer 50mg 3 to 4 times a day by intravenous or intramuscular injection. For intravenous injection, dilute 50mg of this drug in 20ml of normal saline or dextrose solution and inject slowly over at least 2 minutes, or mix in the infusion to administer at a rate of 25mg/hr over 2 hours. For pre-anesthesia dosing (to prevent Mendelson’s syndrome), inject 50mg intramuscularly or slowly intravenously over 1 minute, 45 to 60 minutes before induction.

Children's dosage

Clinical studies for pediatric patients have not been established.

Precautions

This medication can introduce glass particles when the injection container is cut, so it should be handled very carefully during use, especially in children and the elderly. It should not be used in patients with hypersensitivity to this medication or its components. In patients with poor kidney function, this medicine may remain in the body for an extended duration, so the dosage should be reduced or the dosing interval increased. Caution should also be exercised in patients with impaired liver function. Patients with a history of drug hypersensitivity or elderly patients should be administered carefully. It is not recommended for patients with a history of acute porphyria as it may provoke seizures. This medication can very rarely cause severe allergic reactions or shock; if any abnormal symptoms appear after administration, discontinue use immediately and seek appropriate treatment. If symptoms of hypersensitivity such as hives, rash, or difficulty breathing occur, discontinue the use of this medication immediately. Blood abnormalities such as leukopenia or thrombocytopenia may occur, so if symptoms like fatigue, bleeding, or fever arise, blood tests should be conducted and administration should be discontinued if necessary. Liver dysfunction may occur; therefore, if jaundice or symptoms suggesting liver dysfunction appear, discontinue treatment immediately. Arrhythmias may appear rarely, and patients with heart disease should exercise caution. Gastrointestinal symptoms such as constipation, nausea, vomiting, and abdominal pain may occur; severe symptoms should prompt consulting a physician. Neurological symptoms such as dizziness, drowsiness, and headaches may appear; if abnormal symptoms persist, discontinuation of administration is recommended. Endocrine symptoms such as gynecomastia or sexual dysfunction have been reported rarely, but the cause is not clear. Muscle pain or arthralgia may occur, and in severe cases, rhabdomyolysis may develop; inform healthcare professionals immediately if muscle pain is severe. Skin reactions such as rash or hair loss may occur rarely. Regular blood, liver, and kidney function tests should be conducted during administration, especially when administered intravenously for more than 5 days, daily monitoring of liver enzyme levels is advised. This medication can interact with other drugs, so patients should inform healthcare professionals of any other medications being taken, especially when used with anticoagulants, requiring close monitoring of blood coagulation status. Women who are pregnant or may become pregnant should carefully discuss the need for this medication with their physician, and it should be used cautiously in nursing mothers as it may pass into breast milk. Safety in pediatric patients has not been fully established, so caution is required when administering to children. In cases of overdose, specific toxic symptoms are rare, but symptomatic treatment such as vomiting or gastric lavage may be necessary, and severe cases may require hemodialysis. Intramuscular injections may cause pain or a hard lump at the injection site; caution is needed. Rapid intravenous injection may slow the heart rate; therefore, intravenous infusion should be administered slowly over at least 2 minutes. This medication may mask symptoms of gastric cancer, so patients with gastric ulcers or new or altered dyspeptic symptoms in middle-aged or older patients should confirm malignancy before use. Prolonged use may necessitate eye-related assessments, so an ophthalmologic examination is recommended.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylactic shock
  • bronchospasm
  • vascular edema
  • generalized weakness
  • fatigue
  • subcutaneous or mucosal bleeding
  • fever
  • leukopenia
Show 16 more
  • thrombocytopenia
  • aplastic anemia
  • bone marrow failure
  • aplastic anemia
  • refractory anemia
  • agranulocytosis
  • acquired immune hemolytic anemia
  • jaundice
  • hepatitis
  • cardiac asystole
  • acute pancreatitis
  • seizures
  • altered consciousness
  • myotonic contractions
  • heart block
  • acute interstitial nephritis.

Mild side effects

  • Rash
  • fever
  • hypotension
  • chest pain
  • increased serum creatinine
  • bradycardia
  • atrioventricular block
  • tachycardia
  • vasculitis
  • nausea
Show 28 more
  • vomiting
  • abdominal bloating
  • abdominal pain
  • loss of appetite
  • diarrhea
  • dizziness
  • drowsiness
  • headache
  • heaviness in the head
  • insomnia
  • agitation
  • anxiety
  • confusion
  • depression
  • hallucinations
  • blurred vision
  • involuntary movements
  • gynecomastia
  • excess milk production
  • erectile dysfunction
  • decreased libido
  • arthralgia
  • myalgia
  • skin rash
  • alopecia
  • stomatitis
  • pruritus
  • muscle.

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

Storage

This medication may be sensitive to light, so it should be stored in a tightly sealed container that blocks light. Additionally, it is best to store the medication at room temperature, avoiding extreme heat or cold.

Appearance and packaging

Appearance

Brown ampoule containing a colorless to light yellow transparent solution

Package unit

2mL x 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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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.