Medication info

Latini Tablets (Ranitidine Hydrochloride)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Ranitidine Hydrochloride›168mg / 1 tablet
Manufacturer / importer
(주)제뉴파마
Appearance
Light yellow to light yellowish round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 199500842 · Notified 1995.09.27

This product's status changed to Approval withdrawn on 2024.10.04. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of gastric and duodenal ulcers and gastric mucosal lesions, relief of symptoms of excess stomach acid
Who takes it
Adults · Children
Adult dose
As ranitidine, the dosage is 150 mg orally twice a day, once in the morning and once at bedtime. 1) Gastric and duodenal ulcers: 150 mg orally twice a day or 300 mg once at bedtime. For duodenal ulcer patients, 300 mg may be given twice a day, once in the morning and once at bedtime. For patients with recurrent ulcers, maintenance therapy of 150 mg once at bedtime is provided.
Child dose
For children aged 8 to 18 years, a single dose of 150 mg (2 mg per kg of body weight) may be administered twice a day.

Ingredients

Manufacturer
(주)제뉴파마

Efficacy & effects

Improvement of gastric and duodenal ulcers and gastric mucosal lesions, relief of symptoms of excess stomach acid

  • Gastric and duodenal ulcers
  • Zollinger-Ellison syndrome
  • gastroesophageal reflux disease
  • Mendelson's syndrome
  • postoperative ulcers
  • gastric and duodenal ulcers due to NSAID administration
  • gastric mucosal lesions
  • erosion
  • bleeding
  • redness
  • swelling
  • acute 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. Additionally, it helps prevent Mendelson's syndrome during preoperative anesthesia and treats postoperative ulcers. It is effective for gastric and duodenal ulcers caused by the use of nonsteroidal anti-inflammatory drugs (NSAIDs). It helps improve mucosal erosion, bleeding, redness, and swelling of the gastric mucosa during acute exacerbation of acute and chronic gastritis, and is used for upper gastrointestinal bleeding treatment. It is also effective in relieving symptoms of excess stomach acid, heartburn, and belching. Therefore, it is used to treat various symptoms and diseases related to the digestive system.

How to take

Adult dose

As ranitidine, the dosage is 150 mg orally twice a day, once in the morning and once at bedtime. 1) Gastric and duodenal ulcers: 150 mg orally twice a day or 300 mg once at bedtime. For duodenal ulcer patients, 300 mg may be given twice a day, once in the morning and once at bedtime. For patients with recurrent ulcers, maintenance therapy of 150 mg once at bedtime is provided.

Child dose

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

Precautions

This medication should not be used in patients with known hypersensitivity to its ingredients. Patients with a history of acute porphyria should not be administered this medication as it may provoke seizures. Additionally, since it contains lactose, it should not be administered to patients with genetic disorders such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption. As this medication is excreted via the kidneys, it should be used cautiously in patients with reduced renal function, with dosage adjustments or extended dosing intervals as necessary. Patients with impaired liver function also require caution. Patients with a history of drug hypersensitivity and elderly individuals should be treated with special caution. When taken in conjunction with nonsteroidal anti-inflammatory drugs, particularly in elderly patients or those with a history of peptic ulcers, regular monitoring is necessary. This medication may mask symptoms of gastric cancer, so patients with gastric ulcers or those who develop new or altered dyspeptic symptoms after the age of middle age should confirm malignancy before using it. Patients with gastric and duodenal ulcers infected with Helicobacter pylori should undergo eradication therapy. This drug can rarely cause serious allergic reactions, such as anaphylactic shock, so if any unusual symptoms occur during treatment, administration should be stopped immediately and appropriate treatment received. Symptoms such as hives, rashes, difficulty breathing, and hypotension necessitate cessation of use. Rare blood-related abnormal symptoms may include leukopenia, thrombocytopenia, and anemia; thus, if symptoms such as general fatigue, bleeding, or fever are present, a blood test should be conducted. Jaundice and increased liver function test values can also occur, so administration should be stopped immediately if these symptoms arise. Gastrointestinal symptoms, such as irregular heartbeats, constipation, nausea, abdominal pain, and diarrhea, may occur. Central nervous system adverse effects, such as dizziness, drowsiness, headache, confusion, and hallucinations, have also been reported, necessitating careful attention if any such symptoms arise. During treatment, careful monitoring of the disease course is required, and it should only be used for the minimal period necessary; if ineffective, alternative therapies should be considered. Elderly patients and those with chronic lung disease, diabetes, or immunocompromised conditions may be at increased risk of pneumonia with the use of this medication. Dizziness or drowsiness should prompt avoidance of driving or hazardous machinery operation. This medication may affect the absorption or metabolism of other drugs, so dosage adjustments or discontinuation of concurrently used medications may be necessary. Particularly with concomitant use of warfarin, there is a risk of bleeding, thus routinely checking the coagulation status is recommended. The absorption of this medication may be reduced when taken with high doses of sucralfate; therefore, it is advisable to space the doses. Women who are pregnant or may become pregnant should use this medication cautiously, and breastfeeding women should use it only when the therapeutic benefits significantly outweigh the risks. Safety in children has not been sufficiently established, thus caution is advised in their use. Elderly individuals may have increased blood concentrations due to diminished renal function, so they should use a reduced dose or longer dosing intervals with caution. Some tests may yield false-positive results while taking this medication, thus care should be taken regarding testing methods. Signs of overdose are rare but might include vomiting or require gastric lavage; in severe cases, hemodialysis may be considered. Store out of reach of children, and avoid transferring to other containers as this may lead to quality degradation or accidents. This medication may promote bacterial proliferation in the stomach by reducing acid secretion, thus requiring additional monitoring such as eye examinations with long-term use.

Side effects and when to seek care immediately

Serious side effects

Anaphylactic shock, hives, angioedema, chest pain, bronchospasm, hypotension, vascular edema, jaundice, hepatitis, seizures, altered consciousness, severe headache, convulsions, muscular cramps, aplastic anemia, agranulocytosis, pancytopenia, acquired immune hemolytic anemia, hematological anomalies (hypoplastic marrow, aplastic anemia), Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), atrioventricular block, heart block, acute interstitial nephritis

Mild side effects

Hives, angioedema, rashes, fever, bronchospasm, hypotension, chest pain, granulocytopenia, increased serum creatinine levels, leukopenia, thrombocytopenia, eosinophilia, temporary liver function impairment (increased AST, ALT, γ-GTP, ALP levels), bradycardia, atrioventricular block, tachycardia, vasculitis, constipation, nausea, vomiting, abdominal bloating, abdominal pain, loss of appetite, diarrhea, acute pancreatitis, dizziness, drowsiness, headache, heaviness of the head, insomnia

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

Storage

This medication is sensitive to light; therefore, it should be stored in a container that does not allow light in. Additionally, it is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness.

Appearance and packaging

Appearance

Light yellow to light yellowish 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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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.