Medication info

Cimetidine Tablets (Cimetidine)

Prescription medicationTabletExpired
Ingredient · strength
Cimetidine›200mg / 1 tablet
Manufacturer / importer
조아제약(주)
Appearance
Pale green round tablets
Packaging
500 T/bottle, 1000 T/bottle
Approval status
Expired

MFDS item code 201500381 · Approved 2015.01.26

This product's status changed to Expired on 2025.01.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of gastric and duodenal ulcers and gastroesophageal reflux disease, improvement of gastric mucosal lesions
Who uses it
Adults · Children
Adult dosage
As cimetidine, take 400 mg orally twice daily (in the morning and at bedtime) or a single dose of 800 mg orally at bedtime. Alternatively, take 300 mg orally four times daily (after meals and at bedtime). The dose may be increased up to 1.6 g daily in divided doses of 400 mg taken four times daily (after meals and at bedtime). For acute gastritis or acute exacerbations of chronic gastritis, administer 200 mg twice daily or 400 mg once daily.
Children's dosage
Administer orally in divided doses of 20-40 mg per kg of body weight daily.

Ingredients

Manufacturer
조아제약(주)

Efficacy & effects

Treatment of gastric and duodenal ulcers and gastroesophageal reflux disease, improvement of gastric mucosal lesions

  • Gastric ulcer
  • duodenal ulcer
  • gastroesophageal reflux disease
  • recurrent ulcer
  • anastomotic ulcer
  • Zollinger-Ellison syndrome
  • gastric mucosal lesions
  • erosion
  • bleeding
  • redness
  • swelling
  • acute gastritis
View approved original text

This medication is used for the treatment of ulcers occurring in the stomach and duodenum, gastroesophageal reflux disease, and recurrent or surgical complications causing anastomotic ulcers. It is also effective for conditions caused by excessive gastric acid secretion, such as Zollinger-Ellison syndrome. It improves lesions such as erosion, bleeding, redness, and swelling of the gastric mucosa occurring during acute exacerbations of acute gastritis and chronic gastritis, alleviating symptoms. Thus, it helps treat damage to the gastrointestinal mucosa and reduces inflammation, restoring gastric health. Therefore, it is a very effective medication for treating gastrointestinal diseases.

Dosage and Administration

Adult dosage

As cimetidine, take 400 mg orally twice daily (in the morning and at bedtime) or a single dose of 800 mg orally at bedtime. Alternatively, take 300 mg orally four times daily (after meals and at bedtime). The dose may be increased up to 1.6 g daily in divided doses of 400 mg taken four times daily (after meals and at bedtime). For acute gastritis or acute exacerbations of chronic gastritis, administer 200 mg twice daily or 400 mg once daily.

Children's dosage

Administer orally in divided doses of 20-40 mg per kg of body weight daily.

Precautions

Care must be taken when using this medication with glass ampule injections, as glass fragments can cause adverse reactions; therefore, extreme caution is required when cutting the container. Special care is needed when administering to children and the elderly. This medication should not be administered to patients with hypersensitivity to cimetidine or other components, or with a history thereof, and to patients taking dofetilide. The risk of ventricular arrhythmia may increase when combined with dofetilide. Patients with impaired kidney or liver function, those with a history of drug hypersensitivity, elderly individuals, children under 19, and patients undergoing hemodialysis should use this medication with caution. In particular, patients with renal dysfunction may have increased blood drug concentrations, thus the dosage should be reduced or the dosing interval should be extended. This medication can obscure symptoms of gastric cancer, so it should only be used after confirming that it is non-malignant, and patients with Helicobacter pylori infection should undergo eradication therapy. During administration, various adverse reactions may occur, such as leukopenia, hepatic dysfunction, renal dysfunction, hypersensitivity reactions, gynecomastia, gastrointestinal symptoms, neurological symptoms, skin rash; symptoms should be reported to a healthcare provider immediately if they occur. Particularly, if hematologic symptoms such as fatigue, bleeding, or fever occur, blood tests should be conducted, and if necessary, medication should be stopped. In elderly patients or those with renal failure, symptoms such as confusion or seizures, indicating neurological complications, may infrequently occur, necessitating careful observation. This medication can interact with various other drugs, and dosage adjustments or cessation of treatment may be needed when taken with anticoagulants, antidepressants, antiarrhythmics, calcium channel blockers, or hypoglycemics. Women who are pregnant or may become pregnant should only use this medication if the therapeutic benefits outweigh the risks, as the effects on the fetus are not fully known. Additionally, this medication is excreted in breast milk, so breastfeeding should be discontinued during treatment. Safety in pediatric patients has not been adequately established, so it should be used only when necessary. In elderly patients, due to potential renal impairment, the dosage may need to be reduced or the dosing interval extended for careful usage. In case of overdose, severe side effects such as respiratory depression may occur, requiring emergency measures such as artificial respiration or gastric lavage depending on the symptoms. When administered intravenously, rapid infusion may lead to arrhythmias or hypotension, hence it should be administered slowly in small amounts.

Side effects and when to seek care immediately

Serious side effects

General malaise, weakness, subcutaneous hemorrhage, mucosal hemorrhage, fever (early sign of hematologic abnormalities), jaundice, acute renal failure, shock, anaphylaxis-like reaction (general rash, respiratory distress), altered consciousness, seizures, confusion (anxiety, psychosis, depression, agitation, hallucinations, disorientation), Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell's syndrome), epidermal necrosis, erythema multiforme, exfoliative dermatitis, generalized exfoliative erythema, respiratory

Mild side effects

  • Leukopenia
  • granulocytopenia
  • agranulocytosis
  • thrombocytopenia
  • pancytopenia
  • aplastic anemia
  • hepatitis
  • increased AST
  • ALT
  • interstitial seizures
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  • interstitial nephritis
  • urinary retention
  • elevated BUN
  • gynecomastia
  • excessive lactation
  • increased discharge
  • erectile dysfunction
  • abdominal bloating
  • constipation
  • diarrhea
  • headache
  • dizziness
  • limb numbness
  • drowsiness
  • hypochondriasis
  • weakness
  • bradycardia
  • tachycardia
  • palpitations
  • heart block
  • fatigue
  • fever

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 an opaque container to prevent light exposure. Additionally, it should be stored at room temperature between 1 to 30 degrees Celsius for optimal efficacy.

Appearance and packaging

Appearance

Pale green round tablets

Package unit

500 T/bottle, 1000 T/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.