Medication info
Gastric Capsule (Roxatidine Acetate Hydrochloride)

Gastric Capsule (Roxatidine Acetate Hydrochloride)

Prescription medicationHard capsuleOral
Ingredient · strength
Roxatidine Acetate Hydrochloride›75mg / 1 capsule
Manufacturer / importer
Dae Hwa Pharmaceutical Co., Ltd.
Appearance
A hard capsule with white granules inside, upper and lower white.
Packaging
30 capsules/bottle, 250 capsules/bottle
Approval status
Active

MFDS item code 200503334 · Notified 2005.07.05 · Insurance code 645600030

Summary

Main use
Treatment of acid-related disorders (including ulcers and gastroesophageal reflux disease), improvement of gastric mucosal lesions, and prevention of gastric acid aspiration
Who takes it
Adults
Adult dose
1) Gastric and duodenal ulcers, reflux esophagitis, Zollinger-Ellison syndrome: Administer 75mg of roxatidine acetate hydrochloride orally per dose twice daily, after breakfast and dinner. For gastric and duodenal ulcers, 150mg per dose may also be administered once daily in the evening. Gastric and duodenal ulcers are usually treated within 4 weeks, but symptoms subside within a few days. For patients who are not cured after 4 weeks of treatment, administer the same dose for an additional 2 weeks. For patients with impaired renal function and creatinine clearance of approximately 20-50ml/min, administer 75mg per dose once daily in the evening. For patients with creatinine clearance of 20ml/min or less, administer 75mg per dose once every 2 days in the evening. 2) Acute gastritis and acute exacerbation of chronic gastritis: Administer 75mg per dose once daily after the evening meal or at bedtime. 3) Preanesthetic medication: Administer 75mg per dose twice (at bedtime on the day before surgery and 2 hours before induction of anesthesia on the day of surgery). Adjust the dose appropriately according to age and symptoms.

Ingredients

Manufacturer
Dae Hwa Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of acid-related disorders (including ulcers and gastroesophageal reflux disease), improvement of gastric mucosal lesions, and prevention of gastric acid aspiration

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

This medication is used to treat gastric and duodenal ulcers, gastroesophageal reflux disease, and Zollinger-Ellison syndrome. It is also helpful for patients who are at risk of aspiration of gastric acid, especially during pre-anesthesia of labor. It is used to improve gastric mucosal lesions (erosion, bleeding, redness, swelling) caused by acute exacerbation of acute gastritis or chronic gastritis. It effectively improves symptoms of various gastric diseases.

How to take

Adult dose

1) Gastric and duodenal ulcers, reflux esophagitis, Zollinger-Ellison syndrome: Administer 75mg of roxatidine acetate hydrochloride orally per dose twice daily, after breakfast and dinner. For gastric and duodenal ulcers, 150mg per dose may also be administered once daily in the evening. Gastric and duodenal ulcers are usually treated within 4 weeks, but symptoms subside within a few days. For patients who are not cured after 4 weeks of treatment, administer the same dose for an additional 2 weeks. For patients with impaired renal function and creatinine clearance of approximately 20-50ml/min, administer 75mg per dose once daily in the evening. For patients with creatinine clearance of 20ml/min or less, administer 75mg per dose once every 2 days in the evening. 2) Acute gastritis and acute exacerbation of chronic gastritis: Administer 75mg per dose once daily after the evening meal or at bedtime. 3) Preanesthetic medication: Administer 75mg per dose twice (at bedtime on the day before surgery and 2 hours before induction of anesthesia on the day of surgery). Adjust the dose appropriately according to age and symptoms.

Precautions

This medicine should not be used in patients with allergic reactions to this medicine or its ingredients. Patients with liver function issues or impaired renal function should use this medicine with caution, and in cases of renal impairment, the dose may need to be decreased or the dosing interval increased. Elderly patients often have reduced renal function, leading to prolonged drug retention in the body, so caution is especially required. During medication, serious allergic reactions like shock may occur, so if symptoms such as pale face or low blood pressure appear, the medication should be stopped immediately and medical staff notified. Although rare, allergic symptoms such as skin rash or itching may occur, and upon such symptoms, the medication should be discontinued, and a doctor consulted. Blood tests may reveal anomalies such as thrombocytopenia or anemia, so regular tests should be conducted, and if any abnormalities are detected, the medication should be stopped. Liver function abnormalities or jaundice symptoms may occur, so liver health should be carefully monitored, and if abnormalities arise, the medication should be stopped immediately. Gastrointestinal symptoms such as constipation, diarrhea, nausea, and abdominal bloating may occur. Rarely, mental confusion, hallucinations, drowsiness, and headache may occur, and if such symptoms arise, medical staff should be consulted. Severe skin disorders may develop, so if any skin abnormalities develop, the medication should be discontinued immediately. Muscle-related issues such as muscle pain or signs of muscle damage may occur, in which case the medication should be stopped immediately and treated accordingly. This medicine may rarely cause side effects such as gynecomastia, excessive milk secretion, lethargy, and elevated blood pressure. When using this with other medications, there may be interactions, especially with drugs like ketoconazole or midazolam, requiring caution. Women who are pregnant or may become pregnant should carefully consider the risks and benefits of using this medication, as its safety is not well established. This medication can be transmitted through breast milk, so it is advisable to avoid breastfeeding during treatment. It is not used in children under 14 years old due to lack of established safety. The medication should be kept out of reach of children, and transferring it to other containers is not advisable for maintaining quality.

Side effects

shock

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended to keep the storage temperature between 1 degree and 30 degrees Celsius. By storing it this way, the efficacy of the medication can be maintained for a longer time.

Appearance and packaging

Appearance

A hard capsule with white granules inside, upper and lower white.

Package unit

30 capsules/bottle, 250 capsules/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.

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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.