Medication info
Roxatin Extended Release Capsule (Roxatidine Acetate Hydrochloride)

Roxatin Extended Release Capsule (Roxatidine Acetate Hydrochloride)

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

MFDS item code 200100602 · Approved 2001.05.17 · Insurance code 670300370

Summary

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

Ingredients

Manufacturer
Kolon Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of gastric acid-related disorders (ulcers, etc.), improvement of gastric mucosal lesions, and prevention of gastric aspiration before anesthesia

  • Gastric and duodenal ulcers
  • gastroesophageal reflux disease
  • Zollinger-Ellison syndrome
  • gastric mucosal lesions (erosion
  • bleeding
  • redness
  • swelling)
  • acute gastritis
  • acute exacerbations of chronic gastritis
View approved original text

This medication is effective in treating ulcers in the stomach and duodenum, and it is also used to treat gastroesophageal reflux disease and Zollinger-Ellison syndrome. It is administered as a prophylactic measure before anesthesia in patients at risk of aspiration of gastric acid, especially pregnant patients. It helps improve lesions in the gastric mucosa presenting with erosion, bleeding, redness, and swelling associated with acute and chronic gastritis. Based on these effects, it effectively manages and treats symptoms related to gastric diseases.

How to take

Adult dose

Adults 1) Gastric and duodenal ulcers, reflux esophagitis, Zollinger-Ellison syndrome: Administer 75mg of roxatidine acetate hydrochloride orally twice daily, after breakfast and dinner. For gastric and duodenal ulcers, 150mg may also be administered once daily in the evening. Gastric and duodenal ulcers are generally treated within 4 weeks, but symptoms resolve within a few days. If the ulcer has not healed after 4 weeks of treatment, continue administering the same dose for an additional 2 weeks. For patients with impaired renal function and a creatinine clearance of 20-50ml/min, administer 75mg once daily in the evening. For patients with a creatinine clearance of 20ml/min or less, administer 75mg every 2 days in the evening. 2) Acute gastritis and acute exacerbation of chronic gastritis: Administer 75mg once daily after dinner or at bedtime. 3) Pre-anesthetic administration: Administer 75mg twice (at bedtime on the day before surgery and 2 hours before induction of anesthesia on the day of surgery). Adjust the dose as appropriate according to age and symptoms.

Precautions

This medication should not be used by individuals who are allergic to it or its ingredients. Patients with poor liver function and those with impaired kidney function should exercise caution when using this medication. Particularly, in cases of reduced kidney function, drug concentration may increase, necessitating a reduction in dosage or extension of dosing intervals. Elderly patients are at higher risk of decreased kidney function, which may lead to increased retention of the medication in the body, therefore caution should be exercised during administration. Those with a history of drug allergies or hypersensitivity should also be careful, as this medication contains Yellow No. 4, and individuals allergic to this component should be particularly cautious. During use, hypersensitivity reactions such as shock symptoms, skin rashes, and itching may occur, and if any unusual symptoms arise, medication should be discontinued immediately and a physician should be notified. Regular blood tests should be performed to monitor changes in platelet levels and blood cell counts, and if abnormalities are found, medication should be discontinued and appropriate treatment should be administered. Liver dysfunction or jaundice symptoms may occur, so liver status should be observed closely, and if abnormalities arise, use should be stopped immediately. Gastrointestinal symptoms such as constipation, diarrhea, nausea, and abdominal bloating may occur, and if discomfort persists, consultation with healthcare professionals is advised. Rarely, neurological symptoms such as mental confusion, hallucinations, drowsiness, and headaches may appear, so caution is necessary in these cases. Severe skin reactions may occur, so if skin rashes or abnormalities in the mucous membranes arise, medication should be stopped immediately. If symptoms of muscle pain or muscle damage are observed, medication use should be stopped immediately, and consultation with healthcare professionals is advised. This medication may interact with other drugs, so particularly if taking ketoconazole or midazolam, inform your physician or pharmacist. Women who are pregnant or may become pregnant should carefully weigh the benefits and risks of using this medication. Nursing mothers should avoid breastfeeding during treatment, as this medication may be transmitted through breast milk. It is recommended not to use this medication in children under 14 years of age, as safety has not been established. This medication should be stored out of the reach of children and it is advisable not to transfer it to another container.

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 air or moisture from entering. The storage temperature should be maintained at room temperature between 1 and 30 degrees.

Appearance and packaging

Appearance

A hard capsule with green upper and white lower containing white granules.

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.