Medication info
Rosadins Sustained Release Capsule 75mg (Roxatidine Acetate Hydrochloride Suspended Granule 45.45%)

Rosadins Sustained Release Capsule 75mg (Roxatidine Acetate Hydrochloride Suspended Granule 45.45%)

Prescription medicationHard capsuleOral
Ingredient · strength
Roxatidine Acetate Hydrochloride Extended-release Granules (45.45%)›165mg / 1 capsule
Manufacturer / importer
YouYoung Pharmaceutical Co., Ltd.
Appearance
A capsule with a blue-green upper part and a white lower part containing white sustained-release granules.
Packaging
30 capsules/bottle, 500 capsules/bottle
Approval status
Active

MFDS item code 200202753 · Approved 2002.06.12 · Insurance code 648200310

Summary

Main use
Treatment of acid-related disorders (including ulcers and reflux); improvement of gastric lesions; prevention of acid aspiration before anesthesia
Who takes it
Adults
Adult dose
1) Gastric and duodenal ulcers, gastroesophageal reflux disease, Zollinger-Ellison syndrome: Administer 75 mg of roxatidine acetate hydrochloride orally twice daily, after breakfast and dinner. For gastric and duodenal ulcers, 150 mg may be administered once daily in the evening. Gastric and duodenal ulcers usually heal within 4 weeks, but symptoms resolve within several days. If the ulcer has not healed after 4 weeks of treatment, continue the same dose for an additional 2 weeks. In patients with impaired renal function and a creatinine clearance of 20-50mL/min, administer 75 mg once daily in the evening. If the creatinine clearance is 20mL/min or less, administer 75 mg every other day in the evening. 2) Acute gastritis or acute exacerbation of chronic gastritis: Administer 75 mg once daily after dinner or at bedtime. 3) Pre-anesthetic administration: Administer 75 mg 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
YouYoung Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of acid-related disorders (including ulcers and reflux); improvement of gastric lesions; prevention of acid aspiration before anesthesia

  • Gastric ulcers
  • duodenal ulcers
  • gastroesophageal reflux disease
  • Zollinger-Ellison syndrome
  • risk of gastric acid aspiration
  • gastric mucosal lesions
  • erosion
  • bleeding
  • erythema
  • edema
  • acute gastritis
  • acute exacerbations of chronic gastritis
View approved original text

This medication is used for various gastrointestinal diseases such as gastric and duodenal ulcers, gastroesophageal reflux disease, and Zollinger-Ellison syndrome. It is also used for pre-anesthesia in patients at risk of gastric acid aspiration, especially in parturient patients prior to anesthesia. Additionally, it is effective in treating improvements in gastric mucosal lesions and during acute exacerbations of acute and chronic gastritis. Overall, it is used to improve various diseases and symptoms related to the stomach.

How to take

Adult dose

1) Gastric and duodenal ulcers, gastroesophageal reflux disease, Zollinger-Ellison syndrome: Administer 75 mg of roxatidine acetate hydrochloride orally twice daily, after breakfast and dinner. For gastric and duodenal ulcers, 150 mg may be administered once daily in the evening. Gastric and duodenal ulcers usually heal within 4 weeks, but symptoms resolve within several days. If the ulcer has not healed after 4 weeks of treatment, continue the same dose for an additional 2 weeks. In patients with impaired renal function and a creatinine clearance of 20-50mL/min, administer 75 mg once daily in the evening. If the creatinine clearance is 20mL/min or less, administer 75 mg every other day in the evening. 2) Acute gastritis or acute exacerbation of chronic gastritis: Administer 75 mg once daily after dinner or at bedtime. 3) Pre-anesthetic administration: Administer 75 mg 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 in patients who are allergic to this drug or its ingredients. Patients with liver function issues or impaired kidney function should use this medication with caution. In particular, those with significant kidney impairment should reduce the dosage or extend the intervals between doses. Elderly patients may also have decreased kidney function, so caution should be exercised when administering this medication. Patients with a history of hypersensitivity reactions to medications should also use caution. While taking this medication, severe allergic reactions such as shock may occur, so symptoms should be closely monitored, and if they occur, the medication should be discontinued immediately and appropriate treatment sought. Skin reactions such as rash or itching may occur rarely, and if these symptoms appear, the medication should be stopped. Blood tests may show abnormalities such as thrombocytopenia or anemia, so regular monitoring of blood status is necessary. If any abnormalities are found, the medication should be discontinued, and appropriate treatment should be administered. Liver function abnormalities or jaundice may occur, so liver status should be observed carefully. Gastrointestinal symptoms such as constipation, diarrhea, nausea, abdominal distension, and dry mouth may occur. Rarely, neurological symptoms such as confusion, hallucinations, drowsiness, headache, or dizziness may occur. Serious skin conditions such as Stevens-Johnson syndrome or toxic epidermal necrolysis may develop, so if skin abnormalities appear, the medication should be discontinued immediately. Muscle-related adverse symptoms or rapid elevation of muscle enzyme levels may also require discontinuation of the medication and treatment. Rare adverse effects such as gynecomastia, excessive milk secretion, fatigue, and elevated blood pressure have also been reported. There may be interactions when taken with other medications, especially when taken with ketoconazole and midazolam. Pregnant women or women who may become pregnant should use this medication with caution, as its safety has not been established, and it should only be used if necessary. Women who are breastfeeding should avoid breastfeeding while taking this medication, as it can be transmitted through breast milk. This medication is not recommended for children under 14 years of age, as its safety has not been confirmed. This medication should be kept out of the reach of children, and transferring it to another container should be avoided.

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 protect it from air or moisture, and it's best kept at a temperature between 1°C and 30°C at room temperature. Proper storage helps to maintain the effectiveness of the medication.

Appearance and packaging

Appearance

A capsule with a blue-green upper part and a white lower part containing white sustained-release granules.

Package unit

30 capsules/bottle, 500 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.