Medication info
Roxarex Extended-Release Capsule 75mg (Roxatidine Acetate Hydrochloride)

Roxarex Extended-Release Capsule 75mg (Roxatidine Acetate Hydrochloride)

Prescription medicationHard capsuleOral
Ingredient · strength
Roxatidine Acetate Hydrochloride›75mg / 1 capsule
Manufacturer / importer
Palmgen Science Co., Ltd.
Appearance
Hard capsule with upper green and lower light yellow color containing white granules
Packaging
30 capsules/bottle, 250 capsules/bottle
Approval status
Active

MFDS item code 200301683 · Approved 2003.08.21 · Insurance code 670100320

Summary

Main use
Treatment of acid-related disorders (ulcers, esophagitis, etc.), improvement of gastritis, and prevention of aspiration of gastric acid before anesthesia
Who takes it
Adults
Adult dose
Adults: 1) Gastric and duodenal ulcers, gastroesophageal 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 ulcers have not healed 4 weeks after starting 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 75mg once daily in the evening. If creatinine clearance is 20mL/min or less, administer 75mg once every 2 days in the evening. 2) Acute gastritis and acute exacerbation of chronic gastritis: Administer 75mg once daily after the evening meal or at bedtime. 3) Preanesthetic 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
Palmgen Science Co., Ltd.

Efficacy & effects

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

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

This medication is effective in treating ulcers occurring in the stomach and duodenum, and is also used for conditions caused by excessive gastric acid secretion, such as gastroesophageal reflux disease and Zollinger-Ellison syndrome. Additionally, it is administered in advance to patients at risk of aspiration of gastric acid during anesthesia, particularly pregnant patients, to ensure safety. It also helps alleviate symptoms of acute and chronic gastritis and improve damaged areas of the gastric mucosa. In summary, it is used for treating various gastritis-related conditions and improving the status of gastric mucosa.

How to take

Adult dose

Adults: 1) Gastric and duodenal ulcers, gastroesophageal 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 ulcers have not healed 4 weeks after starting 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 75mg once daily in the evening. If creatinine clearance is 20mL/min or less, administer 75mg once every 2 days in the evening. 2) Acute gastritis and acute exacerbation of chronic gastritis: Administer 75mg once daily after the evening meal or at bedtime. 3) Preanesthetic 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 in patients with allergy to this drug or any of its ingredients. Patients with liver or kidney function issues should use this drug with caution. Especially in patients with impaired kidney function, drug concentration may increase, so the dosage should be reduced or the dosing interval increased. Elderly patients are often prone to decreased kidney function, so dosages should be adjusted carefully when administering this medication. Patients allergic or hypersensitive to the dye known as Yellow No. 5, included in this drug, should also use it with caution. During the use of this medication, allergic reactions such as shock symptoms, rashes, and itching may occur, so if any abnormal symptoms appear, drug use should be stopped immediately and a physician consulted. Regular blood tests should be conducted to monitor for any anomalies in blood test results. Changes in liver function can occur, so liver function tests should be monitored carefully. Gastrointestinal symptoms such as constipation, diarrhea, nausea, and abdominal bloating may appear, and if symptoms are severe, consultation with a physician is recommended. Neurological symptoms such as confusion, hallucinations, drowsiness, and headache may rarely occur, and attention should be paid if any abnormal symptoms arise. Severe adverse skin reactions may occur, so if there are skin rashes or mucosal abnormalities, drug use should be stopped immediately. If muscle-related adverse reactions occur, symptoms such as myalgia or changes in urine color should be carefully monitored, and drug use should be discontinued if any abnormalities are noted. This drug can interact with other medications; therefore, patients should inform their physician especially if they are taking ketoconazole or midazolam and use it with caution. Women who are pregnant or may become pregnant should carefully consider the benefits and risks of using this drug. Lactating women should avoid breastfeeding while using this drug as it may be transmitted through breast milk. This medication is not used in children under 14 years of age as safety has not been established. The medication should be stored out of reach of children, and transferring it to another container poses a risk of accidents or quality degradation.

Side effects

shock

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, ideally at a temperature between 1 and 30 degrees Celsius. Proper storage maintains the medication's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

Hard capsule with upper green and lower light yellow color 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.