Medication info
Risendronate Sodium Tablet

Risendronate Sodium Tablet

Prescription medicationTabletOral
Ingredient · strength
Anhydrous Risedronate Sodium›35mg / 1 tablet
Manufacturer / importer
Genupharm Co., Ltd.
Appearance
Light orange round film-coated tablets
Packaging
4 tablets/PTP
Approval status
Active

MFDS item code 200800330 · Notified 2008.01.08 · Insurance code 698000980

Summary

Main use
Treatment of osteoporosis in postmenopausal women and men, and prevention in postmenopausal women
Who takes it
Adults · Children
Adult dose
Adults: Administer 35 mg of risedronate sodium orally once weekly. No dosage adjustment is necessary in older adults (over 60 years of age), because the bioavailability and pharmacodynamics of this drug are similar to those in younger people. No dosage adjustment is necessary in patients with a creatinine clearance of 30 mL/min or greater. This drug is contraindicated in patients with severe renal impairment and a creatinine clearance of less than 30 mL/min. Food interferes with the absorption of this drug. To ensure adequate absorption, take it at least 30 minutes before breakfast, or at least 2 hours before or after consuming food or beverages at any other time of day. To help the drug reach the stomach easily and reduce the possibility of esophageal irritation, take it in an upright position with a sufficient amount of plain water (170 ∼ 230 mL). Taking this drug with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this drug because of the possibility of oropharyngeal ulceration. Patients should not lie down for at least 30 minutes after taking it. If a patient forgets to take the drug on the scheduled day, take it the next morning when remembered. Resume the next dose on the originally scheduled day. Do not take 2 tablets on the same day.
Child dose
The safety and efficacy of this drug in children under 18 years of age have not been established.

Ingredients

Manufacturer
Genupharm Co., Ltd.

Efficacy & effects

Treatment of osteoporosis in postmenopausal women and men, and prevention in postmenopausal women

View approved original text

This medication is used for the treatment and prevention of osteoporosis in postmenopausal women and men.

How to take

Adult dose

Adults: Administer 35 mg of risedronate sodium orally once weekly. No dosage adjustment is necessary in older adults (over 60 years of age), because the bioavailability and pharmacodynamics of this drug are similar to those in younger people. No dosage adjustment is necessary in patients with a creatinine clearance of 30 mL/min or greater. This drug is contraindicated in patients with severe renal impairment and a creatinine clearance of less than 30 mL/min. Food interferes with the absorption of this drug. To ensure adequate absorption, take it at least 30 minutes before breakfast, or at least 2 hours before or after consuming food or beverages at any other time of day. To help the drug reach the stomach easily and reduce the possibility of esophageal irritation, take it in an upright position with a sufficient amount of plain water (170 ∼ 230 mL). Taking this drug with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this drug because of the possibility of oropharyngeal ulceration. Patients should not lie down for at least 30 minutes after taking it. If a patient forgets to take the drug on the scheduled day, take it the next morning when remembered. Resume the next dose on the originally scheduled day. Do not take 2 tablets on the same day.

Child dose

The safety and efficacy of this drug in children under 18 years of age have not been established.

Precautions

This medication may irritate the gastrointestinal mucosa, so patients with esophageal or gastric problems should consult a doctor before taking it. Special caution is required in cases of esophagitis, esophageal ulcers, Barrett's esophagus, gastritis, and duodenitis. When taking this medication, it should be taken with a sufficient amount of water, and patients should not lie down for at least 30 minutes after taking it. If symptoms such as dysphagia, pain behind the sternum, or heartburn occur during treatment, the medication should be stopped immediately and a doctor consulted. This medication should not be administered to patients with certain esophageal diseases, hypocalcemia, pregnant or breastfeeding women, and those with severe renal impairment. Additionally, patients with lactose intolerance should not take this medication. Before taking this medication, any bone and mineral metabolism disorders such as hypocalcemia and vitamin D deficiency should be treated, and adequate intake of calcium and vitamin D is important. This medication may interfere with the absorption of foods or medications containing calcium, magnesium, and iron, so it should be taken with an interval. Rarely, long-term use may result in jaw necrosis, atypical femoral fractures, or external auditory canal bone necrosis, so any unusual symptoms should be reported to a doctor immediately. Maintaining weight-bearing exercise and healthy lifestyle habits during treatment is beneficial. Pregnant or breastfeeding women should not take this medication, and those planning to become pregnant should consult with healthcare providers. Overdose may cause symptoms of hypocalcemia, so immediate medical attention is necessary. The safety and efficacy of this medication have not been established in children under 18 years of age. Elderly patients can take it like other adults, but should consult their doctor if they experience any unusual symptoms. Always read the product information before taking the medication and follow the prescribed dosage and instructions from your doctor.

Side effects

  • esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • gastric ulcer
  • duodenal ulcer
  • indigestion
  • diarrhea
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  • abdominal pain
  • nausea
  • joint pain
  • arthritis
  • bone trauma
  • joint abnormalities
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • allergic reaction
  • hypertension
  • peripheral edema
  • headache
  • fatigue
  • neck pain
  • chest pain
  • cataract
  • urinary tract infection
  • uveitis
  • scleritis
  • iritis
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • angioedema
  • blisters
  • jawbone necrosis
  • liver dysfunction
  • jaundice
  • loss of appetite
  • myasthenia
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • burning sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • eye pain
  • acute phase reaction
  • vomiting

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

Storage

This medication should be stored in a tightly closed container that is well-ventilated and kept at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the drug's effectiveness and prevents degradation.

Appearance and packaging

Appearance

Light orange round film-coated tablets

Package unit

4 tablets/PTP

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.