Medication info
Risedronate Sodium Tablets

Risedronate Sodium Tablets

Prescription medicationTabletOral
Ingredient · strength
Risedronate Sodium›35mg / 1 tablet
Manufacturer / importer
White Life Sciences Co., Ltd.
Appearance
Light orange oval film-coated tablets
Packaging
4 tablets (4 tablets/PTP x 1)
Approval status
Active

MFDS item code 201309403 · Approved 2013.09.23 · Insurance code 625200160

Summary

Main use
Treatment and prevention of osteoporosis in postmenopausal women; treatment of osteoporosis in men
Who takes it
Adults · Children
Adult dose
Adults: Administer 35 mg of risedronate sodium orally once weekly. No dose adjustment is necessary in older adults (over 60 years of age), as the bioavailability and pharmacodynamics of this drug are similar to those in younger people. No dose adjustment is necessary in patients with creatinine clearance of 30 mL/min or more. This drug is contraindicated in patients with severe renal impairment and creatinine clearance below 30 mL/min. Food interferes with the absorption of this drug. For adequate absorption, take it at least 30 minutes before breakfast or at least 2 hours before or after food or beverages at any time of day. To help the drug reach the stomach easily and reduce the possibility of esophageal irritation, take it while upright 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 dose on the scheduled day, take it the next morning when remembered. Resume the usual schedule for the next dose. Do not take 2 tablets on the same day.
Child dose
Children younger than 18 years: Safety and efficacy have not been established.

Ingredients

Manufacturer
White Life Sciences Co., Ltd.

Efficacy & effects

Treatment and prevention of osteoporosis in postmenopausal women; treatment of osteoporosis in men

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 dose adjustment is necessary in older adults (over 60 years of age), as the bioavailability and pharmacodynamics of this drug are similar to those in younger people. No dose adjustment is necessary in patients with creatinine clearance of 30 mL/min or more. This drug is contraindicated in patients with severe renal impairment and creatinine clearance below 30 mL/min. Food interferes with the absorption of this drug. For adequate absorption, take it at least 30 minutes before breakfast or at least 2 hours before or after food or beverages at any time of day. To help the drug reach the stomach easily and reduce the possibility of esophageal irritation, take it while upright 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 dose on the scheduled day, take it the next morning when remembered. Resume the usual schedule for the next dose. Do not take 2 tablets on the same day.

Child dose

Children younger than 18 years: Safety and efficacy have not been established.

Precautions

This drug can irritate the gastric and esophageal mucosa, so patients with gastrointestinal diseases such as gastritis, esophagitis, or esophageal ulcers should exercise particular caution. If issues arise with the esophagus or symptoms of difficulty swallowing occur, discontinue use immediately and consult a physician. It is important to take this medication while sitting or standing, with a sufficient amount of water, and not to lie down for at least 30 minutes after taking it. Patients with specific esophageal diseases, pregnant women, or those with severe renal impairment should not take this medication. This drug may interfere with the absorption of food or medications containing calcium, magnesium, iron, etc., so it is necessary to space the intake time. Rarely, serious side effects such as jaw osteonecrosis or atypical fractures may occur with long-term use, so patients should consult a physician if any unusual symptoms arise. Pregnant or nursing women should avoid taking this medication or consult a physician before making a decision. Safety has not been established in children, so it is advisable not to use in those under 18 years of age. It is important to consume sufficient calcium and vitamin D while taking this medication, and to maintain weight-bearing exercise and healthy lifestyle habits. In case of overdose, hypocalcemia may occur, so if symptoms arise, seek emergency medical treatment immediately.

Side effects

  • Esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • infection
  • low back pain
  • accidental injury
  • pain
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  • abdominal pain
  • flu symptoms
  • headache
  • fatigue
  • throat pain
  • chest pain
  • allergic reaction
  • hypertension
  • constipation
  • diarrhea
  • dyspepsia
  • nausea
  • peripheral edema
  • arthralgia
  • arthritis
  • fracture
  • joint abnormalities
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • cataract
  • urinary tract infection
  • loss of appetite
  • myalgia
  • weakness
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • burning sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • eye pain
  • skin and mucous membrane syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Riel syndrome
  • angioedema
  • blisters
  • skin reactions
  • external auditory canal osteonecrosis
  • iritis
  • uveitis
  • jawbone necrosis
  • liver dysfunction
  • jaundice
  • vomiting

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

Storage

This medication should be stored in a sealed container to prevent air ingress, and it is recommended to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer time.

Appearance and packaging

Appearance

Light orange oval film-coated tablets

Package unit

4 tablets (4 tablets/PTP x 1)

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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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.