Medication info
Risedronate Sodium Tablet 35 mg

Risedronate Sodium Tablet 35 mg

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

MFDS item code 200801815 · Notified 2008.02.14 · Insurance code 642704290

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. Older adults : No dosage adjustment is necessary in older adults (over 60 years of age), because the bioavailability and pharmacodynamics of this medication are similar to those in younger people. Patients with renal impairment : No dosage adjustment is necessary in patients with a creatinine clearance of 30 mL/min or greater. This medication 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 medication. 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 time of day. To help this medication reach the stomach easily and reduce the possibility of esophageal irritation, take it while upright with an adequate amount of plain water (170 ∼ 230 mL). Taking it with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this medication 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 medication 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 medication in children under 18 years of age have not been established.

Ingredients

Manufacturer
Dongwha Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Osteoporosis
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. Older adults : No dosage adjustment is necessary in older adults (over 60 years of age), because the bioavailability and pharmacodynamics of this medication are similar to those in younger people. Patients with renal impairment : No dosage adjustment is necessary in patients with a creatinine clearance of 30 mL/min or greater. This medication 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 medication. 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 time of day. To help this medication reach the stomach easily and reduce the possibility of esophageal irritation, take it while upright with an adequate amount of plain water (170 ∼ 230 mL). Taking it with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this medication 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 medication 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 medication in children under 18 years of age have not been established.

Precautions

This medication can irritate the gastrointestinal mucosa and worsen upper gastrointestinal diseases such as esophagitis or esophageal ulcers, so special caution is required for patients with Barrett's esophagus, dysphagia, gastritis, duodenitis, or ulcers. You must take this medication with a sufficient amount of water, and do not lie down for at least 30 minutes after taking it. If you experience symptoms such as chest pain, difficulty swallowing, or heartburn, discontinue use immediately and consult a physician. This medication should not be administered to certain patient groups, such as those with esophageal motility disorders or hypocalcemia, pregnant or breastfeeding women, and those with severe renal impairment. Patients with genetic disorders that prevent the breakdown of lactose should also avoid taking this medication. It is important to ensure adequate intake of calcium and vitamin D while taking this medication, and avoid taking it simultaneously with foods or medications containing calcium, magnesium, iron, etc., as this may interfere with its absorption. Rarely, serious side effects such as osteonecrosis of the jaw or atypical femoral fractures can occur with long-term use, so consult healthcare providers if these symptoms are suspected. This medication is not recommended for women who are pregnant or breastfeeding, and safety for children has not been established. In case of overdose, hypocalcemia may occur, so if symptoms arise, administer milk or calcium supplements and seek emergency treatment if necessary. Finally, keep this medication out of reach of children and avoid transferring it to other containers.

Side effects

  • esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • gastric ulcer
  • duodenal ulcer
  • dyspepsia
  • diarrhea
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  • abdominal pain
  • nausea
  • peripheral edema
  • arthralgia
  • arthritis
  • bone trauma
  • joint abnormalities
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • cataract
  • urinary tract infection
  • mucous membrane syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Leigh syndrome
  • angioedema
  • blisters
  • jaw necrosis
  • liver dysfunction
  • jaundice
  • appetite loss
  • asthenia
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • burning sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • eye pain

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

Storage

This medication should be stored in a tightly closed container to prevent air and moisture from entering. It is best to maintain a storage temperature between 1 and 30 degrees Celsius. Proper storage will help retain the efficacy and safety of the medication for a long time.

Appearance and packaging

Appearance

Light orange oval film-coated tablet

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.