Medication info
Risedronate Sodium 35 mg Tablets

Risedronate Sodium 35 mg Tablets

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

MFDS item code 200801819 · Notified 2008.02.14 · Insurance code 622801280

Summary

Main use
Treatment and prevention of osteoporosis in postmenopausal women; treatment of osteoporosis in men
Who takes it
Adults · Children
Adult dose
Administer 35 mg orally once weekly. No dosage adjustment is necessary in elderly patients (over 60 years of age), as 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. 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 facilitate passage of this drug into the stomach and reduce the possibility of esophageal irritation, take it while sitting or standing upright with a sufficient amount of plain water (170 ∼ 230 mL). Taking it with other beverages, including mineral water, may decrease 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 a dose 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
Safety and efficacy in children under 18 years of age have not been established.

Ingredients

Manufacturer
Mothers Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Osteoporosis in postmenopausal women
  • 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

Administer 35 mg orally once weekly. No dosage adjustment is necessary in elderly patients (over 60 years of age), as 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. 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 facilitate passage of this drug into the stomach and reduce the possibility of esophageal irritation, take it while sitting or standing upright with a sufficient amount of plain water (170 ∼ 230 mL). Taking it with other beverages, including mineral water, may decrease 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 a dose 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

Safety and efficacy in children under 18 years of age have not been established.

Precautions

This medication can irritate the stomach and esophagus, so individuals with gastritis or esophageal disease must consult a doctor before taking it. Take with a sufficient amount of water and avoid lying down for at least 30 minutes after taking it to reduce the risk of esophageal irritation. If you experience pain in the esophagus, difficulty swallowing, or chest pain, immediately discontinue use and contact a healthcare professional. This medication is not to be used in individuals with certain esophageal diseases, hypocalcemia, severe renal impairment, or in pregnant or nursing women. Additionally, individuals with lactose intolerance should avoid this medication due to certain components. Taking this medication with calcium, magnesium, iron, or other substances may interfere with absorption; it is important to space out the timing of other medications or foods. Long-term use may rarely lead to issues with the jawbone or femur fractures, so regular check-ups with a doctor are recommended. Adequate intake of calcium and vitamin D, along with weight-bearing exercises, can help enhance the medication's effects. If pregnant or breastfeeding, consult healthcare professionals before use, and the safety in children under 18 has not been established. Overdose may lead to hypocalcemia; therefore, follow the prescribed dosage and instructions from your physician. Store this medication in a location out of children's reach, and do not transfer it to another container for safety.

Side effects

  • esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • infection
  • back pain
  • accidental injury
  • pain
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  • abdominal pain
  • flu symptoms
  • headache
  • weakness
  • throat pain
  • chest pain
  • allergic reaction
  • hypertension
  • constipation
  • diarrhea
  • indigestion
  • 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
  • asthenia
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • burning sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • eye pain
  • mucous membrane syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Liell syndrome
  • angioedema
  • blisters
  • skin reactions
  • external ear bone necrosis
  • iritis
  • uveitis
  • scleral inflammation
  • jawbone necrosis
  • hepatic dysfunction
  • jaundice
  • hypocalcemia
  • acute phase reaction
  • vomiting
  • atypical fracture
  • low-energy fracture
  • low-trauma fracture

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

Storage

Store this medication in a sealed container to prevent exposure to air and moisture, ideally at a temperature between 1 and 30 degrees Celsius. This way, the medication's efficacy can be maintained over time.

Appearance and packaging

Appearance

Pale orange oval 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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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.