Medication info
Withus Risedronate Sodium 35 mg

Withus Risedronate Sodium 35 mg

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

MFDS item code 201310380 · Approved 2013.11.29 · Insurance code 660702540

Summary

Main use
Treatment and prevention of osteoporosis in postmenopausal women; treatment of osteoporosis in men
Who takes it
Adults · Children
Adult dose
1. Adults: Administer one 35mg tablet orally once weekly. 2. Older adults: No dosage adjustment is necessary because the bioavailability and pharmacokinetics of this medicine in older adults (60 years of age and older) are similar to those in younger adults. 4. Patients with renal impairment: No dosage adjustment is necessary in patients with a creatinine clearance of 30ml/min or greater. This medicine is contraindicated in patients with severe renal impairment and a creatinine clearance below 30ml/min. Because food interferes with the absorption of this medicine, take it as follows 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 the medicine reach the stomach readily and reduce the possibility of esophageal irritation, take it in an upright position with a sufficient amount of plain water (170 ~ 230ml). Taking this medicine with other beverages, including mineral water, may reduce its absorption. Do not chew or suck the tablet 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 medicine on the scheduled day, take it the next morning when remembered. Resume taking it on the originally scheduled day for the next dose. Do not take 2 tablets on the same day.
Child dose
3. Children: The safety and efficacy of this medicine in children and adolescents who are still growing have not been established.

Ingredients

Manufacturer
Withus Pharmaceutical 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 for the treatment of osteoporosis in men.

How to take

Adult dose

1. Adults: Administer one 35mg tablet orally once weekly. 2. Older adults: No dosage adjustment is necessary because the bioavailability and pharmacokinetics of this medicine in older adults (60 years of age and older) are similar to those in younger adults. 4. Patients with renal impairment: No dosage adjustment is necessary in patients with a creatinine clearance of 30ml/min or greater. This medicine is contraindicated in patients with severe renal impairment and a creatinine clearance below 30ml/min. Because food interferes with the absorption of this medicine, take it as follows 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 the medicine reach the stomach readily and reduce the possibility of esophageal irritation, take it in an upright position with a sufficient amount of plain water (170 ~ 230ml). Taking this medicine with other beverages, including mineral water, may reduce its absorption. Do not chew or suck the tablet 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 medicine on the scheduled day, take it the next morning when remembered. Resume taking it on the originally scheduled day for the next dose. Do not take 2 tablets on the same day.

Child dose

3. Children: The safety and efficacy of this medicine in children and adolescents who are still growing have not been established.

Precautions

This drug may irritate the gastrointestinal mucosa, so individuals with diseases of the esophagus or stomach should consult a physician before use. Particularly, conditions such as esophagitis, esophageal ulcers, and esophageal inflammation can be serious, so if symptoms such as difficulty swallowing or chest pain occur, discontinue use immediately and inform a healthcare professional. When taking this medication, it should be taken while sitting or standing with plenty of water, and one should not lie down for at least 30 minutes after taking it. This drug is contraindicated for individuals with certain esophageal diseases, hypocalcemia, severe renal impairment, or for women who are pregnant or breastfeeding. Individuals with genetic disorders that prevent lactose digestion should also avoid this medication. Those with upper gastrointestinal disorders such as Barrett's esophagus, gastritis, or duodenitis should use with caution, and individuals with allergies to the coloring agents in the medication should be careful. Common side effects include dyspepsia, abdominal pain, diarrhea, headache, joint pain, and muscle pain, while rare but serious skin reactions or esophageal damage have been reported. Long-term use may also lead to rare side effects such as atypical femoral fractures or osteonecrosis of the jaw, so one should consult a healthcare professional immediately if any unusual symptoms arise. Taking this medication simultaneously with other drugs or foods containing minerals such as calcium, magnesium, or iron may interfere with its absorption, so dosage intervals should be maintained. If pregnant or breastfeeding, alternatives should be sought or medical advice should be obtained; safety in children under 18 has not been established. In cases of overdose, symptoms of hypocalcemia may appear, and one should visit a healthcare institution immediately. Store in a safe place out of reach of children.

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 anomalies
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • cataract
  • urinary tract infection
  • fever
  • influenza-like symptoms
  • vomiting
  • uveitis
  • scleritis
  • iritis
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Rielle syndrome
  • angioedema
  • blisters
  • skin reactions
  • osteonecrosis of the jaw
  • liver dysfunction
  • jaundice
  • loss of appetite
  • asthenia
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • burning sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • ocular pain

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 kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Pale 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.