Medication info
Osteron Tablet (Risedronate Sodium)

Osteron Tablet (Risedronate Sodium)

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

MFDS item code 200800318 · Notified 2008.01.08 · Insurance code 684500260

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 35 mg of risedronate sodium orally once weekly. 2. Elderly patients : 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. 4. Patients with renal impairment : 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. ○ Because food interferes with the absorption of this drug, take it at least 30 minutes before breakfast for adequate absorption, or at least 2 hours before or after consuming any 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 with an adequate amount of plain water (170 ∼ 230 mL) while in an upright position. 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 this 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
3. Children : The safety and efficacy of this drug in children under 18 years of age have not been established.

Ingredients

Manufacturer
Hwaill 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 to treat and prevent osteoporosis in postmenopausal women. It is also effective in treating osteoporosis in men. It helps increase bone density and reduce the risk of fractures. Therefore, it is used to improve bone health issues caused by osteoporosis.

How to take

Adult dose

1. Adults : Administer 35 mg of risedronate sodium orally once weekly. 2. Elderly patients : 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. 4. Patients with renal impairment : 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. ○ Because food interferes with the absorption of this drug, take it at least 30 minutes before breakfast for adequate absorption, or at least 2 hours before or after consuming any 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 with an adequate amount of plain water (170 ∼ 230 mL) while in an upright position. 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 this 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

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

Precautions

This medication can irritate the stomach and esophagus, thus patients with esophageal disorders, gastric inflammation, ulcers, etc., should take caution. It should be taken with a sufficient amount of water, and it is advised not to lie down for at least 30 minutes after taking it. If symptoms such as pain in the esophagus or difficulty swallowing occur, stop taking the medication immediately and consult a physician. This medication is contraindicated in patients with specific esophageal diseases, hypocalcemia, severe renal impairment, women who are pregnant or may become pregnant, and nursing mothers. Patients with genetic issues such as lactose intolerance should also not take this medication. As a bisphosphonate, there is a rare risk of serious side effects such as jaw necrosis, so it is important to maintain oral health and consult a professional if dental treatment is necessary. Adequate intake of calcium and vitamin D is important, and the timing and method of taking the medication should be strictly followed as it may affect absorption when taken with other medications or foods. This medication has not been proven safe and effective for children, and elderly patients can use it without special differences. In case of overdose, symptoms of hypocalcemia may occur, and immediate contact with a healthcare facility for appropriate treatment is necessary. Lastly, this medication should be stored out of reach of children and not transferred to other containers for safety.

Side effects

  • Esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • gastric ulcer
  • duodenal ulcer
  • infection
  • low back pain
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  • accidental injury
  • pain
  • abdominal pain
  • flu symptoms
  • headache
  • weakness
  • 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 coughing
  • rash
  • cataract
  • urinary tract infection
  • mucous membrane syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Riel syndrome
  • angioedema
  • blister
  • skin reaction
  • external auditory canal osteonecrosis
  • iritis
  • uveitis
  • liver dysfunction
  • jaundice
  • loss of appetite
  • asthenia
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • warmth 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 tightly sealed container to prevent moisture and air from entering. It is best to maintain a storage temperature between 1°C and 30°C.

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.