Medication info
Ostol Tablet (Risedronate Sodium)

Ostol Tablet (Risedronate Sodium)

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

MFDS item code 200801822 · Notified 2008.02.14 · Insurance code 657803180

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. ○ 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
Children under 18 years of age: Safety and efficacy have not been established.

Ingredients

Manufacturer
Hana 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 is also helpful for the treatment of osteoporosis in men. Therefore, it is effective in increasing bone density and reducing the risk of fractures.

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. ○ 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

Children under 18 years of age: Safety and efficacy have not been established.

Precautions

This medication may irritate the gastrointestinal mucosa, so caution is needed for patients with esophageal or gastric disorders or those with dysphagia. It should be taken with plenty of water, and patients should not lie down for a certain period after taking it. If severe esophageal symptoms such as esophagitis or esophageal ulcer occur, discontinue use immediately and consult a doctor. This medication should not be taken by individuals with specific esophageal diseases, hypocalcemia, women who are pregnant or breastfeeding, or patients with severe renal impairment. This medication contains lactose and Yellow No. 5, so patients allergic to these ingredients should exercise caution. Rarely, prolonged use may lead to serious side effects such as jaw necrosis or atypical femoral fractures, so patients should consult healthcare professionals immediately if symptoms arise. It is important to take calcium or vitamin D concurrently, and patients should inform healthcare providers when taking this medication with other drugs due to possible interactions. Pregnant or breastfeeding women should avoid taking this medication, and the safety in children has not been established. In cases of overdose, symptoms of hypocalcemia may occur, so patients should visit a medical institution immediately for appropriate treatment. This medication should be kept out of reach of children and should not be transferred to another container.

Side effects

  • esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • infection
  • low back pain
  • accidental injury
  • pain
Show 57 more
  • abdominal pain
  • flu symptoms
  • headache
  • weakness
  • throat pain
  • chest pain
  • allergic reaction
  • hypertension
  • constipation
  • diarrhea
  • dyspepsia
  • nausea
  • peripheral edema
  • joint pain
  • arthritis
  • fracture
  • joint abnormalities
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • cataract
  • urinary tract infection
  • vomiting
  • uveitis
  • scleritis
  • iritis
  • mucocutaneous syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • angioedema
  • blisters
  • skin reactions
  • jaw necrosis
  • liver dysfunction
  • jaundice
  • anorexia
  • 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 sealed container to prevent air and moisture ingress. The storage temperature should be maintained at room temperature between 1 to 30 degrees Celsius. Storing in this manner will help maintain the medication's effectiveness for a long time.

Appearance and packaging

Appearance

Pale 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.