Medication info
Osonel Tablet (Risedronate Sodium)

Osonel Tablet (Risedronate Sodium)

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

MFDS item code 200711925 · Notified 2007.10.30

Summary

Main use
Treatment of osteoporosis in postmenopausal women and men, and prevention of osteoporosis in postmenopausal women
Who takes it
Adults · Children
Adult dose
Adults: Administer 35 mg of risedronate sodium orally once weekly. Elderly: No dose adjustment is necessary in elderly patients (over 60 years) because the bioavailability and pharmacodynamics of this drug are similar to those in younger people. Patients with renal impairment: No dose adjustment is necessary in patients with a creatinine clearance of 30 mL/min or higher. 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 apart from food or beverages at any time of day. To help this drug 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 ∼ 230 mL). Taking it with other beverages, including mineral water, may reduce 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 the 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
The safety and efficacy of this drug in children under 18 years of age have not been established.

Ingredients

Manufacturer
Guju Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of osteoporosis in postmenopausal women and men, and prevention of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This medication is used for the treatment and prevention of osteoporosis in both postmenopausal women and men.

How to take

Adult dose

Adults: Administer 35 mg of risedronate sodium orally once weekly. Elderly: No dose adjustment is necessary in elderly patients (over 60 years) because the bioavailability and pharmacodynamics of this drug are similar to those in younger people. Patients with renal impairment: No dose adjustment is necessary in patients with a creatinine clearance of 30 mL/min or higher. 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 apart from food or beverages at any time of day. To help this drug 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 ∼ 230 mL). Taking it with other beverages, including mineral water, may reduce 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 the 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

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

Precautions

This medication can cause irritation to the stomach and esophagus, so patients with upper gastrointestinal diseases such as gastritis, esophagitis, or esophageal ulcers should use it with caution. It should be taken with a sufficient amount of water, and patients should remain upright for at least 30 minutes after taking to reduce esophageal irritation. This medication should not be administered to patients with esophageal stricture or achalasia, patients with hypocalcemia, pregnant or breastfeeding women, or patients with severe renal impairment. Additionally, patients allergic to lactose contained in this medication should not take it. It's important to have adequate calcium and vitamin D intake during treatment, and any hypocalcemia or other bone metabolic disorders should be treated beforehand. There is a possibility of rare side effects such as osteonecrosis of the jaw, so consultation with a doctor is necessary before any dental procedures, and oral hygiene should be maintained. If pain occurs in the legs or hip region during treatment, consult a doctor immediately, and consider the risk of atypical fractures with long-term use. This medication may interfere with the absorption of foods or medications containing calcium, magnesium, or iron, so be mindful of the timing and intervals of intake. Women who are pregnant or may become pregnant should not take this medication, and breastfeeding women should stop either the medication or breastfeeding. Safety and efficacy have not been established in children under 18 years of age, so it should not be used. In case of overdose, hypocalcemia may occur, so immediate medical attention is necessary, and calcium supplementation may be required if needed. This medication should be kept in a safe place out of reach of children and should not be transferred to other containers.

Side effects

  • Esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • infection
  • lumbago
  • accidental injury
  • pain
Show 59 more
  • abdominal pain
  • flu symptoms
  • headache
  • weakness
  • throat pain
  • chest pain
  • allergic reactions
  • 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
  • vomiting
  • uveitis
  • sclereitis
  • iritis
  • mucocutaneous syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Riel syndrome
  • angioedema
  • blisters
  • skin reactions
  • external auditory canal osteonecrosis
  • jaw necrosis
  • liver dysfunction
  • jaundice
  • loss of appetite
  • weakness
  • 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 tightly closed container to prevent air and moisture exposure. It is best to maintain a storage temperature between 1 and 30 degrees Celsius.

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

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.