Medication info
Actonel 35 mg (Risedronate Sodium)

Actonel 35 mg (Risedronate Sodium)

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

MFDS item code 200801821 · Notified 2008.02.14 · Insurance code 645402540

Summary

Main use
Treatment and prevention of osteoporosis in postmenopausal women; treatment of osteoporosis in men
Who takes it
Adults · Children
Adult dose
Adults: Administer 35 mg of risedronate sodium orally once weekly. Elderly patients (over 60 years of age): No dosage adjustment is necessary, 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
Children under 18 years of age: Safety and efficacy have not been established.

Ingredients

Manufacturer
Jeil 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 men.

How to take

Adult dose

Adults: Administer 35 mg of risedronate sodium orally once weekly. Elderly patients (over 60 years of age): No dosage adjustment is necessary, 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

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

Precautions

This medication may irritate the mucosa of the stomach and esophagus, so patients with esophageal diseases, gastritis, duodenitis, ulcers, etc., should exercise special caution. If symptoms such as difficulty swallowing, chest pain, or heartburn occur during treatment, the medication should be stopped immediately and a doctor consulted. It is essential to take this medication with plenty of water, and to remain upright for at least 30 minutes after taking it to reduce esophageal irritation. Patients with esophageal diseases or functional issues, hypocalcemia patients, pregnant or breastfeeding women, and patients with severe kidney disease should not use this medication. Patients with genetic disorders like lactose deficiency should also not take this medication due to its lactose content. Taking this medication with supplements or antacids that contain divalent cations such as calcium, magnesium, iron, or aluminum can interfere with absorption, so a time interval should be maintained between doses. Rarely, long-term use may cause serious side effects such as osteonecrosis of the jaw or atypical fractures, so if unusual symptoms appear, immediate consultation with a doctor is advised. It is imperative to treat other metabolic disorders such as hypocalcemia or vitamin D deficiency before taking this medication, and to maintain appropriate calcium and vitamin D intake. The safety and efficacy of this medication have not been established in children, while it can be used in elderly patients without special dose adjustments. In cases of overdose, hypocalcemia may occur, and if symptoms appear, immediate medical attention should be sought. Keep this medication out of the reach of children and do not transfer it to another container.

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
  • dyspepsia
  • 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
  • scleritis
  • iritis
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Riehl's phenomenon
  • angioedema
  • blisters
  • skin reactions
  • external auditory canal osteonecrosis
  • jaw necrosis
  • liver dysfunction
  • jaundice
  • loss of appetite
  • myasthenia
  • 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 tightly closed container to prevent exposure to air or moisture, and it should be kept at room temperature between 1 and 30 degrees Celsius for safety. Storing it this way will help maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Light orange oval-shaped film-coated tablet

Package unit

4 tablets (4 tablets/PTP*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

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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.