Medication info
Actonel 35 mg (Risedronate Sodium)

Actonel 35 mg (Risedronate Sodium)

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

MFDS item code 200801817 · Notified 2008.02.14 · Insurance code 641904630

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. In older adults (over 60 years of age), no dosage adjustment is necessary because the bioavailability and pharmacodynamics of this medication 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 medication 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 medication. 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 this medication reach the stomach easily and reduce the possibility of esophageal irritation, take it while upright with an adequate amount of plain water (170 ∼ 230 mL). Taking it with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this medication 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 medication 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 medication in children under 18 years of age have not been established.

Ingredients

Manufacturer
Boryung 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 the treatment of osteoporosis in men. Osteoporosis is a condition where bones become weak and may fracture easily; this medication can help increase bone strength and reduce the risk of fractures, thus assisting in the prevention of complications related to osteoporosis.

How to take

Adult dose

Adults: Administer 35 mg of risedronate sodium orally once weekly. In older adults (over 60 years of age), no dosage adjustment is necessary because the bioavailability and pharmacodynamics of this medication 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 medication 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 medication. 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 this medication reach the stomach easily and reduce the possibility of esophageal irritation, take it while upright with an adequate amount of plain water (170 ∼ 230 mL). Taking it with other beverages, including mineral water, may reduce its absorption. Do not chew or suck this medication 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 medication 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 medication in children under 18 years of age have not been established.

Precautions

This medication can irritate the gastric and esophageal mucosa, so patients with gastritis or esophageal disorders should use it with caution. It is essential to take this medication with a sufficient amount of water and avoid lying down for at least 30 minutes after taking it. If symptoms such as pain in the esophagus or difficulty swallowing arise, discontinue use immediately and consult a doctor. This medication should not be administered to patients with certain esophageal diseases, severely impaired kidney function, pregnant women, or those who are breastfeeding. Patients with gastrointestinal disorders such as Barrett's esophagus or gastric ulcers and those with allergies to specific dyes should use it cautiously. Taking this medication alongside substances rich in calcium, magnesium, iron, etc., may hinder absorption, so it should be spaced apart from such medications or foods. Rarely, prolonged use can lead to serious side effects such as jaw osteonecrosis or atypical fractures; report any abnormal symptoms to a doctor. Adequate intake of calcium and vitamin D is important, and especially those receiving long-term corticosteroid treatment should pay extra attention. Women who are pregnant or may become pregnant and breastfeeding mothers should avoid taking this medication and consult with a doctor if necessary. The safety of this medication has not been established for children, so it is advisable not to use it in patients under the age of 18. In case of overdose, serum calcium and phosphorus levels may decrease, necessitating emergency treatment. This medication should be kept out of the reach of children and should not be transferred to other containers.

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
  • skin-mucous membrane syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Lyell syndrome
  • angioedema
  • blister
  • skin reaction
  • external ear bone necrosis
  • iritis
  • uveitis
  • liver dysfunction
  • jaundice
  • loss of appetite
  • fatigue
  • 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 protect it from air and kept at room temperature between 1 and 30 degrees Celsius. Doing so will help maintain the drug's effectiveness for a longer period.

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

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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.