Medication info
Actonel 150 mg Tablet (Risedronate Sodium)

Actonel 150 mg Tablet (Risedronate Sodium)

Prescription medicationTabletOral
Ingredient · strength
Risedronate Sodium›150mg / 1 tablet
Manufacturer / importer
Yuyu Pharma
Appearance
Bright blue oval film-coated tablet
Packaging
1 tablet/box
Approval status
Active

MFDS item code 200808241 · Approved 2008.07.30 · Insurance code 644503320

Summary

Main use
Treatment and prevention of osteoporosis in postmenopausal women
Who takes it
Adults · Children
Adult dose
1. Adults Administer risedronate sodium 150 mg orally once monthly. 2. Older adults No dose adjustment is necessary in older adults (over 60 years) because the bioavailability and pharmacodynamics of this medicine are similar to those in younger people. 4. Patients with renal impairment No dose adjustment is necessary in patients with creatinine clearance of 30 mL/min or more. This medicine is contraindicated in patients with severe renal impairment and creatinine clearance less than 30 mL/min. ○ Food interferes with the absorption of this medicine. For adequate absorption, take it at least 30 minutes before the first food or beverage other than water of the day. To help this medicine reach the stomach easily and reduce the possibility of esophageal irritation, take it in an upright position with plenty of plain water (170 ∼ 230 mL). Taking it with other beverages, including mineral water, may reduce absorption. Do not chew or suck this medicine 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 medicine on the scheduled day, take it as follows. - If the next scheduled dose is 7 days or more away, take 1 tablet the next morning after remembering. Resume the regular schedule on the originally scheduled day for the next dose. Do not take more than 1 tablet of this medicine within 7 days. - If the next scheduled dose is within 7 days, wait until the originally scheduled day and then take 1 tablet of this medicine.
Child dose
3. Children Safety and efficacy have not been established in children under 18 years of age.

Ingredients

Importer
Yuyu Pharma

Efficacy & effects

Treatment and prevention of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

Used for the treatment and prevention of osteoporosis in postmenopausal women.

How to take

Adult dose

1. Adults Administer risedronate sodium 150 mg orally once monthly. 2. Older adults No dose adjustment is necessary in older adults (over 60 years) because the bioavailability and pharmacodynamics of this medicine are similar to those in younger people. 4. Patients with renal impairment No dose adjustment is necessary in patients with creatinine clearance of 30 mL/min or more. This medicine is contraindicated in patients with severe renal impairment and creatinine clearance less than 30 mL/min. ○ Food interferes with the absorption of this medicine. For adequate absorption, take it at least 30 minutes before the first food or beverage other than water of the day. To help this medicine reach the stomach easily and reduce the possibility of esophageal irritation, take it in an upright position with plenty of plain water (170 ∼ 230 mL). Taking it with other beverages, including mineral water, may reduce absorption. Do not chew or suck this medicine 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 medicine on the scheduled day, take it as follows. - If the next scheduled dose is 7 days or more away, take 1 tablet the next morning after remembering. Resume the regular schedule on the originally scheduled day for the next dose. Do not take more than 1 tablet of this medicine within 7 days. - If the next scheduled dose is within 7 days, wait until the originally scheduled day and then take 1 tablet of this medicine.

Child dose

3. Children Safety and efficacy have not been established in children under 18 years of age.

Precautions

This medication can irritate the stomach and esophagus, so individuals with esophageal diseases or upper gastrointestinal diseases such as gastritis, duodenitis, or ulcers should take special care. When taking this medication, it must be taken with a sufficient amount of water, and the patient should not lie down for at least 30 minutes after taking it. If symptoms such as pain in the esophagus, difficulty swallowing, or heartburn occur, the medication should be stopped immediately and the doctor should be consulted. Patients with esophageal motility disorders, hypocalcemia, severe renal impairment, pregnant or nursing women should not use this medication. This medication contains lactose, and patients with lactose intolerance should not take it. Before administration, deficiencies of calcium and vitamin D, and any parathyroid disorders related to bone and mineral metabolism should be treated, and supplementation with calcium and vitamin D is recommended if necessary. Serious side effects can rarely occur, including osteonecrosis of the jaw, esophageal ulcers, and atypical femoral fractures, so any abnormal symptoms should be discussed with healthcare professionals immediately. This medication should not be taken simultaneously with drugs or foods containing calcium, magnesium, iron, etc., and sufficient time intervals between doses must be maintained. In cases of pregnancy or nursing, use of this medication should be avoided; if nursing, the medication should be discontinued or breastfeeding should be stopped. Safety and efficacy have not been established in children, so it is not used in pediatric patients. In cases of overdose, hypocalcemia may occur, so if symptoms are present, immediate medical treatment must be sought. This medication should be kept out of reach of children, and it is advisable not to transfer it to another container.

Side effects

  • esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • hemorrhage
  • gastric ulcer
  • duodenal ulcer
  • dyspepsia
  • diarrhea
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  • abdominal pain
  • nausea
  • arthralgia
  • arthritis
  • bone trauma
  • joint abnormalities
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • allergic reaction
  • cataract
  • urinary tract infection
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • angioedema
  • blister
  • jaw necrosis
  • uveitis
  • scleritis
  • iritis
  • impaired liver function
  • jaundice
  • decreased appetite
  • asthenia
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • warmth sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • ocular pain
  • vomiting
  • acute phase reaction
  • pyrexia
  • influenza-like symptoms
  • hypocalcemia
  • atypical fracture
  • external auditory canal bone necrosis

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 exposure, and kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Bright blue oval film-coated tablet

Package unit

1 tablet/box

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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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.