Medication info
Kentonel Tablets 35 mg (Sodium Risedronate)

Kentonel Tablets 35 mg (Sodium Risedronate)

Prescription medicationTabletOral
Ingredient · strength
Anhydrous Risedronate Sodium›35mg / 1 tablet
Manufacturer / importer
Gunil Biopharm Co., Ltd.
Appearance
Pale orange round film-coated tablets
Packaging
Domestic - 4 tablets/PTP[(4 tablets/PTPX1)]
Approval status
Active

MFDS item code 201903166 · Approved 2019.05.16 · Insurance code 073000170

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 risedronate sodium 35 mg orally once weekly. 2. Older adults : No dosage adjustment is necessary in older adults (over 60 years of age), as the bioavailability and pharmacodynamics of this medicine are similar to those in younger people. 4. Patients with renal impairment : No dosage adjustment is necessary in patients with creatinine clearance of 30 mL/min or higher. This medicine is contraindicated in patients with severe renal impairment with creatinine clearance below 30 mL/min. ○ Food interferes with the absorption of this medicine. For adequate absorption, take it at least 30 minutes before breakfast or at least 2 hours before or after food or beverages at any other time of day. To ensure that this medicine reaches the stomach easily and to 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 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, they should take it the next morning when they remember. The next dose should be taken on the originally scheduled day. Do not take 2 tablets on the same day.
Child dose
3. Children : The safety and efficacy in children under 18 years of age have not been established.

Ingredients

Manufacturer
Gunil Biopharm 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 men.

How to take

Adult dose

1. Adults : Administer risedronate sodium 35 mg orally once weekly. 2. Older adults : No dosage adjustment is necessary in older adults (over 60 years of age), as the bioavailability and pharmacodynamics of this medicine are similar to those in younger people. 4. Patients with renal impairment : No dosage adjustment is necessary in patients with creatinine clearance of 30 mL/min or higher. This medicine is contraindicated in patients with severe renal impairment with creatinine clearance below 30 mL/min. ○ Food interferes with the absorption of this medicine. For adequate absorption, take it at least 30 minutes before breakfast or at least 2 hours before or after food or beverages at any other time of day. To ensure that this medicine reaches the stomach easily and to 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 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, they should take it the next morning when they remember. The next dose should be taken on the originally scheduled day. Do not take 2 tablets on the same day.

Child dose

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

Precautions

This medication can irritate the gastrointestinal mucosa, so patients with esophageal or gastric diseases should use caution when taking it. Serious side effects such as esophagitis, esophageal ulcers, and esophageal strictures can occur, so if symptoms such as difficulty swallowing, chest pain, or heartburn appear, stop taking the medicine immediately and consult a physician. It is important to take this medication with plenty of water and avoid lying down for at least 30 minutes after taking it. This medication should not be administered to patients with certain esophageal diseases, hypocalcemia, severe kidney impairment, or women who are pregnant or breastfeeding. Patients with lactose intolerance should also avoid this medication. As a bisphosphonate, serious side effects such as jaw osteonecrosis or atypical femoral fractures can occur with long-term use, so regular monitoring and management are required. Ensuring adequate intake of calcium and vitamin D can help enhance treatment effects and reduce side effects. This medication may interfere with the absorption of other drugs, so it should be taken at a certain time distance from medications or foods containing calcium, magnesium, or iron. Use of this medication during pregnancy may affect the fetus, so it should be avoided, and if breastfeeding, either the medication should be discontinued or breastfeeding should be stopped. This medication should not be used in children under 18 years of age as its safety and efficacy have not been established. In case of overdose, blood calcium and phosphate levels may decrease, so symptoms of hypocalcemia should be monitored, and appropriate treatment should be administered as necessary. Finally, this medication should be kept out of the reach of children and it's advisable not to change the container.

Side effects

  • Esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • gastric ulcer
  • duodenal ulcer
  • dyspepsia
  • diarrhea
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  • abdominal pain
  • nausea
  • peripheral edema
  • arthralgia
  • arthritis
  • bone trauma
  • joint abnormalities
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • cataract
  • urinary tract infection
  • mucous membrane syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • angioedema
  • blister
  • skin reaction
  • external auditory canal osteonecrosis
  • iritis
  • uveitis
  • 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
  • acute phase reaction
  • vomiting

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 or moisture from entering. Additionally, it is best to store it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pale orange round film-coated tablets

Package unit

Domestic - 4 tablets/PTP[(4 tablets/PTPX1)]

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.