Risedronate Sodium 35 mg Tablets (Risedronate Sodium Dihydrate)

Adult dose

1. Adults : Administer 35 mg of risedronate sodium orally once weekly. 2. Elderly patients : No dose adjustment is necessary in elderly patients (over 60 years of age), as the bioavailability and pharmacodynamics of this drug are similar to those in younger people. 4. 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 below 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 facilitate passage of this drug into the stomach 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 this drug on the scheduled day, take it the next morning when remembered. Resume the usual schedule for the next dose. Do not take 2 tablets on the same day.

Child dose

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

This medicine is an oral bisphosphonate used for the treatment of osteoporosis of bones. It may irritate the mucosa of the upper gastrointestinal tract, so patients with esophageal disease, gastritis, duodenitis, or ulcers should take caution. If symptoms such as difficulty swallowing, pain upon swallowing, pain behind the sternum, or heartburn occur after taking this medication, discontinue use immediately and consult a doctor. This medication should be taken with a sufficient amount of water (170-230 mL), and remain upright for at least 30 minutes after taking. It should not be administered to patients with esophageal stricture or achalasia causing delayed esophageal clearance, hypocalcemia, pregnant women or women who may become pregnant, and patients with severe renal impairment. Caution is also required for patients with genetic problems such as lactose intolerance. Before taking this medication, conditions such as hypocalcemia, parathyroid dysfunction, or vitamin D deficiency that may affect bone and mineral metabolism must be treated, and adequate calcium and vitamin D intake is important. This medication may interfere with absorption when taken with other drugs or food containing divalent cations such as calcium, magnesium, iron, and aluminum. Therefore, it is essential to adhere to the timing and intervals of administration. Rarely, severe adverse effects such as osteonecrosis of the jaw, atypical femoral fractures, and osteonecrosis of the external auditory canal may occur with prolonged use, so consult a doctor immediately if abnormal symptoms develop. Additionally, if severe pain in bones, joints, or muscles occurs, it is necessary to discontinue use and consult a doctor. Pregnant or breastfeeding women should not take this medication, or should stop breastfeeding, and its safety and effectiveness have not been confirmed in children. Elderly patients can take it like an adult, but the dosage must be strictly followed. In case of overdose, hypocalcemia may ensue; in such cases, administer milk or calcium preparations, and emergency measures such as gastric lavage may be necessary. Finally, this medication should be stored out of the reach of children, and it is preferable not to transfer it to other containers.

• esophagitis
• esophageal ulcer
• esophageal erosion
• esophageal obstruction
• esophageal perforation
• gastric ulcer
• duodenal ulcer
• dyspepsia
• diarrhea
• abdominal pain

This medication should be stored in a tightly closed container that does not allow air and moisture to enter. It is advisable to keep it at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness and safety for an extended period.

Appearance

Orange rectangular film-coated tablets

Package unit

4 tablets/PTP