Medication info
Risedronate Sodium Tablet (Risedronate Sodium Dihydrate)

Risedronate Sodium Tablet (Risedronate Sodium Dihydrate)

Prescription medicationTabletOral
Ingredient · strength
Risedronate Sodium Monohydrate›37.07mg / 1 tablet
Manufacturer / importer
CMG Pharmaceutical Co., Ltd.
Appearance
Pale orange oblong film-coated tablet
Packaging
4 tablets/PTP
Approval status
Active

MFDS item code 200800286 · Notified 2008.01.08 · Insurance code 648602160

Summary

Main use
Treatment of osteoporosis in postmenopausal women and men; prevention of osteoporosis in postmenopausal women
Who takes it
Adults · Children
Adult dose
Adults: Administer 35 mg of risedronate sodium orally once weekly. No dosage 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. 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. Because food interferes with the absorption of this drug, take it at least 30 minutes before breakfast for adequate absorption, or at least 2 hours before or after consuming any 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 with an adequate amount of plain water (170 ∼ 230 mL) while in an upright position. Taking this drug with other beverages, including mineral water, may reduce its 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 next dose on the originally scheduled day. Do not take 2 tablets on the same day.
Child dose
The safety and efficacy of this drug in children under 18 years of age have not been established.

Ingredients

Manufacturer
CMG Pharmaceutical Co., Ltd.

Efficacy & effects

Treatment of osteoporosis in postmenopausal women and men; prevention of osteoporosis in postmenopausal women

  • 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

Adults: Administer 35 mg of risedronate sodium orally once weekly. No dosage 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. 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. Because food interferes with the absorption of this drug, take it at least 30 minutes before breakfast for adequate absorption, or at least 2 hours before or after consuming any 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 with an adequate amount of plain water (170 ∼ 230 mL) while in an upright position. Taking this drug with other beverages, including mineral water, may reduce its 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 next dose on the originally scheduled day. Do not take 2 tablets on the same day.

Child dose

The safety and efficacy of this drug in children under 18 years of age have not been established.

Precautions

This medication may irritate the gastric and esophageal mucosa; therefore, patients with esophageal diseases or gastric ulcers should take it cautiously. When taking, it must be taken with a sufficient amount of water, and the patient should not lie down for at least 30 minutes after taking. If symptoms such as dysphagia, chest pain, or heartburn occur, stop taking the medication immediately and consult a physician. This medication should not be used by patients with esophageal motility disorders, hypocalcemia, pregnant or breastfeeding women, or those with severe renal impairment. This medication will be less effective if there is insufficient calcium and vitamin D intake, thus adequate nutritional intake is necessary. As a bisphosphonate, it can rarely cause serious side effects such as osteonecrosis of the jaw and atypical fractures; any abnormal symptoms should be reported to healthcare professionals immediately. This medication can be absorbed poorly when taken with food or medications containing calcium and magnesium, so sufficient time intervals should be maintained between doses. Pregnant and breastfeeding women should avoid this medication, and safety in children has not been established. Overdosing may result in symptoms of hypocalcemia, and appropriate treatment may be necessary as needed. This medication should be stored out of reach of children and should not be transferred to other containers.

Side effects

esophagitis, esophageal ulcer, esophageal erosion, esophageal obstruction, esophageal perforation, hemorrhage, infection, back pain, accidental injury, pain, abdominal pain, flu symptoms, headache, weakness, pain in the neck area, chest pain, allergic reaction, hypertension, constipation, diarrhea, dyspepsia, nausea, peripheral edema, arthralgia, arthritis, fracture, joint abnormality, 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, Reye's syndrome, angioedema, blister, skin reaction, osteonecrosis of the external auditory canal, jaw necrosis, liver dysfunction, jaundice, anorexia, asthenia, heartburn, epigastric pain, chest discomfort, palpitations, increased sweating, facial flushing, burning sensation, kidney stones, belching, hematuria, fever, ocular pain

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°C and 30°C. Storing it this way will help maintain its effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pale orange oblong 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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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.