Medication info
Risedronate Sodium 35 mg Tablet

Risedronate Sodium 35 mg Tablet

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

MFDS item code 201602328 · Approved 2016.04.26

Summary

Main use
Treatment of osteoporosis in men; treatment and prevention of osteoporosis in postmenopausal women
Who takes it
Adults · Children
Adult dose
* 35 mg 1. Adults: Administer risedronate sodium 35 mg 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 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 greater. This medicine is contraindicated in patients with severe renal impairment and creatinine clearance below 30 mL/min. ○ Since 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 time of day. To ensure that this medicine reaches the stomach easily and reduce the risk of esophageal irritation, take it in an upright position with plenty of plain water (170 ∼ 230 mL). Taking this medicine with other beverages, including mineral water, may reduce its absorption. This medicine must not be chewed or sucked 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 medicine on the scheduled day, take it the next morning when remembered. Take the next dose on the originally scheduled day. Do not take 2 tablets on the same day.
Child dose
Safety and efficacy in children under 18 years of age have not been established.

Ingredients

Manufacturer
IQURE Co., Ltd.

Efficacy & effects

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

  • Osteoporosis
View approved original text

This medication is used to treat and prevent osteoporosis in postmenopausal women and men.

How to take

Adult dose

* 35 mg 1. Adults: Administer risedronate sodium 35 mg 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 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 greater. This medicine is contraindicated in patients with severe renal impairment and creatinine clearance below 30 mL/min. ○ Since 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 time of day. To ensure that this medicine reaches the stomach easily and reduce the risk of esophageal irritation, take it in an upright position with plenty of plain water (170 ∼ 230 mL). Taking this medicine with other beverages, including mineral water, may reduce its absorption. This medicine must not be chewed or sucked 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 medicine on the scheduled day, take it the next morning when remembered. Take the next dose on the originally scheduled day. Do not take 2 tablets on the same day.

Child dose

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

Precautions

This medication may irritate the stomach and esophagus, so individuals with gastrointestinal disorders such as gastritis, esophagitis, or esophageal ulcers should use it with caution. Especially for those with esophageal problems or difficulty swallowing, it is advisable not to take this medication. Take this medication with sufficient water and do not lie down for 30 minutes after taking it. Women who are pregnant or may become pregnant, individuals with severely impaired kidney function, and those with certain genetic disorders should not take this medication. If there is a lack of calcium and vitamin D, they should be supplemented beforehand, and it is important to consistently consume appropriate amounts of calcium and vitamin D. This medication may have rare side effects like jaw osteonecrosis, so consult a physician if dental treatment is needed. Long-term use may rarely result in atypical femoral fractures, so inform the doctor immediately if experiencing pain in the thigh or groin. This medication can interfere with the absorption of other drugs, so it should be taken with time intervals apart from drugs containing calcium or iron. During use, this medication should be taken for a certain period before or after food intake, and should be swallowed whole without chewing or sucking. Children and elderly individuals may also take it, but safety has not been established for children under 18 years. Overdosage may lead to low blood calcium levels, so immediate medical attention should be sought if symptoms occur. Store it out of reach of children and do not transfer it to another container.

Side effects

Esophagitis, esophageal ulcer, esophageal erosion, esophageal obstruction, esophageal perforation, gastric ulcer, duodenal ulcer, dyspepsia, diarrhea, 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, acute phase reactions (fever, influenza-like symptoms), uveitis, scleritis, iritis, Steven-Johnson syndrome, toxic epidermal necrolysis, angioedema, blister, skin reactions, external auditory canal bone necrosis, jaw bone necrosis, liver dysfunction, jaundice, loss of appetite, asthenia, 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 tightly sealed container to prevent air exposure, at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Light orange round film-coated tablet

Package unit

4 tablets

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.

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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.