Medication info
Risendronate Tablet 35 mg (Sodium Risendronate Anhydrous)

Risendronate Tablet 35 mg (Sodium Risendronate Anhydrous)

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

MFDS item code 200800331 · Notified 2008.01.08 · Insurance code 646002650

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 35 mg of risedronate sodium orally once weekly. 2. Older adults : No dosage adjustment is necessary in older adults (over 60 years of age), because the bioavailability and pharmacodynamics of this drug are similar to those in younger people. 4. Patients with renal impairment : 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. ○ Food interferes with the absorption of this drug. To ensure adequate absorption, take it at least 30 minutes before breakfast, or at least 2 hours before or after consuming food or beverages at any other time of day. To help the drug reach the stomach easily and reduce the possibility of esophageal irritation, take it in an upright position with a sufficient amount of plain water (170 ∼ 230 mL). 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 the 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
3. Children : The safety and efficacy of this drug in children under 18 years of age have not been established.

Ingredients

Manufacturer
Medica Korea 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. Osteoporosis is a condition where bones become weak and can break easily, and this medication strengthens bones to reduce fracture risk. Therefore, it is effective for those concerned about bone health.

How to take

Adult dose

1. Adults : Administer 35 mg of risedronate sodium orally once weekly. 2. Older adults : No dosage adjustment is necessary in older adults (over 60 years of age), because the bioavailability and pharmacodynamics of this drug are similar to those in younger people. 4. Patients with renal impairment : 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. ○ Food interferes with the absorption of this drug. To ensure adequate absorption, take it at least 30 minutes before breakfast, or at least 2 hours before or after consuming food or beverages at any other time of day. To help the drug reach the stomach easily and reduce the possibility of esophageal irritation, take it in an upright position with a sufficient amount of plain water (170 ∼ 230 mL). 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 the 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

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

Precautions

This medication can irritate the esophagus and stomach, so individuals with esophageal or stomach conditions should take special care when taking it. When taking this medication, it should be taken with a sufficient amount of water, and one should not lie down for at least 30 minutes afterward. It should be taken before meals or at times separated from meals, and should not be chewed or sucked. If swallowing is difficult or symptoms such as chest pain or heartburn occur, stop taking it immediately and consult a physician. This medication should not be used by individuals with specific esophageal abnormalities, hypocalcemia, severe renal impairment, pregnant or nursing women, and those with lactose intolerance. During osteoporosis treatment, it is important to consume adequate calcium and vitamin D; rare cases of unusual bone fractures or jaw necrosis can occur with prolonged use. Calcium, magnesium, iron, or foods containing these while taking this medication can obstruct absorption, so timings should be observed carefully. During treatment, gastrointestinal disorders, muscle pain, joint pain, headaches, and dizziness may occur, so consult a physician if symptoms worsen. Pregnant or nursing women are advised not to take this medication, and it should not be used for individuals under 18 years for safety. In cases of overdose, symptoms of hypocalcemia may appear, and one should immediately visit a medical institution for appropriate treatment. This medication should be kept out of reach of children and stored in its original container to maintain quality.

Side effects

esophagitis, esophageal ulcer, esophageal erosion, esophageal obstruction, esophageal perforation, bleeding, gastric ulcer, duodenal ulcer, indigestion, diarrhea, abdominal pain, nausea, joint pain, arthritis, myalgia, bone pain, dizziness, depression, insomnia, bronchitis, sinusitis, rhinitis, pharyngitis, increased cough, rash, cataract, urinary tract infection, acute phase reaction (fever, influenza-like symptoms), vomiting, uveitis, scleritis, iritis, Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, blister, skin reaction, osteonecrosis of the jaw, liver dysfunction, jaundice, loss of appetite, myalgia, weakness, heartburn, epigastric pain, discomfort in the chest, 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 an airtight container that allows for good air circulation, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pale orange round film-coated tablet

Package unit

4 tablets (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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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.