Medication info
Rizonal 35 mg (Risedronate Sodium)

Rizonal 35 mg (Risedronate Sodium)

Prescription medicationTabletOral
Ingredient · strength
Risedronate Sodium›35mg / 1 tablet
Manufacturer / importer
IYON Pharmaceutical Co., Ltd.
Appearance
Pale orange oval film-coated tablet
Packaging
4 tablets (4 tablets/PTP × 1)
Approval status
Active

MFDS item code 200713913 · Notified 2007.12.31 · Insurance code 658602100

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), since 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 below 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 any time of day at least 2 hours before or after consuming food or beverages. To help this 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 it with other beverages, including mineral water, may reduce absorption of this drug. 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 a dose on the scheduled dosing day, take it the next morning when remembered. Take the next dose on the originally scheduled dosing 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
IYON Pharmaceutical Co., Ltd.

Efficacy & effects

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

  • Osteoporosis
View approved original text

This drug is used for the treatment and prevention of osteoporosis in both postmenopausal women and men.

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), since 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 below 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 any time of day at least 2 hours before or after consuming food or beverages. To help this 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 it with other beverages, including mineral water, may reduce absorption of this drug. 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 a dose on the scheduled dosing day, take it the next morning when remembered. Take the next dose on the originally scheduled dosing 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 may irritate the mucosa of the esophagus and stomach, so patients with esophageal diseases, gastritis, duodenitis, or ulcers should be cautious when taking it. If symptoms such as difficulty swallowing, chest pain, or heartburn occur after taking it, stop taking the medication immediately and consult a doctor. It is essential to take this medication with a sufficient amount of water and to avoid lying down for at least 30 minutes after taking it. This drug should not be used by patients with specific esophageal diseases, severe renal impairment, pregnant women, women who may become pregnant, or patients with lactose intolerance. Patients with Barrett's esophagus or gastrointestinal diseases, or allergies to any dyes included in this medication should be cautious when taking it. Various side effects such as indigestion, abdominal pain, headache, muscle pain, joint pain, rash, etc., may occur during use, so if symptoms are severe, inform a doctor. Calcium and vitamin D supplementation may be needed, so treatment should be received before therapy, especially if there is calcium deficiency or abnormal parathyroid function. Since this drug may interfere with the absorption of other medications or food that contain calcium, magnesium, iron, etc., dosing times should be strictly observed. It is advisable that pregnant or breastfeeding women do not take this medication, and must consult a doctor if they do. Safety for use in children under 18 years of age has not been established, so use is not recommended. In the case of overdose, calcium levels in the blood may decrease; if hypocalcemia symptoms appear, treatment should be sought immediately, and emergency measures such as gastric lavage may be performed if necessary. This medication should be kept out of reach of children, and transferring it to another container is not advisable for maintaining quality.

Side effects

  • esophagitis
  • esophageal ulcer
  • esophageal erosion
  • esophageal obstruction
  • esophageal perforation
  • bleeding
  • infection
  • low back pain
  • accidental injury
  • pain
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  • abdominal pain
  • flu symptoms
  • headache
  • weakness
  • neck pain
  • chest pain
  • allergic reaction
  • hypertension
  • constipation
  • diarrhea
  • dyspepsia
  • nausea
  • peripheral edema
  • arthralgia
  • arthritis
  • fracture
  • joint abnormalities
  • myalgia
  • bone pain
  • dizziness
  • depression
  • insomnia
  • bronchitis
  • sinusitis
  • rhinitis
  • pharyngitis
  • increased cough
  • rash
  • cataract
  • urinary tract infection
  • loss of appetite
  • weakness syndrome
  • heartburn
  • epigastric pain
  • chest discomfort
  • palpitations
  • increased sweating
  • facial flushing
  • burning sensation
  • kidney stones
  • belching
  • hematuria
  • fever
  • eye pain
  • mucous membrane syndrome
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • Lyle syndrome
  • angioedema
  • blister
  • skin reaction
  • external auditory canal osteonecrosis
  • iritis
  • uveitis
  • jaw necrosis
  • liver dysfunction
  • jaundice
  • vomiting
  • upper abdominal pain
  • acute phase reaction
  • fever
  • influenza-like symptoms
  • hypocalcemia
  • signs and symptoms of hypocalcemia

Not everyone experiences these, and they can vary from person to person.

Storage

Store this medication in a tightly sealed container to prevent air or moisture from entering. Additionally, avoid storing it in extremely hot or cold places; it is best to keep it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pale orange oval film-coated tablet

Package unit

4 tablets (4 tablets/PTP × 1)

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.