Medication info

Ibandronate Sodium 150 mg Tablets (Sodium Ibandronate Trihydrate)

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Ibandronate Sodium Monohydrate›168.8mg / 1 tablet
Manufacturer / importer
(주)한독테바
Appearance
White rectangular film-coated tablets
Packaging
1 tablet/PTP
Approval status
Approval withdrawn

MFDS item code 201309842 · Approved 2013.10.21

This product's status changed to Approval withdrawn on 2025.02.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of postmenopausal osteoporosis
Who takes it
Adults · Children
Adult dose
Take 1 tablet regularly once a month on the same day in the morning with sufficient water at least 1 hour before consuming food, beverages (excluding water), or other oral medications or dietary supplements (including calcium). You must swallow it while standing or sitting upright with a sufficient amount (180-240 ml) of water and must not lie down for 60 minutes after taking it. Mineral water may reduce the absorption of this medication.
Child dose
Efficacy and safety in children under 18 years have not been studied.

Ingredients

Importer
(주)한독테바

Efficacy & effects

Improvement of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

This medication is used to treat osteoporosis that may occur in postmenopausal women. Osteoporosis is a condition that increases the risk of fractures as bones weaken, which occurs frequently in postmenopausal women. Taking this medication helps increase bone density and reduce the risk of fractures.

How to take

Adult dose

Take 1 tablet regularly once a month on the same day in the morning with sufficient water at least 1 hour before consuming food, beverages (excluding water), or other oral medications or dietary supplements (including calcium). You must swallow it while standing or sitting upright with a sufficient amount (180-240 ml) of water and must not lie down for 60 minutes after taking it. Mineral water may reduce the absorption of this medication.

Child dose

Efficacy and safety in children under 18 years have not been studied.

Precautions

This medication should not be administered to certain patients. For example, it should not be used in individuals who are allergic to this medication or its components, in patients with untreated hypocalcemia, in those who cannot sit or stand upright for at least 60 minutes, in patients with esophageal dysfunction that makes it difficult for food to pass down, and in individuals with genetic issues like lactose intolerance. Caution is required when using this medication in patients with severely impaired kidney function, especially in those with a creatinine clearance of less than 30 mL/min. Possible side effects include dyspepsia, nausea, abdominal pain, diarrhea, headache, muscle pain, joint pain, and rashes. Some patients may also experience flu-like symptoms or gastrointestinal disorders such as esophagitis and esophageal ulcers. When taking this drug, it is essential to remain seated or standing for at least 60 minutes after ingestion and to avoid taking it with food or products containing calcium, magnesium, or iron as this may interfere with the absorption of the medication. Patients undergoing dental treatment are advised to have an oral exam before using this medication and to avoid excessive dental treatments while taking it because this drug may rarely cause issues with the jawbone. Additionally, this medication has the potential to cause serious side effects such as eye inflammation, severe allergic reactions, skin disorders, and atypical femoral fractures, so patients should consult a healthcare professional immediately if they notice any symptoms. Pregnant or nursing women are recommended not to use this medication as its safety has not been established. The safety and efficacy of this medication have not been established in children, thus it is not prescribed for them. In cases of overdose, gastrointestinal discomfort, esophagitis, hypocalcemia, etc., may occur. In such instances, milk or antacids should be ingested without inducing vomiting, and the patient should be kept in an upright position. Finally, this medication should be stored out of reach of children, and unused medications should be disposed of properly to prevent environmental contamination.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing or shortness of breath, asthma attacks, abnormal respiratory issues with cough + fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning-like headaches, seizures, confusion, vision abnormalities, paralysis, significantly reduced urine output, systemic effects

Mild side effects

  • Dyspepsia
  • nausea
  • abdominal pain
  • diarrhea
  • bloating
  • gastroesophageal reflux disease
  • headache
  • flu-like illness
  • fatigue
  • muscle pain
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  • joint pain
  • rashes
  • dizziness
  • low back pain
  • esophagitis
  • weakness
  • itching
  • vomiting
  • gastritis
  • muscle cramps
  • musculoskeletal pain
  • musculoskeletal stiffness
  • abnormal sensations in the eyes

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is also important to keep it in a cool room temperature between 1 to 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

White rectangular film-coated tablets

Package unit

1 tablet/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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.