Medication info
Ibandronate Sodium Hydrate Tablets (Ibandronic Acid)

Ibandronate Sodium Hydrate Tablets (Ibandronic Acid)

Prescription medicationTablet경구
Ingredient · strength
Ibandronate Sodium Monohydrate›168.75mg / 1 tablet
Manufacturer / importer
조아제약(주)
Appearance
White or nearly white, rectangular film-coated tablet
Packaging
1 T/PTP
Approval status
Active

MFDS item code 201205941 · Approved 2012.06.27 · Insurance code 644602670

Summary

Main use
Improvement of postmenopausal osteoporosis
Who takes it
Adults · Children
Adult dose
One tablet once a month regularly on the same day each month taken in the morning at least 1 hour before food, drinks (excluding water), or other oral medications or supplements (including calcium) with an adequate amount of water. - It should be swallowed while standing or sitting upright with plenty of water (180-240ml) and you should 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

Manufacturer
조아제약(주)

Efficacy & effects

Improvement of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

Used for the treatment of osteoporosis in postmenopausal women.

How to take

Adult dose

One tablet once a month regularly on the same day each month taken in the morning at least 1 hour before food, drinks (excluding water), or other oral medications or supplements (including calcium) with an adequate amount of water. - It should be swallowed while standing or sitting upright with plenty of water (180-240ml) and you should 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 patients who are allergic to this drug or any of its components, patients with untreated hypocalcemia, patients who cannot sit or stand upright for more than 60 minutes, patients with esophageal disorders that prevent food from passing easily, and patients with genetic conditions such as lactose intolerance. For patients with severe renal impairment, this medication should be administered with caution. While taking this medication, side effects such as dyspepsia, nausea, abdominal pain, diarrhea, headache, myalgia, arthralgia, and rash may occur. Occasionally, gastrointestinal issues resembling influenza symptoms, esophagitis, or esophageal ulcers may appear and, rarely, allergic reactions such as dizziness, angioedema, and urticaria have also been reported. It is important to take this medication with calcium and vitamin D, and patients should remain upright for at least 60 minutes after taking it to reduce esophageal irritation. Additionally, this medication may irritate the gastric mucosa, so caution is advised for patients with gastritis or esophageal diseases. Patients undergoing dental treatment or with issues related to the jawbone should have an oral examination prior to taking this medication, and excessive dental treatments should be avoided. Serious bone issues such as osteonecrosis of the jaw or osteonecrosis of the external auditory canal may also arise while taking this medication, hence caution is needed. This medication may have impaired absorption when taken with food, milk, calcium supplements, antacids, etc., therefore, it is advisable not to consume other food or drugs for at least one hour after taking it. Women who are pregnant or breastfeeding should not use this medication, and safety and efficacy in children under 18 years have not been established. In the case of overdose, symptoms such as gastrointestinal discomfort, esophagitis, and hypocalcemia may occur, and immediate consultation with a healthcare professional is advised if these symptoms appear. Finally, this medication should be kept out of reach of children, and unused medication should be disposed of properly to prevent environmental contamination.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • facial swelling
  • hypersensitivity reactions
  • anaphylaxis reactions/shock
  • worsening asthma
  • Stevens-Johnson syndrome
  • erythema multiforme
  • bullous dermatitis
  • uveitis
Show 4 more
  • scleritis
  • episcleritis
  • profuse sweating
  • pallor.

Mild side effects

  • Dyspepsia
  • nausea
  • abdominal pain
  • diarrhea
  • bloating
  • gastroesophageal reflux disease
  • headache
  • influenza-like illness
  • fatigue
  • myalgia
Show 15 more
  • arthralgia
  • rash
  • dizziness
  • low back pain
  • esophagitis
  • dysphagia
  • vomiting
  • gastritis
  • esophageal ulcer or stricture
  • muscle cramps
  • musculoskeletal pain
  • musculoskeletal stiffness
  • weakness
  • pruritus
  • abnormal sensations in the eyes.

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and kept at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the drug's efficacy for a longer period.

Appearance and packaging

Appearance

White or nearly white, rectangular film-coated tablet

Package unit

1 T/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.