Medication info
Ibatron Tablet 150mg (Ibandronic Acid Sodium Monohydrate)

Ibatron Tablet 150mg (Ibandronic Acid Sodium Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Ibandronate Sodium Monohydrate›168.75mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
White to almost white rectangular film-coated tablet
Packaging
1 tablet/PTP
Approval status
Active

MFDS item code 201208995 · Approved 2012.11.30 · Insurance code 651203800

Summary

Main use
Improvement of osteoporosis in postmenopausal women
Who takes it
Adults · Children
Adult dose
Take 1 tablet regularly once a month on the same day in the morning at least 1 hour before ingesting food, beverages (except water), or other oral medications or dietary supplements (including calcium). This medication should be swallowed with an adequate amount of water (180-240ml) while in a standing or seated position, and patients must not lie down for 60 minutes after taking it. Mineral water can reduce the absorption of this medication.
Child dose
Efficacy and safety in children under 18 years of age have not been studied.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Improvement of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This medication is used to treat osteoporosis that may occur in postmenopausal women, a condition where bones weaken and are at risk of breaking easily. It helps to prevent bone density loss, reducing the risk of fractures and maintaining healthy bones. Therefore, it is effective for the treatment of osteoporosis in postmenopausal women.

How to take

Adult dose

Take 1 tablet regularly once a month on the same day in the morning at least 1 hour before ingesting food, beverages (except water), or other oral medications or dietary supplements (including calcium). This medication should be swallowed with an adequate amount of water (180-240ml) while in a standing or seated position, and patients must not lie down for 60 minutes after taking it. Mineral water can reduce the absorption of this medication.

Child dose

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

Precautions

This medication should not be used by certain patients. For example, those allergic to this medicine or its components, untreated hypocalcemia patients, those who cannot sit or stand upright for more than 60 minutes, patients with esophageal function issues that hinder swallowing, and individuals with lactose intolerance or genetic metabolic disorders should not take this medication. Patients with severe renal impairment should be particularly cautious when using this medication. If kidney function is significantly diminished, the effects of the drug may vary. While taking this medication, mild to moderate side effects such as dyspepsia, nausea, abdominal pain, diarrhea, headache, myalgia, arthralgia, and rash may occur. Most of these symptoms are mild to moderate and often do not require discontinuation of treatment. In rare cases, patients may experience symptoms such as esophagitis, esophageal ulcers, dysphagia, dizziness, back pain, angioedema, or urticaria, in which case they should consult a medical professional. This medication may irritate the esophagus and gastric mucosa, thus it is important to remain upright for at least 60 minutes after taking it and not to take it with food or other medications. Additionally, calcium and vitamin D levels should be adequately managed prior to using this medication, and it should be taken at an interval from any drugs that may interfere with absorption, such as calcium, antacids, or iron supplements. Severe side effects such as osteonecrosis of the jaw have been reported, so it is recommended to consult with healthcare providers before undergoing dental treatment and to avoid excessive dental procedures during treatment. It is advised not to use this medication during pregnancy or breastfeeding. Safety in children and adolescents under 18 years of age has not been established. In cases of overdose, gastrointestinal disturbances or hypocalcemia may occur, and vomiting should not be induced; the patient should be kept sitting or standing. This medication should be kept out of reach of children, and expired medicines should be disposed of properly to avoid environmental harm.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema, facial swelling), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, difficulty or trouble breathing, asthma attacks, cough with fever accompanied breathing abnormalities, yellowing of the skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances

Mild side effects

  • Dyspepsia
  • nausea
  • abdominal pain
  • diarrhea
  • bloating
  • gastroesophageal reflux disease
  • headache
  • influenza-like illness
  • fatigue
  • myalgia
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  • arthralgia
  • rash
  • dizziness
  • back pain
  • vomiting
  • gastritis
  • esophagitis
  • 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 may be sensitive to air or moisture, so it should be stored in a tightly sealed container. The storage temperature should ideally be room temperature between 1°C and 30°C. This ensures the medication's efficacy is maintained for a longer period.

Appearance and packaging

Appearance

White to almost white rectangular film-coated tablet

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.