Medication info

Bonbaro Injection (Ibandronate Sodium Hydrate)

Prescription medicationInjections정맥
Ingredient · strength
Ibandronate Sodium Monohydrate›3.375mg / 1 prefilled syringe
Manufacturer / importer
(주)바스칸바이오제약
Appearance
A colorless, transparent solution in a colorless, transparent glass pre-filled syringe, attached with a single-use needle.
Packaging
3ml x 1 vial
Approval status
Active

MFDS item code 201801801 · Notified 2018.04.27

Summary

Main use
Improvement of postmenopausal osteoporosis
Who receives it
Adults
Adult administration
Administer 3mg intravenously every 3 months over 15 - 30 seconds. Patients should also intake calcium and vitamin D as adjuncts. If a dose is missed on the scheduled date, administer the injection as soon as possible and continue the regular dosing at 3-month intervals thereafter.

Ingredients

Manufacturer
(주)바스칸바이오제약

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 where bone strength is reduced, increasing the risk of fractures. This medication helps to strengthen bones, reduce the risk of fractures, and improve bone density. Therefore, it is effective for the prevention and treatment of postmenopausal osteoporosis.

How it is given

Adult administration

Administer 3mg intravenously every 3 months over 15 - 30 seconds. Patients should also intake calcium and vitamin D as adjuncts. If a dose is missed on the scheduled date, administer the injection as soon as possible and continue the regular dosing at 3-month intervals thereafter.

Precautions

This medication must be administered intravenously and extreme caution is required when administering it intrarterially or perivascularly as it may cause tissue damage. It should not be used in patients with allergies to this drug or its components, and in those with untreated hypocalcemia. During treatment with this drug, some patients may experience gastrointestinal adverse reactions such as gastritis, diarrhea, abdominal pain, dyspepsia, nausea, or constipation. Musculoskeletal side effects such as myalgia, arthralgia, and musculoskeletal pain may also occur, and systemic symptoms similar to influenza, fatigue, headaches, and rashes have been reported. When administering this medication, it is important to ensure adequate intake of calcium and vitamin D, and it should be used following treatment if there are issues with hypocalcemia or bone metabolism. Serious side effects such as osteonecrosis of the jaw or external auditory canal may rarely occur, so it is advisable to have an oral examination before dental treatment and avoid excessive dental procedures. Long-term use of this medication may result in atypical fractures in the femur and other bones, requiring patients to consult healthcare providers immediately if they experience pain in the thigh or groin area. This medication can provoke severe allergic reactions such as anaphylaxis; thus, it should be discontinued immediately and appropriate treatment should be sought if any abnormal symptoms arise during administration. It is advisable not to use this medication in pregnant or breastfeeding women as its safety has not been established. The safety and efficacy have not been confirmed in children and adolescents under 18 years old, so its use is not recommended. In case of overdose, this medication may affect the kidneys and liver, so if overdose is suspected, inform healthcare providers immediately and calcium or magnesium supplementation may be administered as needed. This medication should not be mixed with calcium-containing solutions or other intravenous medications and must only be administered intravenously. After use, syringes and needles should not be reused and must be disposed of safely.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis reaction/shock, severe rash with high fever, blisters, exfoliative dermatitis, mucosal pain in the mouth/eyes, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness,

Mild side effects

  • Gastritis
  • diarrhea
  • abdominal pain
  • dyspepsia
  • nausea
  • constipation
  • musculoskeletal pain
  • arthralgia
  • myalgia
  • influenza-like illness
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  • fatigue
  • headache
  • rash
  • bone pain
  • weakness
  • injection site reactions
  • phlebitis/thrombophlebitis
  • dizziness
  • optic nerve atrophy
  • lower motor neuron lesions
  • tremors
  • unspecified gastrointestinal disorders
  • benign gastrointestinal neoplasms
  • toothache
  • hyperventilation
  • cough
  • laryngitis
  • vaginitis
  • menopausal symptoms
  • insomnia
  • anxiety
  • tinnitus
  • hearing loss

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

Storage

This medication should be stored in a sealed container to keep air and moisture out, and it is best stored at a temperature between 1 degree and 30 degrees Celsius at room temperature. Proper storage will help maintain the effectiveness of the medication and prevent deterioration.

Appearance and packaging

Appearance

A colorless, transparent solution in a colorless, transparent glass pre-filled syringe, attached with a single-use needle.

Package unit

3ml x 1 vial

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.

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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.