Medication info

Hivandron Injection (Ibandronic Acid Sodium Hydrate)

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

MFDS item code 202000457 · Notified 2020.01.29

Summary

Main use
Improvement of postmenopausal osteoporosis
Who receives it
Adults
Adult administration
3 mg intravenously every 3 months over 15 - 30 seconds.

Ingredients

Manufacturer
(주)휴메딕스

Efficacy & effects

Improvement of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

This medication is used to treat osteoporosis that occurs in postmenopausal women. Osteoporosis is a condition in which bones become weak and have a high risk of fractures, particularly occurring in women due to decreased estrogen levels after menopause. This medication helps to prevent bone loss and increase bone density, thereby reducing the risk of fractures. It improves bone health and enhances the quality of life. Therefore, it is effective in the treatment of osteoporosis in postmenopausal women.

How it is given

Adult administration

3 mg intravenously every 3 months over 15 - 30 seconds.

Precautions

This medication must be administered intravenously and care should be taken to avoid injecting into arteries or around the veins, as this may cause tissue damage. It should not be administered to patients who are allergic to this drug or its components and to untreated hypocalcemia patients. In clinical trials with long-term use of this drug, side effects such as gastritis, diarrhea, abdominal pain, dyspepsia, nausea, constipation, musculoskeletal pain, arthralgia, myalgia, headache, rash, and fatigue have been reported. When administered via injection, temporary flu-like symptoms (arthralgia, myalgia, fever, chills, fatigue, etc.) may occur but most are mild and resolve without treatment. Before administering this medication, it is important to treat hypocalcemia and metabolic disorders of bones and minerals, and to ensure adequate intake of calcium and vitamin D. During osteoporosis treatment, severe bone, joint, and muscle pain may occur, and if symptoms arise, immediate consultation with healthcare professionals is required. Reports of osteonecrosis of the jaw have been noted; therefore, especially in cancer patients or those needing dental treatment, an oral examination should be conducted before administration, and excessive dental interventions should be avoided during treatment. This drug is not metabolized by the liver and is excreted via the kidneys, so patients with impaired kidney function require regular monitoring. Women who are pregnant or breastfeeding should avoid using this drug, as its safety has not been established. In cases of overdose, careful monitoring is necessary as it may affect kidney and liver function, and appropriate treatment is needed if hypocalcemia or other complications arise. This medication should not be mixed with calcium-containing solutions, and syringes and needles should not be reused and must be disposed of safely.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, facial swelling/edema, anaphylaxis/shock, hypersensitivity, Stevens-Johnson syndrome, erythema multiforme, vesicular dermatitis, osteonecrosis (jaw, external auditory canal), acute renal failure, respiratory distress, multiple organ failure, death

Mild side effects

  • Gastritis
  • diarrhea
  • abdominal pain
  • dyspepsia
  • nausea
  • constipation
  • musculoskeletal pain
  • arthralgia
  • myalgia
  • flu-like symptoms
Show 26 more
  • fatigue
  • headache
  • rash
  • bone pain
  • weakness
  • injection site reactions
  • phlebitis/thrombophlebitis
  • sensory impairment
  • dizziness
  • insomnia
  • anxiety
  • tinnitus
  • hearing loss
  • hypothyroidism
  • lipomatosis
  • ocular hemorrhage
  • heart failure
  • urination disorders
  • hematuria
  • skin shedding
  • dental pain
  • hyperventilation
  • cough
  • laryngitis
  • vaginitis
  • menopausal symptoms

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

Storage

This medication should be stored in a sealed container to protect it from air exposure and is best kept at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

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

Package unit

3 milliliters/prefilled syringe

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.