Medication info

Ibandronate Injection (Ibandronate Sodium Hydrate)

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

MFDS item code 201803290 · Notified 2018.08.13 · Insurance code 640903671

Summary

Main use
Improvement of osteoporosis in postmenopausal women
Who receives it
Adults
Adult administration
3 mg is administered as an intravenous injection every 3 months over 15 - 30 seconds.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

Improvement of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This medication used for the treatment of osteoporosis in postmenopausal women helps to increase bone density and reduce the risk of fractures. Hormonal changes due to menopause can weaken bones, and this medication can prevent and treat such changes to maintain bone health. It helps to prevent bone loss and strengthens bones, which reduces the risk of fractures in daily life. Additionally, it is effective in lowering the incidence of pain and complications associated with osteoporosis. Therefore, it is an important treatment that supports healthy living for postmenopausal women.

How it is given

Adult administration

3 mg is administered as an intravenous injection every 3 months over 15 - 30 seconds.

Precautions

This medication must be administered intravenously, and great caution should be taken to avoid administering it intra-arterially or around the vein, as this can cause tissue damage. It should not be used in patients who are allergic to this medication or any of its components or in those with untreated hypocalcemia. While using this medication, side effects such as gastritis, diarrhea, abdominal pain, indigestion, nausea, constipation, musculoskeletal pain, arthralgia, myalgia, headache, rash, etc., may occur, so if any unusual symptoms arise, consult healthcare professionals immediately. Especially when this medication is administered for the first time, flu-like symptoms may temporarily occur, which are usually mild and resolve quickly. There is a risk of osteonecrosis of the jaw while receiving this medication, so it is important to undergo an oral examination and plan any dental treatments prior to starting therapy. Additionally, long-term use may lead to atypical fractures of the femur or other bones, so if there is pain in the thigh or groin area, notify the doctor immediately. This medication can temporarily lower serum calcium levels, so pre-existing hypocalcemia or bone and mineral metabolism disorders must be treated before administration, and adequate intake of calcium and vitamin D is important. Women who are pregnant or breastfeeding should avoid using this medication, as its safety has not been established. In cases of overdose, renal and liver function can be affected, so careful monitoring is necessary and appropriate treatment should be received if required. This medication has minimal metabolic interactions with other drugs; however, patients taking medications that can affect kidney function should undergo regular monitoring during treatment. This medication should not be mixed with solutions containing calcium or other intravenous medications and must be administered with the specified solution. After use, do not reuse the injection needle and syringe, and dispose of them securely, keeping them out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, facial swelling, severe allergic reactions, anaphylaxis/shock, difficulty breathing, respiratory distress, exacerbation of asthma, severe skin reactions such as Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, severe rash with fever, blisters, skin peeling, oral/ocular mucosal pain, liver abnormalities (jaundice) have not been documented, but acute renal failure, multiple organ failure, death, and other serious adverse effects may occur.

Mild side effects

  • Gastritis
  • diarrhea
  • abdominal pain
  • indigestion
  • nausea
  • constipation
  • musculoskeletal pain
  • arthralgia
  • myalgia
  • flu-like illness
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  • fatigue
  • headache
  • rash
  • bone pain
  • weakness
  • injection site reactions
  • low back pain
  • dizziness
  • insomnia
  • anxiety
  • tinnitus
  • hearing loss
  • hypothyroidism
  • lipomas
  • ocular hemorrhage
  • urinary disorders
  • hematuria
  • skin exfoliation

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

Storage

Store this medication in a sealed container to prevent air ingress, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

A colorless, transparent solution in a colorless, transparent glass prefilled syringe containing a single-use injection needle.

Package unit

3 mL 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.