Sodium Ibandronate Injection (Sodium Ibandronate Hemihydrate)

Adult administration

Administer 3mg by intravenous injection once every three months for 15-30 seconds. Patients are encouraged to supplement with calcium and vitamin D. If a dose is missed on the scheduled dosing day, inject as soon as possible and continue regular dosing every three months.

Child administration

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

This medication must be administered intravenously, and caution is necessary to avoid injection near the arteries or veins, as this may cause tissue damage. It should not be administered to patients with an allergy to this drug or its ingredients or to those with untreated hypocalcemia. Using this medication may cause gastrointestinal adverse reactions such as gastritis, diarrhea, abdominal pain, indigestion, nausea, and constipation. Muscle pain, joint pain, headache, rash, and fatigue have also been reported, with most symptoms being mild to moderate. Upon initial administration, symptoms similar to influenza such as joint pain, muscle pain, fever, chills, fatigue, nausea, loss of appetite, and bone pain may occur, but most resolve naturally in a short period. Some patients receiving this medication may develop osteonecrosis of the jaw, so oral examination and appropriate dental treatment are recommended before administration. During treatment, it is advisable to avoid unnecessary dental work and consult a specialist if osteonecrosis is suspected. This medication may temporarily lower calcium levels, so treatment for hypocalcemia or bone and mineral metabolism disorders must be completed before administration, and it is important to ensure adequate intake of calcium and vitamin D. Patients with chronic kidney disease or those taking medications that may affect the kidneys require regular examinations and tests. Patients receiving this medication may experience severe pain in muscles, joints, and bones, and if such symptoms occur, immediate consultation with healthcare professionals is necessary. Long-term use may lead to atypical fractures of the femur or other bones, so immediate evaluation is required if pain occurs in the legs or groin. This medication is not metabolized by the liver and is excreted through the kidneys, so its impact on liver function is minimal, but kidney function should be closely monitored. It is preferable to avoid this medication during pregnancy or breastfeeding as its safety has not been established. The efficacy and safety of this medication have not been confirmed in children, so it should not be used in pediatric populations. In cases of overdose, hypocalcemia, hypophosphatemia, and hypomagnesemia may occur, so careful monitoring is necessary, and appropriate treatment should be provided if necessary. This medication must not be mixed with calcium-containing solutions or other intravenous medications and should only be administered with normal saline or 5% dextrose solution. After use, the syringe and needle should not be reused and should be disposed of safely, keeping them out of reach of children.

Serious side effects

• Urticaria
• severe swelling (edema)
• angioedema
• facial swelling/edema
• chest tightness
• difficulty breathing
• worsening of asthma
• anaphylaxis/shock
• Stevens-Johnson syndrome
• erythema multiforme

Mild side effects

• Gastritis
• diarrhea
• abdominal pain
• indigestion
• nausea
• constipation
• musculoskeletal pain
• joint pain
• muscle pain
• influenza-like illness

This medication should be stored in a sealed container to prevent air from entering and kept at room temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain its effectiveness for a long time.

Appearance

A colorless and transparent solution contained in a colorless and transparent glass prefilled syringe, accompanied by a single-use needle.

Package unit

3ml x 1 vial