Medication info

Ibandronate Injection (Ibandronic Acid Sodium Hydrate)

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

MFDS item code 202003406 · Notified 2020.05.11 · Insurance code 660703481

Summary

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

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Improvement of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This medication is used for the treatment of osteoporosis that occurs in postmenopausal women. Osteoporosis is a condition where bones become weak and are at a greater risk of fractures. This medication helps strengthen the bones and increase bone density, preventing fractures. Therefore, it is effective in maintaining healthy bones in patients with postmenopausal osteoporosis.

How it is given

Adult administration

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

Precautions

This medication must be administered intravenously, and caution is advised as injecting into the arteries or around the veins may cause tissue damage. It should not be used in patients with allergy to this medication or its components or in patients with untreated hypocalcemia. During treatment, gastrointestinal adverse reactions such as gastritis, diarrhea, abdominal pain, dyspepsia, nausea, and constipation may occur, as well as musculoskeletal adverse reactions such as musculoskeletal pain, joint pain, and muscle pain. Additionally, during the initial administration, flu-like symptoms such as joint pain, muscle pain, fever, chills, fatigue, nausea, loss of appetite, and bone pain may temporarily occur, although they are mostly mild and resolve without treatment. This medication can temporarily lower serum calcium levels, so underlying conditions of hypocalcemia or bone and mineral metabolism disorders should be treated before administration, and adequate intake of calcium and vitamin D is important. Patients undergoing dental treatment or cancer patients may face a risk of jaw bone necrosis; therefore, an oral examination and preventive dental treatment are recommended before administration, and excessive dental treatment should be avoided during treatment. Rarely, osteonecrosis of the external auditory canal may occur in patients receiving this medication, so be cautious if there is pain or discharge from the ear. Long-term use may result in atypical fractures of the femur or other bones, so if there is pain in the thigh or groin, consult a physician immediately. This medication may cause serious allergic reactions or anaphylaxis; if abnormal symptoms occur during administration, discontinue immediately and seek appropriate treatment. Safety during pregnancy and lactation has not been established, so its use is not recommended. The risk of drug interactions with this medication is low, but it may affect kidney function; therefore, patients with kidney disease or those taking medications affecting the kidneys require regular monitoring. In the event of overdose, kidney and liver functions should be carefully monitored, and if any electrolyte abnormalities such as hypocalcemia occur, appropriate treatment should be administered. This medication must not be mixed with calcium-containing solutions and should only be administered intravenously with the designated solution. Keep out of reach of children, do not reuse needles and syringes, and dispose of safely after use.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • facial swelling/edema
  • anaphylactic reactions/shock
  • worsening of asthma
  • Stevens-Johnson syndrome
  • erythema multiforme
  • bullous dermatitis
  • acute renal failure
  • respiratory distress
Show 8 more
  • severe edema
  • multiple organ failure
  • death
  • optic nerve atrophy
  • lower motor neuron lesions
  • tremors
  • hyperventilation
  • laryngitis

Mild side effects

  • Gastritis
  • diarrhea
  • abdominal pain
  • dyspepsia
  • nausea
  • constipation
  • musculoskeletal pain
  • joint pain
  • muscle pain
  • flu-like illness
Show 19 more
  • fatigue
  • headache
  • rash
  • bone pain
  • weakness
  • injection site reactions
  • phlebitis/thrombophlebitis
  • dizziness
  • insomnia
  • anxiety
  • tinnitus
  • hearing loss
  • hypothyroidism
  • lipoma
  • ocular hemorrhage
  • heart failure
  • urination disorders
  • hematuria
  • skin peeling

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

Storage

This medication should be stored in a sealed container to prevent air and moisture exposure. It is important to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage will help maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

A colorless and transparent solution in a colorless and transparent glass prefilled syringe with a single-use 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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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.