Medication info

Ostepose Injection (Ibandronate Sodium Hydrate)

Prescription medicationInjections정맥
Ingredient · strength
Ibandronate Sodium Monohydrate›3.375mg / 1 prefilled syringe
Manufacturer / importer
(주)휴비스트제약
Appearance
This injectable medication is a colorless, transparent solution contained in a colorless, transparent glass prefilled syringe with an attached single-use needle.
Packaging
3ml x 1 vial
Approval status
Active

MFDS item code 201801955 · Notified 2018.05.09

Summary

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

Ingredients

Manufacturer
(주)휴비스트제약

Efficacy & effects

Improvement of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This medication is used for the treatment of osteoporosis in postmenopausal women.

How it is given

Adult administration

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

Precautions

This medication must be administered intravenously, and caution is required as administration into the artery or around the vein can cause tissue damage. It must not be used in patients with a history of allergic reactions to this drug or its components, or in patients with untreated hypocalcemia. Various side effects may occur, including gastritis, diarrhea, abdominal pain, indigestion, nausea, constipation, muscle pain, joint pain, headache, and rash. Some patients may experience flu-like symptoms such as fever, chills, fatigue, arthralgia, myalgia, which are generally transient and mild to moderate in severity. Osteonecrosis of the jaw may occur during treatment, so special caution is needed for cancer patients or those receiving dental treatments. Calcium and vitamin D intake must be sufficient before administration and during treatment; hypocalcemia or bone and mineral metabolism disorders must be adequately treated. Patients with poor renal function or taking medications that may affect the kidneys require regular check-ups and monitoring. During the administration of this drug, excessive dental treatment should be avoided, and oral hygiene should be well managed. This drug can rarely cause severe side effects such as ocular inflammation, severe allergic reactions, skin rashes, atypical fractures, so any unusual symptoms should be reported to medical staff immediately. Women who are pregnant or breastfeeding are advised not to use this drug, and safety and efficacy have not been established for children under 18 years of age. In cases of overdose, renal and liver damage may occur, necessitating careful monitoring and appropriate treatment. This drug should not be mixed with calcium-containing solutions or other intravenous medications and should be administered only as an intravenous injection. After use, the syringe and needle 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), angioedema, facial swelling/edema, severe allergic reactions, anaphylactic reaction/shock, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, severe skin adverse reactions, difficulty breathing, respiratory difficulty, exacerbation of asthma, respiratory problems, liver abnormalities (jaundice), multiple organ failure, death, severe neurological symptoms, severely elevated blood pressure associated with severe edema or urinary abnormalities, acute renal failure, vascular abnormalities (thrombophlebitis

Mild side effects

  • Gastritis
  • diarrhea
  • abdominal pain
  • indigestion
  • nausea
  • constipation
  • musculoskeletal pain
  • joint pain
  • muscle pain
  • flu-like illness
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  • fatigue
  • headache
  • rash
  • bone pain
  • weakness
  • injection site reactions
  • urticaria

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

Storage

This medication should be stored in a sealed container to prevent exposure to air, and it is safe to store at a temperature between 1 and 30 degrees Celsius. Proper storage at the correct temperature can maintain the drug's efficacy and stability.

Appearance and packaging

Appearance

This injectable medication is a colorless, transparent solution contained in a colorless, transparent glass prefilled syringe with an attached 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.

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.