Medication info

Amikabon Injection (Ibandronate Sodium Monohydrate)

Prescription medicationInjections정맥
Ingredient · strength
Ibandronate Sodium Monohydrate›3.375mg / 1 prefilled syringe
Manufacturer / importer
(주)휴온스
Appearance
An injection that appears as a colorless, transparent solution in a colorless, transparent glass prefilled syringe with a single-use syringe needle attached.
Packaging
3mL/glass prefilled syringe x 1
Approval status
Active

MFDS item code 201402517 · Notified 2014.06.03 · Insurance code 670606941

Summary

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

Ingredients

Manufacturer
(주)휴온스

Efficacy & effects

Improvement of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

This medication is used for the treatment of osteoporosis in postmenopausal women. It helps increase bone density and reduce the risk of fractures. Therefore, it is effective in preventing fractures caused by osteoporosis.

How it is given

Adult administration

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

Precautions

This medication must be administered through intravenous injection. Care must be taken as administration into the arteries or around the veins may cause damage to the surrounding tissues. Individuals allergic to this medication or its components should not use it. Additionally, patients with untreated hypocalcemia, where blood calcium levels are low, should not take this medication. Using this medication may lead to gastrointestinal adverse reactions such as gastritis, diarrhea, abdominal pain, indigestion, nausea, and constipation. Musculoskeletal adverse reactions may include myalgia, arthralgia, and musculoskeletal pain. Some patients may experience influenza-like symptoms, including arthralgia, myalgia, fever, chills, fatigue, nausea, loss of appetite, and bone pain. These symptoms are usually transient and mild, resolving without treatment. Long-term use of this medication may rarely result in osteonecrosis of the jaw or osteonecrosis of the external auditory canal. Patients with cancer or those undergoing chemotherapy, radiation therapy, steroid treatment, or who have poor oral hygiene are at greater risk, thus a dental examination is required prior to administration. During the administration of this medication, it is advisable to avoid excessive dental treatment, and if osteonecrosis is suspected, immediate consultation with medical personnel is necessary. Additionally, this medication may temporarily lower serum calcium levels, so patients with hypocalcemia or bone and mineral metabolism disorders must be treated prior to administration. Sufficient intake of calcium and vitamin D is important, and supplements should be taken if necessary. This medication has been associated with atypical fractures in some patients, such as in the femur and humerus; therefore, if persistent pain in the thigh or groin occurs, assessment should be undertaken. The safety of this medication in pregnant or breastfeeding women has not been established, so it is advisable not to use it. This medication is primarily eliminated through the kidneys and does not undergo metabolism in the liver, so patients with impaired renal function require regular monitoring. In case of overdose, there may be toxicity to the kidneys and liver, necessitating careful monitoring, and appropriate treatment should be provided if electrolyte abnormalities like hypocalcemia occur. This medication has low interaction risks with other medications, but administration should be in accordance with a physician's instructions, and its effects on driving or operating machinery are not known. Finally, this medication should not be mixed with solutions that contain calcium or other drugs, and must be administered only via 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

  • Hives, angioedema, facial swelling → severe allergic reactions
  • Severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucous membranes → severe skin reactions
  • Shortness of breath or difficulty breathing, worsening asthma, dyspnea → respiratory issues
  • Yellowing of the skin or eyes (jaundice) → liver issues (jaundice)
  • Multiple organ failure, death → severe edema or urinary issues
  • Severe headache, seizures, confusion, visual disturbances

Mild side effects

  • Gastritis
  • diarrhea
  • abdominal pain
  • indigestion
  • nausea
  • constipation
  • musculoskeletal pain
  • arthralgia
  • myalgia
  • influenza-like illness
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  • fatigue
  • headache
  • rash
  • bone pain
  • weakness
  • injection site reactions
  • dizziness
  • fever
  • hypothyroidism
  • peripheral neuropathy
  • hearing loss
  • skin peeling
  • insomnia
  • anxiety
  • tinnitus
  • lipoma
  • eye hemorrhage
  • heart failure
  • urinary disorders
  • hematuria

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 or moisture, and it is best stored at room temperature between 1 to 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

An injection that appears as a colorless, transparent solution in a colorless, transparent glass prefilled syringe with a single-use syringe needle attached.

Package unit

3mL/glass prefilled syringe x 1

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.