Medication info

Ibandronate Sodium Injection (Ibandronate Sodium Monohydrate)

Prescription medicationExpired
Ingredient · strength
Ibandronate Sodium Monohydrate›Strength being verified
Manufacturer / importer
(주)비보존제약
Appearance
This is an injectable solution that is colorless and transparent, contained in a colorless and transparent glass prefilled syringe, with a single-use injection needle attached.
Packaging
3mL x 1 vial
Approval status
Expired

MFDS item code 201802102 · Notified 2018.05.18

This product's status changed to Expired on 2023.05.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of postmenopausal osteoporosis
Who uses it
Adults
Adult dosage
Administer 3mg as an intravenous injection every 3 months over 15 to 30 seconds.

Ingredients

Manufacturer
(주)비보존제약

Efficacy & effects

Improvement of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

This medication is used to treat osteoporosis in postmenopausal women. After menopause, women tend to lose bone density and suffer from weak bones due to decreased estrogen levels, which can increase the risk of fractures. This medication helps prevent bone loss and increase bone density to reduce the risk of fractures. With regular administration, it helps maintain bone health and allows for more stable daily living. Therefore, it is used for the treatment of osteoporosis in postmenopausal women.

Dosage and Administration

Adult dosage

Administer 3mg as an intravenous injection every 3 months over 15 to 30 seconds.

Precautions

This medication must be administered intravenously; caution is necessary to avoid tissue damage if administered intramuscularly or around the veins. It should not be used in patients with allergies to this drug 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. Musculoskeletal side effects may include myalgia, arthralgia, and musculoskeletal pain; systemic and skin reactions such as flu-like symptoms, fatigue, headache, and rash have also been reported. Initial administration may temporarily cause flu-like symptoms, although these are usually mild and resolve without treatment. This medication can temporarily lower serum calcium levels, so hypocalcemia or bone and mineral metabolism disorders should be treated before administration, and calcium and vitamin D intake must be adequate. Patients undergoing dental treatment or with a risk of osteonecrosis of the jaw should undergo an oral examination before administration and should ideally avoid dental procedures during treatment. Long-term use of this medication may increase the risk of atypical femoral fractures, so immediate consultation with healthcare professionals is warranted if experiencing thigh or groin pain. Since this medication is not metabolized in the liver and is primarily excreted through the kidneys, patients with impaired renal function require regular monitoring. It is recommended that pregnant or nursing women avoid this medication, and the safety and efficacy in pediatric patients under 18 years old have not been established. Overdose may cause toxicity to the kidneys and liver, necessitating appropriate treatment for hypocalcemia and other conditions. This medication should not be mixed with calcium-containing solutions or other intravenous medications and must be administered intravenously as a single agent. After use, do not reuse the injection needle and syringe; discard them in a safe container and store out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, facial swelling/edema, anaphylaxis/shock, exacerbation of asthma, severe allergic reactions, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, severe skin adverse reactions, osteonecrosis (jaw and external ear canal), atypical femoral fractures, acute renal failure, multiple organ failure, death, dyspnea, respiratory problems

Mild side effects

  • Gastritis
  • diarrhea
  • abdominal pain
  • dyspepsia
  • nausea
  • constipation
  • musculoskeletal pain
  • arthralgia
  • myalgia
  • flu-like illness
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  • fatigue
  • headache
  • rash
  • bone pain
  • weakness
  • injection site reactions
  • back pain
  • dizziness
  • fever
  • hypothyroidism
  • peripheral neuropathy
  • hearing loss
  • skin loss
  • insomnia
  • anxiety
  • tinnitus
  • lipoma
  • urination disorders
  • hematuria
  • benign gastrointestinal neoplasms
  • tooth pain
  • hyperventilation
  • cough
  • laryngitis
  • vaginitis
  • menopausal symptoms

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, ideally at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

This is an injectable solution that is colorless and transparent, contained in a colorless and transparent glass prefilled syringe, with a single-use injection needle attached.

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.

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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.