Medication info

Evans Injection (Sodium Ibandronate Dihydrate)

Prescription medicationInjections정맥Expired
Ingredient · strength
Ibandronate Sodium Monohydrate›3.375mg / 1 prefilled syringe
Manufacturer / importer
(유)한풍제약
Appearance
This injection is a colorless and transparent solution contained in a colorless, transparent glass prefilled syringe, supplied with a single-use needle.
Packaging
3 milliliters/prefilled syringe
Approval status
Expired

MFDS item code 201905932 · Notified 2019.08.22

This product's status changed to Expired on 2024.08.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

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
(유)한풍제약

Efficacy & effects

Improvement of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This medication is used for the treatment of osteoporosis that may occur in postmenopausal women. Osteoporosis is a condition where the strength of bones decreases, leading to an increased risk of fractures. This medication helps strengthen bones and maintain bone density, reducing the risk of fractures. Therefore, it is an appropriate treatment for those experiencing difficulties with bone health due to menopause.

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 great caution is required as administering it intra-arterially or around veins may cause tissue damage. Patients who are allergic to this drug or its components, or have untreated hypocalcemia, should not use this medication. During treatment with this drug, gastrointestinal symptoms such as gastritis, diarrhea, abdominal pain, dyspepsia, nausea, constipation, as well as musculoskeletal symptoms such as musculoskeletal pain, arthralgia, and myalgia may occur. Moreover, flu-like symptoms such as fever, chills, fatigue, arthralgia, and myalgia may temporarily occur, most often resolved without interruption of treatment at mild to moderate levels. Among patients receiving this drug, rare reports of skin rash, headaches, and fatigue have been recorded. Rarely, bisphosphonate therapy may lead to osteonecrosis of the jaw, particularly in cancer patients or those receiving dental treatment. It is advisable to undergo oral examination before receiving this drug and to avoid excessive dental procedures during treatment. Osteonecrosis of the external auditory canal has also been reported rarely; consult a physician if there is any ear pain or discharge. During osteoporosis treatment, severe bone, joint, or muscle pain may arise, and it is crucial to inform healthcare providers immediately if such symptoms occur. Patients using this drug for an extended period may experience atypical femoral fractures, so immediate evaluation is essential if pain arises in the thigh or groin. When using this drug, adequate intake of calcium and vitamin D is necessary, and usage should be considered after treatment in cases of hypocalcemia or bone metabolism disorders. This drug is primarily excreted through the kidneys without being metabolized in the liver, so patients with poor kidney function should undergo regular monitoring. Its safety has not been established during pregnancy or breastfeeding; therefore, avoiding its use is recommended. In cases of overdose, renal and liver function should be closely monitored, and appropriate treatment should be administered if hypocalcemia or other electrolyte imbalances occur. This medication should not be mixed with calcium-containing solutions and must only be administered intravenously. After use, the injection needle and syringe should not be reused and should be safely disposed of.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, facial swelling/edema, severe allergic reactions (anaphylaxis, shock), Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, angioedema, respiratory distress, difficulty breathing, severe cutaneous adverse reactions (severe rash, blistering, skin peeling, mucosal pain), headaches (sudden and very severe headaches, thunderclap headaches), paralysis, altered consciousness, visual disturbances, multiple organ failure, death, osteonecrosis, atypical femoral fractures

Mild side effects

Gastritis, diarrhea, abdominal pain, dyspepsia, nausea, constipation, musculoskeletal pain, arthralgia, myalgia, flu-like symptoms (including arthralgia, myalgia, fever, chills, fatigue, nausea, loss of appetite, bone pain), fatigue, headache, rash, back pain, weakness, injection site reactions, phlebitis/thrombophlebitis, sensory impairment, dizziness, insomnia, anxiety, tinnitus, hearing loss, hypothyroidism, lipoma, ocular bleeding, heart failure, urinary disorders,

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

Storage

This medication should be stored in a sealed container to prevent contact with air and kept at room temperature between 1°C and 30°C. Proper storage maintains the drug's efficacy and safety.

Appearance and packaging

Appearance

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

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.

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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.