Medication info

Ibandronate Sodium Hydrate Tablets

Prescription medicationTablet경구Expired
Ingredient · strength
Ibandronate Sodium Monohydrate›168.75mg / 1 tablet
Manufacturer / importer
동성제약(주)
Appearance
White to almost white oblong film-coated tablets
Packaging
1 tablet/VTB
Approval status
Expired

MFDS item code 201908267 · Approved 2019.12.05

This product's status changed to Expired on 2024.12.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of postmenopausal osteoporosis
Who takes it
Adults · Children
Adult dose
Take 1 tablet once a month regularly on the same day in the morning with a sufficient amount of water at least 1 hour before taking food, beverages (excluding water), or other oral medications or dietary supplements (including calcium). - This medication must be swallowed with a sufficient amount (180-240ml) of water while standing or sitting upright, and do not lie down for 60 minutes after taking it. - Mineral water may hinder the absorption of this medication.
Child dose
Efficacy and safety in pediatric patients under 18 have not been established.

Ingredients

Manufacturer
동성제약(주)

Efficacy & effects

Improvement of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

Used for the treatment of osteoporosis in postmenopausal women.

How to take

Adult dose

Take 1 tablet once a month regularly on the same day in the morning with a sufficient amount of water at least 1 hour before taking food, beverages (excluding water), or other oral medications or dietary supplements (including calcium). - This medication must be swallowed with a sufficient amount (180-240ml) of water while standing or sitting upright, and do not lie down for 60 minutes after taking it. - Mineral water may hinder the absorption of this medication.

Child dose

Efficacy and safety in pediatric patients under 18 have not been established.

Precautions

This medication may not be suitable for certain patients. For instance, it should not be administered to patients with allergies to this medication or its ingredients, untreated hypocalcemia, patients who cannot sit or stand upright for more than 60 minutes, and those with esophageal dysfunction causing difficulty in swallowing food. Additionally, patients with genetic disorders that prevent lactose breakdown should not take this medication. Caution is advised for patients with severely impaired kidney function. This medication can cause gastrointestinal side effects, including dyspepsia, nausea, abdominal pain, diarrhea, and in some cases, serious issues such as esophagitis or esophageal ulcers, so immediate consultation with a doctor is necessary if there is difficulty swallowing or chest pain after taking it. Symptoms such as myalgia, arthralgia, fatigue, and headache have also been reported, and rarely, skin rashes, allergic reactions, or ocular inflammation may occur. If severe bone, joint, or muscle pain happens while taking this medication, notify healthcare personnel immediately. Taking this medication with calcium, milk, antacids, etc., may impede absorption, so it is crucial not to eat other foods or medications for 1 hour after taking it. Pregnant or breastfeeding women are advised against using this medication, and its efficacy and safety have not been established in children under 18. Before taking this medication, hypocalcemia or bone and mineral metabolic disorders must be treated first, and adequate calcium and vitamin D intake is necessary. Also, cases of osteonecrosis of the jaw have been reported rarely, so if dental treatment is required, consult a doctor beforehand. Follow the prescribed method and dosage strictly, and consult medical personnel immediately if symptoms worsen or adverse reactions occur. This medication should be kept out of the reach of children, and unused medication should be disposed of properly to prevent environmental harm.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, facial edema, hypersensitivity reactions, anaphylactic reactions/shock, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, uveitis, scleritis, episcleritis, esophageal ulcers or strictures, osteonecrosis of the jaw, osteonecrosis of the external auditory canal

Mild side effects

  • Dyspepsia
  • nausea
  • abdominal pain
  • diarrhea
  • bloating
  • gastroesophageal reflux disease
  • headache
  • influenza-like illness
  • fatigue
  • myalgia
Show 14 more
  • arthralgia
  • muscle cramps
  • musculoskeletal pain
  • musculoskeletal rigidity
  • rash
  • difficulty swallowing
  • vomiting
  • gastritis
  • esophagitis
  • dizziness
  • low back pain
  • ocular paresthesia
  • asthenia
  • pruritus

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The storage temperature should be kept between 1 to 30 degrees Celsius, which helps maintain the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

White to almost white oblong film-coated tablets

Package unit

1 tablet/VTB

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.