Medication info
Ibandronate Sodium Hydrate Tablets

Ibandronate Sodium Hydrate Tablets

Prescription medicationTablet경구
Ingredient · strength
Ibandronate Sodium Monohydrate›168.75mg / 1 tablet
Manufacturer / importer
대화제약(주)
Appearance
White to almost white oblong film-coated tablets
Packaging
1 tablet per blister
Approval status
Active

MFDS item code 201206148 · Approved 2012.07.16 · Insurance code 645604140

Summary

Main use
Improvement of osteoporosis in postmenopausal women
Who takes it
Adults · Children
Adult dose
Take 1 tablet once a month regularly on the same morning at least 1 hour prior to consuming food, drinks (excluding water), or other oral medications or dietary supplements (including calcium) with a sufficient amount of water. - The tablet should be swallowed upright or in a sitting position with a sufficient amount (180-240ml) of water, and you should not lie down for 60 minutes after taking it. - Carbonated mineral water may reduce the absorption of this medication.
Child dose
Efficacy and safety in children under 18 years have not been studied.

Ingredients

Manufacturer
대화제약(주)

Efficacy & effects

Improvement of osteoporosis in postmenopausal women

  • 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 morning at least 1 hour prior to consuming food, drinks (excluding water), or other oral medications or dietary supplements (including calcium) with a sufficient amount of water. - The tablet should be swallowed upright or in a sitting position with a sufficient amount (180-240ml) of water, and you should not lie down for 60 minutes after taking it. - Carbonated mineral water may reduce the absorption of this medication.

Child dose

Efficacy and safety in children under 18 years have not been studied.

Precautions

This medication should not be used in certain patients. Patients who are allergic to this drug or its components, those with untreated hypocalcemia, patients who cannot remain sitting or standing upright for long durations, those with esophageal dysfunction making it difficult for food to pass, and patients with genetic issues like lactose intolerance should not take this medication. In patients with severe renal failure, this medication should be used cautiously and physician evaluation is required. Gastrointestinal side effects may occur, such as dyspepsia, nausea, abdominal pain, and diarrhea. Symptoms like headache, muscle pain, fatigue, and rash have also been reported. Particularly, this drug may irritate the esophagus, leading to difficulty swallowing, pain, chest pain, or heartburn. If such symptoms occur, discontinue the medication immediately and consult a physician. It is important to take this drug with calcium and vitamin D. Since absorption may be hindered if taken with milk, calcium supplements, antacids, iron supplements, etc., it is advised to not eat or take other medications for at least 1 hour after taking this medication. Osteonecrosis of the jaw is a serious side effect that can occur rarely, hence dental treatment should be discussed with your doctor beforehand, and excessive dental work should be avoided during treatment. This medication is not recommended for use in women who are pregnant or breastfeeding. Long-term use may rarely lead to atypical femoral fractures; therefore, if there is pain in the thigh or groin, a visit to the hospital should be made for examination without delay. This medication has not been proven safe or effective in children, therefore it should not be used. In case of overdose, gastrointestinal disturbances or hypocalcemia may occur, thus exact dosing should be adhered to and healthcare professionals should be contacted immediately in case of any side effects. Finally, this medication should be kept out of reach of children, and expired medicines should be disposed of properly to prevent environmental pollution.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, anaphylactic reactions/shock, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in the mucous membranes of mouth/eyes, Stevens-Johnson syndrome, erythema multiforme, vesicular dermatitis, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities along with cough and fever, yellowing of the skin or eyes (jaundice), general malaise, acute renal failure

Mild side effects

  • Dyspepsia
  • nausea
  • abdominal pain
  • diarrhea
  • bloating
  • gastroesophageal reflux disease
  • headache
  • influenza-like illness
  • fatigue
  • muscle pain
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  • joint pain
  • rash
  • dizziness
  • back pain
  • difficulty swallowing
  • vomiting
  • gastritis
  • esophagitis
  • muscle spasms
  • musculoskeletal pain
  • musculoskeletal stiffness
  • pruritus
  • weakness
  • sensory disturbances in the eyes

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White to almost white oblong film-coated tablets

Package unit

1 tablet per blister

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.