Medication info

Bondex Tablet 150 mg (Ibandronic Acid Sodium Hydrate)

Prescription medicationApproval withdrawn
Ingredient · strength
Ibandronate Sodium Monohydrate›Strength being verified
Manufacturer / importer
Korea United Pharm Co., Ltd.
Appearance
White to off-white rectangular film-coated tablet
Packaging
1 tablet/PTP
Approval status
Approval withdrawn

MFDS item code 201307524 · Approved 2013.05.29

This product's status changed to Approval withdrawn on 2023.05.25. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of osteoporosis in postmenopausal women
Who uses it
Adults · Children
Adult dosage
Take 1 tablet once a month on the same morning each month, with plenty of water, at least 1 hour before consuming food, beverages (except water), or other oral medications or dietary supplements (including calcium): - Swallow this medicine with a sufficient amount of water (180-240ml) while standing or sitting upright, and do not lie down for 60 minutes after taking it. - Mineral water may reduce the absorption of this medicine; take it with plain water. - To avoid esophageal ulcers, do not chew or suck the tablet. If the patient forgets to take a dose on the scheduled day: - If 8 days or more remain until the next scheduled dose, take 1 tablet the morning after realizing that the dose was missed, and thereafter take 1 tablet each month on the previously scheduled dosing day. - If 7 days or fewer remain until the next scheduled dose, take 1 tablet on the next scheduled dosing day, and thereafter continue taking 1 tablet each month on the previously scheduled dosing day. - Do not take 2 tablets in the same week. Patients with inadequate dietary intake should supplement with calcium or vitamin D, etc. Patients with hepatic impairment No dose adjustment is necessary. Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment and a creatinine clearance of 30mL/min or greater. Use of this medicine is not recommended in patients with a creatinine clearance of less than 30mL/min, as clinical experience is insufficient. Older adults No dose adjustment is necessary.
Children's dosage
Efficacy and safety in children aged 18 years and younger have not been studied.

Ingredients

Manufacturer
Korea United Pharm Co., Ltd.

Efficacy & effects

Treatment of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This medication is used for the treatment of osteoporosis that occurs in postmenopausal women. Osteoporosis is a condition where bones become weak and are likely to break easily, commonly seen in postmenopausal women. This medication helps in increasing bone density and reducing fracture risk. With consistent use, it effectively treats osteoporosis symptoms by improving bone health.

Dosage and Administration

Adult dosage

Take 1 tablet once a month on the same morning each month, with plenty of water, at least 1 hour before consuming food, beverages (except water), or other oral medications or dietary supplements (including calcium): - Swallow this medicine with a sufficient amount of water (180-240ml) while standing or sitting upright, and do not lie down for 60 minutes after taking it. - Mineral water may reduce the absorption of this medicine; take it with plain water. - To avoid esophageal ulcers, do not chew or suck the tablet. If the patient forgets to take a dose on the scheduled day: - If 8 days or more remain until the next scheduled dose, take 1 tablet the morning after realizing that the dose was missed, and thereafter take 1 tablet each month on the previously scheduled dosing day. - If 7 days or fewer remain until the next scheduled dose, take 1 tablet on the next scheduled dosing day, and thereafter continue taking 1 tablet each month on the previously scheduled dosing day. - Do not take 2 tablets in the same week. Patients with inadequate dietary intake should supplement with calcium or vitamin D, etc. Patients with hepatic impairment No dose adjustment is necessary. Patients with renal impairment No dose adjustment is necessary for patients with mild or moderate renal impairment and a creatinine clearance of 30mL/min or greater. Use of this medicine is not recommended in patients with a creatinine clearance of less than 30mL/min, as clinical experience is insufficient. Older adults No dose adjustment is necessary.

Children's dosage

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

Precautions

This medication should not be used in certain patients. For instance, patients who are allergic to this medication or its ingredients, patients with untreated hypocalcemia, patients who cannot remain upright or standing for more than 60 minutes, patients with esophageal dysfunction that hinders food passage, and patients with genetic lactose intolerance issues should not receive this medication. Patients with severe renal impairment should use this medication with caution, as significantly decreased kidney function may increase the risk of side effects. During the use of this medication, side effects such as dyspepsia, nausea, abdominal pain, diarrhea, headache, muscle pain, joint pain, rashes, etc., may occur. Some patients may temporarily experience symptoms similar to influenza, including fever, chills, fatigue, and bone pain. Esophageal issues such as esophagitis, esophageal ulcers, or dysphagia may occur, so patients must remain upright or standing for at least 60 minutes after taking the medication, and should immediately discontinue use and consult a doctor if symptoms like difficulty swallowing, chest pain, or heartburn occur. Rare reports of serious side effects such as osteonecrosis of the jaw necessitate a thorough oral examination before dental treatments, and it's advisable to avoid excessive dental procedures during treatment. The absorption of this medication may be hindered when taken with food, milk, or calcium supplements, so no other foods or medications should be consumed for at least 1 hour after taking it. The safety of this medication for pregnant or breastfeeding women has not been established, so its use is not recommended. No dosage adjustment is needed for the elderly; however, safety and effectiveness in children under 18 have not been established. In cases of overdose, gastrointestinal disturbances or hypocalcemia may occur. Immediate medical attention should be sought, and the patient should be kept upright and not induce vomiting. This medication must be stored out of the reach of children and unused medication should be disposed of properly to prevent environmental contamination.

Side effects

Dyspepsia, nausea, abdominal pain, diarrhea, bloating, gastroesophageal reflux disease, headache, influenza-like illness, fatigue, myalgia, arthralgia, rash, gastritis, esophagitis, muscle cramps, musculoskeletal pain, musculoskeletal stiffness, dysphagia, vomiting, esophageal ulcer, stricture, dizziness, low back pain, duodenitis, hypersensitivity reactions, angioedema, facial swelling, urticaria, uveitis, scleritis, osteonecrosis of the jaw and external ear, anaphylactic reaction, shock, exacerbation of asthma, Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis, atypical femoral and intertrochanteric fractures, visual disturbances, asthenia, pruritus

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

Storage

This medication can be sensitive to air and moisture, hence it should be stored in a tightly sealed container. A storage temperature of between 1 to 30 degrees Celsius is recommended to maintain the medication's effectiveness.

Appearance and packaging

Appearance

White to off-white rectangular film-coated tablet

Package unit

1 tablet/PTP

Same-ingredient medicines

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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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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.