Medication info
Osmac Tablet 150 mg (Ibandronic Acid Sodium Monohydrate)

Osmac Tablet 150 mg (Ibandronic Acid Sodium Monohydrate)

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

MFDS item code 201205499 · Approved 2012.06.12 · Insurance code 670701640

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 day in the morning, at least 1 hour before eating food, drinking (excluding water), or taking other oral medications or dietary supplements (including calcium) with a sufficient amount of water. - It should be swallowed upright or in a sitting position with a sufficient amount (180-240ml) of water, and lying down is prohibited for 60 minutes after taking it. - Mineral water may reduce the absorption of this medication.
Child dose
Efficacy and safety in children under 18 has not been studied.

Ingredients

Manufacturer
초당약품공업(주)

Efficacy & effects

Improvement of osteoporosis in postmenopausal women

  • Osteoporosis
View approved original text

This medication is used for the treatment of osteoporosis in postmenopausal women. It helps to increase bone density, reduce the risk of fractures, and maintain bone health.

How to take

Adult dose

Take 1 tablet once a month regularly on the same day in the morning, at least 1 hour before eating food, drinking (excluding water), or taking other oral medications or dietary supplements (including calcium) with a sufficient amount of water. - It should be swallowed upright or in a sitting position with a sufficient amount (180-240ml) of water, and lying down is prohibited for 60 minutes after taking it. - Mineral water may reduce the absorption of this medication.

Child dose

Efficacy and safety in children under 18 has not been studied.

Precautions

This medication should not be used in certain patients. For instance, patients with allergies to this medication or its components, untreated hypocalcemia, those who cannot sit or stand upright for more than 60 minutes, patients with esophageal difficulties that hinder food intake, and those with lactose intolerance or certain metabolic disorders should not take it. Caution is advised when using this medication in patients with severe renal impairment, especially if kidney function is significantly diminished. While taking this medication, side effects such as dyspepsia, nausea, abdominal pain, diarrhea, headache, muscle pain, joint pain, and rash may occur. Occasionally, influenza-like symptoms such as fever, chills, fatigue, and muscle pain may appear temporarily. This medication can irritate the gastrointestinal mucosa, so patients with gastritis or esophageal conditions should take special care, remaining upright for at least 60 minutes after taking it. If symptoms like difficulty swallowing, pain when swallowing, chest pain, or heartburn occur, stop taking the medication immediately and consult a doctor. As a bisphosphonate, there have been rare reports of serious side effects like osteonecrosis of the jaw, so it is important to have a dental examination and treatment plan in place if dental treatment is needed. It is advisable to avoid excessive dental treatment while on this medication. This medication may interfere with absorption if taken with food or products containing calcium, aluminum, magnesium, iron, etc., so it is required to avoid other foods or medications for at least 1 hour after taking it. It is recommended that women who are pregnant or breastfeeding do not use this medication, and the safety for children under 18 has not been established. In case of overdose, gastrointestinal disturbances or hypocalcemia may occur, so it is important to adhere to the prescribed dosage, and if any adverse symptoms appear, seek immediate medical advice. The effects of this medication on driving or operating machinery have not been studied, so caution should be taken if any unusual symptoms occur after taking it. Finally, this medication should be stored out of reach of children, and unused medication should be disposed of properly to prevent environmental pollution.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema, facial swelling), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities associated with coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances

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
  • muscle cramps
  • musculoskeletal pain
  • musculoskeletal stiffness
  • rash
  • difficulty swallowing
  • vomiting
  • gastritis
  • esophagitis
  • dizziness
  • low back pain
  • duodenitis
  • eye disturbances
  • weakness
  • pruritus

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

Storage

This medication may be sensitive to air or moisture, so it must be stored in a tightly sealed container. Additionally, to maintain its effectiveness, it is important to store it at room temperature, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White to almost white oblong film-coated tablet

Package unit

1 tablet (1 tablet/PTP)

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.