Medication info
Proivan Tablet 150 mg (Ibandronic Acid Monohydrate)

Proivan Tablet 150 mg (Ibandronic Acid Monohydrate)

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

MFDS item code 201207294 · Approved 2012.10.18 · Insurance code 657202450

Summary

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

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Improvement of postmenopausal osteoporosis

  • Osteoporosis
View approved original text

This medication is used to prevent and treat osteoporosis that may occur in postmenopausal women. It helps to increase bone density, reduce the risk of fractures, and improve bone health. Consistent use can improve complications resulting from osteoporosis.

How to take

Adult dose

Take 1 tablet regularly once a month on the same day in the morning before consuming food, beverages (excluding water), or other oral medications or dietary supplements (including calcium) with a sufficient quantity of water at least 1 hour prior. - This medication should be swallowed with a sufficient amount (180-240 mL) of water while standing or sitting upright, and lying down for 60 minutes after taking it is prohibited. - Mineral water may decrease 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 by certain patients. For example, individuals allergic to this medication or its components, patients with untreated hypocalcemia, those unable to sit or stand upright for at least 60 minutes, individuals with esophageal function problems that impede swallowing, and those with lactose intolerance or certain genetic metabolic disorders should not take this medication. In cases of severe renal impairment, the administration of this medication should be done with caution, following a doctor's instructions. Adverse effects such as gastrointestinal discomfort, nausea, abdominal pain, diarrhea, headache, muscle pain, joint pain, and rash may occur upon taking this medication. Particularly during initial administration, flu-like symptoms may temporarily appear, so caution is advised. Severe esophageal issues such as esophagitis, esophageal ulcers, and esophageal erosion may arise, necessitating that patients remain upright or standing for at least 60 minutes after taking this medication. If difficulty swallowing or chest pain occurs, take this medication immediately and consult a doctor. Bisphosphonate medications may cause serious side effects such as osteonecrosis of the jaw, so consult your doctor before any dental treatments, and avoid excessive dental treatment while taking this medication. Additionally, this medication may have impaired absorption when taken with food, calcium, aluminum, magnesium, iron, or other components, so other medications or foods should not be consumed for at least 1 hour after taking this medication. It is safest for pregnant or nursing women to avoid this medication, and safety and efficacy have not been established for children under 18 years of age. In case of overdose, gastrointestinal disturbances or hypocalcemia may occur, so strict adherence to the prescribed dosage is essential, and medical attention should be sought immediately if symptoms arise. Lastly, keep this medication out of the reach of children and dispose of expired medications properly to avoid environmental harm.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, angioedema, facial edema → severe allergic reaction
  • Uveitis, scleritis, and other eye inflammations
  • Stevens-Johnson syndrome, erythema multiforme, bullous dermatitis → severe skin reactions
  • Osteonecrosis of the jaw, osteonecrosis of the external auditory canal → severe swelling or abnormal urination
  • Anaphylactic reactions/shock → severe allergic reaction
  • Asthma exacerbation → respiratory issues
  • Severe esophagitis, esophageal ulcers, esophageal erosions, bleeding, esophageal strictures, perforation
  • Atypical fractures

Mild side effects

  • Dyspepsia
  • nausea
  • abdominal pain
  • diarrhea
  • flatulence
  • gastroesophageal reflux disease
  • headache
  • flu-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
  • abnormal sensations in the eyes
  • weakness
  • itching

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is essential to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness for a long period.

Appearance and packaging

Appearance

White to almost white rectangular film-coated tablet

Package unit

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.