The action of Ibandronic Acid on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronic Acid inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.
Ibandron® Tablet: Each film coated tablet contains Ibandronate Sodium INN equivalent to Ibandronic Acid 150 m
Ibandron® is indicated for the treatment and prevention of osteoporosis in postmenopausal women. Ibandron® increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.
The dose of Ibandron® is one 150 mg tablet once monthly on the same date of each month.
The following points should be ensured when taking Ibandron® :
1. One Ibandron® 150 mg Tablet should be taken once a month, preferably on the same date of each month.
2. In case, a monthly dose is missed, patient can take the tablet within next 21 days. Patient should then return to take their dose once a month on the actually scheduled date.
3. After rising in the morning, patient should take Ibandron® in an empty stomach with a full glass of plain water while sitting or standing in an upright position.
4. Fruit juice, milk or any other liquid except water cannot be taken with Ibandron® .
5. After taking Ibandron® , patient can usually sit or walk around but must not lie down or take any food or liquid for 1 hour
Ibandronic Acid is contraindicated in any patient who has shown a hypersensitivity reaction to the drug or to any of the excipients, hypocalcemia and inability to stand or sit upright for at least 1 hour.
Hypocalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting therapy with Ibandronic Acid. Adequate intake of calcium and vitamin D is important in all patients. It is not recommended for use in patients with severe renal impairment (creatinine clearance <30 mL/min).
The most common side effects include back pain, allergic reaction, dyspepsia, diarrhea, nausea, vomiting, gastritis, myalgia, headache, dizziness, vertigo etc.
Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron), including milk, food, and antacids are likely to interfere with absorption of Ibandronic Acid.It should be taken at least 1 hour before any oral medications, including medications containing multivalent cations (such as antacids, supplements or vitamins). Also, patients should wait at least 1 hour after dosing before taking any other oral medications. Caution should also be exercised in the concomitant use of aspirin or NSAIDs with Ibandronic Acid.
Use in pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.
Use in nursing mothers: It is not known whether it is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when it is administered to a nursing woman.
Pediatric use: Safety and effectiveness in pediatric patients have not been established. Geriatric use: No overall differences in effectiveness or safety were observed between elderly patients and younger patients. Therefore, no dosage adjustment is necessary in the elderly.
Hepatic Insufficiency: No studies have been performed to assess the pharmacokinetics of Ibandronic Acid in patients with hepatic impairment because Ibandronic Acid is not metabolized in the human liver.
Renal Insufficiency: It is not recommended for use in patients with severe renal impairment (creatinine clearance of < 30 mL/min).
Ibandron® Tablet: Each box contains 1 tablet in alu-alu blister pack.
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