HEALTHCARE PHARMACEUTICALS LTD.
Ibandronic Acid is indicated for the: Treatment of osteoporosis in women (specially postmenopausal) Prevention of osteoporosis in women (specially postmenopausal) Prevention and treatment of osteoporosis in men
Osteoporosis causes the body to remove more bone than it replaces. This means that bones get weaker. Weak bones are more likely to break. Osteoporosis is a bone disease that is quite common in women after menopause. It also affects men. At first, osteoporosis has no symptoms, but people with osteoporosis may develop loss of height and are more likely to break (fracture) their bones, especially the back (spine), wrist, and hip bones. Osteoporosis can be prevented, and with proper therapy it can be treated. Ibandronic acid inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to a progressive gain in bone mass. The absorption of ibandronate occurs in the upper gastrointestinal tract. After absorption, ibandronate either rapidly binds to bone or is excreted unchanged into urine.
Intravenous (Adult)- Hypercalcaemia of malignancy: 2-4 mg as a single infusion over 2 hr. Max: 6 mg. Postmenopausal osteoporosis: 3 mg by inj over 15-30 seconds once every 3 mth. Missed dose: Give inj as soon as possible; then re-schedule next inj 3 mth from this inj; should not be given more frequently than once every 3 mth. Prophylaxis of skeletal events in patients with breast cancer and bone metastases: 6 mg by infusion over at least 15 min 3-4 wkly. Oral (Adult)- Prophylaxis of skeletal events in patients with breast cancer and bone metastases: 50 mg tablet daily Postmenopausal osteoporosis, Prophylaxis of postmenopausal osteoporosis: 150 mg tablet once-a-month on the same date each month, alternatively, 2.5 mg daily. Missed once-monthly dose: If next scheduled dose is >7 days away: Take dose the next morning and return to original schedule; if next dose is <7 days away: Wait until the next scheduled dose; 2 tabs must not be taken w/in the same wk.Oral Administrations- The tablet should preferably be taken on the same date each month. To maximize absorption and clinical benefit, Ibandronic acid should be taken at least 60 minutes before the first food or drink or any oral medication or supplementation (including calcium). To facilitate delivery to the stomach and reduce the potential for esophageal irritation, Ibandronic acid should be swallowed whole with a full glass of plain water. The tablet should not be chewed or sucked. Patients should not lie down for 60 minutes after takin Ibandronic acid . However, patients can sit down, walk, exercise or do the regular activities. If the once-monthly dose is missed and the patient8s next scheduled Ibandronic acid day is more than 7 days away, the patient should be instructed to take one Ibandronic acid 150 mg tablet in the morning following the date that it is remembered. Then the patient should return to the original schedule. If the next scheduled dose is within 7 days, patients should wait until the next dose? and then continue taking one tablet once-a-month as originally scheduled. Two 150 mg tablets should not be taken within the same week.
It is likely that products containing calcium and other multivalent cations (such as aluminium, magnesium, iron) including milk, food, and antacids are likely to interfere with absorption of ibandronate. Therefore, patients must wait 60 minutes after taking Ibandronic Acid before taking other oral medications.
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.
In a one-year study in patients with osteoporosis treated with ibandronate 150 mg once monthly, the majority of adverse drug reactions observed, were mild to moderate in intensity, and most cases did not lead to cessation of therapy. Common adverse reactions include dyspepsia, nausea, diarrhoea, constipation, abdominal pain, myalgia, headache, mild flu-like symptoms, dizziness, skin rash.
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.
No specific information is available on the treatment of overdose with ibandronic acid. However, oral overdose may result in hypocalcemia, hypophosphatemia, upset stomach, dyspepsia, esophagitis, gastritis. Milk or antacids should be given to bind Ibandronic Acid
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.
Store in a cool and dry place below 308 C. Protect from light and moisture.