Ibandronic acid @ Bisphosphanates- (FDC- List )- (May 2004)
Drug Name:Ibandronic acid @ Bisphosphanates- (FDC- List )- (May 2004)
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Interaction with Food
Pregnancy and lactation
Drug Interaction:
Patients must wait 60 minutes after taking ibandronic acid, before taking other oral medications viz, calcium supplements, antacids, and oral medications containing multivalent cations such as aluminium, magnesium and iron
No potential interactions have been demonstrateed with tamoxifen or hormone replacement therapy (estrogen) in postmenopausal women.
No dosage adjustment is required when ibandronic acid is administered with H2 antagonists (ranitidine) or other drugs which increase gastric pH. In relation to disposition, no drug interactions of clinical significance are considered likely since ibandronic acid does not inhibit the major human hepatic P450 isoenzymes
Plasma protein binding is low at therapeutic concentrations and ibandronic acid is thefore unlikely to displace other drugs.
Indication:
Adverse Reaction:
Majority of adverse reactions weree mild to moderate intensity and in most cases did not lead to cessation of therapy
Following adverse reactions in more than 1% of patients treated with 150mg monthly. Abdominal pain, diarrhea, headache, influenza like illness, myalgia, and rash
Contra-Indications:
Contraindicated in patients with known hypersensitivity to ibandronic acid or exceipients and in patients with uncorrected hypocalcemia
Preexisting hpocalcemia needs to be corrected before initiating therapy.
Precautions
Hypercalcemia and other disturbances of bone and mineral metabolism should be effectively treated before starting therapy Bisphosphonates have been associated with dysphagia, esophagitis and esophageal gastric ulcers.
Excercise caution during concomittant medication of NSAIDs and ibandrionic acid, as both are associted with gastrointestinal irritation.
Osteonecrosis of jaw ONJ has been reported in patients treated with bisphosphanates mostly in patients treated intravenously than in orally treated patients.
For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. There are no data available to suggest whether discontinuation of bisphosonates therapy, reduces the risk of ONJ
Dosages/ Overdosage Etc:
Indication-
Postmenopausal osteoporosis
Dosage-
One 150mg of ibandronic acid film coated tablet once a month, upon rising, swallowed whole with a glass of water , 60 mins. before food, drink, or other oral medications Patient to remain upright for 60 mins after dose
Patient Information:
One tablet to be taken one per calender month upon rising, swallowed whole with a glass of water , 60 mins. before food, drink, or other oral medications
Patient to remain upright for 60 mins after dose
Pharmacology/ Pharmacokinetics:
Pharmacology
Mechanism of action of ibandronic acid is typical of bisphosphonate class. Once absorbed and distributed in the body bisphosponates localise at and bind to bone mineral surface exposed to osteoclasts, which reabsorb bone mineral during reabsorption phase of normal bone remodelling cycle. During the process of reabsorption the space directly beneath osteoclasts is acidified , bone mineral is dissolved and enzymes breakdown the bone matrix.
It is likely that bisphoshonates bound to mineral bone material at sites of osteoclasts -medicated bone resorption is released giving rise to high conc of bisposphonates in the immediate vicinity of the osteoclast.
The free bisphosphonate is internalised by osteoclasts probably throgh endocytosis Once internalized by the mature active osteoclsts nitrogen containing bisphosponates inhibit osteoclast medicated bone resorption by interfering with reactions in the osteoclast.
Pharmacokinetics
Following oral admin ibandronic acid is rapidly absorbed reaching peak plasm aconc at approx 1 hour. Once absorbed ibandronate is rapidly distributed and cleared from the blood with plasma conc declining to 10% of Cmax within 38 hrs. of admin. Preclinical studies estimate that 40-50% of the circulating ibandsroonic acid dose binds to and concentrate in bone tissue. Once bound to bone mineral release is extremely slow As with other bisphosphonates ibandronic acid is not metabolised . No hepatic biotransfermation takes plkce and ibadronic acid is excreted unchanged in the urine.
Interaction with Food:
Drug food interaction- Intake of products containg calcium and other multivalent cations sucs aluminium , magnesium, iron, including milk and food must be delayed for 60 minutes following oral administration
Pregnancy and lactation:
Pregnancy- Should not be given during pregnancy.
Lactation- Not known whether it is excreted in breast human milk.