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After initial systemic exposure, ibandronic acid rapidly binds to bone or is excreted into urine. In humans, the apparent terminal volume of distribution is at least 90 l and the amount of dose reaching the bone is estimated to be 40-50 % of the circulating dose. Protein binding in human plasma is approximately 85 % - 87 % (determined in vitro at therapeutic concentrations), and thus there is a low potential for interaction with other medicinal products due to displacement. Hi Alison, I don’t know where the time has gone but I’ve just read this and your previous blog and you’ve certainly, as usual, been busy. The photos of your grandchildren are joyful and now that I have Arthur I certainly understand the love and pride that we have for them and our children. Arthur is 6 months old now and pure joy. My mother in law was 89 on the 29th April, a mere youngster compared to Colin’s mum who sounds like she’s being beautifully cared for and has a fabulous life. Total clearance of ibandronic acid is low with average values in the range 84-160 ml/min. Renal clearance (about 60 mL/min in healthy postmenopausal females) accounts for 50-60 % of total clearance and is related to creatinine clearance. The difference between the apparent total and renal clearances is considered to reflect the uptake by bone.
Boniva is prescription medicine used to treat or prevent osteoporosis in women after menopause. Ibandronate helps increase bone mass and helps reduce the chance of having a spinal fracture. Orally administered bisphosphonates may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects and a potential for worsening of the underlying disease, caution should be used when Bonviva is given to patients with active upper gastrointestinal problems (e.g. known Barrett's oesophagus, dysphagia, other oesophageal diseases, gastritis, duodenitis or ulcers). Adverse reactions such as oesophagitis, oesophageal ulcers and oesophageal erosions, in some cases severe and requiring hospitalisation, rarely with bleeding or followed by oesophageal stricture or perforation, have been reported in patients receiving treatment with oral bisphosphonates. The risk of severe oesophageal adverse experiences appears to be greater in patients who do not comply with the dosing instruction and/or who continue to take oral bisphosphonates after developing symptoms suggestive of oesophageal irritation. Patients should pay particular attention to and be able to comply with the dosing instructions (see section 4.2). Uses: Treatment and prevention of postmenopausal osteoporosis, to increase bone mineral density (BMD) and to reduce the incidence of vertebral fractures Do not take a tablet if you have problems with your esophagus, or if you cannot sit upright or stand for at least 60 minutes after taking the tablet.Avoid drinking large amounts of alcohol. Heavy drinking can also cause bone loss. What other drugs will affect Boniva? Calcium supplements, antacids and some oral medicinal products containing multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with the absorption of Bonviva. Therefore, patients should not take other oral medicinal products for at least 6 hours before taking Bonviva and for 1 hour following intake of Bonviva. Due to limited clinical experience, Bonviva is not recommended for patients with a creatinine clearance below 30 ml/min (see section 5.2). It is not known whether ibandronate will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
There is no relevant use of Bonviva in children below 18 years, and Bonviva was not studied in this population. (see section 5.1 and section 5.2). Since Acetylsalicylic acid, Nonsteroidal Anti-Inflammatory medicinal products (NSAIDs) and bisphosphonates are associated with gastrointestinal irritation, caution should be taken during concomitant administration (see section 4.4). Since the injections are given by a healthcare professional in a medical setting, an overdose is unlikely to occur. What to avoidOcular inflammation events such as uveitis, episcleritis and scleritis have been reported with ibandronic acid. In some cases, these events did not resolve until the ibandronic acid was discontinued. In a Phase 1 bioequivalence study conducted in 72 postmenopausal women receiving 150 mg orally every 28 days for a total of four doses, inhibition in serum CTX following the first dose was seen as early as 24 hours post-dose (median inhibition 28 %), with median maximal inhibition (69 %) seen 6 days later. Following the third and fourth dose, the median maximum inhibition 6 days post dose was 74 % with reduction to a median inhibition of 56 % seen 28 days following the fourth dose. With no further dosing, there is a loss of suppression of biochemical markers of bone resorption. Take the tablet first thing in the morning, at least 60 minutes before you eat or drink anything or take any other medicine. Take the medicine on the same day each month and always first thing in the morning.
Potency of the medicinal product that inhibit bone resorption (higher risk for highly potent compounds), route of administration (higher risk for parenteral administration) and cumulative dose of bone resorption therapy I’m sure it’ll be busy on the 3rd May too when we have a four-hour Diamonique jewellery event that begins at 5pm, features the lovely Tova Borgnine collection, and finishes with my show at 8pm. Do join me if you can. During bisphosphonate treatment patients should be advised to report any thigh, hip or groin pain and any patient presenting with such symptoms should be evaluated for an incomplete femur fracture. 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. Based on the results of study BM 16549, Bonviva 150 mg once monthly is expected to be at least as effective in preventing fractures as ibandronic acid 2.5 mg daily.
The absorption of ibandronic acid in the upper gastrointestinal tract is rapid after oral administration and plasma concentrations increase in a dose-proportional manner up to 50 mg oral intake, with greater than dose-proportional increases seen above this dose. Maximum observed plasma concentrations were reached within 0.5 to 2 hours (median 1 hour) in the fasted state and absolute bioavailability was about 0.6 %. The extent of absorption is impaired when taken together with food or beverages (other than water). Bioavailability is reduced by about 90 % when ibandronic acid is administered with a standard breakfast in comparison with bioavailability seen in fasted subjects. There is no meaningful reduction in bioavailability provided ibandronic acid is taken 60 minutes before the first food of the day. Both bioavailability and BMD gains are reduced when food or beverage is taken less than 60 minutes after ibandronic acid is ingested. Animal models confirm that ibandronic acid is a highly potent inhibitor of osteoclastic activity. In growing rats, there was no evidence of impaired mineralization even at doses greater than 5,000 times the dose required for osteoporosis treatment.
Oral bioavailability of ibandronic acid is generally reduced in the presence of food. In particular, products containing calcium, including milk, and other multivalent cations (such as aluminium, magnesium, iron), are likely to interfere with absorption of Bonviva, which is consistent with findings in animal studies. Therefore, patients should fast overnight (at least 6 hours) before taking Bonviva and continue fasting for 1 hour following intake of Bonviva (see section 4.2). The most frequently reported adverse reactions are arthralgia and influenza-like symptoms. These symptoms are typically in association with the first dose, generally of short duration, mild or moderate in intensity, and usually resolve during continuing treatment without requiring remedial measures (see paragraph “Influenza like illness”). Have you watched the Davina documentary on HRT, there’s another one out soon ..I have been going through menopause for 7 years..started at 49, now 56..and I honestly thought I’d be done by now! How nieve of me…my doctor wouldn’t let me have HrT because my migraine symptoms are numbness down one side of my face and arm. So basically i had no advice other than eat healthy, lose weight ( which I’ve been trying to do since I was 10!) And take supplements..so I take a handful of supplements every morning and am too frightened to stop incase I feel worse than i do now..my migraines are now cluster migraines meaning I get them on and over over a period of 3 days, my nails that were once long and strong are like flaky pastry despite using every strengthener on the market and my hair texture has changed..however, my hot flushes seem to be less frequent although still daily, just not as many in a day and I have a fan on at night with the window open..in all weather’s! The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be re-evaluated periodically based on the benefits and potential risks of Bonviva on an individual patient basis, particularly after 5 or more years of use. Your doctor will determine how long to treat you with this medicine. Ibandronate is often given for only 3 to 5 years. Dosing information
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When a more stringent criterion is considered, which combines both lumbar spine and total hip BMD, 83.9 % (p<0.001) and 65.7 % of patients receiving Bonviva 150 mg once monthly or ibandronic acid 2.5 mg daily, respectively, were responders at one year. At two years, 87.1 % (p<0.001) and 70.5 %,of patients met this criterion in the 150 mg monthly and 2.5 mg daily arms respectively. In table 1 a complete list of known adverse reactions is presented. The safety of oral treatment with ibandronic acid 2.5 mg daily was evaluated in 1251 patients treated in 4 placebo-controlled clinical studies, with the large majority of patients coming from the pivotal three year fracture study (MF4411). Osteonecrosis of the external auditory canal has been reported with bisphosphonates, mainly in association with long-term therapy. Possible risk factors for osteonecrosis of the external auditory canal include steroid use and chemotherapy and/or local risk factors such as infection or trauma. The possibility of osteonecrosis of the external auditory canal should be considered in patients receiving bisphosphonates who present with ear symptoms including chronic ear infections.
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