Bonova 150mg

Indications

Ibandronic acid is used to treat postmenopausal osteoporosis and lower the risk of fractures.

Treatment of Osteoporosis: The presence of low bone mass (T-score -2.0 SD) plus the presence or history of osteoporotic fracture, or a low bone mass (T-score -2.5 SD) in the absence of documented pre-existing osteoporotic fracture, can confirm osteoporosis.

Pharmacology

Ibandronic acid’s pharmacodynamic effect is to prevent bone resorption. Ibandronic acid inhibits experimentally induced bone deterioration caused by gonadal dysfunction, retinoids, tumors, or tumor extracts in vivo. Endogenous bone resorption is also slowed in young (rapidly developing) rats, resulting in increased bone mass relative to untreated animals. Ibandronic acid is a highly effective inhibitor of osteoclastic activity in animal studies. Even at dosages more than 5,000 times the amount necessary for osteoporosis therapy, there was no indication of altered mineralization in developing rats. Ibandronic acid’s strong potency and therapeutic margin allow for more flexible dosage regimens and intermittent therapy with lengthy drug-free periods at comparably low doses.

Ibandronic acid is a very powerful bisphosphonate that belongs to the nitrogen-containing category of bisphosphonates. It acts on bone tissue and particularly inhibits osteoclast activity. It has no effect on osteoclast recruitment. Ibandronic acid’s selective impact on bone tissue is based on its strong affinity for hydroxyapatite, which is the mineral matrix of the bone. Ibandronic acid inhibits bone resorption but has no impact on bone production. It lowers the increased rate of bone turnover in postmenopausal women to premenopausal levels, resulting in a gradual net gain in bone mass. Ibandronic acid treatment on a daily or intermittent basis reduces bone resorption, as evidenced by lower levels of serum and urine biochemical indicators of bone turnover, higher BMD, and a lower incidence of fractures.

Dosage & Administration

The recommended dose of Ibandronic acid for treatment is one 150 mg film-coated tablet once a month. The tablet should preferably be taken on the same date each month. Ibandronic acid should be taken 60 minutes before the first food or drink (other than water) of the day or any other oral medication or supplementation (including calcium):
 

Tablets should be swallowed whole with a full glass of plain water (180 to 240 ml) while the patient is sitting or standing in an upright position. Patients should not lie down for 60 minutes after taking Ibandronic acid.

Plain water is the only drink that should be taken with Ibandronic acid. Please note that some mineral waters may have a higher concentration of calcium and therefore should not be used.

Patients should not chew or suck the tablet because of the potential for oropharyngeal ulceration. Patients should receive supplemental calcium or vitamin D if dietary intake is inadequate. In case a once-monthly dose is missed, patients should be instructed to take one Ibandronic Acid 150 mg tablet the morning after the tablet is remembered unless the time to the next scheduled dose is within 7 days. Patients should then return to taking their dose once a month on their originally scheduled date. If the next scheduled dose is within 7 days, patients should wait until their next dose and then continue taking one tablet once a month as originally scheduled. Patients should not take two 150 mg tablets within the same week.

Interaction

Calcium supplements, antacids, and other oral medicines containing multivalent cations (such as aluminum, magnesium, and iron) are likely to interfere with Ibandronic Acid absorption. Patients must thus wait 60 minutes after taking Ibandronic Acid before taking any other oral medicines. Pharmacokinetic interaction investigations in postmenopausal women have revealed that there is no possibility for interaction with tamoxifen or hormone replacement treatment (estrogen).In patients with multiple myeloma, there was no interaction when co-administered with melphalan/prednisolone. I.V. ranitidine increased ibandronic acid absorption by around 20% in healthy male volunteers and postmenopausal women, most likely due to decreased stomach acidity. However, because this rise is within the usual range of ibandronic acid bioavailability, no dose modification is necessary when Ibandronic Acid is taken with H2-antagonists or other medicines that elevate stomach pH.

In terms of disposition, no clinically significant drug interactions are expected because ibandronic acid does not inhibit the main human hepatic P450 isoenzymes and has not been proven to activate the hepatic cytochrome P450 system in rats. Furthermore, at therapeutic doses, plasma protein binding is minimal, and ibandronic acid is unlikely to displace other medicines. Ibandronic acid is excreted solely by the kidneys and does not undergo any biotransformation. The secretory route does not appear to contain recognized acidic or basic transport mechanisms involved in drug excretion. A one-year study of postmenopausal women with osteoporosis was conducted (BM16549). The incidence of upper gastrointestinal problems in people taking aspirin or NSAIDs at the same time was comparable in those receiving Ibandronic Acid 2.5 mg daily or 150mg once monthly. 14 percent of the approximately 1500 patients participating in the BM 16549 trial comparing monthly versus daily dosage regimens of ibandronic acid utilized histamine (H2) blockers or proton pump inhibitors. The incidence of upper gastrointestinal events was comparable in patients treated with Ibandronic Acid 150 mg once monthly to those treated with Ibandronic Acid 2.5 mg daily.

Contraindications

Ibandronic Acid is not recommended for patients who have a history of hypersensitivity to ibandronic acid or any of the excipients. Ibandronic Acid is not recommended for people who have uncorrected hypocalcemia. Pre-existing hypocalcemia must be addressed before starting Ibandronic Acid therapy, as with all bisphosphonates used to treat osteoporosis. Ibandronic Acid, like other bisphosphonates, is contraindicated in individuals with esophageal anomalies that impede esophageal emptyings, such as stricture or achalasia. Ibandronic Acid is not recommended for people who cannot stand or sit erect for at least 60 minutes.

Side Effects

Ibandronic acid’s most common adverse effects include dyspepsia, nausea, diarrhea, stomach discomfort, muscular pains, headaches, and dizziness.

Pregnancy & Lactation

Ibandronic Acid should not be used during pregnancy. In daily orally treated rats and rabbits, there was no indication of a direct fetal toxic or teratogenic impact of ibandronic acid, and there were no detrimental effects on the development of F1 offspring in rats. In reproductive toxicity tests in rats, ibandronic acid had the same negative effects as bisphosphonates as a class. They include a reduction in the number of implantation sites, disruption of natural delivery (dystocia), and an increase in visceral abnormalities (renal pelvis ureter syndrome). No research on the monthly regimen have been conducted.There is no clinical data on the use of Ibandronic Acid in pregnant women.

Ibandronic Acid should not be taken by nursing mothers since it interferes with breastfeeding. The maximum quantity of ibandronic acid in breast milk was 8.1 ng/ml in nursing rats treated with 0.08 mg/kg/day IV ibandronic acid and was found in the first 2 hours after i.v. treatment. The concentration in milk and plasma was comparable after 24 hours, and equated to roughly 5% of the concentration tested after 2 hours.

Precautions & Warnings

Before beginning Ibandronic Acid treatment, hypocalcemia and other bone and mineral metabolic abnormalities should be adequately addressed. Calcium and vitamin D consumption should be adequate in all individuals. Bisphosphonates used orally may induce local irritation of the upper gastrointestinal mucosa. Because of these potential irritant effects and the risk of worsening the underlying disease, Ibandronic Acid should be used with caution in patients who have active upper gastrointestinal problems (e.g., known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis, or ulcers). Patients using oral bisphosphonates have experienced esophagitis, esophageal ulcers, and esophageal erosions, in some cases severe and necessitating hospitalization, rarely with bleeding or followed by esophageal stricture or perforation. Patients who do not follow dosage instructions and/or continue to use oral bisphosphonates despite having symptoms suggestive of esophageal irritation appear to be at a higher risk of serious esophageal side events. Patients should pay close attention and be able to follow dosage recommendations.

Physicians should be on the lookout for any indications or symptoms of an esophageal response, and patients should be advised to stop taking Ibandronic Acid and seek medical treatment if they have dysphagia, odynophagia, retrosternal discomfort, or new or worsening heartburn. While no higher risk was shown in controlled clinical studies, there have been post-marketing reports of the stomach and duodenal ulcers associated with oral bisphosphonate usage, some of which were serious and caused problems. Because NSAIDs and bisphosphonates are both known to cause gastrointestinal discomfort, they should be used with care when used with Ibandronic Acid. In individuals receiving bisphosphonates, osteonecrosis of the jaw (ONJ) has been described. The majority of instances occurred in cancer patients undergoing dental treatments, but some occurred in individuals with postmenopausal osteoporosis or other illnesses. Cancer diagnosis, concurrent treatments (e.g., chemotherapy, radiation, corticosteroids), and co-morbid diseases are all known risk factors for osteonecrosis of the jaw (e.g., anemia, coagulopathy, infection, pre-existing dental disease). The majority of reported instances were patients who were given bisphosphonates intravenously, although some involved individuals who were given bisphosphonates orally.Dental surgery may aggravate osteonecrosis of the jaw in people who acquire the disease while on bisphosphonate treatment. There is no data to show if discontinuing bisphosphonate therapy decreases the risk of ONJ in patients undergoing dental operations. The treating physician’s clinical judgment should lead the care approach for each patient based on an individual benefit-risk evaluation.

Storage Conditions

Keep below 30?C and away from light and moisture. Keep out of children’s reach.