Generic

Ibandronic Acid & Calcium Orotate

Indications

This medication is for the treatment and prevention of osteoporosis in postmenopausal women. It improves bone mineral density and lowers the risk of vertebral fractures.

Pharmacology

Ibandronate, like alendronate and risedronate, is a nitrogen-containing bisphosphonate. Ibandronate prevents bone resorption caused by osteoclasts. Bisphosphonates all work to keep bone cells called osteoclasts from breaking it down. Bisphosphonates not only boost bone mass and strength in people at high risk for osteoporosis, but they also lower the risk of hip fractures and other bone fractures.

Calcium orotate is a supplement that is used to prevent or treat low blood calcium levels in those who do not consume enough calcium through their diet. It could be used to address diseases like bone loss that are caused by low calcium levels (osteoporosis).

Dosage & Administration

One tablet of Ibandronic Acid 150 mg once monthly of the same date of each month is recommended. To maximize the clinical benefit of Ibandronic Acid, two tablets of Calcium Orotate per day are usually recommended in divided dosage.

To maximize absorption and clinical benefit, Ibandronic Acid tablet of this Kit should be taken at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation, including calcium, antacids, or vitamins.

To facilitate delivery to the stomach and thus reduce the potential for esophageal irritation, Ibandronic Acid tablet should be swallowed whole with a full glass of plain water (250 ml) while the patient is standing or sitting in an upright position. Patients should not lie down for 60 minutes after taking Ibandronic Acid tablet.

Ibandronic Acid 150 mg tablet of this Kit should be taken on the same date of each month (i.e., the patients Ibandronic Acid day)

If the once monthly dose is missed, and the patients 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. The patient should then return to taking one Ibandronic Acid 150 mg tablet every month in the morning of their chosen day, according to their original schedule.

If the once monthly dose is missed, and the patients next scheduled Ibandronic Acid day is only 1 to 7 days away, the patient must wait until the subsequent month’s scheduled Ibandronic Acid day to take their tablet. The patient should then return to taking one Ibandronic Acid 150 mg tablet every month in the morning of their chosen day according to their original schedule.

The Patient must not take two Ibandronic Acid 150 mg tablets within the same week.

Start taking Calcium Orotate tablets from the next day of Ibandronic Acid day (from day-2 and onwards).

Interaction

Ibandronic Acid-

Calcium Supplements/Antacids: Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron) are likely to interfere with absorption of Ibandronic Acid. Ibandronic Acid should be taken at least 60 minutes before any oral medications, including medications containing multivalent cations (such as antacids, supplements or vitamins). Also, patients should wait at least 60 minutes after dosing before taking any other oral medications.

Aspirin/Nonstemidal Anti-Inflammatory Drugs (NSAIDs): Because aspirin, NSAIDs, and bisphosphonates are all associated with gastrointestinal irritation, caution should be exercised in the concomitant use of aspirin or NSAIDs with Ibandronic Acid.

H2 Blockers: In healthy volunteers, co-administration with ranitidine resulted in a 20% increased bioavailability of Ibandronic Acid, which was not considered to be clinically relevant.

Calcium Orotate-

Calcium can decrease absorption of the following drugs when taken together: biphosphonates (e.g., alendronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotics (e.g., doxycycline, minocycline), levothyroxine, phenytoin (an anticonvulsant), and tiludronate disodium (to treat Paget’s disease). Thiazide-type diuretics can interact with Calcium supplements, increasing the risks of hypercalcemia and hypercalciuria. Both Aluminum and Magnesium-containing antacids increase urinary Calcium excretion.

Contraindications

Abnormalities of the esophagus, hypocalcemia, and known hypersensitivity to Ibandronic Acid or any of its components are all symptoms of Ibandronic Acid.

Incomplete bowel movements, kidney stones, kidney disease, and lung disease are all symptoms of calcium orotate.

Side Effects

Ibandronic Acid: Common side effects include Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Localized Osteoarthritis, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bronchitis, Urinary Tract Infection, Upper Respiratory Tract Infection, Headache, Dizziness, Skin rash, Insomnia etc.

Calcium Orotate: Bloating and swelling in the abdomen are common side effects of Calcium Orotate. Loss of appetite, upset stomach, constipation, nausea, vomiting, unusual weight loss, mood changes, bone/muscle pain, headache, increased thirst/urination, weakness, unusual tiredness, formation of kidney stones may occur infrequently.

Pregnancy & Lactation

There are no adequate and well-controlled studies in pregnant women. This should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Pregnancy Category of Ibandronic Acid is C. It is not known whether Ibandronic Acid & Calcium Orotate is excreted in human milk. Caution should be exercised when this is administered to a nursing woman.

Precautions & Warnings

Ibandronic Acid-

Upper Gastrointestinal Adverse Reactions: Ibandronic acid of Ibandronic Acid & Calcium Orotate 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 Ibandronic acid is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers). The risk of severe esophageal adverse experiences appears to be greater in patients who lie down after taking oral bisphosphonates and/or who fail to swallow it with the recommended full glass (250 ml) of water, and/or who continue to take oral bisphosphonates after developing symptoms suggestive of esophageal irritation. There have been post-marketing reports of gastric and duodenal ulcers with oral bisphosphonate use, some severe and with complications, although no increased risk was observed in controlled clinical trials.

Hypocalcemia and Mineral Metabolism: Adequate intake of calcium is important in all patients to prevent hypocalcemia.

Therapeutic Class

Minerals in bone formation, Specific mineral preparations

Storage Conditions

Protect from light and moisture by storing in a cool, dry place below 30°C. Keep out of children’s reach.

Pharmaceutical Name

Beximco Pharmaceuticals Ltd.