BoneStar Kit150 mg+ 400 mg

This Kit is indicated for the treatment and prevention of osteoporosis in women (especially after menopause) & men. It increases bone mineral density (BMD) and reduces the incidence of vertebral fractures.

Each Kit contains- 1 tablet of ibandronic Acid 150 mg 60 tablets of Calcium Orotate 400 mg

Minerals in bone formation, Specific mineral preparations

Ibandronate is a nitrogen-containing bisphosphonate in the same class as alendronate and risedronate. Ibandronate inhibits osteoclast-mediated bone resorption. All of the bisphosphonates prevent the breakdown of bone by bone cells called osteoclasts. In persons who are at high risk for osteoporosis, bisphosphonates not only result in increased amounts of bone and bone strength, they also reduce the risk of hip fractures and other bone fractures.Calcium Orotate is used to prevent or treat low blood calcium levels in people who do not get enough calcium from their diets. It may be used to treat conditions caused by low calcium levels such as bone loss (osteoporosis), weak bones (osteomalacia/rickets), decreased activity of the parathyroid gland (hypoparathyroidism), and a certain muscle disease (latent tetany). It may also be used in certain patients to make sure they are getting enough calcium (e.g., women who are pregnant, nursing, or postmenopausal, people taking certain medicationssuch as phenytoin, phenobarbital, or prednisone).Calcium plays a very important role in the body. It is necessary for normal functioning of nerves, cells, muscle, and bone. If there is not enough calcium in the blood, then the body will take calcium from bones, thereby weakening bones. Having the right amount of calcium is important for building and keeping strong bones.

To maximize absorption and clinical benefit, Ibandronic Acid tablet of Ibandronic Acid + Calcium Orotate 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 maximize absorption and clinical benefit, Ibandronic Acid tablet of Ibandronic Acid + Calcium Orotate 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.Patients should not eat, drink anything except water, or take other medications for at least 60 minutes after taking Ibandronic Acid tablet.Plain water is the only drink that should be taken with Ibandronic Acid tablet. Note that some mineral waters may have a higher concentration of calcium and therefore should not be used.Patients should not chew, crush or let the tablet dissolve in mouths because of a potential for oropharyngeal ulceration.Ibandronic Acid 150 mg tablet of Ibandronic Acid + Calcium Orotate should be taken on the same date of each month (i.e., the patient's Ibandronic Acid day).The patient must not take two Ibandronic Acid 150 mg tablets within the same week.If the once-monthly dose is missed, and the patient’s 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 patient’s 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.Start taking Calcium Orotate tablets from the next day of Ibandronic Acid Day (from 'Day 2' and onwards).Recommendations tor Calcium Supplementation: Patients should receive supplemental calcium (already provided asCalcium Orotate 400 mg tablet) if dietary intake is inadequate.

Ibandronic Acid: Products containing calcium and other multivalent cautions (such as aluminium, magnesium, iron) are likely to interfere with absorption of Ibandronic Acid. Ibandronic Acid should be taken at least 60 minutes before any oral medications. Aspirin, NSAIDs, and bisphosphonates are all associated with gasrointestinal irritation, caution should be exercised in the concomitant use of aspirin of NSNADs with Ibandronic Acid.Calcium Orotate: Calcium can decrease the absorption of the other drugs such as bisphosphonates (e.g., alendronate/risedronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotic (e.g., doxycycline, levofloxacin).

Ibandronic Acid: Common side effects include Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Localized Osteoarthritis, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bonchitis, 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: 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. Nursing Mothers: 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.Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Ibandronic Acid: Ibandronic Acid of this Kit may cause local irritation of the upper gastrointestinal mucosa. Adequate intake of Calcium is important in all patient hypocalcaemia Severe and occasionally incapacitating bone joint, and/or muscle pain has been reported in patients taking Ibandronic Acid. Ibandronic Acid is not recommended for use in patients with severe renal impairment (Creatinine clearance of <30 ml/min). Calcium Orotate: Before taking Calcium Orotate, precaution is needed if the patient is allergic to Calcium Orotate. Any Calcium supplement taken without food may increase the risk of kidney stones. Therefore, it is advisable that Calcium Orotate be taken with food.

Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.

Minerals in bone formation, Specific mineral preparations

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

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.Renal and hepatic impaired patient: No dose adjustment is necessary for patients with mild or moderate renal impairment where creatinine clearance is equal to or greater than 30 ml/min. No dose adjustment is required for patients with hepatic impairment.