O-Cal Kit

Generic

Indications

This medication is used for the treatment and prevention of osteoporosis in women following menopause. It improves bone mineral density (BMD) 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 from being broken down by bone cells called osteoclasts. Bisphosphonates not only enhance bone mass and strength in people at high risk of osteoporosis, but they also lower the risk of hip fractures and other bone fractures.

Calcium orotate is a medication used to prevent or cure low blood calcium levels in persons who do not obtain enough calcium from their diet. It can be used to treat diseases caused by low calcium levels, such as bone loss (osteoporosis), weak bones (osteomalacia/rickets), decreased parathyroid gland function (hypoparathyroidism), and a specific muscle illness (latent tetany). It may also be used to ensure that some patients obtain adequate calcium (e.g., women who are pregnant, nursing, or postmenopausal, people taking certain medicationssuch as phenytoin, phenobarbital, or prednisone). Calcium is essential to the human body.It is required for proper neuron, cell, muscle, and bone function. If there is insufficient calcium in the blood, the body will remove calcium from the bones, weakening them. Getting enough calcium is essential for creating and maintaining healthy bones.

Dosage 

One tablet of Ibandronic Acid 150 mg once monthly on the same date of each month is recommended. To maximize clinical benefit of Ibandronic acid, two tablets of Calcium Orotate 400 mg per day are usually recommended in divided dosage or as directed by physician.

Recommendations tor Calcium Supplementation: Patients should receive supplemental calcium (already provided as Calcium Orotate 400 mg tablet) if dietary intake is inadequate.

Administration

• 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).

Ibandronic Acid is a kind of ibandronic acid-

• Calcium Supplements/Antacids: Calcium and other multivalent cations (such as aluminum, magnesium, and iron) are likely to interfere with Ibandronic Acid absorption. Ibandronic Acid should be taken at least 60 minutes before any oral medicines, including multivalent cation treatments (such as antacids, supplements or vitamins). In addition, patients should wait at least 60 minutes following dose before taking any further oral medicines.
• Aspirin/Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Because aspirin, NSAIDs, and bisphosphonates have all been linked to gastrointestinal irritation, concurrent use of aspirin or NSAIDs with Ibandronic Acid should be avoided.
• H2 Blockers: Co-administration of Ibandronic Acid with ranitidine resulted in a 20% increase in bioavailability, which was not considered clinically significant.

Calcium Orotate- 

• When taken together, calcium can reduce absorption of the following drugs: biphosphonates (e.g., alendronate), quinolone antibiotics (e.g., ciprofloxacin, levofloxacin), and tetracycline antibiotics (e.g., doxycycline, minocycline), levothyroxine, phenytoin (an anticonvulsant), and tiludron Thiazide-type diuretics can interact with calcium supplements, thereby raising the risk of hypercalcemia and hypercalciuria. Antacids containing aluminum and magnesium both enhance urine calcium excretion. Calcium absorption is reduced by mineral oil and stimulant laxatives.When taken for months, glucocorticoids such as prednisone can induce calcium depletion and, eventually, osteoporosis. Oral contraceptives and estrogenic chemicals both lower calcium levels. Calcium is depleted by anti-inflammatory medications such as NSAIDs, aspirin, and ibuprafen. Calcium is depleted by corticosteroids.

Contraindications

Ibandronic Acid is contraindicated in conditions like:

• Abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia.
• Inability to stand or sit upright for at least 60 minutes.
• Hypocalcemia.
• Known hypersensitivity to Ibandronic Acid.

Calcium Orotate is contraindicated in conditions like:

• Incomplete or infrequent bowel movements.
• Kidney stone, kidney disease.
• Sarcoidosis.
• Increased activity of the parathyroid gland.
• Extreme loss of body water.

Side Effects

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, and others are common side effects of Iband

Calcium Orotate: Common adverse effects of Calcium Orotate include bloating and abdominal edema. Loss of appetite, upset stomach, constipation, nausea, vomiting, unexpected weight loss, mood changes, bone/muscle pain, headache, increased thirst/urination, weakness, unusual fatigue, and kidney stone development are all rare occurrences.

Pregnancy & Lactation

In pregnant women, there are no appropriate and well-controlled trials. This should only be taken during pregnancy if the possible benefit outweighs the danger to the mother and fetus. Ibandronic Acid's pregnancy category is C. It is unknown if Ibandronic Acid and Calcium Orotate are eliminated in human milk. When administering this to a breastfeeding mother, use extreme caution.

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.
• Musculoskeletal pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Ibandronic Acid. Consider discontinuing use if severe symptoms develop.
• Severe Renal Impairment: 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 has any allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Precaution is needed before using this product in kidney disease, kidney stones, little or no stomach acid (achlorhydria), heart disease, disease of the pancreas, sarcoidosis (a certain lung disease), difficulty absorbing nutrition from food (malabsorption syndrome).

Therapeutic Class

Storage Conditions

Keep below 30°C and away from light and moisture. Keep out of children's reach.

Pharmaceutical Name