Orocal Kit

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 utilized to anticipate or treat moo blood calcium levels in individuals who don't get sufficient calcium from their diets. It may be utilized to treat conditions caused by moo calcium levels such as bone misfortune (osteoporosis), powerless bones (osteomalacia/rickets), diminished action of the parathyroid organ (hypoparathyroidism), and a certain muscle illness (inactive tetany). It may too be utilized in certain patients to form beyond any doubt they are getting sufficient calcium (e.g., ladies who are pregnant, nursing, or postmenopausal, individuals taking certain medicationssuch as phenytoin, phenobarbital, or prednisone). Calcium plays an awfully vital part within the body. It is necessary for ordinary working of nerves, cells, muscle, and bone. On the off chance that there's not sufficient calcium within the blood, at that point the body will take calcium from bones, in this manner debilitating bones. Having the correct sum of calcium is imperative for building and keeping solid bones.

Dosage & Administration

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.

• 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).

Interaction

Ibandronic Acid- Calcium Supplements/Antacids: Items containing calcium and other multivalent cations (such as aluminum, magnesium, press) are likely to meddled with assimilation of Ibandronic Corrosive. Ibandronic Corrosive ought to be taken at slightest 60 minutes some time recently any verbal drugs, counting medicines containing multivalent cations (such as stomach settling agents, supplements or vitamins). Too, patients ought to hold up at slightest 60 minutes after dosing some time recently taking any other verbal medications. Aspirin/Nonstemidal Anti-Inflammatory Drugs (NSAIDs): Since ibuprofen, NSAIDs, and bisphosphonates are all related with gastrointestinal disturbance, caution ought to be worked out within the concomitant utilize of ibuprofen or NSAIDs with Ibandronic Acid. H2 Blockers: In sound volunteers, co-administration with ranitidine brought about in a 20% expanded bioavailability of Ibandronic Corrosive, which was not considered to be clinically important.

Calcium Orotate- Calcium can diminish retention of the taking after drugs when taken together: biphosphonates (e.g., alendronate), quinolone anti-microbials (e.g., ciprofloxacin, levofloxacin), and tetracycline anti-microbials (e.g., doxycycline, minocycline), levothyroxine, phenytoin (an anticonvulsant), and tiludronate disodium (to treat Paget's infection). Thiazide-type diuretics can connected with Calcium supplements, expanding the dangers of hypercalcemia and hypercalciuria. Both Aluminum and Magnesium-containing stomach settling agents increment urinary Calcium excretion.

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

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

Pregnancy: There are no adequate and well-controlled studies in pregnant women for Ibandronic Acid and Calcium Orotate combination: The combination should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus. Pregnancy Category of Ibandronic Acid: C.

Nursing Mothers

It is not known whether Ibandronic Acid and Calcium Orotate combination is excreted in human milk. Caution should be exercised when Ibandronic Acid and Calcium Orotate combination is administered to a nursing woman.

Precautions & Warnings

Ibandronic Acid- Upper Gastrointestinal Antagonistic Responses: Ibandronic corrosive of Ibandronic Corrosive & Calcium Orotate may cause nearby bothering of the upper gastrointestinal mucosa. Since of these conceivable aggravation impacts and a potential for compounding of the fundamental infection, caution ought to be utilized when Ibandronic corrosive is given to patients with dynamic upper gastrointestinal issues (such as known Barrett's esophagus, dysphagia, other esophageal infections, gastritis, duodenitis or ulcers). The chance of serious esophageal antagonistic encounters shows up to be more prominent in patients who lie down after taking verbal bisphosphonates and/or who fall flat to swallow it with the prescribed full glass (250 ml) of water, and/or who proceed to require verbal bisphosphonates after creating indications suggestive of esophageal aggravation.

Calcium Orotate- If the patient has any allergies, attention should be taken before using Calcium Orotate. Inactive chemicals may be included in this product, causing allergic reactions or other issues. Before taking this product, use caution if you have kidney disease, kidney stones, low or no stomach acid (achlorhydria), heart illness, pancreas disease, sarcoidosis (a lung disease), or difficulties absorbing nourishment from food (malabsorption syndrome).

Therapeutic Class

Minerals involved in bone growth, mineral preparations.

Storage Conditions

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

Pharmaceutical Name

Ziska Pharmaceuticals Ltd.