Calorate Kit

Ibandronic Acid and Calcium Orotate
Tablet

What Calorate Kit is and what it is used for?
Calorate Kit is a unique monthly Calendar Kit for the treatment of Osteoporosis. Each Kit contains 1 Tablet of Ibandronic Acid 150 mg + 60 Tablets of Calcium Orotate 400 mg. Calorate Kit increases bone mineral density (BMD) and reduces the incidence of fractures. Ibandronic acid is a potent bisphosphonate which reduces bone resorption and enhances mineralization. Calcium Orotate is a unique calcium supplement helps maximizing clinical benefits of Ibandronic Acid.

Before you take Calorate Kit
Do not take this medicine and tell your doctor if:
You have abnormalities of the esophagus, hypocalcemia, kidney disease, increased activity of the parathyroid gland, incomplete or infrequent bowel movements, inability to stand or sit upright for at least 60 minutes and known hypersensitivity to any of its active excipients.


Take special care with Calorate Kit
Before taking Calorate Kit, precaution is needed if you have any allergies for calcium and ibandronic acid. Special care should be taken if you have severe renal impairment, active GI problems, hypocalcemia, severe bone, joint and muscle pain, osteonecrosis, kidney disease, heart disease, disease of the pancreas, difficulty absorbing nutrition from food (malabsorption syndrome) etc.

Taking other medicines
Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron) are likely to interfere with absorption of Ibandronic Acid. Aspirin, NSAIDs, and bisphosphonates are all associated with gastrointestinal irritation, caution should be exercised in concomitant use of aspirin or NSAIDs with Ibandronic Acid. Ranitidine increases bioavailability of ibandronate, which is not considered to be clinically relevant.

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. Mineral oil and stimulant laxatives decrease calcium absorption. Glucocorticoids, such as prednisone, can cause calcium depletion and eventually osteoporosis when they are used for months. Oral contraceptives as well as estrogen compounds reduce calcium. NSAIDs (Aspirin, Ibuprofen), Corticosteroids deplete calcium.


Pregnancy, breast-feeding & Pediatric use
There are no adequate and well-controlled studies in pregnant women for Ibandronic Acid. Ibandronic Acid 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. It is not known whether Ibandronic Acid is excreted in human milk. Caution should be exercised when Ibandronic acid is administered to a nursing woman. Safety and effectiveness in pediatric patients have not been established.

How to take Calorate Kit?
Taking this medicine
Always use Calorate Kit exactly as your doctor has told you. You should check with your doctor if you are not sure.

How much to take?
One tablet of Ibandronic Acid 150 mg once monthly on the same date each month is recommended. To maximize clinical benefit of Ibandronic acid, from second day onwards, 02 tablets of Calorate (Calcium Orotate 400 mg) per day are usually recommended in divided dosage or as directed by physician.

Dosage Instruction
Instruction to take Ibandronic Acid Tablet (Round shape tablet-01 pc):
To start taking your once-monthly Ibandronic Acid 150 mg tablet as instructed by your doctor, choose a date of the month that you will remember and that best fits your schedule.
Then follow these steps:

  • At certain date, get up in the morning and take Ibandronic Acid tablet (Round shape) on an empty stomach at ‘Day 1’ as mentioned in the strip.
  • Swallow Ibandronic Acid tablet (do not chew, crush or let it dissolve in the mouth) with at least 1 glass (250 ml) of plain water.
  • Do not eat, drink anything except plain water or other medicine for at least 1 hour (60 minutes) after taking the tablet.
  • Do not take Ibandronic Acid tablet with coffee, tea, milk or juice.
  • Avoid lying down for at least 1 hour (60 minutes) after taking Ibandronic Acid tablet. Preferably you may sit in a chair in an upright position in this time peroid.
  • Take Ibandronic Acid tablet on the same date of each month. For any missed dose, consult with your doctor.


Instruction to take Calcium Orotate Tablet (Caplet shaped tablet-60 pcs):

  • Start taking Calcium Orotate tablet from the next day of Ibandronic acid Day (from ‘Day 2’ and onwards).
  • Please follow the instruction of your doctor for daily intake of Calcium Orotate tablets.


If you take more Calorate Kit than you should
If you have too much of this medicine, talk to your doctor straight away.

If you forget to take Calorate Kit
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.

If you stop taking Calorate Kit
Do not stop taking this medicine without talking to your doctor. You should not stop taking Calorate Kit just because you feel better. If you have any further questions on the use of this product, ask your doctor.

Possible side effects
Like all medicines, Calorate Kit can cause side effects, although not everybody gets them.
Common side effects of ibandronic acid include high blood pressure, dyspepsia, nausea, diarrhea, abdominal pain, arthralgia, back pain, muscle cramp, influenza, bronchitis, urinary tract infection, upper respiratory tract infection, headache, dizziness, insomnia etc.
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, unusual tiredness, formation of kidney stones may occur infrequently.

How to store Calorate Kit
Store in a cool and dry place, away from light. Keep out of reach of children.


Calorate Kit Prescribing Information