Cora Kit®: ®

lbandronic Acid & Calcium (Coral Source)+ Vitamin 03
Cora Kit®: ®

Prescribing Details



Description

Cora Kit® contains lbandronic Acid, Calcium (Coral Source) and Vitamin D3.

lbandronic Acid
lbandronic Acid (lbandronate Monosodium Monohydrate) is a nitrogen-containing bisphosphonate that inhibits osteoclast mediated bone resorption. The action of lbandronate on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. lbandronate inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.


Calcium (Coral Source) and Vitamin D3
Calcium from coral source ensures better absorption than calcium of other calcium carbonate origin due to its chemical structure that is very similar to the composition of human bone calcium carbonate. Vitamin 03 aids in the absorption of calcium from GI tract and helps to maintain calcium balance in the body.


Uses

No Data


Indications

Cora Kit® is indicated for the treatment and prevention of osteoporosis.


Dosage and administration
Route of administration: Cora Kit® is given in oral route. 
Dosing instructions:
Day 1
• Take ibandronic acid tablet of Cora Kit® on an empty stomach 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. 
• Swallow ibandronic acid tablet whole with a glass of plain water while standing or sitting in an upright position.
• Do not lie down for 60 minutes and do not chew or crush the tablet.
• Do not eat, drink anything except plain water and do not take other medications for at least 60 minutes after taking ibandronic acid.
Day 2-31
• Take one tablet of calcium and vitamin 03 at the morning and at the evening after meal.
• Tablets should be taken in order as directed on the blister strip for ease of dose tracking.

Use in pregnancy & lactation

Pregnancy: There are no data with ibandronic acid use in pregnant women to inform any drug associated risks. This kit is not indicated for use in women of reproductive potential.

Lactation: There is no information on the presence of ibandronate in human milk, the effects of ibandronate on the breastfed infant or the effects of ibandronate on milk production. This kit is not indicated for use in women of reproductive potential.

Use in children and adolescents
Safety and effectiveness in pediatric patients have not been established.


Geriatric use
No Data

Precautions

lbandronic Acid

• Caution should be exercised 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).
• Hypocalcaemia and other disturbances of bone and mineral metabolism should be treated before starting ibandronic acid therapy.
• Discontinue ibandronic acid if any patient develops severe bone, joint and muscle pain.
If any patient develops osteonecrosis of the jaw, discontinuation of bisphosphonate therapy should be considered.

• Any patient with thigh or groin pain should be evaluated to rule out an incomplete femur fracture and interruption of bisphosphonate therapy should be considered.
• lbandronic acid is not recommended for use in patients with severe renal impairment (creatinine clearance of <30 ml/min).

Calcium & Vitamin D3

• Patients with mild to moderate renal failure or mild hypercalciuria should be periodically checked for plasma calcium levels and urinary calcium excretion.

• Calcium should be used cautiously in patients with pre-existing heart disease, sarcoidosis, kidney stones and kidney diseases. 

• When hypercalcaemia occurs, discontinuing of the drug should be considered.
• Patients with a history of stone formation should increase their fluid intake.

• Doses of calcium and iron should be separated by several hours.


Side effects

Most common side effects are back pain, dyspepsia, pain in extremity, diarrhea, flatulence, constipation, headache, myalgia and upper GI discomfort.


Contraindications

This kit is contraindicated in patients with known hypersensitivity to ibandronic acid, calcium, vitamin 03 or any other components of this product.
lbandronic Acid: It is contraindicated in patients with-

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

 

Calcium & Vitamin 03: This combination is contraindicated in patients with-

• Hypercalcaemia

•Severe renal insufficiency

• Hyperparathyroidism

• Concomitant digoxin therapy

• Hypercalciuria
• Nephrolithiasis

• Renal calculi
• Zollinger-Ellison syndrome


Drug interactions

Drug interaction with medication
lbandronic Acid: Products containing calcium and other multivalent cations (such as aluminium, magnesium, iron) are likely to interfere with absorption of ibandronic acid. Caution should be exercised in the concomitant use of aspirin or NSAIDs with ibandronic acid.
Calcium (Coral Source) and Vitamin D3: This combination has possible interaction with digoxin, antacids containing calcium, aluminium or magnesium, other calcium supplements and calcitriol. Oral calcium can reduce the absorption of tetracycline, doxycycline, aminocycline or oxytetracycline. Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of calcium. Thiazide diuretics reduce the renal excretion of calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of vitamin D.


Drug interaction with food and others: Calcium supplements, antacids and some oral medications may interfere with absorption of ibandronate.


Overdose
Oral overdose of ibandronic acid may result in hypocalcaemia, hypophosphatemia and upper gastrointestinal adverse events such as upset stomach, dyspepsia, esophagitis, gastritis or ulcer. Milk or antacids should be given to bind ibandronic acid. Symptoms of calcium and vitamin 03 combination overdose include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, unconsciousness, diarrhea, weakness, headache, constipation, dizziness or irritability. Treatment includes cessation of therapy and adequate rehydration. 

 


Preparation

No Data


Pharmaceutical precautions

Store in a cool (below 30oC) and dry place protected from light. Keep away from the reach of children.


Presentation

No Data


Package quantities

 

Cora Kit®:Each box contains one kit in blister pack. Each kit contains 1 tablet of 150 mg lbandronic Acid & 60 tablets of 600 mg Calcium (Coral Source) and 400 IU Vitamin 03.