Crben DS | 600 mg Tablet
Price: 0.00Generic: Calcium + Cholecalciferol (Vit. D3
Manufactured By: Benham Pharmaceuticals Ltd.Variant: Tablet 400 IU
COMPOSITION
Crben DS Tablet: Each film coated tablet contains Calcium Carbonate BP 1500 mg (as Coral Calcium which is equivalent to 600 mg elemental calcium) and Cholecalciferol (vitamin D3) BP 400 IU.
DESCRIPTION
Crben DS contains Coral Calcium and Vitamin D3 where Coral Calcium is composed of Calcium Carbonate with small amounts of Magnesium and other trace minerals. Coral Calcium has a chemical structure that is very similar to the composition of human bone Calcium Carbonate. Coral Calcium is similar to other sources but ensures better absorption than Calcium of other Calcium Carbonate origin. Vitamin D3 aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.
PHARMACOKINETICS
Calcium
Absorption: The amount of Calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose.
Distribution and Metabolism: 99% of the Calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra and extracellular fluid. About 50% of the total blood-Calcium content is in the physiologically active ionized form with approximately 10% being complex to Citrate, Phosphate or other anions, the remaining 40% being bound to proteins, principally Albumin.
Elimination: Calcium is eliminated through feces, urine and sweat. Renal excretion depends on Glomerular filtration and Calcium tubular reabsorption.
Vitamin D3 (Cholecalciferol)
Absorption: Vitamin D3 is easily absorbed in the small intestine.
Distribution and Metabolism: Cholecalciferol and its metabolites circulate in the blood bound to a specific Globulin. Cholecalciferol is converted in the liver by hydroxylation to the active form 25-hydroxycholecalciferol. It is then further converted in the kidneys to 1, 25-dihydroxycholecalciferol; 1,25-dihydroxycholecalciferol is the metabolite responsible for increasing Calcium absorption. Vitamin D3, which is not metabolized, is stored in adipose and muscle tissues.
Elimination: Vitamin D3 is excreted in feces and urine.
INDICATIONS AND USAGE
Crben DS is indicated for the treatment and prevention of Vitamin D/Calcium deficiency (hyperphosphatemia associated with increased bone loss, raised PTH serum level and lowered 25-hydroxy vitamin D) particularly in the housebound and institutionalized elderly subjects, osteoporosis, osteomalacia, tetany, hypoparathyroidism and disorder of osteogenesis. Also used as supplement in case of inadequate intake of Calcium in childhood
diet, rickets, elderly patient, pregnancy and lactation. Other indications include pancreatitis, Phosphate binder in chronic renal failure etc.
DOSAGE AND ADMINISTRATION
Normal dose of Crben DS is twice daily, preferably one tablet in the morning and another in the evening with a full glass of water. It is better to take with or just after a meal to improve absorption. No dose adjustment is required in hepatic impairment.
CONTRAINDICATIONS
Hypersensitivity to any of the components, hypocalcaemia resulting from overdose of Vitamin D3, hyperparathyroidism, bone metastasis, severe renal insufficiency, severe hypercalciuria, renal calculi nephrolithiasis, sarcoidosis etc.
SIDE EFFECTS
Flatulence, diarrhoea, constipation, upper GI discomfort etc. are rare manifestation. Hypercalcaemia due to prolong use has rarely been reported.
OVERDOSE
At high doses it may result in hypercalcaemia, nausea, vomiting, dizziness, anorexia, abdominal cramps, headache, constipation, irritability etc. Treatment includes cessation of therapy and adequate rehydration.
WARNING AND PRECAUTIONS
During long-term treatment, serum Calcium levels should be followed and renal function should be monitored. Monitoring is especially important in elderly patients on concomitant treatment with cardiac glycosides or diuretics and in patients with a high tendency to calculus formation. In case of hypercalcaemia or signs of impaired renal function the dose should be reduced or the treatment discontinued. Vitamin D3 should be used with caution in patients with impairment of renal function and the effect on Calcium and Phosphate levels should be monitored. Calcium Carbonate and Vitamin D3 tablets should be prescribed with caution to patients suffering from sarcoidosis. Calcium Carbonate and Vitamin D3 tablets are not intended for use in children.
USE IN PREGNANCY AND LACTATION
During pregnancy the daily intake should not exceed 1500 mg Calcium and 600 IU Cholecalciferol. Studies in animals have shown reproductive toxicity with high doses of Vitamin D3. Calcium Carbonate and Vitamin D3 tablets can be used during pregnancy, in case of a Calcium and vitamin D3 deficiency. Calcium Carbonate and Vitamin D3 tablets can be used during breast-feeding. Calcium and Vitamin D3 pass into breast milk. This should be considered when giving additional Vitamin D3 to the child. Crben DS can be given to pregnant and lactating mother as per recommendation of physician.
DRUG INTERACTIONS
Oral Calcium can reduce the absorption of Tetracycline Fluoride preparations. Thiazide diuretics reduce the renal excretion of Calcium. Phenytoin, Barbiturates or Glucocorticoids may induce metabolism of Vitamin D3. Concomitant ingestion of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.
STORAGE CONDTION
Store in a cool & dry place, protect from light. Keep out of the reach of children.