COMPOSITION
- D TM : Each tablet contains Calcium Carbonate BP equivalent to 500 mg of elemental Calcium and Cholecalciferol (Vitamin D3) BP 200 IU.
PHARMACOLOGICAL INFORMATION
Pharmacological Action
Calcium is used as a pharmacological agent in humans almost entirely to remedy deficiency. Adequate calcium in the blood is so vital to a wide variety of bodily functions that our internal biochemistry will not tolerate a deficiency even for short periods .Clinical evidence suggests that calcium is useful for the prevention and treatment of osteoporosis and associated fractures. Vitamin-D is also essential for healthy bones as it aids calcium absorption from the GI tract. In addition to this it stimulates bone formation. Clinical studies show that calcium and vitamin-D has synergistic effects on bone growth as well as in Osteoporosis and fracture prevention.
Mechanism of Action
PROTEBON-D(Calcium with Vitamin D3) supports optimal calcium absorption and bone mineral composition, in addition of promoting potential cardiovascular and colon health. Several clinical trials reveal the positive effects of combined supplemental calcium and vitamin D for bone health. Vitamin D is important for its ability to promote intestinal calcium and phosphorous absorption, reduce urinary calcium loss and enhance healthy bone composition. Supplementation with calcium and vitamin D daily for one and a half years supported bone composition of the femur. Calcium and vitamin D supplementation promoted calcium utilization and maintained healthy bones in postmenopausal women. Vitamin D may also provide cardiovascular support for some individuals, which may be attributed to its effect on calcium metabolism or possibly by helping to maintain healthy plasma renin function. Additionally, calcium has been associated with supporting distal colon health. A role for vitamin D in supporting colon health by promoting healthy cellular function has also been suggested. Preliminary evidence suggests that vitamin D may also support healthy glucose metabolism, since vitamin D receptors are present on the islet cells of the pancreas.
CLINICAL INFORMATION
Therapeutic Indications
PROTEBON-D is used for the treatment of osteoporosis, osteomalacia, rickets, tetany and parathyroid disease. Also used in raised calcium requirement for children and adolescents at times of rapid growth, inadequate intake of calcium in the diet due to malnutrition, prevention and treatment of osteoporosis, disorders of osteogenesis and tooth formation (in addition to specific treatment).
Dosage and Administration
Two tablets daily or one tablet twice daily. It is best taken with or just after a meal to improve absorption. Each dose should be taken with a full glass of water.
Use in Pregnancy & Lactation
It should be used as directed by the physician during pregnancy and lactation. During pregnancy and lactation requirements for Calcium and Vitamin-D are increased but in deciding on the required supplementation allowances should be made for availability of these agents from other sources.
Contraindications
Absolute contraindications are hypercalcaemia, primary hyperparathyroidism, kidney stone, severe renal failure, Calcium & Vitamin D overdose, hypersensitivity to any of the tablet ingredients.
Drug Interactions
It has possible interaction with digoxin , antacids containing calcium, aluminum or magnesium, other calcium supplements, calcitriol or other vitamin-D supplements; tetracycline, doxycycline, aminocycline or oxytetracycline etc. So before taking any of these drugs consultations with the physicians are needed.
Adverse Effects
Orally administered Calcium Carbonate may be irritating to the GI tract. It may also cause constipation. Hypercalcaemia is rarely produced by administration of calcium alone, but may occur when large doses are given to patients with chronic renal failure. Also there may be allergic reactions, irregular heart beats, nausea, vomiting, decreased appetite dry mouth and drowsiness.
Overdose
Symptoms of overdose may include nausea and vomiting, severe drowsiness, dry mouth, loss of appetite, metallic taste, stomach cramps, unconsciousness, diarrhea, weakness, headache, constipation, dizziness or irritability.
PHARMACEUTICAL INFORMATION
Storage and Shelf-life
PROTEBON-D tablets should be stored at a temperature not exceeding 25°. Protect from light and keep away from children.
Presentation & Packaging
PROTEBON-D Tablet: Each commercial box contains 30 tablets in HDPE container. |