Decal

COMPOSITION

Each tablet contains

Tribasic Calcium Phosphate                    400mg

Vitamin D₃                                              200IU                                                                     

DESCRIPTION

DECAL, a nutritional supplement contains Tribasic Calcium Phosphate and Vitamin D₃. Calcium and Vitamin D₃ tablet are much prescribed mineral and vitamin supplements for various conditions.

PHARMACOLOGY

Pharmacodynamics

Vitamin D is best characterized as a positive regulator of Ca²⁺ homeostasis besides other processes. The mechanisms by which vitamin D acts to maintain normal concentrations of Ca²⁺ and phosphate in plasma are to facilitate their absorption by the small intestine, to interact with parathyroid hormone (elicits the adaptive changes that maintain a constant concentration of Ca²⁺ in the extra cellular fluid by intestinal Ca²⁺ absorption, mobilization of bone Ca²⁺ and excretion of calcium in urine, feces, sweat, and milk) to enhance their mobilization from bone, and to decrease their excretion by the kidney. Although difficult to validate, Vitamin D has both direct and indirect effects on the cells that are involved in bone remodeling.

Pharmacokinetics

Tribasic Calcium Phosphate

In gastric medium, Tribasic Calcium Phosphate releases the calcium ion, according to the pH. Calcium is primarily absorbed in the high part of the small intestine. The rate of absorption through the gastro-intestinal way is about 30% of the introduced amount. [Urinary excretion of Ca²⁺ is the net result of the quantity filtered at the glomerulus and the amount reabsorbed. Tubular re-absorption is very efficient, more than 98% of the filtered Ca²⁺ returning to the circulation.] Urinary calcium depends on glomerular filtration and the tubular rate of re-absorption of calcium.

Vitamin D₃ (Cholecalciferol)

Vitamin D₃ is absorbed from the small intestine and is transported by protein components in blood to the liver (first hydroxylation) and the kidney (second hydroxylation). [Bile is essential for adequate absorption of vitamin D and thus hepatic or biliary dysfunction seriously impairs Vitamin D absorption.] The non-hydroxylated Vitamin D₃ is stored in the reserves compartments such as fat and muscles. The primary route of excretion of Vitamin D is the bile; only a small percentage of an administered dose is found in urine. Its plasmatic half-life is about 19-25 hours.

INDICATIONS AND USAGE

·         Calcium and Vitamin D3 deficiency and increased needs

·         Calcium supplementation in pregnancy and lactation

·         Osteoporosis, fractures, menopausal women

DOSAGE AND ADMINISTRATION

The usual dose is 1-2 tablets daily, depending on individual requirements of the patient. However the amount per day should not exceed 1500 mg calcium and 600 I.U. Vitamin D₃.

CONTRAINDICATIONS

§  Hypersensitivity to either one of the components

§  Hypocalcaemia

§  Hypercalciuria

WARNINGS AND PRECAUTIONS

The overdose results in a hypercalciuria and a hypocalcaemia whose symptoms are as follows: nausea, vomiting, polydipsia, polyuria, and constipation.

An overdose of Vitamin D₃ can cause vascular calcifications and tissue calcification because of the hypocalcaemia.

DECAL should be used cautiously in renal insufficiency. This product can be used during the pregnancy and breast-feeding. However, the amount per day should not exceed 1500 mg of Calcium and 600 I.U. of Vitamin D₃.

ADVERSE EFFECTS

§  Constipation

§  Flatulence

§  Nausea

§  Epigastric pain

§  Diarrhea

§  Calciuria (augmentation)

§  Calcemia (augmentation)

DRUG INTERACTIONS

§  Digitalis: The oral calcium administration associated with Vitamin D increases the toxicity of digitalis (risk of disorders of the rate/rhythm).

§  Thiazide diuretic: Monitoring of the calcium is recommended (reduction in the urinary elimination of calcium).

§  Tetracycline: It is recommended to administer at least three hours before/after the administration (possible reduction in the absorption of the tetracycline).

§  Phenytoin, barbiturates: Possible reduction in the effect of the Vitamin D₃ by inhibition of its metabolism.

§  Glucocorticoids: Possible reduction in the effect of the vitamin D₃.