Nexcal

                                                                                                         

COMPOSITION

Each  Chewable Tablet contains;                        

Calcium Citrate Malate……………250mg

Vitamin D3 …………………………200I.U                 

DESCRIPTION
Calcium citrate malate is a water-soluble calcium supplement. It is the calcium salt of citric acid and malic acid with variable composition. It is purported to be highly bioavailable.
Calcium citrate malate's bioavailability stems from its water-solubility and its method of dissolution. When dissolved, it releases calcium ions and a calcium-citrate complex. Calcium ions are absorbed directly into intestinal cells, and the citrate complex enters the body through paracellular absorption.
 Calcium Citrate Malate is the most absorbable calcium available. This patented ingredient combines calcium carbonate with citric acid (from citrus fruits) and malic acid (from apples) that help to increase calcium absorption.
 This combination medication is used to prevent or treat low blood calcium levels in people who do not get enough calcium from their diets. .
Calcium plays a critical role in the body. It is essential for normal functioning of nerves, cells, muscle and bone. Calcium prevents bone loss and is associated with a modest reduction in fracture risk. Calcium and vitamin D preparations are used to prevent or to treat calcium deficiency. A vitamin D resistant state may exist in uremic patients because of the failure of the kidney to adequately produce calcitriol.

PHARMACODYNAMIC

In case of calcium deficiency, oral intake of calcium supplementation supports the remineralisation of the skeleton. Vitamin D3 increases the intestinal absorption of calcium.Calcium and Vitamin D deficiency causes an increase in parathyroid hormone (PTH) which is responsible for increased bone resorption. Administration of calcium and vitamin D3 counteracts this increase in PTH and thereby bone resorption.

PHARMACOKINETICS ]

Vitamin D3

Absorption

Vitamin D is readily 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

hydroxycholecalciferol. 1,25 hydroxycholecalciferol is the metabolite responsible for

increasing calcium absorption. Vitamin D that is not metabolised is stored in adipose and muscle tissues.

Elimination

Vitamin D is excreted in faeces and urine.

Calcium Citrate Malate

Absorption

Calcium Citrate Malate salt is comprised of 23.7% elemental calcium. In a study conducted to calculate percent absorption of test dose in humans it was seen that calcium citrate malate had a mean percent absorption of 37.3%.

Distribution and metabolism

99% of calcium in the body is concentrated in the hard structure of bones and teeth. The remaining 1% is present in the intra- and extracellular fluids. About 50% of the total blood calcium content is physiologically active ionized form with approximately 10% being complexed to citrate, phosphate or other anions, the remaining 40% being bound to proteins, principally albumin.

 Elimination

Calcium is eliminated through faeces, urine and sweat. Renal excretion depends on glomerular filtration and calcium tubular reabsorption.

 

INDICATIONS AND DOSAGE;

ü   In pregnancy

ü   Prevention and treatment of calcium deficiency or vitamin D deficiency especially in the elderly subjects,

ü  Osteoporosis

ü  Management of hypocalcaemia in patients undergoing dialysis for chronic renal failure.and improvement in renal osteodystrophy

ü  Post-menopausal osteoporosis.

ü  Hypocalcaemia in hypoparathyroidism

ü  Parathyroidectomy

ü  Renal tubular osteocalcaemia

ü  Sporadic and oncogenic hypophasphatemicosteomalacia

ü  X-linked hypophosphatemicosteomalacia

ü  Osteomalacia in Malabsorption syndrome

ü  Hypocalcaemia after small bowel resection

.

DOSAGE AND ADMINISTRATION; one to three tablet per day as Need.

Missed Dose

Calcium/vitamin D3

If the calcium/vitamin D3  dose is missed, the patient should be instructed to take the

tablets as soon as remembered and then continue taking Calcium/vitamin D3 tablet

twice  or thrice daily as scheduled.

   Overdose

Overdose can lead to hypervitaminosis, hypercalciuria and hypercalcaemia.

Symptomsof hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain, nephrocalcinosis, renal calculi and in severe cases, cardiac arrhythmias.

Extreme hypercalcaemia may result in coma and death.

  Persistently high calcium levels may lead to irreversible renal damage and soft tissue calcification

.

Treatment of hypercalcaemia: The treatment with calcium must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D3 and cardiac glycosides must also be discontinued.

Emptying of the stomach in patients with impaired consciousness. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and central venous pressure should be followed.

CONTRA-INDICATIONS

ü  .Hypercalcaemia

ü  Primary hyperparathyroidism and vitamin D overdosage,

ü  Severe renal failure,

ü  Hypersensitivity to any component of the product.

ü  Osteoporosis due to prolonged immobilisation,

ü  Renal stones,

ü  Severe hypercalciuria

ü  Hypervitaminosis D

PRECAUTION AND WARNING;

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.

The risk of soft tissuecalcification should be taken into account.

In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol is not metabolized normally and another form of vitamin D should be used.

During long-term treatment, serum and urinary calcium levels should be followed and renal function should be monitored through measurement of serum creatinine.

 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.

Treatment must be reduced or suspended if urinary calcium exceeds 7.5 mmol/24 hours (300 mg/24 hour).

In case of hypercalcaemia or signs of impaired renal function, treatment with calcium/vitamin D3 should be discontinued.

The dose of vitamin D3  should be considered when prescribing other drugs containing

vitamin D.

Additional doses of calcium or vitamin D should be taken under close medical supervision. In such cases it is necessary to monitor serum calcium levels and urinary calcium excretion frequently.

Calcium/vitamin D3 should be used with caution in patients suffering from sarcoidosis because of the risk of increased metabolism of vitamin D to its active metabolite.

In these patients, serum calcium levels and urinary calcium excretion must be monitored.

Calcium/vitamin D3  should be used with caution in immobilized patients with osteoporosis due to the increased risk of hypercalcaemia.

The calcium/vitamin D3   treatment might be discontinued in prolonged immobilization and should only be resumed once the patient becomes mobile again

Pregnancy & lactation ;

Category C. There are no adequate and well-controlled studies in pregnant women. NEXCAL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Calcitriol may be excreted in human milk. A mother should not nurse while taking  NEXCAL.

Paediatric use

Safety and effectiveness in pediatric patients have not been established.

Geriatric use

No overall differences in safety between geriatric and younger patients were observed in the calcium/vit D3 trials, but greater sensitivity of some older individuals cannot be ruled out.

No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (>60 years of age) compared to younger subjects. This has also been shown in the very elderly, 75 years old and above in postmenopausal population

ADVERSE REACTION

Adverse reactions are listed below, by system organ class and frequency following

convention: very common (1/10); common (1/100; <1/10); uncommon (1/1,000; <1/100);

rare (1/10,000; <1/1,000); very rare (<1/10,000).

Metabolism and nutrition disorders Uncommon: Hypercalcaemia and hypercalciuria.

Gastrointestinal disorders

Rare: Constipation, flatulence, nausea, abdominal pain and diarrhoea.

Skin and subcutaneous disorders

Rare: Pruritus, rash and urticaria.

DRUG INTERACTION

Thiazide diuretics

Thiazide diuretics reduce the urinary excretion of calcium. Due to increased risk of hypercalcaemia serum calcium should be regularly monitored during concomitant use of thiazide diuretics.

Systemic corticosteroids

Systemic corticosteroids reduce calcium absorption. During concomitant use, it may be necessary to increase the dose of calcium.

Tetracycline

Calcium citrate malate may interfere with the absorption of concomitant administered tetracycline preparations. For this reason, tetracycline preparations should be administered at least two hours before or four to six hours after oral intake of calcium

/vitamin D3.

Digitalis

Hypercalcaemia may increase the toxicity of digitalis and other cardiac glycosides (risk of dysrhythmia) during treatment with calcium combined with vitamin D3. Such patients should be monitored with regard to electrocardiogram (ECG) and serum calcium levels.

Sodium fluoride

If sodium fluoride is used concomitantly, this preparation should be administered at least three hours before intake of calcium /vitamin D3 since gastrointestinal absorption may be reduced.

Oxalic acid and Phytic acid

Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals) may inhibit calcium absorption through formation of insoluble compounds with calcium ions. The patient should not take calcium products within two hours of eating foods with high concentration of oxalic acid and phytic acid.

Cholestyramine or laxatives

Simultaneous treatment with ion exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.

STORAGE AND HANDLING INSTRUCTIONS

Store in a cool dry place, protect from light.

PRESENTATION:

Nexcal is available in a blister of 10 Tablets.

Each box of Nexcal contains 10X 10’s