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Milical
 

Composition
Each Film coated Tablet contains:

Calcium Citrate USP ..... 1000 mg

Vitamin D3 Granules Type 850 equivalent to Cholecalciferol USP ..... 200 IU

Appropriate Overages of Vitamin added to compensate for loss on storage

 

Preservatives
Methyl Hydroxybenzoate BP .....1.04 mg

Propyl Hydroxybenzoate BP ..... 0.65 mg


Colour: Titanium Dioxide BP


Therapeutic class

Calcium Supplement


Identification
A printed carton containing 3 printed, blister strips each containing 10 white, capsule shaped, film coated tablets with breakline on one side


Indications
Pregnancy and lactation.
For treatment & prevention of postmenopausal osteoporosis.
For prevention of osteoporosis in other susceptible populations such as the elderly, chronic bed-ridden patients; those on chronic steroid medication, anticonvulsants.
As a therapeutic adjunct while treating established osteoporosis.


Dosage
The usual dose is 1 tablet twice daily or as directed by the Physician.


Contraindications
Hypercalcemia (Secondary to primary hyperparathyroidism, Vitamin D overdosage, sarcoidosis, malignant bone diseases, myeloma, bone metastases).
Severe Hypercalciuria and extensive nephrolithiasis.
Severe renal failure.


Adverse Effects
MILICAL is generally well tolerated with an overall safety profile. In recommended dosage, MILICAL usually does not cause side effects such as flatulence, bloating, abdominal discomfort and constipation which are frequently encountered with calcium carbonate and other supplements. MILICAL relatively carries lower risk for the development of oxalate stones in the susceptible lithogenic population. Calcium citrate administration has not been demonstrated to interfere with the absorption of iron. Concurrent tetracycline preparations are not advised, for MILICAL may lower the bioavailability of the former. MILICAL can interfere with the absorption of bisphosphonates. Thiazides reduces urinary excretion of calcium and may increase the risk of hypercalcemia. Indiscriminate and prolonged ingestion of vitamin D in high doses can cause hypervitaminosis of vitamin D that may result in hypercalcemia. Hypercalcemia is particularly dangerous in patients receiving cardiac glycosides.


Precautions and warning
MILICAL should be used cautiously in following conditions:
Arteriosclerosis (potential exacerbation related to persistent hypercalcemic effects during therapeutic use)
Cardiac conditions (potential exacerbation related to persistent hypercalcemic effects during therapeutic use)
Concurrent use of calcium-containing preparations, other vitamin D-containing preparations or vitamin D analogs, or thiazide diuretics (enhanced risk of hypercalcemia)
Hyperlipidemia (potential exacerbation of LDL elevation)
Hyperphosphatemia (risk of metastatic calcification; normalization of phosphate levels indicated prior to therapy)
Liver disease (impaired absorption)
Renal impaired (potential exacerbation related to hyperealvemic effects during therapeutic use)
Renal osteodystrophy/other conditions requiring high doses of pure vitamin D (vitamin D metabolites preferred, such as calcitriol)
Sarcoidosis/other granulomatous disease (potential for enhanced sensitivity to vitamin D)


Symptoms and treatment of overdose
Excessive calcium intake can lead to constipation, anorexia, nausea, vomiting and kidney failure. Vitamin D3 should be given with care to patients with impaired renal function. Calcium and phosphorus levels in serum and urine are raised following massive doses and hypertension and renal failure may follow. Withdraw treatment immediately and administer large quantities of fluids and electrolytes.


Presentation: 3 x 10's


Storage Instructions and shelf life
Store below 25C. Protect from moisture & light.


Shelf Life: 24 Months

 

Distribution Category: OTC

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