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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 25°C. Protect from moisture & light.
Shelf Life: 24 Months
Distribution Category: OTC
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