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Product Information
OKICAL
Okical
Calcium Carbonate (natural coral) & Cholecalciferol
Presentation
Okical-D tablet: White, oblong shaped, film coated tablet; each tablet contains Calcium Carbonate (natural coral) USP equivalent
to Elemental Calcium 500 mg and Cholecalciferol USP equivalent to Vitamin D3 400 IU.
Okical-DX tablet: White, oval shaped, having engraved on one side, film coated tablet; each tablet contains Calcium Carbonate
(natural coral) USP equivalent to Elemental Calcium 600 mg and Cholecalciferol USP equivalent to Vitamin D3 400 IU.
Indications
Okical (Elemental Calcium & Vitamin D3) tablet is indicated for the treatment and prevention of osteoporosis, osteomalacia,
rickets, tetany and pseudohypoparathyroidism. Also suggested to use as a dietary supplement where calcium intake may be
inadequate; (during pregnancy, lactation, postmenopausal women and the aged).
Dosage and administration
Okical-D tablet: One Okical-D (Elemental Calcium 500 mg & Vitamin D3 400 IU) tablet 2 times daily with meals or as recommended by
a physician.
Okical-DX tablet: One Okical-DX (Elemental Calcium 600 mg & Vitamin D3 400 IU) tablet 2 times daily with meals for elderly
patients or as recommended by a physician.
Contra-indications, warnings etc.
Contra-indications: Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria, nephrolithiasis,
hypervitaminosis D, hypersensitivity to the active substances or to any of the excipients.
Warnings and precautions: During long-term treatment, serum 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. In case of hypercalcaemia or
signs of impaired renal function, the dose should be reduced or the treatment discontinued. Vitamin D 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
tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of
cholecalciferol is not metabolised normally and other forms of vitamin D should be used. Elemental Calcium & Vitamin D3 tablet
should be prescribed with caution to 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. Elemental
Calcium & Vitamin D3 tablet should be used with caution in immobilised patients with osteoporosis due to the increased risk of
hypercalcaemia. The dose of vitamin D in Elemental Calcium & Vitamin D3 tablet 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.
Drug interactions: 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 reduce calcium
absorption. During concomitant use, it may be necessary to increase the dose of calcium tablet. Simultaneous treatment with ion
exchange resins such as cholestyramine or laxatives such as paraffin oil may reduce the gastrointestinal absorption of vitamin D.
Calcium carbonate may interfere with the absorption of concomitantly 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.
Hypercalcaemia may increase the toxicity of cardiac glycosides during treatment with calcium and vitamin D. Patients should be
monitored with regard to electrocardiogram (ECG) and serum calcium levels. If a bisphosphonate or sodium fluoride is used
concomitantly, this preparation should be administered at least three hours before the intake of calcium tablet since
gastrointestinal absorption may be reduced. Oxalic acid (found in spinach and rhubarb) and phytic acid (found in whole cereals)
may inhibit calcium absorption through formation of insoluble calcium salts. The patient should not take calcium products within
two hours of eating foods high in oxalic acid and phytic acid.
Use in pregnancy and lactation: During pregnancy the daily intake should not exceed 1500 mg calcium and 600 IU cholecalciferol (15
mcg vitamin D). Studies in animals have shown reproductive toxicity with high dose of vitamin D. In pregnant women, overdoses of
calcium and vitamin D should be avoided as permanent hypercalcaemia has been related to adverse effects on the developing foetus.
There are no indications that vitamin D at therapeutic doses is teratogenic in humans. Elemental Calcium & Vitamin D3 tablet can
be used during pregnancy, in case of a calcium and vitamin D deficiency. Elemental Calcium & Vitamin D3 tablet can be used during
breast-feeding. Calcium and vitamin D3 pass into breast milk. This should be considered when giving additional vitamin D to the
child.
Side effects: Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: (uncommon
>1/1,000, <1/100 or rare >1/10,000, <1/1,000). 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.
Overdose: Overdose can lead to hypervitaminosis D and hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst,
nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, polyuria, bone pain,
nephrocalcinosis, nephrolithiasis 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 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 CVP should be followed.
Pharmaceutical precautions
Store in a cool and dry place, protected from light.
Packaging quantities
Okical-D tablet: Cartons containing 30 tablets in Alu-Alu blisters.
Okical-DX tablet: Cartons containing 30 tablets in Alu-Alu blisters.
Manufactured by
UniMed & UniHealth Manufacturers Ltd.
B K Bari, Gazipur, Bangladesh.
® Registered Trademark
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৳48.00
-
৳120.40
-
৳30.00
-
৳100.00
-
৳120.00
-
৳300.00