COMPOSITION
Each film-coated tablet contains:
– Active ingredients:
Calcium Carbonate……………..750mg (e.q to 300mg Calcium)
Cholecalciferol ………………..5mcg
– Excipients: Crospovidone, microcrystalline cellulose, hypromellose, titanium dioxide, maltodextrin, carnauba wax, yellow iron oxide, carmellose sodium, magnesium stearate, macrogol 8000
PHARMACOKINETIC & PHARMACOLOGY
PHARMACOKINETIC
Vitamin D increases the intestinal absorption of calcium.
Administration of calcium and Vitamin D3 (cholecalciferol) counteracts the increase of parathyroid hormone (PTH), which is caused by calcium deficiency and which causes increased bone resorption.
A clinical study of institutionalised patients suffering from vitamin D deficiency indicated that a daily intake of two tablets of calcium 500mg/ Vitamin D 400 IU for six months normalised the value of the 25-hydroxylated metabolite of Vitamin D3 and reduced secondary hyperparathyroidism and alkaline phosphatases.
An 18-month double-blind, placebo-controlled study including 3270 insitutionalised women aged 84±6 years that received supplementation of vitamin D (800 IU/ day) and calcium (1200 mg/day) as calcium phosphate, showed a significant decrease of PTH secretion. After 18 months, an “intent-to-treat” analysis showed 80 hip fractures in the calcium-vitamin D group and 110 hip fractures in the placebo group (p=0.004). A follow-up study after 36 months showed 137 women with at least one hip fracture in the calcium-vitamin D group (n=1176) and 178 in the placebo group (n=1127, p<0.02).
PHARMACOLOGY
PHARMACOKINETIC PROPERTIES
Calcium
Absorption:
The amount of calcium absorbed through the gastrointestinal tract is approximately 30% of the swallowed dose.
Distribution and metabolism:
99% of the 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 in the physiologically active ionised 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.
Vitamin D
Absorption:
Vitamin D3 is 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 which is not metabolised is stored in adipose and muscle tissues.
Elimination:
Vitamin D is excreted in faeces and urine
INDICATION
Supplementing calcium and vitamin D in cases of calcium deficiency due to diet, reduce the risk of osteoporosis.
Supporting reducing the risk of bone density loss and fractures due to osteoporosis
DOSE AND USAGE
Adults and children over 12 years old: 1-2 tablets per dose, 2 times a day. Children ≤ 12 years old: There is no recommended dosage for this age group.
Hepatic impairment: No dose adjustment is required.
Renal impairment: Should not be used, especially in patients with severe renal impairment.
OKVITKA is taken orally. It is recommended that OKVITKA is taken within one and a half hours of a meal with a glass of water or juice.
CONTRAINDICATION & UNEXPECTED EFFECTS
Contraindication
Diseases and/or conditions resulting in hypercalcaemia and/or hypercalciuria (e.g. myeloma, bone metastases primary hyperparathyroidism).
Nephrolithiasis, nephrocalcinosis
Severe renal impairment and renal failure
Hypervitaminosis D
Hypersensitivity to the active substances or to any of the excipients of OKVITKA
Unexpected effects
Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as:
uncommon (>1/1.000 to <1/100); rare (>1/10.000 to <1/1.000); very rare (<1/10.000)
Metabolism and nutrition disorders
Uncommon: Hypercalcaemia and hypercalciuria.
Very rare: Milk-alkali syndrome (Seen usually only in overdose)
Gastrointestinal disorders
Rare: Constipation, flatulence, nausea, abdominal pain, and diarrhoea.
Very rare: Dyspepsia
Skin and subcutaneous disorders
Rare: Pruritus, rash and urticaria.
Other special population
Patients with renal impairment: potential risk of hyperphosphatemia, nephrolithiasis and nephrocalcinosis.
WARNING AND CAUTION
During treatment, serum calcium levels should be followed and renal function should be monitored through measurements 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 of OKVITKA should be reduced or the treatment discontinued if urinary calcium exceeds 7.5 mmol/24 h (or 300 mg elemental calcium/24 h).
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.
OKVITKA should be prescribed with caution to patients suffering from sarcoidosis, due to the risk of increased metabolism of vitamin D into its active form. These patients should be monitored with regard to the calcium content in serum and urine.
OKVITKA should be used with caution in immobilised patients with osteoporosis due to increased risk of hypercalcaemia.
Considering when prescribing other medicinal products 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. Milk-alkali syndrome (Burnett’s syndrome), i.e. hypercalcaemia, alkalosis and renal impairment can develop when large amounts of calcium are ingested with absorbable alkali.
PREGNANT AND BREASTFEEDING WOMEN
Pregnancy
OKVITKA may be given during pregnancy in cases of calcium and vitamin D3 deficiency.
During pregnancy the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D (equivalent to 15 mcg of cholecalciferol). Animal studies have shown toxic effects on reproduction at high doses of vitamin D. In pregnant women, all calcium or vitamin D overdoses must be avoided as prolonged hypercalcaemia in pregnancy may lead to retardation of physical and mental development, supravalvular aortic stenosis and retinopathy in the child. There are no indications that Vitamin D3 at therapeutic doses is teratogenic in human.
Breastfeeding
OKVITKA can be used during breastfeeding. Calcium and vitamin D pass into breast milk. Therefore, caution is advised when supplementing vitamin D for infants.
EFFECT OF MEDICINE WHILE DRIVING AND MACHINE OPERATION
There are no data on the effect of this product on the ability to driver or use machines.
INTERACTION WITH OTHER MEDICINES; OTHER KINDS OF INTERACTION
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 OKVITKA
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 with OKVITKA, these medicinal products should be administered at least three hours before the intake of OKVITKA since gastrointestinal absorption may be reduced.
Rifampicin, phenytoin or barbiturates may reduce the activity of vitamin D3, since they increase the rate of its metabolism.
The absorption of quinolone antibiotics may be impaired if administered concomitantly with calcium. Quinolone antibiotics should be taken two hours before or six hours after intake of calcium.
Calcium salts may decrease the absorption of iron, zinc or strontium. Consequently, the iron, zinc or strontium preparation should be taken at a distance of two hours from the calcium preparation.
Calcium salts may reduce the absorption of the estramustin or thyroid hormones. It is recommended that taking OKVITKAs be spaced at least 2 hours from these medicines.
Oxalic acid (found in spinach, sorrel and rhubarb), phosphate 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 high in oxalic acid and phytic acid.
Over dosage:
Overdose can lead to hypervitaminosis and hypercalcaemia. Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, paralysis, 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.
Milk-alkali syndrome may occur in patients who ingest large amounts of calcium and absorbable alkali. Symptoms are frequent urge to urinate, continuing headache, continuing loss of appetite, nausea or vomiting, unusual tiredness or weakness, hypercalcaemia, alkalosis and renal impairment.
Treatment of hypercalcaemia: The treatment with calcium and vitamin D must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, vitamin D and cardiac glycosides must also be discontinued. Induce vomiting, 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.
Packaging: 03 blisters x 10 Film coated tablets
Period of use: 2 years from date of manufacture.
Storage: I Storage at a cool dry place, protected from light, at temperatures below 30°C.
Prescription only medicine
Keep out of the reach of children
Read carefully the leaflet before use
If you have any question, ask our doctor
MANUFACTURER
Toll manufacturer
LIPA PHARMACEUTICALS LTD.
21 Reaghs Farm Road, MINTO NSW 2566, Australia.
