BRIVITA Vitamin D3
Vitamin D3 is the body’s natural form of Vitamin D – essential for the efficient absorption of calcium and phosphorus which is vital for strong bones, muscle development and the immune system.
Composition
Active ingredients
Each softgel capsule contains:
Colecalciferol 25 mcg, equivalent to Vitamin D3 1000 I.U.
Colecalciferol 25 mcg, equivalent to Vitamin D3 1000 I.U.
Excipients
Medium Chain Triglycerides, dl-alpha Tocopherol. Rice bran Oil, glycerol, gelatin
THERAPEUTIC INDICATIONS
Colecalciferol (vitamin D3) is a fat-soluble vitamin that helps the body absorb calcium used in:
- Treatment of vitamin D deficiency
- Prevention of vitamin D deficiency in high risk patients
- As an adjunct to specific therapy for osteoporosis in patients with vitamin D deficiency or at risk of vitamin D insufficiency
- Colecalciferol is also used to assist in the treatment of common lupus, rheumatoid arthritis and psoriasis.
CONTRAINDICATIONS
Do not use the medicine if:
- Hypersensitivity to Vitamin D or any of the ingredients of the medicine.
- Conditions of hypercalcemia or hypercalciuria.
- Calcium renal calculi, renal calculi, Vitamin D toxicity.
- Severe renal impairment.
DOSAGE AND ADMINISTRATION
The dosage should be established for each patient depending on the level of Vitamin D supplementation required.
The dosage must be as prescribed by the physician.
Method of administration: Oral. Swallow the tablet whole (do not chew) with water.
Missed dose: If a dose is missed, take it as soon as you realize. If it is near the time for the next dose, skip the missed dose and continue the dosing schedule. Do not take a double dose to make up for a missed dose.
The dosage must be as prescribed by the physician.
Adults and the elderly:
- Prevention of Vitamin D deficiency: take 1 tablet/day. Take with or without food.
- Treatment of Vitamin D deficiency (serum 25 - 50nmol/l or 10 - 20 ng/ml): take 1 to 4 tablets/day for 10 weeks or as prescribed by the physician.
- Osteoporosis: take 1 tablet/day. Patients should supplement Calcium if the diet is inadequate.
Children (12-18 years old):
- Vitamin D deficiency or insufficiency: take 1 tablet/day, only use when prescribed by the physician.
Do not use for children under 12 years old.
Hepatic impairment: No dose adjustment is required for patients with hepatic impairment.Method of administration: Oral. Swallow the tablet whole (do not chew) with water.
Missed dose: If a dose is missed, take it as soon as you realize. If it is near the time for the next dose, skip the missed dose and continue the dosing schedule. Do not take a double dose to make up for a missed dose.
WARNINGS AND PRECAUTIONS
Caution should be exercised when using Colecalciferol in patients with impaired renal function and the effects of Calcium and Phosphate levels should be monitored. The risk of soft tissue calcification should be considered. In patients with severe renal impairment, Vitamin D in the form of Colecalciferol is not metabolized normally and other forms of Vitamin D should be used.
Colecalciferol should not be used in patients prone to the formation of calcium renal stones. Caution is required in patients undergoing treatment for cardiovascular disease.
Colecalciferol should be prescribed with caution in patients with sarcoidosis due to the risk of increased metabolism of Vitamin D to its active form. These patients should be monitored for serum and urinary Calcium levels.
Consider Vitamin D supplementation, other drugs containing Vitamin D, or supplementation from other sources.
Consider additional Calcium supplementation on a patient-by-patient basis. Calcium supplementation should be carried out under close medical supervision.
Medical supervision is necessary during treatment to prevent hypercalcemia.
Colecalciferol should not be used in patients prone to the formation of calcium renal stones. Caution is required in patients undergoing treatment for cardiovascular disease.
Colecalciferol should be prescribed with caution in patients with sarcoidosis due to the risk of increased metabolism of Vitamin D to its active form. These patients should be monitored for serum and urinary Calcium levels.
Consider Vitamin D supplementation, other drugs containing Vitamin D, or supplementation from other sources.
Consider additional Calcium supplementation on a patient-by-patient basis. Calcium supplementation should be carried out under close medical supervision.
Medical supervision is necessary during treatment to prevent hypercalcemia.
BRIVITA Vitamin D3 contains 45.58mg of Glycerol per tablet
PACKAGING
Box of 1 bottle, the bottle contains 30 or 60 soft capsules. Each capsule contains 1000 international units of Vitamin D3. The box includes a Vietnamese package insert.
PREGNANCY AND LACTATION
Pregnancy
Colecalciferol should not be used during pregnancy unless the clinical condition of the woman requires treatment with colecalciferol, at a dose necessary to overcome the deficiency.
During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment.
Based on human experience and animal studies, vitamin D overdose causes physical and mental disability and congenital heart and eye conditions, due to hypercalcaemia, when administered during pregnancy.
Lactation
Vitamin D and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed. However, when prescribing additional vitamin D to a breast-fed child the practitioner should consider the dose of any additional vitamin D given to the mother.
Colecalciferol should not be used during pregnancy unless the clinical condition of the woman requires treatment with colecalciferol, at a dose necessary to overcome the deficiency.
During pregnancy women should follow the advice of their medical practitioner as their requirements may vary depending on the severity of their disease and their response to treatment.
Based on human experience and animal studies, vitamin D overdose causes physical and mental disability and congenital heart and eye conditions, due to hypercalcaemia, when administered during pregnancy.
Lactation
Vitamin D and its metabolites are excreted in breast milk. Overdose in infants induced by nursing mothers has not been observed. However, when prescribing additional vitamin D to a breast-fed child the practitioner should consider the dose of any additional vitamin D given to the mother.
UNDESIRABLE EFFECTS
The adverse reactions are classified according to frequency of observation: Very common: ≥ 1/10, Common ≥ 1/100, No Common ≥ 1 / 1,000 - ≤1 / 100 Rare: ≥ 10,000 -
Adverse reactions are listed below, by system organ class and frequency.
Metabolism and nutrition disorders
Adverse reactions are listed below, by system organ class and frequency.
Metabolism and nutrition disorders
- Uncommon: Hypercalcaemia, hypercalciuria
- Rare : Pruritus,Rash, Urticaria
EFFECTS ON THE ABILITY TO DRIVE AND USE MACHINES
Vitamin D has no known side effects that are likely to affect the ability to drive and use or operate machines.
INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
- Phosphate infusions should not be administered to lower hypercalcaemia of hypervitaminosis D because of the dangers of metastatic calcification.
- Patients treated with cardiac glycosides may be susceptible to high calcium levels and should have ECG parameters and calcium levels monitored. It is recommended to reduce the dose or interrupt treatment if the calcium content in the urine exceeds 7.5 mmol/24 hours (300 mg/24 hours).
- Simultaneous administration of benzothiadiazine derivatives (thiazide diuretics) increases the risk of hypercalcaemia because they decrease the calcium excretion in the urine. The calcium levels in plasma and urine should therefore be monitored for patients undergoing long-term treatment.
- If Colecalciferol is combined with metabolites or analogues of vitamin D careful monitoring of serum calcium levels is recommended. Check the label on all prescription and over-the-counter medications / herbal products (such as antacids, laxatives, vitamins) if you are using them because they may contain calcium, magnesium, phosphate or vitamin D. Vitamin D is very similar to calcitriol. Do not use medications containing calcitriol while using vitamin D.
- Anti-convulsants e.g. phenytoin, phenobarbital, primidone may diminish the effect of Colecalciferol due to hepatic enzyme induction.
- Rifampicin may reduce the effectiveness of Colecalciferol due to hepatic enzyme induction.
- Isoniazid may reduce the effectiveness of Colecalciferol due to inhibition of the metabolic activation of Colecalciferol.
- Drugs leading to fat malabsorption, e.g. orlistat, liquid paraffin, cholestyramine, may impair the absorption of Colecalciferol.
- The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.
Concomitant use of glucocorticoids can decrease the effect of vitamin D.
- Patients treated with cardiac glycosides may be susceptible to high calcium levels and should have ECG parameters and calcium levels monitored. It is recommended to reduce the dose or interrupt treatment if the calcium content in the urine exceeds 7.5 mmol/24 hours (300 mg/24 hours).
- Simultaneous administration of benzothiadiazine derivatives (thiazide diuretics) increases the risk of hypercalcaemia because they decrease the calcium excretion in the urine. The calcium levels in plasma and urine should therefore be monitored for patients undergoing long-term treatment.
- If Colecalciferol is combined with metabolites or analogues of vitamin D careful monitoring of serum calcium levels is recommended. Check the label on all prescription and over-the-counter medications / herbal products (such as antacids, laxatives, vitamins) if you are using them because they may contain calcium, magnesium, phosphate or vitamin D. Vitamin D is very similar to calcitriol. Do not use medications containing calcitriol while using vitamin D.
- Anti-convulsants e.g. phenytoin, phenobarbital, primidone may diminish the effect of Colecalciferol due to hepatic enzyme induction.
- Rifampicin may reduce the effectiveness of Colecalciferol due to hepatic enzyme induction.
- Isoniazid may reduce the effectiveness of Colecalciferol due to inhibition of the metabolic activation of Colecalciferol.
- Drugs leading to fat malabsorption, e.g. orlistat, liquid paraffin, cholestyramine, may impair the absorption of Colecalciferol.
- The cytotoxic agent actinomycin and imidazole antifungal agents interfere with vitamin D activity by inhibiting the conversion of 25-hydroxyvitamin D to 1,25-dihydroxyvitamin D by the kidney enzyme, 25-hydroxyvitamin D-1-hydroxylase.
Concomitant use of glucocorticoids can decrease the effect of vitamin D.
SPECIAL PRECAUTIONS FOR STORAGE & SHELF LIFE, DRUG QUALITY STANDARDS
Special precautions for Storage: below 30⁰C. in dry place, protect from light. Keep out of reach of children. Do not use medicine beyond the expiry date indicated on the label or when the packaging is damaged.
Shelf life: 36 months from the date of manufacture.
Standard: Manufacturer.
Shelf life: 36 months from the date of manufacture.
Standard: Manufacturer.
PHARMACODYNAMIC PROPERTIES
Pharmacotherapeutic group: Vitamin D and analogues
ATC code: A11CC05
Colecalciferol is produced within the skin under the influence of UV radiation including sunlight. In its biologically active form, Colecalciferol stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, and release of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone (PTH) in the parathyroids is inhibited directly by the biologically active form of Colecalciferol. PTH secretion is inhibited additionally by the increased calcium uptake in the small intestine under the influence of biologically active Colecalciferol.
ATC code: A11CC05
Colecalciferol is produced within the skin under the influence of UV radiation including sunlight. In its biologically active form, Colecalciferol stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, and release of calcium from bone tissue. In the small intestine it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone (PTH) in the parathyroids is inhibited directly by the biologically active form of Colecalciferol. PTH secretion is inhibited additionally by the increased calcium uptake in the small intestine under the influence of biologically active Colecalciferol.
PHARMACOKINETIC PROPERTIES
The pharmacokinetics of Colecalciferol have been widely studied and are well-known. Colecalciferol from nutritional sources is almost completely absorbed from within the gastro-intestinal tract in the presence of dietary lipids and bile acids. Colecalciferol is stored in fat cells and its biological half-life is approximately 50 days.
Colecalciferol is metabolised by microsomal hydroxylase to form 25-hydroxycolecalciferol (25(OH)D3, calcidiol), the primary storage form of vitamin D3. 25(OH)D3 undergoes a secondary hydroxylation within the kidney to form the predominant active metabolite 1,25-hydroxycolecalciferol (1,25(OH)2D3, calcitriol). The metabolites circulate in the blood bound to a specific α-globin.
After a single oral dose of Colecalciferol, the maximum serum concentrations of the primary storage form are reached after approximately 7 days. 25(OH)D3 is then slowly eliminated with an apparent half-life in serum of about 50 days. Colecalciferol and its metabolites are excreted mainly in the bile and faeces.
After high doses of Colecalciferol, serum concentrations of 25(OH)D3 may be increased for months. Overdose-induced hypercalcaemia may persist for weeks (see 4.9 "Overdose”).
Colecalciferol and its metabolites are excreted mainly in bile and faeces, only a small amount appears in the urine. Vitamin D3 can be passed into milk.
Pre-clinical safety data:
Colecalciferol is well known and established product and has been used in clinical practice for many years. No further specific toxicological hazard for humans is expected other than in chronic overdosage where hypercalcaemia could be seen.
Colecalciferol overdosage in animals has been shown to induce malformations in rats, mice and rabbits at doses significantly higher than the human dose. The malformations included skeletal defects, microcephaly and cardiac malformations.
At doses equivalent to those used therapeutically, Colecalciferol has no teratogenic activity.
Colecalciferol has no potential mutagenic or carcinogenic activity.
Colecalciferol is metabolised by microsomal hydroxylase to form 25-hydroxycolecalciferol (25(OH)D3, calcidiol), the primary storage form of vitamin D3. 25(OH)D3 undergoes a secondary hydroxylation within the kidney to form the predominant active metabolite 1,25-hydroxycolecalciferol (1,25(OH)2D3, calcitriol). The metabolites circulate in the blood bound to a specific α-globin.
After a single oral dose of Colecalciferol, the maximum serum concentrations of the primary storage form are reached after approximately 7 days. 25(OH)D3 is then slowly eliminated with an apparent half-life in serum of about 50 days. Colecalciferol and its metabolites are excreted mainly in the bile and faeces.
After high doses of Colecalciferol, serum concentrations of 25(OH)D3 may be increased for months. Overdose-induced hypercalcaemia may persist for weeks (see 4.9 "Overdose”).
Colecalciferol and its metabolites are excreted mainly in bile and faeces, only a small amount appears in the urine. Vitamin D3 can be passed into milk.
Pre-clinical safety data:
Colecalciferol is well known and established product and has been used in clinical practice for many years. No further specific toxicological hazard for humans is expected other than in chronic overdosage where hypercalcaemia could be seen.
Colecalciferol overdosage in animals has been shown to induce malformations in rats, mice and rabbits at doses significantly higher than the human dose. The malformations included skeletal defects, microcephaly and cardiac malformations.
At doses equivalent to those used therapeutically, Colecalciferol has no teratogenic activity.
Colecalciferol has no potential mutagenic or carcinogenic activity.
OVERDOSE AND TREATMENT OF OVERDOSE
Overdose: probable hypervitaminosis D can occur during high dose or prolonged therapy or when increased response to normal doses of vitamin D, and will lead to clinical manifestations of calcium metabolic disorders.
Some children may increase their response to a small amount of vitamin D. In adults, hypervitaminosis D may be due to the use of vitamin D overdose in the case of hypoparathyroidism or prefer to take vitamin D in too high a dose weirdly
The amount of vitamin D that causes hypervitaminosis D varies widely from person to person. Normally, in normal people (parathyroid function and vitamin D sensitivity) continuous intake of 50,000 units or more of vitamin D / daily, may be contaminated with vitamin D toxicity. Hypervitaminosis D is particularly dangerous for people who are taking digitalis, because the toxicity of cardiac glycosides increases with hypercalcemia.
Early signs and symptoms of hypervitaminosis D are signs and symptoms of hypercalcemia
Symptoms:
Acute or chronic overdose of Colecalciferol can cause hypercalcaemia, an increase in the serum and urinary concentrations of calcium. The symptoms of hypercalcaemia are not very specific and consist of nausea, vomiting, diarrhoea often in the early stages and later constipation, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, polydipsia, polyuria formation of renal calculi, nephrocalcinosis, kidney failure, calcification of soft tissues, changes in ECG measurements, arrhythmias and pancreatitis. In rare and isolated cases there are reports that hypercalcaemia is fatal.
Treatment of overdose
Some children may increase their response to a small amount of vitamin D. In adults, hypervitaminosis D may be due to the use of vitamin D overdose in the case of hypoparathyroidism or prefer to take vitamin D in too high a dose weirdly
The amount of vitamin D that causes hypervitaminosis D varies widely from person to person. Normally, in normal people (parathyroid function and vitamin D sensitivity) continuous intake of 50,000 units or more of vitamin D / daily, may be contaminated with vitamin D toxicity. Hypervitaminosis D is particularly dangerous for people who are taking digitalis, because the toxicity of cardiac glycosides increases with hypercalcemia.
Early signs and symptoms of hypervitaminosis D are signs and symptoms of hypercalcemia
Symptoms:
Acute or chronic overdose of Colecalciferol can cause hypercalcaemia, an increase in the serum and urinary concentrations of calcium. The symptoms of hypercalcaemia are not very specific and consist of nausea, vomiting, diarrhoea often in the early stages and later constipation, anorexia, fatigue, headache, muscle and joint pain, muscle weakness, polydipsia, polyuria formation of renal calculi, nephrocalcinosis, kidney failure, calcification of soft tissues, changes in ECG measurements, arrhythmias and pancreatitis. In rare and isolated cases there are reports that hypercalcaemia is fatal.
Treatment of overdose
- A normalisation of hypercalcaemia due to vitamin D intoxication lasts several weeks. The recommendation for the treatment of hypercalcaemia is the avoidance of any further administration of vitamin D, including supplements, dietary intakes and the avoidance of sunlight. A low calcium or calcium-free diet can also be considered.
- Rehydration and the treatment with diuretics e.g. furosemide to ensure adequate diuresis should be considered. Additional treatment with calcitonin or corticosteroids can also be considered.
- Phosphate infusions should not be administered to lower hypercalcaemia of hypervitaminosis D because of the dangers of metastatic calcification.
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