India Product

Depocal 400 IU Drops

Depocal 400 IU Drops

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Vitamin D analogues are used in treatment of refractory rickets (Vitamin D-resistant rickets), familial hypophosphatemia and hypoparathyroidism, and in the management of hypocalcemia and renal osteodystrophy in patients with chronic renal failure undergoing dialysis. Vitamin D is used in conjunction with calcium in the management and prevention of primary or corticosteroid-induced osteoporosis. Vitamin D supplementation is indicated when dietary intake is insufficient, e.g., breast-fed infants. Depocal 400 IU Drops is recommended for premature infants as well.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

Vitamin D analogues are well tolerated in normal daily doses. Chronic excessive dosing can lead to toxicity.

WHAT TO DO IF YOU MISS A DOSE?

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

Things you MUST NOT DO while on this medicine?

Known hypersensitivity to Vitamin D or any of its analogues and derivatives.
Hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of Vitamin D and hypervitaminosis D.

Vitamin D analogues are usually non-toxic in physiologic doses. Chronic or acute administration of excessive doses may lead to hypervitaminosis D, manifested by hyperkalemia and its sequelae.

Early symptoms of hypercalcemia may include weakness, fatigue, somnolence, headache, anorexia, dry mouth, metallic taste, nausea, vomiting, vertigo, tinnitus, ataxia, hypotonia. Later and possibly more serious manifestations include nephrocalcinosis, renal dysfunction, osteoporosis in adults, impaired growth in children, anemia, metastatic calcification, pancreatitis, generalized vascular calcification and seizures.

What to do if you accidentally take too much (overdose) of the medicine?

Overdose can lead to hypervitaminosis D. An excess of vitamin D causes abnormally high levels of calcium in the blood, which can eventually severely damage the soft tissues, and kidneys. Tolerable Upper Intake Level for vitamin D3(colecalciferol) is set at 4000 IU (100 µg) per day. Vitamin D3 should not be confused with its active metabolites.
Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, 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.
Treatment of hypercalcaemia: The treatment with vitamin D must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, and cardiac glycosides must also be discontinued. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed.

Is it safe in pregnancy and breast-feeding?

This product is for infant and children only.

Storage Conditions:

Store in cool and dry place below 30°C.

Drug Description

Active substances: Cholecalciferol;
1 ml contains Cholecalciferol 400 IU/ml;

Indications and dosage.

Indications
Vitamin D analogues are used in treatment of refractory rickets (Vitamin D-resistant rickets), familial hypophosphatemia and hypoparathyroidism, and in the management of hypocalcemia and renal osteodystrophy in patients with chronic renal failure undergoing dialysis. Vitamin D is used in conjunction with calcium in the management and prevention of primary or corticosteroid-induced osteoporosis. Vitamin D supplementation is indicated when dietary intake is insufficient, e.g., breast-fed infants. Depocal 400 IU Drops is recommended for premature infants as well.

Dosage:
Recommendations of Indian Association Pediatrics (IAP) on dosing of Vitamin D –

Group

Daily regimen (8-12
weeks)

Weekly regimen
(8-12 weeks)

Maintenance

<1 month old

1,000 IU

50,000 IU

400-1,000 IU

1-12 month old

1,000-5000
IU

50,000 IU

400-1,000 IU

1-18 y old

5,000 IU

50,000 IU

600-1,000 IU

>18 y old

6,000 IU

50,000 IU

1,500-2,000 IU

The recommended dose of Depocal 400 IU Drops is 1 ml/day

Side effects and drug interactions.

Side effect
Vitamin D analogues are well tolerated in normal daily doses. Chronic excessive dosing can lead to toxicity.

Drug interactions
Antacids  (Magnesium-containing):  Hypermagnesemia  may  develop  when  these
agents are used concurrently with Vitamin D, particularly in patients with chronic renal failure.

Anticonvulsants (Phenytoin, Phenobarbital): Decreased Vitamin D effects may occur when certain anticonvulsants are administered, as they may induce hepatic microsomial enzymes and accelerate the conversion of Vitamin D to inactive metabolites.
Cholestyramine. Colestipol, Mineral OiI: Intestinal absorption of Vitamin D may be impaired. Patients on chotestyramine or colestipol should be advised to allow as much time as possible between the ingestion of these drugs and Vitamin 
Different Vitamin D analogues should be administered concurrently.

Hypercalcemia  during  pregnancy  may  also  lead  to  suppression  of  parathyroid hormone release in the neonate, resulting in hypocalcemia, tetany and seizures.

Warnings and precautions

IVitamin D analogues are usually non-toxic in physiologic doses. Chronic or acute administration of excessive doses may lead to hypervitaminosis D, manifested by hyperkalemia and its sequelae.

The therapeutic index of Vitamin D analogues is narrow, and there is great interindividual variation in the dose that will lead be chronic toxicity. Daily doses of ergocalciferol ranging from 1.25 to 2.5 mg in adults and 25 μg in children may result in hypervitaminosis. Other Vitamin D analogues with shorter duration of action may have a lower propensity to accumulate and to cause hypercalcemia.

Early symptoms of hypercalcemia may include weakness, fatigue, somnolence, headache, anorexia, dry mouth, metallic taste, nausea, vomiting, vertigo, tinnitus, ataxia, hypotonia. Later and possibly more serious manifestations include nephrocalcinosis, renal dysfunction, osteoporosis in adults, impaired growth in children, anemia, metastatic calcification, pancreatitis, generalized vascular calcification and seizures.

Periodic monitoring of serum calcium, phosphate, magnesium, and alkaline phosphatase is recommended for patients taking Vitamin D analogues. Serum calcium should be maintained the range of 2.25 to 2.5 mmol/L and not allowed to exceed 2.75 mmol/L.


Overdosage and Contraindications

Overdose
Overdose can lead to hypervitaminosis D. An excess of vitamin D causes abnormally high levels of calcium in the blood, which can eventually severely damage the soft tissues, and kidneys. Tolerable Upper Intake Level for vitamin D3(colecalciferol) is set at 4000 IU (100 µg) per day. Vitamin D3 should not be confused with its active metabolites.
Symptoms of hypercalcaemia may include anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disturbances, polydipsia, 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.
Treatment of hypercalcaemia: The treatment with vitamin D must be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, and cardiac glycosides must also be discontinued. Rehydration, and, according to severity, isolated or combined treatment with loop diuretics, bisphosphonates, calcitonin and corticosteroids should be considered. Serum electrolytes, renal function and diuresis must be monitored. In severe cases, ECG and CVP should be followed

Contraindication

Known hypersensitivity to Vitamin D or any of its analogues and derivatives.
Hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of Vitamin D and hypervitaminosis D.

Clinical pharmacology.

PHARMACOLOGICAL PROPERTIES:

Vitamin  D  is  a  fat-soluble  vitamin  and  has  properties  of  both  vitamins  and minerals. Vitamin D is essential for the absorption and utilization of calcium and phosphate and aids in the mobilization of bone calcium and maintenance of serum calcium concentrations.
Cholecalciferol (Vitamin D3) is synthesized in the skin on exposure to ultraviolet radiation. Cholecalciferol is also present in fish liver oils. Ergocalciferol (Vitamin D2) is produced by ultraviolet irradiation of a provitamin D sterol (ergosterol) which occurs in yeast and fungi.Both of these agents who have equal biologic activity are metabolized in the liver to calcifediol (25 hydroxycholecalciferol) which is then hydroxylated in the kidney to calcitriol (1, 25 dihydroxycholecalciferol). Calcitriol is considered the most active form. Dihydrotachysterol is produced by synthetic reduction of ergocalciferol. Patients with chronic renal disease cannot convert calcifediol to calcitriol. Alfacalcidol (1 α hydroxyvitamin D3), a synthetic analogue of calcitriol, is rapidly converted in the liver to calcitriol, bypassing the renal conversion step. Because alfacalcidol, calcitriol and dihydrotachysterol do not require renal hydroxylation, they are useful in patients with renal failure.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare
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PHASE-I, NEW DELHI,
Pin 110020
INDIA
Tel: 011-41005147, 011-40514919
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