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Depocal 60 K Tablets

Depocal 60 K Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:
Depocal 60 K is indicated treatment of established post-menopausal osteoporosis.

When you should consult your doctor?

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

The adverse reactions listed below reflect the experience from investigational studies of Depocal 60 K, and the post-marketing experience.
The most commonly reported adverse reaction was hyper calcaemia.
The ADRs listed in Table 1 are presented by system organ class and frequency categories, defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

Table 1 Summary of ADRs Occurring in Patients Receiving Depocal 60 K® (calcitriol)

System Organ Class

Very common

Common

Uncommon

Not known

Immune System Disorders

 

 

 

Hypersensitivity, Urticaria

Metabolism and Nutrition Disorders

Hypercalcaemia

 

Decreased appetite

Polydipsia, Dehydration, Weight decreased

Psychiatric Disorders

 

 

 

Apathy, Psychiatric disturbances

Nervous System Disorders

 

Headache

 

Muscular weakness, Sensory disturbance, Somnolence

Cardiac Disorders

 

 

 

Cardiac arrhythmias

Gastrointestinal Disorders

 

Abdominal pain, Nausea

Vomiting

Constipation, Abdominal pain upper, Paralytic ileu

Skin and subcutaneous tissue disorders

 

Rash

 

Erythema, Pruritus

Musculoskeletal and Connective Tissue Disorders

 

 

 

Growth retardation

Renal and Urinary Disorders

 

Urinary tract infection

 

Polyuria, Nocturia

General disorders and administration site conditions

 

 

 

Calcinosis, Pyrexia, Thirst

Investigations

 

 

Blood creatinine increased

 

Since calcitriol exerts vitamin D activity, adverse effects may occur which are similar to those found when an excessive dose of vitamin D is taken, i.e. hypercalcaemia syndrome or calcium intoxication (depending on the severity and duration of hypercalcaemia) (see sections 4.2 and 4.4). Occasional acute symptoms include decreased appetite, headache, nausea, vomiting, abdominal pain or abdominal pain upper and constipation.
Because of the short biological half-life of calcitriol, pharmacokinetic investigations have shown normalisation of elevated serum calcium within a few days of treatment withdrawal, i.e. much faster than in treatment with vitamin D3 preparations.
Chronic effects may include muscular weakness, weight decreased, sensory disturbances, pyrexia, thirst, polydipsia, polyuria, dehydration, apathy, growth retardation and urinary tract infections.
In concurrent hypercalcaemia and hyperphosphataemia of > 6 mg/100 ml or > 1.9 mmol/l, calcinosis may occur; this can be seen radiographically.
Hypersensitivity reactions including rash, erythema, pruritus and urticaria may occur in susceptible individuals.
Laboratory Abnormalities
In patients with normal renal function, chronic hypercalcaemia may be associated with a blood creatinine increase.


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?

- Excessive dosage of depocal 60 k induces hypercalcemia Also because of some instances hypercalciuria; therefore, early treatment during dosage adjustment, serum calcium and phosphorus should be determined at least twice weekly.
- Depocal 60 K should be given cautiously to patients on digitalis, because hypercalcemia in such patients may precipitate cardiac arrhythmias.

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

Treatment of asymptomatic hypercalcaemia .
Since calcitriol is a derivative of vitamin D, the symptoms of overdose are the same as for an overdose of vitamin D. Intake of high doses of calcium and phosphate together with Depocal 60 K may give rise to similar symptoms. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg2 / dl2. A high calcium level in the dialysate may contribute to the development of hypercalcaemia.
Acute symptoms of vitamin D intoxication: anorexia, headache, vomiting, constipation.
Chronic symptoms: dystrophy (weakness, loss of weight), sensory disturbances, possibly fever with thirst, polyuria, dehydration, apathy, arrested growth and urinary tract infections. Hypercalcaemia ensues, with metastatic calcification of the renal cortex, myocardium, lungs and pancreas.
The following measures should be considered in treatment of accidental overdosage: immediate gastric lavage or induction of vomiting to prevent further absorption. Administration of liquid paraffin to promote faecal excretion. Repeated serum calcium determinations are advisable. If elevated calcium levels persist in the serum, phosphates and corticosteroids may be administered and measures instituted to bring about adequate diuresis.
Hypercalcaemia at higher levels (>3.2 mmol/L) may lead to renal insufficiency particularly if blood phosphate levels are normal or elevated due to impaired renal function.
Should hypercalcaemia occur following prolonged treatment, Depocal 60 K should be discontinued until plasma calcium levels have returned to normal. A low-calcium diet will speed this reversal. Depocal 60 K can then be restarted at a lower dose or given in the same dose but at less frequent intervals than previously.
In patients treated by intermittent haemodialysis, a low concentration of calcium in the dialysate may also be used. 

Is it safe in pregnancy and breast-feeding?

The safety of Depocal 60 K during pregnancy has not been established.
Supra valvular aortic stenosis has been produced in foetuses by near-fatal oral doses of vitamin D in pregnant rabbits. There is no evidence to suggest that vitamin D is teratogenic in humans even at very high doses. Depocal 60 K should be used during pregnancy only if the benefits outweigh the potential risk to the foetus.
It should be assumed that exogenous calcitriol passes into breast milk. In view of the potential for hypercalcaemia in the mother and for adverse reactions from Depocal 60 K in nursing infants, mothers may breastfeed while taking Depocal 60 K, provided that the serum calcium levels of the mother and infant are monitored.

Storage Conditions:

Store in cool and dry place below 30°C

Drug Description

Each chewable tablet contains:
Active substances: Calcitriol60000 IU

Indications and dosage.

Indications
Depocal 60 K is indicated treatment of established post-menopausal osteoporosis.

Dosage:
The usual doses are 1 tablet (60,000 IU) once a week for 6-8 weeks.
Post-menopausal Osteoporosis
The recommended dose of Depocal 60 K is 1 tablet once a week for 6-8 weeks.
Serum calcium and creatinine levels should be determined at 1, 3 and 6 months and at 6 monthly intervals thereafter.
Elderly
Clinical experience with Depocal 60 K in elderly patients indicates that the dosage recommended for use in younger adults may be given without apparent ill-consequence.
Paediatric Population
The safety and efficacy of calcitriol capsules in children have not been sufficiently investigated to enable dosing recommendations. Limited data are available for the use of calcitriol capsules in paediatric patients.
Depocal 60 K capsules are for oral administration only.

Warnings and precautions

Excessive dosage of depocal 60 k induces hypercalcemia Also because of  some instances hypercalciuria; therefore, early treatment during dosage adjustment, serum calcium and phosphorus should be determined at least twice weekly. If hypercalcemia occurs the drug should be discontinued immediately. Depocal 60 K should be given cautiously to patients on digitalis, because hypercalcemia in such patients may precipitate cardiac arrhythmias.


Overdosage and Contraindications

Overdose
Treatment of asymptomatic hypercalcaemia (see section 4.2).
Since calcitriol is a derivative of vitamin D, the symptoms of overdose are the same as for an overdose of vitamin D. Intake of high doses of calcium and phosphate together with Depocal 60 K may give rise to similar symptoms. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg2 / dl2. A high calcium level in the dialysate may contribute to the development of hypercalcaemia.
Acute symptoms of vitamin D intoxication: anorexia, headache, vomiting, constipation.
Chronic symptoms: dystrophy (weakness, loss of weight), sensory disturbances, possibly fever with thirst, polyuria, dehydration, apathy, arrested growth and urinary tract infections. Hypercalcaemia ensues, with metastatic calcification of the renal cortex, myocardium, lungs and pancreas.
The following measures should be considered in treatment of accidental overdosage: immediate gastric lavage or induction of vomiting to prevent further absorption. Administration of liquid paraffin to promote faecal excretion. Repeated serum calcium determinations are advisable. If elevated calcium levels persist in the serum, phosphates and corticosteroids may be administered and measures instituted to bring about adequate diuresis.
Hypercalcaemia at higher levels (>3.2 mmol/L) may lead to renal insufficiency particularly if blood phosphate levels are normal or elevated due to impaired renal function.
Should hypercalcaemia occur following prolonged treatment, Depocal 60 K should be discontinued until plasma calcium levels have returned to normal. A low-calcium diet will speed this reversal. Depocal 60 K can then be restarted at a lower dose or given in the same dose but at less frequent intervals than previously.
In patients treated by intermittent haemodialysis, a low concentration of calcium in the dialysate may also be used. 

Contraindication
Depocal 60K is contraindicated:
• In all diseases associated with hypercalcaemia
• In patients with evidence of metastatic calcification
• In patients with known hypersensitivity to calcitriol (or drugs of the same class) and any of the constituent excipients
• If there is evidence of vitamin D toxicity.

Clinical pharmacology.

The biological effects of calcitriol are mediated by the vitamin D receptor, a nuclear hormone receptor expressed in most cell types and functioning as a ligand-activated transcription factor
In patients with established post-menopausal osteoporosis, Depocal 60 K increases calcium absorption, elevates circulating levels of calcitriol and reduces vertebral fracture frequency.
The onset and reversal of the effects of Depocal 60 K are more rapid than those of other compounds with vitamin D activity and adjustment of the dose can be achieved sooner and more precisely. The effects of inadvertent over dosage can also be reversed more readily.

CERTIFICATES

KEEP IN TOUCH

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