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Decostriol

 

Active ingredient: calcitriol (1α,25-dihydroxycholecalciferol)


Composition
Each capsule contains:
- Pharmaceutically active ingredient:
- calcitriol (1α,25-dihydroxycholecalciferol) 0.25 g
- Other ingredients:
- butylhydroxytoluene (Ph.Eur.) (E 321), butylhydroxyanisole (Ph.Eur.) (E 320), ethanol 100%, arachis oil, gelatin, glycerol 85%, sorbitol, liquid 70% (non crystallising) (Ph.Eur.), iron(lll)oxide (E 172), titanium dioxide (E 171)

 

Pharmaceutical form and content
Capsule, soft, pink
Blister and bottle pack
Pack of 30 soft capsules
Pack of 50 soft capsules
Pack of 100 soft capsules


Product classification
Vitamin D3 metabolite


Indications
- Established postmenopausal osteoporosis
- Renal osteodystrophy (bone changes) in patients with chronic renal failure undergoing dialysis (e.g. artificial kidney)
- Hypofunction of the parathyroid gland (postoperative or idiopathic hypoparathyroidism), hereditary disorder of phosphate excretion (pseudohypoparathyroidism)
- Hypophosphataemic rickets (so-called vitamin D-resistant rickets)


Contraindication
When should you not use Decostriol 0.25 g?
Decostriol 0.25 g must not be used in:
- all diseases associated with an increased blood calcium level (e.g. hyperactivity of the parathyroid gland).

- Hypersensitivity to calcitriol or any other compound in this class of substances or to any of the other ingredients in this medicinal product.


What do you have to consider during pregnancy or while breastfeeding?
Decostriol 0.25 g may only be administered during pregnancy after the possible benefits have been carefully weighed against the potential risks for the mother and the child. In case of overdose (increased blood calcium level, placental transfer of the active ingredient to the foetus) there is a risk of malformation: risk of impaired physical and mental development, hypofunction of the parathyroid gland (hypoparathyroidism), particular forms of arteriostenosis (aortic stenosis). No results of controlled studies in humans are available.

 

It should be assumed that calcitriol passes into breast milk. For this reason, breast-feeding should not be carried out during calcitriol treatment owing to the danger of possible damaging effects on the infant.

 

Precautions for use and warnings
What precautions must be taken?
Since Decostriol 0.25 g contains the most efficacious vitamin D metabolite, neither vitamin D nor any derivatives (e.g. dihydrotachysterol) may be administered simultaneously. If treatment is switched from ergocalciferol (vitamin D2) to calcitriol, it should be noted that it may take several months for the blood ergocalciferol) levels to return to their baseline values.


Pre-requisite for the optimal effect of calcitriol is a sufficient but not excessive intake of calcium (for adults about 800 -1000 mg daily including food calcium intake). If necessary, additional calcium must be taken. The uncontrolled intake of calcium preparations can lead to hypercalcaemia. Owing to an improved absorption of calcium from the gastrointestinal tract, calcium intake may be reduced in some patients on Decostriol 0.25 g.

 

There is a danger of hypercalcaemia occurring under treatment with calcitriol. During investigations of patients with uraemic osteodystrophy hypercalcaemia was observed in about 40% of patients treated with calcitriol. You must strictly adhere to the diet your doctor has prescribed. Your doctor will inform you about how to recognise the symptoms of hypercalcaemia.


In patients on thiazide treatment and in patients who have sarcoidosis or a history of kidney stones, a calciuria (> 300 mg/day or 7.5 mmol/day) must be avoided.


The danger of hypercalcaemia is increased in particular for immobilised patients.


Patients with normal kidney function who are taking Decostriol 0.25 g, should be careful to have an adequate liquid intake to avoid loss of body fluid (dehydration), because such a loss would increase the risk of hypercalcaemia (risk of increased concentration of calcium in blood).


Patients with vitamin D-resistant rickets and simultaneously reduced phosphate concentrations in blood (familial hypophosphataemic rickets) should continue with their oral phosphate therapy.


However, since the intestinal absorption of phosphate is also stimulated by Decostriol 0.25 g, the requirement for oral phosphate may be reduced. Regular checks of the laboratory values are necessary as follows: serum concentrations of calcium, phosphorus, magnesium and alkaline phosphatase and the determination of calcium and phosphate in 24-hour urine.


Calcitriol elevates the inorganic phosphate concentration in serum. Although this has a positive effect for patients with hypophosphataemia, care is needed on the other hand for patients with chronic renal failure since there is danger of ectopic calcification. In such a case, the phosphate concentration has to be kept within the normal range (2 - 5 mg/100ml or 0.65 - 1.62 mmol/l) by the oral administration of the necessary phosphate-binding agents and a low-phosphate diet. Allergic reactions may occur with sensitive patients. In particular owing to the content of butylhydroxyanisole and butylhydroxytoluene hypersensitivity reactions can occur in predisposed patients in the form of irritations of the skin, eyes and mucous membranes.


Interaction with other agents
What other medicinal products influence the effect of Decostriol 0.25 g and what should be considered when other medicinal products are taken at the same time?


Vitamin D and derivatives
An enhancement of the effect of calcitriol is expected by the simultaneous administration of vitamin D or its derivatives (e.g. dihydrotachysterol). That is why Decostriol 0.25 g may not be taken simultaneously with vitamin D or its derivatives (See "Precautions and Warnings').


Calcium
Instructions on diet, in particular instructions related to the calcium consumption, must be followed strictly. In particular uncontrolled consumption of extra calcium-containing products must be avoided (See "Precautions and Warning").


Phosphate-binding agents
Since Decostriol 0.25 g also influences phosphate transport in the intestine, kidney and bone, the administration of phosphate-binding agents (e.g. aluminium hydroxide or aluminium carbonate containing compounds) must be based on the serum phosphate concentration (normal values: 2 - 5 mg/100ml or 0.65 - 1.62 mmol/l).


Magnesium
Magnesium containing medications (e.g. gastric acid binding preparations) may not be administered to patients with impaired kidney function during therapy with Decostriol 0.25 g, because this may lead to elevated magnesium concentrations in blood.


Thiazides and digitalis preparations
A reduction in the elimination of calcium ions caused by thiazide diuretics (medicinal products increasing the amount of urine excreted) results in an increased risk of hypercalcaemia in case of concomitant use of Decostriol 0.25 g and thiazides. Dosing of Decostriol 0.25 g must be cautious under the concomitant administration of digitalis preparations since in these patients, abnormal heart rhythm (arrhythmias) associated with an increased blood calcium concentration (hypercalcaemia) can occur.


Cholestyramine
A reduction in the effect of Decostriol 0.25 g is possible, if cholestyramine (medicinal product reducing the blood fat values) is taken at the some time. Cholestyromine can reduce the absorption of fat-soluble vitamins from the intestine and can also interfere with the absorption of calcitriol from the intestine.

Corticosteroids
The effect of Decostriol 0.25 g may be reduced by the concomitant administration of glucocorticoids. A functional antagonism exists between the promotion of calcium uptake by calcitriol and its inhibition by corticosteroids.


Anticonvulsants, barbiturates
Higher doses of calcitriol may be required during concomitant administration with liver enzyme inducing medicinal products, such as barbiturates or drugs used in the treatment of epilepsy (anticonvulsants). Please note that these data may also be applicable to drugs used a short time ago.

 

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