ALPHA D3. 1 mcg. 30 capsules
ALPHA D3. 1 mcg. 30 capsules
ALPHA D3 0.25 mcg soft capsules ALFA DZ 0.25 mcg soft capsules
ALPHA D3 0.5 mcg soft capsules ALFA DZ 0.5 mcg soft capsules
ALPHA D3 1 mcg soft capsules ALFA D w 1 mcg soft capsules Active substance : alfacalcidol (1a-hydroxyvitamin D3) 0.25 mcg ; 0.5mg ; 1 mcg .
Excipients: anhydrous citric acid , propyl gallate , vitamin E (a- tocopherol ) , anhydrous ethanol , purified peanut butter. The shell of the gelatin capsule ALPHA D3 0.25 mcg and 0.5 ug contain: gelatin , glycerol 85% , anidrisorb 85/70 . red iron oxide ( E172) . The shell of the gelatin capsule ALPHA D3 1 mcg contain: gelatin , glycerol 85% , anidrisorb 85/70 , yellow iron oxide ( E172) . Black ink contains A10379 : edible ink black ( black, black iron oxide ( E172 ) , denatured alcohol, isopropyl alcohol , 1-butanol , ethyl acetate) .
WHAT ALPHA D3 ?
ALPHA D3 capsules of 0.25 micrograms are brownish- red with black lettering 0.25. ALPHA D3 capsules of 0.5 micrograms are pink with a black inscription 0.5. ALPHA D3 capsules from 1 microgram are bright yellow with black lettering 1.
In the liver alfacalcidol ( 1a -hydroxyvitamin D3 : 1A OND3 ) quickly turns into 1,25- dihydroxyvitamin D , which is a metabolite of vitamin DZ and participates as a regulator of calcium and phosphate metabolism . Due to the rapid transformation of alfacalcidol in the body , the therapeutic benefit of taking Alpha D3 is as that of taking 1,25- dihydroxyvitamin D , . The major effects are to increase the level of circulating 1,25- dihydroxyvitamin D3 , and thereby and enhancing the absorption of calcium and phosphate in bone mineralization support , lowering the level of parathyroid hormone in the blood , as well as a decrease in bone resorption , which contributes to the alleviation of pain in the bones and muscles.
The process of 25 - hydroxylation of vitamin D3 in the liver may rarely be disturbed . But when the process of 1a - hydroxylation in the kidney violate reduced endogenous production of 1,25 -dihydroxyvitamin D3 . Diseases in which this can occur are renal bone disease , hypoparathyroidism ( significantly decreased parathyroid function ), and vitamin D - dependent rickets . In order to correct this imbalance is required high doses of vitamin E, which in turn correspond to low doses of alpha D3 , which is not dependent on renal 1a - hydroxylation process . Additionally , alpha E3 process deficient uptake of calcium associated with post- menopausal , senile and steroid - induced osteoporosis, improve the negative calcium balance that occurs in these patients. Positive calcium balance , due to the treatment with alpha E in patients with osteoporosis, decreased bone loss , and incidence of fractures (breaks ) . When using ordinary vitamin D3 high dose and variable response time of the body can lead to unintended hypercalcemia (excess calcium in the body) . The process of balancing takes many weeks and sometimes months. When using ALPHA D3 greater speed of reaction of the body allows better determine the correct dosage and if the presence of hypercalcemia , it can be corrected within a few days of stopping treatment .
For the treatment of conditions in which the calcium metabolism is altered , due to disturbances in the process of 1a- hydroxylation , such as e. decreased renal function; in other disorders associated with vitamin D - resistant ; osteoporosis due to reduced absorption of calcium.
• Renal osteodystrophy ( renal bone disease ) ;
• Hypoparathyroidism ( significantly reduced parathyroid function ) ;
• Hyperparathyroidism ( increased amount of parathyroid hormone ) with a bone disease ;
• Food and malabsorption and osteomalacia rickets ( softening of the bones) .
• hypophosphatemic vitamin D
Pseudo- deficient rickets ( D - dependent Type I) and osteomalacia ;
ALPHA DZ must be administered to :
• Hypercalcemia (excess calcium in the body) ;
• Hyperphosphatemia (excess of phosphate ) in the body ( except in cases where it is associated with hypoparathyroidism ) ;
• Hipermagnezemiya increased amount of magnesium in the body.
ALPHA DZ must not be used in patients with :
• evidence of vitamin D : toxicity; • known hypersensitivity to vitamin D or any of its derivatives. Warning: This product contains peanut butter ! In rare cases, peanut butter may provoke severe allergic reactions.
Precautions for use
There is insufficient evidence to determine whether it is safe ALPHA D3 intake during pregnancy . Animal studies show no risk but, like all other drugs , alfacalcidol can be used during pregnancy only if the treatment is necessary and no better alternatives .
Although it is not known with absolute certainty , it is likely that an elevated level of 1,25- dihydroxyvitamin D3 in breast milk of mothers treated with alpha D3 . This in turn could have an influence on calcium metabolism of the baby and need to consider the termination of breastfeeding.
DOSAGE AND METHOD OF ADMINISTRATION
Dosage and administration ALPHA D3 should be tailored to the specific signs of the disease.
For all indications , except osteoporosis :
Adults: 1mg ( microgram) daily.
Elderly : 0.5 microgram per day.
Children stelesno weight of 20 kg and over 20 without renal osteodystrophy : 1 mcg daily.
Children stelesno weight of 20 kg and over 20 with renal osteodystrophy : 0.04 to 0.08 mcg / kg body weight per day .
Children weighing less than 20 kg: 0,05 ug / kg body weight per day .
Osteoporosis : 0.5 mcg per day.
Where necessary (according to the biochemical reaction of the organism ), the dose should be adjusted in order to avoid hypercalcemia . At the beginning of treatment the level of calcium in the blood should be monitored weekly. ALPHA D3 dose may be increased by 0.25 to 0.5 mcg per day. Most adult patients respond to doses of 1 to 3 mcg daily. In establishing the correct dose , the level of calcium can be monitored every 2-4 week. In patients with osteomalacia ( softening of the bones) , the lack of fast kaltsiemiya does not require dose increases. Other indicators such as the body's reaction e. plasma levels of alkaline phosphatase can be much more useful criterion for dose adjustment . Indicators for the reaction of the body besides increasing the level of calcium in the blood can be progressive decrease in the level of alkaline phosphatase , a decrease in parathyroid hormone, increased excretion of calcium in the urine in patients with impaired renal function, bone radiography and histological improvement. After normalization of biochemical parameters imposed periods of longer treatment before observed radiological and histological improvements in bone marrow . During the first weeks of treatment , often an improvement in clinical symptoms - muscle and bone pain. When there is biochemical and radiographic evidence of bone healing effect (or hypoparathyroidism when the calcium level is normalized ) is dominated by the maintenance dose should be reduced by about 0.25 to 2 mcg daily. If hypercalcemia occurs , administration of an alpha D should be discontinued until normal calcium levels in the blood ( usually about 1 week). It may then begin again with 1/2 of the previous dose .
Renal bone disease (renal osteodystrophy ): Patients who already have a high level of calcium in the blood can develop autonomous hyperparathyroidism . In this case they may not be affected by alfacalcidol and should consider other treatment options .
In patients with chronic kidney disease is particularly important to check the level of calcium in the blood, as prolonged hypercalcemia may further impair renal function. Before and during treatment with alfacalcidol should also be made for taking phosphate binders products to prevent hyperphosphatemia . Pediatric renal osteodystrophy require higher doses than adults , and can even be given a dose for an adult patient . Hypoparathyroidism : low calcium levels in the blood can be dangerous and may be restored more quickly to normal by taking alfacalcidol (alpha D3 ) than by vitamin D. Severe hypocalcemia is corrected much faster with higher doses ALPHA D3 (e.g., 3-5 mcg ) with protective supplements containing calcium.
Hyperparathyroidism : In patients requiring surgery for first- or third-degree hiperparatireodizam . preoperative treatment with Alpha D3 for 2-3 weeks can reduce bone pain and myopathy (a disease or abnormal condition of skeletal muscle ) without aggravation of hypercalcemia . To reduce the risk of postoperative hypocalcemia should be continued on ALPHA D3 to normalize plasma levels of alkaline phosphatase or the occurrence of hypercalcemia .
Nutritional and malabsorptive rickets and osteomalacia ( softening of bones) : malabsorptive osteomalacia, which corresponds to large doses of vitamin D3 or IM will respond to small oral doses of alpha D3 . Nutritional rickets and osteomalacia ( softening of the bones) can be treated quickly with Alpha D3
Hypophosphatemic vitamin D - resistant rickets and osteomalacia : normal doses of alpha D3 quickly relieves myopathy (a disease or abnormal condition of skeletal muscle ) and increased retention of calcium and phosphate. Some patients may need and intake of rich phosphate supplements. In such cases, any intake of large doses of vitamin D or of phosphate -rich dietary supplements can give satisfactory results.
Pseudo- Deficiency ( D - dependent Type I) rickets and osteomalacia ( softening of bones) : A good diet and oral administration of Alpha D3 are effective in conditions that would require higher doses of vitamin D.
Osteoporosis : Poor absorption of calcium from the bones is characteristic of osteoporosis (reduced bone mass volume with reconstruction of bone structure ) whether elderly , steroid - induced or caused by menopause. Lowering the internal absorption of calcium is associated with low levels of 1,25- dihydroxyvitamin D3 , and can be normalized by smaller, more psychological doses of orally administered alfacalcidol ( usually 0.5 mcg ) . The recommended maintenance dose of 0.5-1 ug daily should not be exceeded. The improved calcium absorption is related to the increase of calcium in the urine, whose value depends on the dose and alfacalcidol calcium diet . Therefore, supplementation of calcium is recommended only for patients with osteoporosis, in which calcium diet is insufficient. In the majority of patients is more suitable to maintain the dose at approximately regular alfacalcidol by daily intake of calcium .
Adverse drug- effects usually associated shiperkaltsiemiya ( increased amount of calcium in the blood) , which can be induced by treatment with alfacalcidol and in the case of impaired renal function with hyperphosphataemia (excess of phosphate in the blood) . Patients on dialysis hiperkaptsiemichna must take into account the possibility of the influx of calcium from the dialysate No known drug- other undesirable effects that may be associated directly with therapy alfacalcidol .
Special precautions for use
Alfacalcidol enhancing internal absorption of calcium and phosphate , and so their blood levels should be monitored , especially in patients with renal failure. Throughout treatment with alfacalcidol calcium level in the blood and urine (24-hour collection ) should be regularly monitored at least once every three months . Alfacalcidol treatment requires regular monitoring of the calcium, phosphate , alkaline phosphatase , creatinine , and magnesium , as well as other biochemical parameters. Treatment with alfacalcidol should be conducted only in the presence of relevant results from biochemical studies. If there is biochemical evidence of bone repair (e.g., reaching a normal serum level of alkaline phosphatase ) , hypercalcemia may occur if the dose of E3 ALPHA is not appropriately reduced . If the presence of hypercalcemia or hypercalciuria , it can be quickly adjusted for discontinuation ALPHA D3 and any supplements rich in calcium to restore normal calcium level, which usually lasts about a week. Treatment with alpha D3 may be extended to LA last dose taken .
ALFA DZ should be used cautiously in patients with hypercalciuria , especially those sanamneza for kidney stones .
Alfacalcidol / Digitalis glycosides : Hypercalcemia in patients who take medicines containing digitalis may cause cardiac arrhythmia (disturbance of the rhythmic activity of the heart) . Patients taking both I digitalis and alfacalcidol must be very carefully monitored by your doctor .
Alfacalcidol / Barbiturates / Enzyme -inducing antiepileptic drugs: In patients taking barbiturates or other enzyme-inducing antiepileptic medicinal products may need to take higher doses of alpha DZ , achieving the desired effect of treatment.
Alfakaliidol / Medicinal products affecting domestic absorption : Absorption of alfacalcidol may be prevented by concomitant use of mineral salts ( with prolonged use ) , cholestyramine, colestipol , sucralfate or antacids large amount of aluminum products .
Alfacalcidol / Magnesium: In patients on chronic renal dialysis patients alfacalcidol great caution must be applied magnesium antacid products or laxatives . Can be observed hipermagnezemiya ( increased content of magnesium in the blood).
Alfacalcidol / calcium / Thiazides : The risk of hypercalcaemia is increased in patients who are concurrently taking alfacalcidol and calcium -containing products or thiazide diuretics.
Alfakaliidol / Vitamin E and its derivatives : alfacalcidol product is a derivative of vitamin D. During treatment with alfacalcidol should not be accepted pharmacologic dose of vitamin E and its derivatives, due to the potential additive effects of the increased risk of hypercalcemia .
Events : hypercalcemia, whose clinical manifestations can be anxiety, fatigue , weakness , dizziness, drowsiness , headache, nausea , dry mouth , constipation , diarrhea, heartburn , vomiting , abdominal pain or other gastrointestinal discomfort , pain muscle , joint pain , itchy skin or mucous membranes or palpitations .
Treatment: Treatment with alpha DZ should be discontinued if hypercalcemia occurs . In severe hypercalcemia may require treatment with total supporting products, intravenous solutions , and if necessary can be applied and loop diuretics kortikosteroidi.Pri serious overdose is necessary to make a gastric lavage at the early stage and / or application of liquid paraffin may reduce absorption and accelerate the elimination of faeces. There is no specific antidote
If during treatment with ALFADZ notice side effect not listed in this leaflet, please tell your doctor or pharmacist.
STORAGE OF ALPHA DZ
Do not use after the expiry date stated on the pack . Store in original container. Do not put in another container. Do not store above 25 ° C. Keep out of the reach and sight of children. This product is only available with a prescription.