ALPHA D3 caps. 1 mcg. 30 capsules

 

ACTION

In the liver, alfacalcidol (1a-hydroxyvitamin D3: OND3-1a) is rapidly becoming a 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, therapeutic benefit from taking Alpha D3 is well accepted that of 1,25-dihydroxyvitamin D,. The main effects are increased levels of circulating 1,25-dihydroxyvitamin D3 and thereby increase and absorption of calcium and phosphate, support bone mineralization, lowering parathyroid hormone in the blood, and reduced bone resorption, which may help to alleviate pain in 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 kidneys break reduces endogenous production of 1,25-dihydroxyvitamin D3. Diseases in which this can occur are renal bone disease, hypoparathyroidism (significantly reduced parathyroid function) and vitamin D-dependent rickets. To correct this imbalance need high doses of vitamin D, which in turn correspond to small doses of Alpha D3, which is not dependent on renal 1a-hydroxylation process. Additionally, alpha D3 process nadostatachno absorption of calcium associated with postmenopausal status, elderly and steroid-induced osteoporosis improves negative calcium balance, which is observed in these patients. Positive calcium balance due to alpha D in patients with osteoporosis, reduced bone loss and the incidence of fractures (breaks). When using ordinary vitamin D3 high dose and variable response times of the body can lead to unintended hypercalcemia (high calcium in the body). The process of balancing takes many weeks and sometimes months. When using Alpha D3 greater speed of response allows the body to better identify the correct dose and if the presence of hypercalcemia, it can be corrected within a few days of stopping treatment.

 

INDICATIONS

 

To treat conditions in which altered calcium metabolism disorders due process and first-hydroxylation, eg. decreased renal function in other disorders associated with vitamin D-resistant, osteoporosis due to decreased absorption of calcium.

 

  Renal osteodystrophy (renal bone disease);

 hypoparathyroidism (significantly reduced parathyroid function);

  hyperparathyroidism (excessive parathyroid hormone) with bone disease;

  Food and malabsorption rickets and osteomalacia (softening of bones).

  Hipofosfatemichen vitamin D

 

Pseudo-deficient rickets (D-dependent type I) and osteomalacia;

  Osteoporosis

 

CONTRAINDICATIONS

 

ALFA DZ should not apply to:

 

 Hypercalcemia (high calcium in the body);

  hyperphosphatemia (high amounts of phosphate) in the body (except when associated with hypoparathyroidism);

  Hipermagnezemiya high amounts of magnesium in the body.

  

ALFA DZ should 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 can trigger severe allergic reactions.

 

 

WARNINGS FOR USE

 

Pregnancy

 

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.

 

 

Breastfeeding

 

Although not established 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 and the infant should be given to discontinuation of nursing.

 

 

 DOSAGE AND ADMINISTRATION

 

The dosage and administration of D3 ALPHA must be tailored to the specific symptoms of the disease.

 

Starting dose

 

For all indications, except for osteoporosis:

 

Adults: 1mg (microgram) daily.

 

Elderly: 0.5 CD daily.

 

Stelesno Children weighing 20 kg and over 20 without renal osteodystrophy: 1 mg daily.

 

Stelesno Children weighing 20 kg and over 20 renal osteodystrophy: 0.04 to 0.08 mcg / kg body weight per day.

 

Children weighing less than 20 kg: 0,05 CD / kg body weight per day.

 

Osteoporosis: 0.5 mcg daily.

 

If necessary (depending on the biochemical response of the body) dose should be adjusted to avoid hypercalcemia. At the beginning of treatment the calcium level in the blood should be monitored weekly. ALPHA D3 dose may be increased by 0.25 to 0.5 mcg daily. Most adult patients respond to doses of 1 to 3 mcg daily. In establishing the correct dose of calcium levels can be monitored each 2 to 4 weeks. In patients with osteomalacia (softening of bones), the lack of fast kaltsiemiya not require dose increases. Other indicators of the response of the body eg. plasma alkaline phosphatase can be much more useful criterion for dose adjustment. Indicators for the reaction of the body in addition to increasing the level of calcium in the blood may be progressive decrease in the level of alkaline phosphatase, a decrease in the level of parathyroid hormone, increased excretion of calcium excretion in patients with impaired renal function, bone radiography and histological improvement. After normalization of biochemical parameters imposed periods of longer treatment before monitor radiological and histological improvement in the bone marrow. During the first weeks of treatment, often an improvement in clinical symptoms - bone and muscle 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 there is hypercalcemia, ALPHA D intake should be stopped until recovery of normal levels of calcium in the blood (usually about one week). Then you can start again with half the previous dose.

 

Renal bone disease (renal osteodystrophy): Patients who already have high levels 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, prolonged hypercalcemia may further impair renal function. Before and during treatment with alfacalcidol must also be made for taking phosphate binders for the prevention of hyperphosphatemia. Pediatric renal osteodystrophy require higher doses than adults and may even receive a dose for an adult patient. Hypoparathyroidism: Low levels of calcium in the blood can be dangerous and may be restored more quickly to normal by taking alfacalcidol (ALPHA D3) than through vitamin D. Severe hypocalcemia is corrected much more quickly higher doses Alpha D3 (eg 3-5 mcg) with security supplements containing calcium.

 

Hyperparathyroidism: In patients requiring surgery for the 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 extended ALPHA D3 intake to normalize plasma levels of alkaline phosphatase or the occurrence of hypercalcemia.

 

Food and malabsorbtiven rickets and osteomalacia (softening of bones): Malabsorbtivnata osteomalacia, which corresponds to large doses of vitamin D3 IM or will meet in small oral doses of Alpha D3. Nutritional rickets and osteomalacia (softening of bones) can be treated quickly with Alpha D3

 

Hipofosfatemichen vitamin D-resistant rickets and osteomalacia: normal doses of Alpha D3 rapidly relieves myopathy (a disease or abnormal condition of skeletal muscle) and increased retention of calcium and phosphate. Some patients may also need to be rich intake of phosphate supplements. In these cases, neither the administration of large doses of vitamin D or phosphate-rich supplements can give satisfactory results.

 

Pseudo-Deficiency (D-dependent type I) rickets and osteomalacia (softening of bones): Good diet and oral 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 (reduction in bone volume mass reconstruction of the 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 the smaller, more physiological doses of orally administered alfacalcidol (usually 0.5 mcg). The recommended maintenance dose of 0.5 to 1 CD per day should not be exceeded. Improved calcium absorption is associated with increased calcium in the urine, whose value depends on the dose of alfacalcidol and calcium diet. Therefore, calcium supplementation is recommended only for patients with osteoporosis, in which calcium diet is inadequate. In the majority of patients is much more appropriate to keep the dose of alfacalcidol around the school, through daily intake of calcium.

 

SIDE EFFECTS

 

Adverse reactions are usually lekastveni related shiperkaltsiemiya (increased calcium in the blood) that can be triggered by treatment with alfacalcidol in case of renal impairment with hyperphosphatemia (high amounts of phosphate in the blood). In patients on dialysis hiperkaptsiemichna should consider the possibility of calcium influx of dialysis are unknown lekastveni other adverse reactions that may be associated directly with alfacalcidol treatment.

 

Special precautions for use

 

Alfacalcidol increases internal absorption of calcium and phosphate, so their blood levels should be monitored, especially in patients with renal insufficiency. 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 calcium, phosphate, alkaline phosphatase, magnesium and creatinine and other biochemical parameters. Treatment with alfacalcidol should be performed only with appropriate results from biochemical studies. If there is biochemical evidence of bone recovery (eg reaching normal serum alkaline phosphatase), hypercalcaemia may occur if the dose of Alpha D3 is not adequately reduced. If the presence of hypercalcemia or hypercalciuria, it can be quickly adjusted with the discontinuation ALPHA D3 and any supplements rich in calcium to restore normal calcium levels, which usually lasts about a week. Alpha D3 may be extended to SL last dose taken.

 

ALFA DZ should be used cautiously in patients with hypercalciuria, especially those sanamneza for kidney stones.

 

 

INTERACTIONS

 

Alfacalcidol / Digitalis glycosides: hypercalcemia in patients who take medicines containing digitalis can cause cardiac arrhythmia (disturbance of the rhythmic activity of the heart). Patients taking digitalis both I and alfacalcidol must be carefully monitored by your doctor.

 

Alfacalcidol / Barbiturates / Enzyme-inducing anticonvulsant drugs: patients taking barbiturates or other enzyme-inducing anticonvulsant drugs may require administration of higher doses of alpha DZ, achieving the desired effect of treatment.

 

Alfakaliidol / Medicinal products affecting domestic absorption: Absorption of alfacalcidol can be prevented by concomitant use of mineral salts (with prolonged use), cholestyramine, kolestirol, sucralfate or antacids large amount of aluminum products.

 

Alfacalcidol / Magnesium: In patients on chronic renal dialysis patients alfacalcidol caution should be applied magnesium antacid products or laxatives. It 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 D and its derivatives: alfacalcidol product is a derivative of vitamin D during treatment with alfacalcidol should not be receiving pharmacological doses of vitamin D and its derivatives due to a potential for additive effects and increased risk of hypercalcemi 

 

OVERDOSE

 

Events: Hypercalcaemia and its clinical manifestations may be restlessness, 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 general supportive therapy products, intravenous fluids and, if necessary, may be applied and loop diuretics kortikosteroidi.Pri severe overdose is necessary to gastric lavage in the early stage and / or application of liquid paraffin may reduce absorption and accelerate the elimination of feces. 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.

 SUMMARY OF PRODUCT
 
ALPHA D3 0.25 mcg soft capsules 0.25 mcg Alpha DZ soft capsules
 
ALPHA D3 0.5 mcg soft capsules DZ ALPHA 0.5 mcg soft capsules
 
ALPHA D3  1 mg soft capsules D ALPHA h 1 mg soft capsules Active substance: alfacalcidol (1a-hydroxyvitamin D3) 0.25 mcg, 0.5mg, 1 mg.
 
Other ingredients: citric acid anhydrous, propilgalat, vitamin E (a-tocopherol), anhydrous ethanol, purified peanut butter. Shell gelatin capsule ALPHA D3 0.25 mcg and 0.5 CD contains: gelatin, glycerol 85%, anidrisorb 85/70. red iron oxide (E172). Shell gelatin capsule ALPHA D3 1 mg contains: gelatin, glycerol 85%, anidrisorb 85/70, yellow iron oxide (E172). A10379 black ink contains: edible ink black (carbon black iron oxide (E172), denatured alcohol, isopropyl alcohol, 1-butanol, ethyl acetate).