Alphadale

The alphadale – vitamin, the regulator of calcium-phosphorus exchange, promotes completion of deficit of D3 vitamin.

Form of release and structure

Dosage form – capsules: gelatinous, a round form, red color with transparent structure, in capsules – light yellow oily transparent liquid (on 10 pieces in the blister, in a cardboard pack of 3, 6 or 10 blisters).

Active ingredient of Alfadol – альфакальцидол, in 1 capsule – 0,25 mkg.

Auxiliary components: corn oil, butylhydroxyanisole, the dehydrated ethanol (in a ready-made product is absent).

Structure of a cover of the capsule: глицерол, methylparahydroxybenzoate, 70% sorbitol solution, пропилпарагидроксибензоат, soybeans oil (in a ready-made product it is not found), dye crimson (Ponso 4R), gelatin, the water purified.

Indications to use

Alfadol's use is shown at the diseases caused by disturbance of exchange of phosphorus and calcium against the background of insufficient endogenous synthesis 1,25 D3 dihydroxyvitamins:

• Osteomalacy, D-resistant vitamin rickets;
• Osteoporosis, including senile, post-menopausal, steroid;
• Hypoparathyrosis, pseudohypoparathyroidism;
• Osteodystrophy at a chronic renal failure.

Contraindications

• Hypervitaminosis of D;
• Hypercalcemia, gipermagniyemiya, hyperphosphatemia (except treatment of a hypoparathyrosis);
• Period of pregnancy and breastfeeding;
• Intolerance of fructose;
• Age up to 3 years;
• Age up to 12 years (at osteoporosis, a hypoparathyrosis and a pseudohypoparathyroidism);
• Hypersensitivity to drug components.

With care patients should use Alfadol with a nephrolithiasis, atherosclerosis, chronic heart failure, a chronic renal failure, the sarcoidosis or other granulomatoses, an active form of a pulmonary tuberculosis raised by risk of development of a hypercalcemia (especially at a nephrolithiasis), a hypercalcuria, to children 3 years are more senior.

Use in II and III trimesters of pregnancy is possible only in cases of exceeding of the expected advantage of therapy for mother over potential threat of emergence in a hypersensitivity fruit to vitamin D, a syndrome of specific elfopodobny appearance, an aortal stenosis, a delay of intellectual development, epithelial body function suppression.

Route of administration and dosage

Capsules are intended for intake.

Use of drug should be begun with the minimum dose and to accompany with control of level of concentration of calcium and phosphorus in a blood plasma once a week. Increase in a dose should be made gradually, increasing it by 0,25 or 0,5 mkg a day before emergence of stable biochemical indicators. After achievement of a minimal effective dose blood test is recommended to spend at least 1 time each 3-5 weeks.

The dose and duration of treatment are appointed by the doctor on the basis of clinical indications individually for each patient.

The recommended dosing for adults and children is more senior than 12 years:

• Initial dose: 1 mkg a day;
• Maintenance dose: 0,25-2 mkg a day;
• Rickets and osteomalacy: on 1-3 mkg a day within 2-3 months and more;
• Osteoporosis, including post-menopausal, steroid, senile: on 0,5-1 mkg a day;
• Hypoparathyrosis: on 1-4 mkg a day;
• Osteodystrophy at a chronic renal failure: on 1-2 mkg a day, a course of treatment – 2-3 months, 2-3 courses within 12 months.

The daily mode of dosing for children from 3 to 12 years:

• Rickets and osteomalacy: on 1-3 mkg, the course of treatment – is not less than 2-3 months;
• Osteodystrophy at a chronic renal failure: on 0,5-1 mkg, a course – 2-3 months, 2-3 courses within 12 months.

Alfadol's use can continue from 2 to 12 months and longer.

Side effects

• Alimentary system: dryness in a mouth, anorexia, nausea, vomiting, heartburn, a sensation of discomfort in the area epigastriums, an abdominal pain, diarrhea, a lock, slight increase of activity of liver enzymes, disturbance of functions of a liver;
• Urinary system: acute renal failure;
• Cardiovascular system: increase in arterial pressure, tachycardia;
• Nervous system: drowsiness, general weakness, headache, fatigue, dizziness;
• Musculoskeletal system: moderate muscle, bones, joints pains;
• Allergic reactions: skin itch, rash;
• Laboratory indicators: at heavy disturbances of functions of kidneys – development of a hyperphosphatemia, slight increase of level of concentration of lipoproteins of high density, a hypercalcemia.

Special instructions

At a chronic renal failure use of drug is begun only after preliminary correction of a hyperphosphatemia.

Except regular control of concentration of calcium and phosphates in a blood plasma, it is necessary to watch activity of an alkaline phosphatase, at patients with a chronic renal failure – weekly.

Not to allow development of a hypercalcemia, the dose of drug needs to be lowered after normalization of maintenance of an alkaline phosphatase in a blood plasma.

At a hypercalcemia and a hypercalcuria it is necessary to cancel Alfadol's reception and to reduce calcium consumption. Usually normalization of level of calcium in a blood plasma occurs after a week break. It is recommended to resume reception about 1/2 doses, applied to a break.

It is necessary to consider that because of unequal sensitivity to vitamin D at different patients, use even of therapeutic doses can cause the phenomena of a hypervitaminosis.

The balanced food is prevention of a hypovitaminosis D.

At purpose of drug children should be careful, not to allow overdose, to begin treatment with reception of low doses, to accompany gradual increase in a dose with control of level of content of calcium in a blood plasma, ratios of creatinine and calcium in urine.

Prolonged use of vitamin D increases risk of development of a growth inhibition at children.

The need for vitamin D for advanced age can increase as vitamin D absorption decreases, insolation time, ability of skin to synthesize D3 provitamin, the frequency of development of a renal failure increases.

Alfadol's use can cause drowsiness and dizziness therefore during treatment patients are recommended to refuse control of vehicles and mechanisms.

Medicinal interaction

The perhaps additive interaction of an alfakaltsidol with medicines of vitamin D and its derivatives therefore these combinations should be avoided because of the increasing risk of development of a hypercalcemia.

At simultaneous use of Alfadol:

• Phenobarbital, Phenytoinum and other inductors of microsomal enzymes of a liver – reduce concentration of an alfakaltsidol in a blood plasma;
• Colestyraminum, колестипол, antacids, сукральфат, drugs on the basis of albumine, long reception of mineral oil – decreases absorption of an alfakaltsidol;
• Bisfosfonata, a calcitonin, пликамицин, glucocorticosteroids, gallium nitrate – reduce therapeutic effect of drug;
• Inhibitors of microsomal enzymes of a liver – increase the content of drug in plasma, breaking its efficiency;
• Calcium drugs, thiazide diuretics – can promote development of a hypercalcemia because of increase in absorption of calcium in intestines and a reabsorption in kidneys;
• Antacids – increase probability of emergence of a giperalyuminiyemiya and gipermagniyemiya;
• Cardiac glycosides – the risk of disturbances of a cordial rhythm increases;
• Ascorbic acid, Retinolum, thiamin, tocopherol, pantothenic acid, Riboflavinum – reduce toxic effect of an alfakaltsidol;
• Phosphorus medicines – increase risk of development of a hyperphosphatemia.

Alfadol's combination to estrogen and other means reducing a bone resorption at treatment of patients with osteoporosis is shown.

Terms and storage conditions

To store in the protected from light, dry place at a temperature up to 25 °C. To protect from children.

Period of validity – 2 years.