Alfadol-Sa

Alfadol-Sa – the combined drug regulating calcium - phosphorus exchange and the filling shortage of D3 vitamin and calcium.

Form of release and structure

Alfadol-Sa release in the form of capsules: soft gelatinous, oblong, have double coloring (light blue/dark blue); capsules contain almost white pasty weight (on 10 pieces in blisters, on 3 blisters in a cardboard pack).

Active agents as a part of 1 capsule:

• Alfakaltsidol – 250 mg;
• Calcium carbonate – 500 mg (element calcium – 200 mg).

Auxiliary components: the hydrogenated castor oil – 6 mg, the hydrogenated vegetable oil – 29 mg, the mix LTG: butylhydroxyanisole – 0,063 mg, corn oil – 314,937 mg.

Cover (dark blue/light blue part): titanium dioxide – 0,32/0,32 mg, gelatin – 46,14/46,19 mg, 70% sorbitol solution – 2,31/2,31 mg, глицерол 13,84/13,86 mg, пропилпарагидроксибензоат – 0,13/0,13 mg, methylparahydroxybenzoate – 0,22/0,22 mg, water – 36,91/36,95 mg, dye diamond blue – 0,13/0,02 mg.

Indications to use

• Osteoporosis (стероидный/сенильный/идиопатический/менопаузальный), and also its complications (fractures of bones);
• Chronic renal failure;
• Hyper parathyroidism and hypoparathyroidism (with damage of bones);
• Renal osteodystrophy.

Contraindications

Absolute:

• Urolithiasis (formation of calcic stones);
• Hypersensitivity to D3 vitamin;
• The increased content of calcium in blood (at the strengthened function of epithelial bodies, osteochondrosis, a hypervitaminosis of D, metastasises of tumors in a bone);
• Hyperphosphatemia (except cases when it develops against the background of a hypoparathyroidism);
• Gipermagniyemiya;
• Intolerance of soy or peanut;
• Zollinger's syndrome;
• Age up to 18 years;
• Pregnancy and the period of a lactation (the safety profile for this group of patients is not studied. Purpose of Alfadola-Sa is possible only according to absolute indications and in cases when the potential advantage of its use is higher than possible risk for a fruit. The maximum daily dose at pregnancy – 1500 mg of calcium of a carbonate);
• Hypersensitivity to drug components.

Alfadol-Sa appoint with care in the presence of a renal failure, and also to the patients who are on a hemodialysis.

At purpose of a long medical course it is necessary to check amount of the calcium emitted by kidneys.

Route of administration and dosage

Alfadol-Sa accept inside.

The recommended mode of dosing (daily dose):

• Osteoporosis, hypoparathyrosis, hyperparathyreosis, chronic renal failure – 1-2 capsules;
• Osteodystrophy at a chronic renal failure – 2 capsules.

Duration of a course is defined by the doctor individually.

Side effects

• Urinary system: nephrocalcinosis;
• Alimentary system: diarrhea, lock;
• Metabolism: hypercalcemia; at the expressed functional disturbances of kidneys – a hyperphosphatemia;
• Allergic reactions: rash, itch, urticaria.

Special instructions

Alfakaltsidol treats active derivatives of D3 vitamin. During treatment it is not necessary to appoint D3 vitamin and its derivatives in therapeutic doses (probability of the increased risk of a hypercalcemia and development of the additive effects).

Alfadol-Sa strengthens intestinal absorption of phosphate and calcium which concentration needs to be controlled, in particular at a renal failure. During therapy it is necessary to exercise control of concentration of an alkaline phosphatase, creatinine, phosphate, calcium and magnesium.

The hypercalcuria or hypercalcemia quickly are eliminated with cancellation of Alfadola-Sa (before normalization of plasma concentration of calcium). At a hypercalcuria, in particular at an urolithiasis, it is necessary to appoint drug with care.

Medicinal interaction

At the combined use of Alfadola-Sa with some substances / drugs the following effects can develop:

• Foxglove glycosides: strengthening of cardiac arrhythmia (the combination is recommended to be avoided);
• Barbiturates and anticonvulsant drugs which are inductors of microsomal enzymes of a liver (systematic use): interaction development (increase in a dose of an alfakaltsidol is necessary);
• Mineral oils (at long reception), колестипол, Colestyraminum, сукральфат, and also a large number of antacids with the content of aluminum: disturbance of absorption of an alfakaltsidol;
• Antacids and laxative drugs with the content of magnesium (at the patients who are on a hemodialysis): development of a gipermagniyemiya;
• Thiazide diuretics: increase in risk of development of a hypercalcemia;
• Tetracycline, ciprofloxacin: calcium carbonate absorption disturbance.

Terms and storage conditions

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

Period of validity – 2 years.