Alfadol-Sa, capsules 30 pcs

Pharmacotherapeutic group
Vitamin – calcium-phosphorus metabolism regulator

ATX code
A11CC
Pharmacological properties
Combined drug regulating calcium and phosphorus metabolism. It replenishes the lack of calcium and vitamin D3 in the body.

The main therapeutic effects of Alfacalcidol are increasing concentration of 1,25-hydroxycalciferol in blood and as a consequence intensification of calcium and phosphate absorption; improvement of mineralization and decrease of bone tissue resorption, normalization of parathyroid hormone in plasma, decrease of bone and muscle pain.

Calcium is involved in the formation of bone tissue, blood clotting, transmission of nerve impulses, skeletal muscle contractions, regulation of the heart.

The rationale for the combination of alfacalcidol and calcium

Alfacalcidol increases absorption of calcium from the gastrointestinal tract and causes therapeutic effect in osteoporosis. Content of elemental calcium in calcium carbonate is 40%, i.e. in 500 mg of calcium carbonate there is 200 mg of elemental calcium, which corresponds to minimal physiological need.

Pharmacokinetics
Absorption is high, TCmax is 8-18 h. In blood it binds with specific alpha-globulins.

It is metabolized in the liver with the formation of the active metabolite calcitriol (1,25-dihydroxycalciferol); a smaller portion is metabolized in bone tissue. Unlike natural vitamin D, it is not metabolized in the kidneys, allowing it to be prescribed for vitamin D deficiency in patients with renal insufficiency (the effect does not depend on hydroxylation in the kidneys). It is excreted by the kidneys and with the bile in approximately equal amounts.

Indications

Rakhitis, Osteoporosis, Calcium deficiency, Bone fractures, Osteoarthritis, Climax, Malnutrition Osteoporosis (menopausal, senile, steroidal, idiopathic, etc.) and its complications (bone fractures).Osteoporosis (menopausal and menopausal, steroid and idiopathic) and its complications (bone fractures);
renal osteodystrophy;
hypoparathyroidism and hyperparathyroidism (with bone lesions);
chronic renal insufficiency.

Composition

Each capsule contains:

Active ingredients:

Alfacalcidol 0.25 mcg,

Calcium carbonate in an amount of 500.00 mg, corresponding to elemental calcium 200 mg

Excipients: 6.00 mg hydrogenated castor oil, 29.00 mg hydrogenated vegetable oil, LTG blend: 314.937 mg corn oil, 0.063 mg butylhydroxyanisole.

The dark blue part of the capsule shell contains: gelatin 46.14 mg, glycerol 13.84 mg, sorbitol 70% solution 2.31 mg, methyl parahydroxybenzoate 0.22 mg, propyl parahydroxybenzoate 0.13 mg, water 36.91 mg, brilliant blue dye 0.13 mg, titanium dioxide 0.32 mg.

The light blue capsule shell contains: gelatin 46.19 mg, glycerol 13.86 mg, sorbitol 70% solution 2.31 mg, methyl parahydroxybenzoate 0.22 mg, propyl parahydroxybenzoate 0.13 mg, water 36.95 mg, brilliant blue dye 0.02 mg, titanium dioxide 0.32 mg. Dihydrated ethanol, soybean oil are removed during production.

How to take, the dosage

With osteoporosis – 1-2 capsules a day.

With osteodystrophy in chronic renal insufficiency – 2 capsules a day.

With hypoparathyreosis and hyperparathyreosis (with bone lesions) – 1-2 capsules a day.

Chronic renal insufficiency – 1-2 capsules a day.

The duration of preparation intake is determined by the doctor.

Special Instructions

Alfacalcidol is an active derivative of vitamin D3. Therapeutic doses of vitamin D3 and its derivatives should not be administered during treatment due to the possibility of additive effects and increased risk of hypercalcemia:

The drug increases intestinal absorption of calcium and phosphate, whose concentration should be controlled, especially in patients with renal failure. Concentrations of calcium, phosphate, alkaline phosphatase, magnesium and creatinine should be monitored.

In case of hypercalcemia or hypercalciuria it can be quickly eliminated by cancelling the drug until normalization of calcium concentration in plasma. The drug should be used with caution in patients with hypercalciuria, especially in those with urolithiasis.

Effect on driving and operating machinery
The drug does not affect driving and other potentially dangerous activities that require high concentration and quick psychomotor reactions.

Contraindications

Hypersensitivity to vitamin D3. Urinary stone disease (formation of calcium stones). Increased calcium content in the blood (in people with increased parathyroid gland function, hypervitaminosis D, osteochondrosis, tumor metastases in the bones). Hyperphosphatemia (except when the latter develops against a background of hypoparathyroidism), hypermagnesemia, Zollinger syndrome. Intolerance to peanuts or soybeans. Children under 18 years of age.

With caution
With caution take persons with renal insufficiency, as well as patients on hemodialysis. In case of long-term treatment it is necessary to check the amount of calcium excreted by the kidneys.

Overdose

If hypercalcemia develops, discontinue the drug.

Hypercalcemia manifests as malaise, fatigue, weakness, dizziness, drowsiness, headache, nausea, dry mouth, constipation, diarrhea, heartburn, vomiting, abdominal pain, gastrointestinal disorders, muscle pain, bone pain, joint pain, itching.

Treatment: the drug should be discontinued. Severe hypercalcemia requires supportive therapeutic measures – hydration with infusion of saline solutions, in some cases – administration of “loop” diuretics, corticosteroids.

In cases of acute overdose the preliminary treatment by gastric lavage and/or administration of mineral oil should be conducted, which helps to reduce absorption and increase excretion of the drug through the intestine.

Assignments

For kids

Pregnancy use

Studies have not been carried out; therefore, the drug is contraindicated during pregnancy and lactation. During pregnancy the drug is prescribed only in absolute indications and only if the potential benefit of its use exceeds the possible risk to the fetus. Hypercalcemia during pregnancy may affect fetal development. Daily dose should not exceed 1500 mg of calcium carbonate.