Alphadol

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Instructions for use:

1. Release form and composition
2. Indications for use
3. Contraindications
4. Method of application and dosage
5. Side effects
6. Special instructions
7. Drug interactions
8. Analogs
9. Terms and conditions of storage
10. Terms of dispensing from pharmacies

Alphadol is a vitamin, a regulator of calcium-phosphorus metabolism, helps to replenish vitamin D3 deficiency.

Release form and composition

Dosage form - capsules: gelatinous, round, red with a transparent structure, inside the capsules - a light yellow oily transparent liquid (10 pcs. In a blister, in a cardboard box of 3, 6 or 10 blisters).

The active ingredient of Alfadol is alfacalcidol, in 1 capsule - 0.25 μg.

Auxiliary components: corn oil, butylhydroxyanisole, dehydrated ethanol (absent in the finished product).

The composition of the capsule shell: glycerol, methyl parahydroxybenzoate, 70% sorbitol solution, propyl parahydroxybenzoate, soybean oil (not found in the finished product), crimson dye (Ponso 4R), gelatin, purified water.

Indications for use

The use of Alfadol is indicated for diseases caused by impaired metabolism of phosphorus and calcium against the background of insufficient endogenous synthesis of 1,25-dihydroxyvitamin D3:

Osteomalacia, vitamin D-resistant rickets;
Osteoporosis, including senile, postmenopausal, steroidal;
Hypoparathyroidism, pseudohypoparathyroidism;
Osteodystrophy in chronic renal failure.

Contraindications

Hypervitaminosis D;
Hypercalcemia, hypermagnesemia, hyperphosphatemia (except for the treatment of hypoparathyroidism);
The period of pregnancy and breastfeeding;
Fructose intolerance;
Age up to 3 years;
Age up to 12 years (with osteoporosis, hypoparathyroidism and pseudohypoparathyroidism);
Hypersensitivity to drug components.

Alfadol should be used with caution in patients with nephrolithiasis, atherosclerosis, chronic heart failure, chronic renal failure, sarcoidosis or other granulomatosis, active pulmonary tuberculosis, an increased risk of hypercalcemia (especially with kidney stones), hypercalciuria, children over 3 years of age.

Use in the II and III trimesters of pregnancy is possible only in cases where the expected benefit from therapy for the mother exceeds the potential threat of hypersensitivity to vitamin D in the fetus, syndrome of a specific elf-like appearance, aortic stenosis, mental retardation, suppression of the function of the parathyroid gland.

Method of administration and dosage

The capsules are intended for oral administration.

The use of the drug should be started with the minimum dose and accompanied by monitoring the concentration of calcium and phosphorus in the blood plasma once a week. The dose should be increased gradually, increasing it by 0.25 or 0.5 mcg per day until stable biochemical parameters appear. After reaching the minimum effective dose, a blood test is recommended at least 1 time every 3-5 weeks.

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

Recommended dosage for adults and children over 12 years of age:

Initial dose: 1 mcg per day;
Maintenance dose: 0.25-2 mcg per day;
Rickets and osteomalacia: 1-3 mcg per day for 2-3 months or more;
Osteoporosis, including postmenopausal, steroid, senile: 0.5-1 μg per day;
Hypoparathyroidism: 1-4 mcg per day;
Osteodystrophy in chronic renal failure: 1-2 mcg per day, course of treatment - 2-3 months, 2-3 courses for 12 months.

Daily dosage regimen for children from 3 to 12 years old:

Rickets and osteomalacia: 1-3 μg each, course of treatment - at least 2-3 months;
Osteodystrophy in chronic renal failure: 0.5-1 μg, course - 2-3 months, 2-3 courses within 12 months.

The use of Alfadol can last from 2 to 12 months and longer.

Side effects

Digestive system: dry mouth, anorexia, nausea, vomiting, heartburn, discomfort in the epigastric region, abdominal pain, diarrhea, constipation, a slight increase in the activity of liver enzymes, liver dysfunction;
Urinary system: acute renal failure;
Cardiovascular system: increased blood pressure, tachycardia;
Nervous system: drowsiness, general weakness, headache, fatigue, dizziness;
Musculoskeletal system: moderate pain in muscles, bones, joints;
Allergic reactions: itching, rash;
Laboratory indicators: in severe renal impairment - the development of hyperphosphatemia, a slight increase in the concentration of high-density lipoproteins, hypercalcemia.

special instructions

In chronic renal failure, the use of the drug is started only after preliminary correction of hyperphosphatemia.

In addition to regular monitoring of the concentration of calcium and phosphate in blood plasma, it is necessary to monitor the activity of alkaline phosphatase, in patients with chronic renal failure - weekly.

In order to prevent the development of hypercalcemia, the dose of the drug must be reduced after the normalization of the content of alkaline phosphatase in the blood plasma.

With hypercalcemia and hypercalciuria, Alfadol should be discontinued and calcium intake should be reduced. Plasma calcium levels usually return to normal after a week break. It is recommended to resume taking with 1/2 the dose applied before the break.

It should be borne in mind that due to the unequal sensitivity to vitamin D in different patients, the phenomenon of hypervitaminosis can cause the use of even therapeutic doses.

A balanced diet is the prevention of vitamin D deficiency.

When prescribing the drug, children should be careful not to overdose, start treatment with low doses, accompany a gradual increase in the dose by monitoring the level of calcium in the blood plasma, the ratio of creatinine and calcium in the urine.

Long-term use of vitamin D increases the risk of stunting in children.

The need for vitamin D in old age may increase, since the absorption of vitamin D, the time of insolation, the ability of the skin to synthesize provitamin D3 decreases, and the incidence of renal failure increases.

The use of Alfadol can cause drowsiness and dizziness, therefore, during the period of treatment, patients are advised to refuse to drive vehicles and mechanisms.

Drug interactions

Possible additive interaction of alfacalcidol with drugs of vitamin D and its derivatives, therefore, these combinations should be avoided due to the increased risk of hypercalcemia.

With the simultaneous use of Alfadol:

Phenobarbital, phenytoin and other inducers of liver microsomal enzymes - reduce the concentration of alfacalcidol in blood plasma;
Cholestyramine, colestipol, antacids, sucralfate, albumin-based preparations, long-term intake of mineral oil - absorption of alfacalcidol decreases;
Bisphosphonates, calcitonin, plikamycin, glucocorticosteroids, gallium nitrate - reduce the therapeutic effect of the drug;
Inhibitors of liver microsomal enzymes - increase the plasma content of the drug, disrupting its effectiveness;
Calcium preparations, thiazide diuretics - can contribute to the development of hypercalcemia due to increased absorption of calcium in the intestine and reabsorption in the kidneys;
Antacids - increase the likelihood of hyperaluminaemia and hypermagnesemia;
Cardiac glycosides - the risk of heart rhythm disturbances increases;
Ascorbic acid, retinol, thiamine, tocopherol, pantothenic acid, riboflavin - reduce the toxic effect of alfacalcidol;
Phosphorus medicines - increase the risk of developing hyperphosphatemia.

A combination of Alfadol with estrogens and other agents that reduce bone resorption is shown in the treatment of patients with osteoporosis.

Analogs

Alfadol analogs are: Alpha-D3-Teva, Etalfa.

Terms and conditions of storage

Store in a dark, dry place at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!