Alpha D3-Teva - Instructions For Use, Price, Reviews, Analogues

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

Alpha D3-Teva

Alpha D3-Teva: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Alpha D3-Teva

ATX code: A11CC03

Active ingredient: alfacalcidol (alfacalcidol)

Manufacturer: Teva Pharmaceutical Industries Ltd. (Israel)

Description and photo update: 2019-16-08

Prices in pharmacies: from 273 rubles.

Buy

Alpha D3-Teva is a drug that regulates the exchange of phosphorus and calcium in the body.

Release form and composition

Alpha D3-Teva is available in capsules with a dosage of 1; 0.5 and 0.25 μg. The main active ingredient is alfacalcidol.

Excipients: propyl gallate, peanut butter, anhydrous citric acid, anhydrous ethanol, tocopherol.

Composition of gelatin capsules: glycerol, gelatin, red iron oxide (E172), titanium dioxide (E171), yellow iron oxide (E172), anidrisorb 85/70.

Pharmacological properties

Pharmacodynamics

1α-hydroxyvitamin D ₃ (alfacalcidol) in the liver is rapidly converted to 1,25-dihydroxyvitamin D ₃, which is an active metabolite of vitamin D (calcitriol) and acts as a regulator of phosphorus and calcium metabolism. Increases the absorption of phosphorus and calcium in the intestine, increases the reabsorption of these elements in the kidneys, in the treatment of calcium malabsorption syndrome provides the restoration of a positive calcium balance, reduces the concentration of parathyroid hormone in the blood.

Alfacalcidol affects resorption and synthesis during bone remodeling, increases bone mineralization, increases its elasticity by stimulating the synthesis of bone morphogenetic proteins, bone matrix proteins, bone growth factors (the frequency of fractures decreases).

In elderly patients, against the background of developing endocrine-immune dysfunction (including a deficiency in D-hormone production), total muscle mass decreases, and muscle weakness syndrome appears due to a violation of the normal function of the neuromuscular system. The described phenomena are accompanied by an increased likelihood of falls and, as a result, an increased risk of fractures and injuries. In a number of studies, with the use of alfacalcidol, a significant decrease in the incidence of falls in elderly patients was recorded. Alfacalcidol promotes the regeneration of muscle fibers and restores muscle tone.

Pharmacokinetics

After oral administration, alfacalcidol is rapidly absorbed from the gastrointestinal tract. The time to reach the maximum concentration in blood plasma after a single dose is 8-12 hours.

Alfacalcidol is metabolized to calcitriol (1,25-dihydroxycolecalciferol) in the liver. The main route is hydroxylation at the 25th carbon atom. The hydroxylation process is very fast (it has a substrate-dependent character). Alfacalcidol, unlike native vitamin D, does not need the process of hydroxylation in the kidneys, so it is effective even in those patients who have a reduced activity of renal 1-alpha hydroxylase (with kidney disease or in old age).

It is excreted in approximately equal proportions by the kidneys and with bile through the intestines. The half-life is 19 days.

Indications for use

According to the instructions, Alpha D3-Teva is prescribed for:

• Osteodystrophy in chronic renal failure;
• Osteoporosis, including senile, postmenopausal, steroid;
• Hypoparathyroidism and pseudohypoparathyroidism;
• Pseudo-deficiency (vitamin D-dependent) rickets and osteomalacia;
• Hypophosphatemic (vitamin D-resistant) rickets and osteomalacia;
• Renal acidosis;
• Fanconi syndrome (hereditary renal acidosis with nephrocalcinosis, adiposogenital dystrophy and late rickets).

Contraindications

Alpha D3-Teva is contraindicated in:

• Hypervitaminosis D;
• Hypermagnesemia;
• Hyperphosphatemia (with the exception of hyperphosphatemia in hypoparathyroidism);
• Hypercalcemia;
• Breastfeeding;
• Hypersensitivity to drug components.

Alpha D3-Teva is prescribed with caution to patients with heart and renal failure, atherosclerosis, nephrolithiasis, sarcoidosis, active pulmonary tuberculosis, as well as to patients with a predisposition to hypercalcemia, in particular, with urolithiasis.

Reception of Alpha D3-Teva during pregnancy is prescribed only if the possible benefits of treating the mother outweigh the risk to the fetus. Hypercalcemia during pregnancy can cause fetal defects.

Instructions for the use of Alpha D3-Teva: method and dosage

For adults and children over 3 years of age with rickets and osteomalacia caused by malnutrition, Alpha D3-Teva is prescribed at a dose of 1-3 mcg per day.

The daily dose for adults with hypoparathyroidism is 1-4 μg.

With hypophosphatemic rickets and osteomalacia, the drug is prescribed at an initial dosage of 4 mcg per day, which can be gradually increased to 20 mcg per day. For children over 3 years old, the course of treatment begins with 1 mcg per day.

For osteodystrophy with chronic renal failure, adults are prescribed Alpha D3-Teva at 0.5-2 mcg, children over 3 years old - at 0.5-1 mcg per day.

For senile, steroid, postmenopausal osteoporosis, Alpha D3-Teva is prescribed in an amount of 0.5-1 μg per day.

With renal acidosis and Fanconi syndrome, the dosage for adults and children over 3 years old is 2-6 mcg per day.

The use of Alpha D3-Teva begins with the minimum indicated doses, once a week, monitoring the level of phosphorus and calcium in the blood plasma. It is allowed to increase the dosage of the drug by 0.25-0.5 μg per day until the biochemical parameters stabilize. Upon reaching the minimum effective dose, it is recommended to monitor phosphorus and calcium in blood plasma at least once a month.

The duration of the course is determined by the attending physician individually, depending on the course of the disease and the effectiveness of therapy.

Side effects

The use of Alpha D3-Teva can cause the following side effects:

• From the digestive system: abdominal pain, anorexia, vomiting, heartburn, dry mouth, nausea, constipation or diarrhea, discomfort in the epigastric region. Rarely - a slight increase in AST, ALT in blood plasma;
• From the side of metabolism: rarely - hypercalcemia, very rarely - a slight increase in HDL in plasma, hyperphosphatemia;
• From the side of the cardiovascular system: tachycardia;
• From the side of the central nervous system: weakness, headache, fatigue, drowsiness and dizziness;
• Allergic reactions: itching and rash.

In accordance with the instructions, Alpha D3-Teva in case of an overdose can cause the following phenomena:

• Early symptoms of hypervitaminosis D: constipation or diarrhea, vomiting, nausea, anorexia, dry mouth, headaches, metallic taste in the mouth, fatigue, polydipsia, polyuria, hypercalciuria, pollakiuria / nocturia, myalgia, general weakness, bone pain;
• Late symptoms of hypervitaminosis D: drowsiness, confusion, dizziness, increased blood pressure, heart rhythm disturbances, turbidity of urine, nephrolithiasis, conjunctival hyperemia, pancreatitis, weight loss, gastralgia, photophobia;
• Chronic symptoms of hypervitaminosis D: calcification of blood vessels, soft tissues, lungs and kidneys, cardiovascular and renal failure with a possible fatal outcome.

If these symptoms occur, you should stop taking Alpha D3-Teva. To avoid an overdose of the drug, during the course of treatment, regular checks of the functions of the heart and kidneys should be carried out, and the content of electrolytes in the blood should be monitored.

Overdose

Early symptoms of vitamin D hypervitaminosis include: diarrhea or constipation, dryness of the oral mucosa, thirst, headache, nocturia, pollakiuria, polyuria, anorexia, nausea, vomiting, metallic taste, hypercalciuria, general weakness.

Late symptoms of vitamin D hypervitaminosis include: clouding of urine (the presence of hyaline casts), bone pain, pruritus, increased blood pressure, conjunctival hyperemia, photophobia, drowsiness, myalgia, arrhythmia, nausea, vomiting, weight loss, rarely confusion, changes in mood and psyche.

Symptoms of chronic vitamin D intoxication include: calcification of blood vessels, soft tissues, internal organs (lungs, kidneys), cardiovascular and renal failure, in children - impaired growth.

2-7 days after stopping the intake of Alpha D3-Teva, the calcium content in the blood serum is normalized.

Treatment of hypercalcemia requires temporary cessation of alfacalcidol and calcium supplements and a low calcium diet.

In severe cases, in case of accidental acute overdose and persistent hypercalcemia, general supportive measures are recommended.

In case of an overdose, it is required to cancel Alpha D3-Teva. In the early stages of acute overdose, gastric lavage, the intake of mineral (vaseline) oil, which helps to reduce the absorption of the active substance and increase its excretion through the intestines, are shown. In severe cases (with a serum calcium level of more than 3 mmol / L), supportive measures are recommended, including hydration with the introduction of an infusion saline solution to ensure forced diuresis, and in some cases, the appointment of loop diuretics, glucocorticosteroid drugs, calcitonin, bisphosphonates, peritoneal dialysis or hemodialysis using a calcium-free dialysate. It is imperative to monitor serum electrolytes (especially calcium), renal function,heart conditions (based on electrocardiogram data), especially in patients who are taking digoxin or other digitalis drugs.

special instructions

In the treatment of osteoporosis, it is possible to prescribe Alfa D3-Teva together with drugs that reduce bone resorption and estrogens.

Simultaneous intake of alfacalcidol with cardiac glycosides can cause cardiac arrhythmias.

When the drug is used together with mineral oil, colestipol, cholestyramine, antacids, sucralfate and other preparations based on albumin, its absorption decreases.

Concomitant use with thiazide diuretics, calcium supplements, vitamin D increases the risk of hypercalcemia.

Alpha D3-Teva can cause dizziness and drowsiness, therefore, during the course of treatment, you should be very careful when driving and working with complex mechanisms.

Application during pregnancy and lactation

During pregnancy, if the mother has hypercalcemia due to prolonged overdose of vitamin D, it is possible to develop fetal hypersensitivity to vitamin D with suppression of the function of the parathyroid gland, the appearance of a syndrome of a specific elf-like appearance, mental retardation and aortic stenosis.

During pregnancy, the use of Alpha D3-Teva is allowed only under strict indications, if the expected risk to the fetus is lower than the potential benefit to the mother.

It is forbidden to use Alpha D3-Teva during breastfeeding.

Pediatric use

It is forbidden to use Alpha D3-Teva for the treatment of patients under the age of 3 years, and when treating children from 3 years of age, the drug must be prescribed with caution.

With impaired renal function

In acute or chronic kidney disease, the drug should be used with caution.

For violations of liver function

In acute or chronic liver diseases, the drug should be used with caution.

Use in the elderly

When treating elderly patients, dose adjustment of Alpha D3-Teva is not required.

Drug interactions

When used in conjunction with inducers of microsomal liver enzymes (including phenobarbital and phenytoin), the concentration of alfacalcidol in plasma decreases (its effectiveness may change), and when used concurrently with inhibitors, it increases.

With the simultaneous administration of alfacalcidol and digitalis drugs, the risk of arrhythmia increases.

When used together with colestipol, cholestyramine, sucralfate, mineral oil, antacids, the absorption of alfacalcidol decreases. To reduce the likelihood of such an interaction, the drug Alpha D3-Teva must be used 1 hour before or 4–6 hours after the use of the above drugs.

Alfacalcidol increases the absorption of phosphorus-containing drugs with a corresponding risk of hyperphosphatemia.

Calcitonin, derivatives of pamidronic and etidronic acids, gallium nitrate, glucocorticosteroids and plicamycin reduce the effect of alfacalcidol.

Co-administration of alfacalcidol and calcium preparations or thiazide diuretics can lead to the development of hypercalcemia due to an increase in calcium absorption in the intestine and its reabsorption in the kidneys.

Complex treatment with vitamin D and magnesium-containing antacids can cause an increase in the concentration of magnesium in the blood. With the simultaneous administration of this vitamin and aluminum-containing antacids, an increase in the content of aluminum in the blood is possible (especially in chronic renal failure).

Simultaneous intake of vitamin D analogs causes an additive effect with the development of hypercalcemia, therefore, Alpha D3-Teva should not be taken simultaneously with other vitamin D preparations or its derivatives.

Analogs

The structural analogs of Alpha D3-Teva include the drugs Etalfa and Alphadol.

Storage conditions and periods

Store in a place protected from sunlight at an air temperature not exceeding 25 ° C.

Shelf life - 3 years from the date of production.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Alpha D3-Teva

Reviews of Alpha D3-Teva indicate the high effectiveness of the drug in the treatment of children and adults. Most often, positive reviews are left by the elderly who take the drug during recovery from fractures of the lower and upper extremities, as well as patients over 60 years of age with osteoporosis.

Also, the effectiveness of Alpha D3-Teva is reported by parents who use it to treat rickets in children.

The price of Alpha D3-Teva in pharmacies

The approximate price for Alpha D3-Teva is: 30 capsules 0.25 mcg - 325 rubles, 60 capsules 0.25 mcg - 535 rubles, 30 capsules 0.5 mcg - 555 rubles, 60 capsules 0.5 mcg - 800 rub., 30 capsules 1 mcg - 690 rubles.

Alpha D3-Teva: prices in online pharmacies

Drug name Price Pharmacy

Alpha D3-Teva capsules 0.25mcg 30 pcs. 273 r Buy

Alpha D3-Teva 0.25 mcg capsules 30 pcs. 273 r Buy

Alpha D3-Teva 0.25 mcg capsules 60 pcs. 347 r Buy

Alpha D3-Teva capsules 0.25mcg 60 pcs. 476 r Buy

Alpha D3-Teva 0.5 mcg capsules 30 pcs. RUB 478 Buy

Alpha D3-Teva capsules 0.5mkg 30 pcs. RUB 499 Buy

Alpha D3-Teva capsules 1mkg 30 pcs. 589 r Buy

Alpha D3-Teva 1 mcg capsule 30 pcs. 589 r Buy

Alpha D3-Teva 0.5 mcg capsule 60 pcs. RUB 677 Buy

See all offers from pharmacies

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

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