Alphadol-Ca (Capsules) Instructions for Use

Marketing Authorization Holder

Panacea Biotec, Ltd. (India)

Contact Information

PANACEYA BIOTEK Ltd. (India)

ATC Code

A12AX (Calcium preparations in combination with vitamin D and/or other drugs)

Active Substances

Alfacalcidol (Rec.INN registered by WHO)

Calcium carbonate (Ph.Eur. European Pharmacopoeia)

Dosage Form

Alphadol-Ca

Capsules 0.25 mcg+200 mg: 30 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (3) – cardboard packs.

Clinical-Pharmacological Group

Drug regulating calcium and phosphorus metabolism

Pharmacotherapeutic Group

Calcium-phosphorus metabolism regulator

Pharmacological Action

A combined drug that regulates calcium and phosphorus metabolism. It replenishes the deficiency of calcium and vitamin D₃ in the body.

The main therapeutic effects of alfacalcidol are an increase in the concentration of 1,25-hydroxycholecalciferol in the blood and, as a consequence, an enhancement of calcium and phosphate absorption; improvement of mineralization and reduction of bone tissue resorption, normalization of parathyroid hormone levels in plasma, reduction of bone and muscle pain.

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

Justification for the combination of alfacalcidol and calcium

Alfacalcidol enhances the absorption of calcium from the gastrointestinal tract and produces a therapeutic effect in osteoporosis. The content of elemental calcium in calcium carbonate is 40%, i.e., 500 mg of calcium carbonate contains 200 mg of elemental calcium, which corresponds to the minimum physiological requirement.

Pharmacokinetics

Absorption is high, T_max is 8-18 hours. In the blood, it binds to specific alpha-globulins.

It is metabolized in the liver to form the active metabolite calcitriol (1,25-dihydroxycholecalciferol); a smaller part is metabolized in bone tissue. Unlike natural vitamin D, it is not metabolized in the kidneys, which allows its use for vitamin D deficiency in patients with renal failure (the effect does not depend on hydroxylation in the kidneys).

It is excreted by the kidneys and with bile in approximately equal amounts.

Indications

• osteoporosis (menopausal, senile, steroid, idiopathic and others) and its complications (bone fractures);
• renal osteodystrophy;
• hypoparathyroidism and hyperparathyroidism (with bone involvement);
• chronic renal failure.

ICD codes

Dosage Regimen

Take Alphadol-Ca capsules orally, swallowed whole with a glass of water. Administer the dose once daily or as divided doses, as directed by a physician.

For the treatment of osteoporosis (menopausal, senile, steroid, idiopathic), the typical dosage is 1 to 2 capsules daily.

For patients with renal osteodystrophy in the context of chronic renal failure, the recommended dose is 2 capsules per day.

In cases of hypoparathyroidism and hyperparathyroidism with bone involvement, prescribe 1 to 2 capsules daily.

For the management of chronic renal failure, the standard dose is 1 to 2 capsules per day.

Individualize the dosage based on the patient’s clinical condition, serum calcium, and phosphate levels. Initiate therapy at the lower end of the dosage range.

Regularly monitor serum calcium, phosphate, and creatinine concentrations during treatment, especially at the beginning of therapy and after any dosage adjustment. Adjust the dose to maintain serum calcium within the normal range.

Discontinue treatment immediately if hypercalcemia develops. The total duration of therapy is determined by the physician based on therapeutic response and tolerability.

Adverse Reactions

Metabolism and nutrition disorders hypercalcemia. In patients with severe renal impairment, hyperphosphatemia may develop.

Gastrointestinal disorders constipation, diarrhea.

Renal and urinary disorders nephrocalcinosis.

Allergic reactions itching, rash, urticaria.

Contraindications

• Hypersensitivity to vitamin D₃;
• Urolithiasis (formation of calcium stones);
• Increased calcium content in the blood (in persons with hyperfunction of the parathyroid glands, hypervitaminosis D, osteochondrosis, tumor metastases in bones);
• Hyperphosphatemia (except when it develops against the background of hypoparathyroidism);
• Hypermagnesemia;
• Zollinger’s syndrome;
• Peanut or soy intolerance;
• Children under 18 years of age.

Use with caution in persons suffering from renal failure, as well as in patients on hemodialysis. In case of long-term treatment, it is necessary to check the amount of calcium excreted by the kidneys.

Use in Pregnancy and Lactation

Studies have not been conducted, so the drug is contraindicated during pregnancy and breastfeeding.

During pregnancy, the drug is prescribed only for absolute indications and only if the potential benefit of its use outweighs the possible risk to the fetus. Hypercalcemia during pregnancy can affect fetal development. The daily dose should not exceed 1500 mg of calcium carbonate.

Use in Renal Impairment

Use with caution in persons suffering from renal failure, as well as in patients on hemodialysis. In case of long-term treatment, it is necessary to check the amount of calcium excreted by the kidneys.

Pediatric Use

Contraindicated in children under 18 years of age.

Special Precautions

Alfacalcidol is an active derivative of vitamin D₃. During treatment, therapeutic doses of vitamin D₃ and its derivatives should not be prescribed due to the possibility of additive effects and an increased risk of hypercalcemia.

The drug enhances intestinal absorption of calcium and phosphate, the concentrations of which must be controlled, especially in patients with renal failure. Monitoring of calcium, phosphate, alkaline phosphatase, magnesium, and creatinine concentrations should be performed.

If hypercalcemia or hypercalciuria occurs, they can be quickly eliminated by discontinuing the drug until the plasma calcium concentration normalizes. The drug should be used with caution in patients with hypercalciuria, in particular in persons with urolithiasis.

Effect on ability to drive vehicles and operate machinery

The drug does not affect driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

If hypercalcemia develops, the drug should be discontinued.

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 – the appointment of “loop” diuretics, corticosteroids.

In case of acute overdose, preliminary treatment with gastric lavage and/or administration of mineral oil is necessary, which helps to reduce absorption and increase the excretion of the drug through the intestines.

Drug Interactions

Alfacalcidol/digitalis glycosides

Hypercalcemia in patients taking cardiac glycosides may enhance cardiac arrhythmia, so their concomitant use should be avoided.

Alfacalcidol/barbiturates/anticonvulsants that are inducers of liver microsomal enzymes

Patients systematically receiving barbiturates or other anticonvulsants require increased doses of alfacalcidol to achieve a therapeutic effect.

Alfacalcidol/drugs affecting absorption

The absorption of alfacalcidol can be impaired by simultaneously taken mineral oils (with long-term use), cholestyramine, colestipol, sucralfate, as well as large amounts of aluminum-containing antacids.

When alfacalcidol is used concomitantly with antacids and laxatives containing magnesium in patients on hemodialysis, the possibility of developing hypermagnesemia should be considered.

Alfacalcidol/thiazide diuretics

The interaction of alfacalcidol with thiazide diuretics increases the risk of hypercalcemia.

Calcium carbonate may impair the absorption of simultaneously taken tetracycline and ciprofloxacin.

Storage Conditions

In a dry place, protected from light, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.