Ergocalciferol (Solution, Drops) Instructions for Use

ATC Code

A11CC01 (Ergocalciferol)

Active Substance

Ergocalciferol (Rec.INN registered by WHO)

Clinical-Pharmacological Group

Drug regulating calcium and phosphorus metabolism

Pharmacotherapeutic Group

Vitamins; vitamin A and D, including their combinations; vitamin D and its analogues

Pharmacological Action

Vitamin D₂, a regulator of calcium and phosphorus metabolism.

It increases the permeability of the intestinal epithelium for calcium and phosphorus, ensuring their necessary concentrations in the blood.

It regulates the mineralization of bone tissue, as well as the process of calcium mobilization from bone tissue.

It promotes the reabsorption of phosphates in the renal tubules.

It has cumulative properties.

Pharmacokinetics

It is absorbed in the small intestine in the presence of bile by 60-90% (in hypovitaminosis – almost completely); in the small intestine, it undergoes partial absorption (enterohepatic circulation).

When the flow of bile into the intestine decreases, the intensity and completeness of absorption sharply decrease.

It circulates in the plasma and lymphatic system in the form of chylomicrons and lipoproteins.

It undergoes metabolism, turning into active metabolites: in the liver – into calcidiol, in the kidneys – from calcidiol into calcitriol.

It accumulates in large quantities in the bones, in smaller quantities – in the liver, muscles, blood, small intestine, and persists especially long in adipose tissue.

Ergocalciferol and its metabolites are excreted with bile, a small amount – by the kidneys.

Indications

For systemic use: prevention and treatment of rickets; disorders of calcium metabolism (including in hypoparathyroidism, pseudohypoparathyroidism), accompanied by tetany, osteopathy, spasmophilia; osteoporosis, osteomalacia.

For topical use: first and second degree burns (including sunburns), dermatitis accompanied by dry skin and peeling; infantile diaper rash, “diaper” rash; prevention and treatment of nipple cracks (in the third trimester of pregnancy and during lactation); to improve the healing of abrasions, scratches, and small wounds.

ICD codes

Dosage Regimen

Determine the dosage based on the indication, severity of the condition, and serum 25-hydroxyvitamin D levels.

For oral administration, use the calibrated dropper provided. Administer the solution directly into the mouth or mix with a small amount of infant formula, water, or other liquid immediately before use.

For prevention of rickets in full-term infants, administer 10 mcg (400 IU) once daily, starting from the 4th-5th week of life.

For premature infants, twins, and infants in unfavorable living conditions, administer 10-20 mcg (400-800 IU) daily.

For treatment of rickets, administer 20-100 mcg (800-4000 IU) daily for 30-45 days.

For treatment of osteomalacia and osteoporosis, administer 20-50 mcg (800-2000 IU) daily.

For hypoparathyroidism and pseudohypoparathyroidism, administer 0.75-15 mg (30,000-600,000 IU) daily, adjusting the dose based on serum calcium levels.

For topical use on skin conditions, apply a thin layer to the affected areas 2-3 times daily.

For prevention and treatment of nipple cracks, apply to the nipples after each feeding.

Do not exceed the recommended daily dose without medical supervision. Monitor serum and urinary calcium levels periodically during long-term therapy, especially at high doses.

Adverse Reactions

Possible nausea, vomiting, headache, weakness, irritability, weight loss, increased urination, tissue calcification.

Rarely cardiac arrhythmias.

Contraindications

Hypercalcemia, active form of pulmonary tuberculosis, gastric and duodenal ulcer, acute and chronic diseases of the liver and/or kidneys, organic heart lesions.

Use in Pregnancy and Lactation

When ergocalciferol is prescribed for therapeutic purposes to a nursing mother, breastfeeding is not recommended (to avoid the development of hypercalcemia in the child).

To prevent rickets in newborns and infants, ergocalciferol may be prescribed during pregnancy and during lactation (breastfeeding).

The dosage regimen is established individually.

Use with caution in pregnant women over 35 years of age.

Use in Hepatic Impairment

Contraindicated in acute and chronic liver diseases.

Use in Renal Impairment

Contraindicated in acute and chronic kidney diseases.

Geriatric Use

Use with caution, under medical supervision, in elderly patients.

Special Precautions

Use with caution, under medical supervision, in patients with heart disease, and in elderly patients.

With long-term use, especially in high doses, regular examination of calcium content in the blood and urine should be carried out.

Drug Interactions

The effectiveness of ergocalciferol may decrease during treatment with barbiturates or anticonvulsants.

It can be used in combination with retinol.

The toxic effect is weakened by vitamin A, tocopherol, ascorbic acid, pantothenic acid, thiamine, riboflavin, pyridoxine.

Thiazide diuretics increase the risk of hypercalcemia.

In hypervitaminosis caused by ergocalciferol, the effect of cardiac glycosides may be enhanced due to the development of hypercalcemia (adjustment of the cardiac glycoside dose is advisable).

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Over-the-Counter

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.