Natecal D3 (Tablets) Instructions for Use

ATC Code

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

Active Substances

Calcium carbonate (Ph.Eur.)

Colecalciferol (Rec.INN)

Clinical-Pharmacological Group

Drug regulating calcium and phosphorus metabolism

Pharmacotherapeutic Group

Calcium-phosphorus metabolism regulator

Pharmacological Action

A combined drug that regulates the metabolism of calcium and phosphorus in the body (in bones, teeth, nails, hair, muscles).

It reduces resorption and increases bone density, compensating for the deficiency of calcium and vitamin D₃ in the body, enhances calcium absorption in the intestines and phosphate reabsorption in the kidneys, and promotes the mineralization of bone tissue and dental tissue.

Calcium is involved in the formation of bone tissue, in maintaining stable cardiac activity, in the regulation of nerve conduction, muscle contractions, hormone production, and is a component of the blood coagulation system.

Adequate calcium intake is especially important during periods of growth, pregnancy, and breastfeeding.

Vitamin D₃ (Colecalciferol) increases calcium absorption in the intestine and promotes the formation and mineralization of bone tissue and dental tissue.

The use of calcium and vitamin D₃ prevents an increase in the production of PTH, which is a stimulator of increased bone resorption (leaching of calcium from bones).

Pharmacokinetics

Colecalciferol

Vitamin D₃ is easily absorbed from the small intestine (about 80% of the administered dose).

Colecalciferol and its metabolites circulate in the blood bound to a specific globulin.

Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycholecalciferol.

It is then converted in the kidneys to the active form 1,25-dihydroxycholecalciferol.

1,25-dihydroxycholecalciferol is the metabolite responsible for increasing calcium absorption.

Non-metabolized vitamin D₃ is stored in adipose and muscle tissue.

It is excreted through the intestines and kidneys.

Calcium

Calcium is absorbed in ionized form from the proximal part of the small intestine via an active, vitamin D-dependent transport mechanism.

Typically, the amount of calcium absorbed from the gastrointestinal tract is approximately 30% of the administered dose.

99% of the calcium in the body is concentrated in the hard tissues of teeth and bones.

The remaining 1% is found in intra- and extracellular fluids.

About 50% of the total calcium content in the blood is in the physiologically active ionized form, of which approximately 10% is complexed with citrate, phosphate, or other anions, and the remaining 40% is bound to proteins, primarily albumin.

Calcium is excreted by the intestines, kidneys, and sweat glands.

Renal excretion depends on glomerular filtration and tubular reabsorption of calcium.

Indications

Treatment and prevention of calcium and vitamin D₃ deficiency: osteoporosis, including menopausal, senile, “steroid”, idiopathic (prevention and supplement to specific treatment); osteomalacia (associated with impaired mineral metabolism in patients over 45 years of age); hypocalcemia (including after following diets with avoidance of milk and dairy products); with increased demand during pregnancy and lactation, as well as in children over 12 years of age during periods of intensive growth.

ICD codes

Dosage Regimen

Tablets

Consult a doctor before using the drug.

The tablet should be chewed or allowed to dissolve (should not be swallowed whole).

As a prophylactic agent

Adults are prescribed 1-2 tablets/day, preferably with meals.

Osteoporosis therapyand replenishment of calcium and vitamin D₃ deficiency in elderly patients

The duration of the treatment course and dosage regimen are established in accordance with the doctor’s recommendations.

Adverse Reactions

From the digestive system constipation, flatulence, nausea, stomach pain, diarrhea.

From laboratory parameters hypercalcemia and hypercalciuria.

Other allergic reactions.

Contraindications

Hypersensitivity; hypercalcemia (including as a result of primary or secondary hyperparathyroidism); hypercalciuria; calcium nephrourolithiasis; hypervitaminosis D; sarcoidosis; osteoporosis due to immobilization; pulmonary tuberculosis (active form).

With caution

In renal failure, benign granulomatosis, during pregnancy, during lactation, simultaneously with the use of glycosides and thiazide diuretics, in children (under 12 years of age).

Use in Pregnancy and Lactation

Use with caution during pregnancy and lactation. During pregnancy, the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D₃.

Overdose during pregnancy can lead to impaired mental and physical development of the child.

Calcium and vitamin D₃ pass into breast milk.

Use in Renal Impairment

Use with caution in renal failure.

Pediatric Use

Use with caution in children (under 12 years of age).

Special Precautions

During treatment, it is necessary to constantly monitor urinary calcium excretion and plasma calcium and creatinine concentrations (if calciuria appears, exceeding 7.5 mmol/day (300 mg/day), it is necessary to reduce the dose or discontinue use).

To avoid overdose, additional intake of vitamin D₃ from other sources must be taken into account. Do not use simultaneously with vitamin complexes containing calcium and vitamin D₃.

In elderly people, the need for calcium is 1.5 g/day, for vitamin D₃ – 0.5-1 thousand IU/day.

Drug Interactions

Reduces the absorption of bisphosphonates, sodium fluoride and tetracyclines (the interval between doses should be at least 2-3 hours).

Increases the risk of toxicity of cardiac glycosides (monitoring of ECG and the patient’s condition is necessary).

Phenytoin, barbiturates, glucocorticosteroids reduce the effect of vitamin D₃, vitamin A – toxicity.

Glucocorticosteroids reduce the absorption of calcium.

Cholestyramine, laxatives (mineral oil) reduce the absorption of vitamin D.

Thiazide diuretics increase the risk of hypercalcemia.

Furosemide and other “loop” diuretics increase the renal excretion of calcium.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°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.