Packaging and pharmaceutical form :

5 ml oral drops in dropper form

Therapeutic effects and pharmacology:

Vitamin D is synthesized in the body when the skin is exposed to sunlight. In cases where individuals do not receive direct sunlight, the use of vitamin D supplements is recommended. Due to the physiological conditions of growth and the low levels of vitamin D in breast milk, infants and children have a higher requirement for this vitamin, and deficiency during this period is common.

Severe vitamin D3 deficiency in children leads to rickets (Rickets), and in adults it causes osteomalacia (Osteomalacia). In adults and the elderly, it is also directly associated with an increased risk of bone fractures and osteoporosis (Osteoporosis). Vitamin D plays a key role in calcium absorption in the intestines, and adequate intake helps maintain healthy and strong bones.

Vitamin D3 plays an important role in maintaining immune system function, supporting muscle activity, and reducing the risk of certain cancers. It is also associated with a lower risk of autoimmune diseases such as multiple sclerosis (MS), prevention of cardiovascular diseases (including congestive heart failure and high blood pressure), and a decreased likelihood of developing diabetes and hyperlipidemia (high blood lipid levels).

Another essential fat-soluble vitamin required for growth, development, maintenance of vision, and strengthening of the immune system is vitamin A. Its deficiency leads to reduced resistance to infections, night blindness, and delayed growth.

Side effects:

No side effects have been observed at therapeutic doses.

Excessive intake of vitamin D3 beyond the recommended level can lead to hypercalcemia. This condition may cause gastrointestinal problems such as vomiting, nausea, constipation, and stomach pain. Other possible symptoms include fatigue, dizziness, hallucinations, confusion, loss of appetite, excessive urination, kidney stones, kidney damage and even kidney failure, high blood pressure, cardiac abnormalities, and dehydration.

Increased levels of blood and urinary nitrogen, cholesterol, and liver enzymes are among the other adverse effects of vitamin D toxicity. It may also lead to musculoskeletal problems as well as eye, ear, kidney, and mental disorders.

Drug interactions:

During the use of vitamin D supplements, the intake of fortified foods, dietary supplements, and other concurrently prescribed medications should be evaluated for their vitamin D content to avoid excessive intake.

Thiazide diuretics increase the risk of hypercalcemia when taken with vitamin D. Vitamin D may also increase the risk of digoxin toxicity. Cholestyramine and paraffin reduce the absorption of vitamin D.

Antiepileptic drugs such as carbamazepine, phenobarbital, or phenytoin increase the need for vitamin D.

Precautions and warnings:

It should be used with caution in these patients:

Hyperphosphatemia (with a risk of metastatic calcification), obesity (BMI > 30; individuals may require higher doses of vitamin D and should be carefully monitored), and renal disorders.

In individuals receiving therapeutic doses of vitamin D, there is a possibility of elevated plasma calcium levels, which may lead to calcium deposition in soft tissues and calcification of blood vessels and kidneys. It is recommended that plasma calcium concentrations be measured at regular intervals in these patients, especially at the initiation of therapy or if signs of toxicity become apparent.

Contraindications:

It is contraindicated in people with high serum calcium and vitamin D levels or abnormal sensitivity to vitamin D.

Pregnancy and breastfeeding:

Breastfeeding:

Vitamin D is secreted in breast milk. Maternal intake of appropriate doses (less than 4,000 IU) is considered safe; however, serum calcium and vitamin D levels in the breastfeeding infant should be monitored when the mother is taking vitamin D supplements.

Pregnancy:

Oral intake below the maximum recommended limit (equivalent to 4,000 IU) is considered safe. Hypercalcemia during pregnancy due to excessive vitamin D intake may cause adverse effects in the fetus.

Storage conditions:

Store at a temperature below 25°C and away from light, moisture, frost and the reach of children.