Composition:

Vitamin D3 (cholecalciferol) 5000 IU (125 mcg)

Presentation:

- Chewable tablet: Box of 3 strips x 10 tablets

Pharmacology:

In its biologically active form, vitamin D stimulates intestinal calcium absorption, incorporation of calcium into the osteoid, and release of calcium from bone tissue. In the small intestine, it promotes rapid and delayed calcium uptake. The passive and active transport of phosphate is also stimulated. In the kidney, it inhibits the excretion of calcium and phosphate by promoting tubular resorption. The production of parathyroid hormone (PTH) in the parathyroids is inhibited directly by the biologically active form of vitamin D. PTH secretion is inhibited additionally by the increased calcium uptake in the small intestine under the influence of biologically active vitamin D.

Indication:

To increase 25(OH)D levels in the blood in patients with a lack of vitamin D (serum 25(OH)D levels <30 ng/mL).

Dose:

Adults and children >12 years: 1 tablet, once daily, taken after meals.

The doses should be adjusted based on serum 25-hydroxycholecalciferol [25(OH)D] levels and not exceed 5000 IU/day, or according to the doctor's instructions according to the needs and conditions of the patient.

Contraindications:

- Hypersensitivity

- Hypervitaminosis D

- Nephrolithiasis or nephrocalcinosis

- Diseases or conditions resulting in hypercalcemia and/or hypercalciuria

- Severe renal damage and renal failure

Warning and Precautions:

- Iimpairment of renal function

- Sarcoidosis or other granulomatous disease

- Long-term treatment, serum calcium levels, and renal function (through measurements of serum creatinine) should be monitored.

- The total dose of vitamin D3 should be considered and adjusted accordingly when prescribing this drug with other medicinal products containing vitamin D3l.

- The calcium status and dietary intake of individual patients should also be considered at the same time as starting vitamin D3 replacement or treatment.

- Monitoring may be necessary in patients with increased sensitivity to vitamin D3 therapy.

- Patients with fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine.

- Not recommended for children under 12 years.

- Should not be used during pregnancy unless a woman's clinical condition requires treatment with Cholecalciferol, with the dose needed to overcome the lack of vitamin D.

- Vitamin D3 and its metabolites are excreted in breast milk.

Adverse Reactions:

Hypercalcemia, hypercalciuria, pruritus, rash, urticaria hypersensitivity reactions, nausea, vomiting

Drug Interactions:

Phosphate infusion, cardiac glycoside, thiazide diuretic, metabolites of vitamin D3 or vitamin D analogues, phenytoin, fenobarbital, primidone, rifampicin, isoniazid, orlistat, paraffin cair, cholestyramine, glucocorticoid, multivitamin dan mineral, calcitonin, etidronate, gallium nitrate, pamidronate, atau plicamycin, garam kalsium, conivaptan, aripiprazole, axitinib, saxagliptin, bile acid sequestrant, penginduksi CYP3A4, deferasirox, minyak mineral, orlistat, sevelamer, tocilizumab.

PROVE D3-5000