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Calcitriol *
Application:

For systemic use: renal osteodystrophy genesis (in patients with renal insufficiency, including against the background of dialysis), and postoperative idiopathic hypoparathyroidism, psevdogipoparatireoz, vitamin-D-dependent rickets, gipofosfatemichesky vitamin-D-resistant rickets (phosphate diabetes, congenital ), osteoporosis (postmenopausal, senile and steroid), tetany (including postsurgical, idiopathic).

For use on the skin: psoriasis (mild and severe).

Contraindications:

Hypersensitivity. When the system application: hypercalcaemia, renal osteodystrophy with hyperphosphatemia, hypervitaminosis D, pregnancy, lactation.

When applied topically: hypercalcemia or metabolic Sa2 +, concomitant systemic (maintenance) therapy of calcium homeostasis, pregnancy, lactation.

Restrictions apply to:

For systemic use: atherosclerosis, pulmonary tuberculosis (active form), chronic heart failure, hyperphosphatemia, phosphate nefrourolitiaz, sarcoidosis or other granulomatosis, pregnancy, lactation, old age (it can contribute to the development of atherosclerosis), children's age (18 years).

For local use: childhood (up to 12 years).

Application of pregnancy and breastfeeding:

Teratogenic effects. Teratogenicity studies conducted in rabbits using doses of 0.08 and 0.3 mg / kg (approximately 2 and 6 times higher MRDCH) showed that in three offspring of all 15 fetuses were observed, external and skeletal abnormalities. However, none of the 23 other litters (156 fetuses) did not reveal significant abnormalities compared with controls.

Studies in rats at doses up to 0.45 mg / kg (approximately 5 times higher MRDCH) showed no teratogenic potential.

Nonteratogenic effects. In studies in rabbits treated with calcitriol, from 7 th to 18 th day of pregnancy at doses of 0.3 mg / kg / day (approximately 6 times higher MRDCH), 19% say the death of females, lower body weight of fetuses, the decrease the number of infants surviving 24 h. In studies of perinatal and postnatal development in rats, it was noted the development of hypercalcemia in the offspring of females treated with calcitriol in doses of 0.08 or 0.3 mg / kg / day (approximately equal and are 3 times higher MRDCH) hypercalcemia and hyperphosphatemia in females treated with calcitriol in doses of 0.08 or 0.3 mg / kg / day and increased serum urea nitrogen in females treated with calcitriol at a dose of 0.3 mg / kg / day. In another study in the rat body weight in females was slightly reduced at doses of calcitriol 0.3 mcg / kg / day (approximately 3 times higher MRDCH) introduced from 7 th to 15 th day of pregnancy.

In newborns, women who received calcitriol at doses 17-36 mg / day (approximately 17 and 36 times higher MRDCH) during pregnancy is moderately hypercalcemia on 2 nd day of life returning to normal on the third day.

When pregnancy is possible if the expected effect of therapy outweighs the potential risk to the fetus (adequate and well-controlled studies in pregnant women has not conducted).

Category effects on the fetus by FDA - C.

In small quantities into breast milk of women (2,2 ± 0,1) pg / ml.