Paricap Soft Capsule

Paricalcitol is a synthetic, biologically active vitamin D2 analog of calcitriol. Preclinical and in-vitro studies have shown that paricalcitol's biological actions are mediated through binding of the VDR, resulting in selective activation of vitamin D-responsive pathways. Vitamin D and paricalcitol have been shown to lower parathyroid hormone levels by inhibiting PTH synthesis and secretion.

Pregnancy: Data on Paricalcitol capsule use in pregnant women are limited and not sufficient to determine whether the drug raises the risk of major birth defects or miscarriage. Chronic kidney disease during pregnancy carries its own risks to both the mother and the fetus. In animal reproduction studies, pregnant rats and rabbits given paricalcitol by injection during the period when organs were forming showed a slightly higher rate of embryo/fetal loss, at doses roughly 2 times (rats) and 0.5 times (rabbits) the maximum recommended human dose (MRHD). These adverse reproductive effects occurred at doses that were also toxic to the mother. The background risk of major birth defects and miscarriage for this specific patient population has not been established. Every pregnancy carries some background risk of birth defects, pregnancy loss, or other adverse outcomes; in the general U.S. population, clinically recognized pregnancies carry an estimated background risk of 2 to 4% for major birth defects and 15 to 20% for miscarriage.

Breastfeeding: It is not known whether paricalcitol passes into human breast milk, nor is there information on how it might affect a breastfed infant or milk production. Studies in rats found paricalcitol and/or its breakdown products in the milk of nursing rats, but because lactation physiology differs between species, these animal findings may not reliably predict drug levels in human milk. Given the potential for serious side effects in a breastfed infant, including hypercalcemia, patients should be advised not to breastfeed while being treated with Paricalcitol.

Pediatric use: Paricalcitol capsules have been shown to be safe and effective in pediatric patients 10 to 16 years of age for preventing and treating secondary hyperparathyroidism linked with Stage 3, 4, and 5 CKD. For this age group, the support comes from adequate and well controlled studies in adults with CKD. It also comes from a 12 week double-blind, placebo-controlled, randomized multicenter study in 36 pediatric patients 10 to 16 years of age with CKD Stages 3 and 4. Safety data from a 12-week open-label, single-arm multicenter study add to this. That study included 13 pediatric patients 10 to 16 years of age with CKD Stage 5 who were on peritoneal dialysis or hemodialysis. In children with Stage 5 CKD, the pharmacokinetics of Paricalcitol appear similar to those seen in Stage 3 and 4.

Geriatric use: In the clinical studies of Paricalcitol capsules in CKD Stages 3 and 4 patients (n = 220), 49% were age 65 and over and 17% were age 75 and over. In the pivotal study in CKD Stage 5 patients (n = 88), 28% were age 65 and over and 6% were age 75 and over. Safety and effectiveness showed no overall differences between these patients and younger ones. Other reported clinical experience hasn't found differences in response between elderly and younger patients either, but greater sensitivity in some older people can't be ruled out.

Taking too much Paricalcitol can cause hypercalcemia, hypercalciuria and hyperphosphatemia, and it can suppress PTH too far. In acute overdosage, treatment is general supportive care. If the overdose is found fairly soon after the capsules were taken, inducing vomiting or doing a gastric lavage may help stop more of the drug being absorbed. If the drug has already passed through the stomach, mineral oil may help it leave the body in the stool.

Doctors should check serum electrolytes repeatedly (calcium especially), the rate of urinary calcium excretion, and any electrocardiographic abnormalities caused by hypercalcemia. This monitoring is critical in patients taking digitalis. In accidental overdosage, supplemental calcium should be stopped and a low-calcium diet started.

The pharmacological action of Paricalcitol is fairly short, so further measures are probably not needed. If serum calcium stays markedly high, there are several treatment options, and the choice depends on the patient's underlying condition. These include drugs such as phosphates and corticosteroids, and measures to induce an appropriate forced diuresis. Paricalcitol is not significantly removed by dialysis.

Keep Paricalcitol below 30°C, in a dry place and away from light. Keep it out of children's reach.