Chronic Kidney Disease Stages 3 and 4 : Paricap capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Chronic Kidney Disease Stage 5 ... Read more Chronic Kidney Disease Stages 3 and 4 : Paricap capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Chronic Kidney Disease Stage 5 : Paricap capsules are indicated in adults and pediatric patients 10 years of age and older for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD).
Paricalcitol is a synthetic, biologically active vitamin D2 analog of calcitriol Preclinical and in vitro studies have demonstrated that paricalcitol’s biological actions are mediated through binding of the VDR, which results in the selective activation of vitamin D responsive pathways. Vitamin D and paricalcitol have been shown to reduce parathyroid hormone levels by inhibiting PTH synthesis and secretion.
Always consult a registered doctor before taking any medicine. This information is for general knowledge only.
Administer the dose of Paricalcitol capsules orally three times a week, no more frequently than every other day based upon the following formula:Dose* (micrograms) = baseline iPTH (pg/mL) divided by 120 ( Round down to the nearest whole number ) Dose Titration: Subsequent dosing should be individualized and based on IPTH, serum calcium and phosphorus levels to maintain an iPTH level within target range. Every 4 weeks, each administered Paricalcitol dose may be increased in 1 mcg increments, maintaining the three times per week regimen (e.g., increase from 1 mcg three times per week to 2 mcg three times per week). At any time, each administered dose may be decreased by 2 meg. Paricalcitol may be stopped if the patient requires reduction while receiving 2 mcg three times per week or 1 mcg three times per week, resuming when appropriate. Monitoring : Monitor serum calcium and phosphorus levels closely after initiation of Paricalcitol, during dose titration periods and during co-administration with strong CYP3A inhibitors. If hypercalcemia is observed, the dose of Paricalcitol should be reduced or withheld until these parameters are normalized.
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
Paricalcitol capsules should not be given to patients with evidence of hypercalcemia or vitamin D toxicity.
Strong CYP3A inhibitors (e.g. ketoconazole) will increase the exposure of Paricap. Use with caution. Cholestyramine, Mineral Oil: Intestinal absorption of Paricap may be reduced if administered simultaneously with cholestyramine or mineral oil. Take Paricap capsules at least 1 hour before or 4 to 6 hours after taking cholestyramine or mineral oil.
Hypercalcemia : Progressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention Acute hypercalcemia may exacerbate tendencies for cardiac arrhythmias and seizures and may potentiate the action of digitalis. Chronic hypercalcemia can lead to generalized vascular calcification and others soft tissue calcification Concomitant administration of high doses of calcium-containing preparations or thiazide diuretics with Paricap may increase the risk of hypercalcemia, High intake of calcium and phosphate concomitant with vitamin D compounds may lead to serum abnormalities requiring more frequent patient monitoring and individualized dose titration. Patients also should be informed about the symptoms of elevated calcium, which include feeling tired, difficulty in thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss. Prescription-based doses of vitamin D and its derivatives should be withheld during Paricap treatment to avoid hypercalcemia. Digitalis Toxicity : Digitalis toxicity is potentiated by hypercalcemia of any cause. Use caution when Paricap capsules are prescribed concomitantly with digitalis compounds.