Zemplar, 1 mcg capsules, 28 pcs.

Prevention and treatment of secondary hyperparathyroidism developing in chronic kidney disease stage 3 and 4, as well as in patients with chronic kidney disease stage 5 who are on hemodialysis or peritoneal dialysis.

Indications

Prevention and treatment of secondary hyperparathyroidism that develops in chronic kidney disease stages 3 and 4, as well as in patients with stage 5 chronic kidney disease who are on hemodialysis or peritoneal dialysis.

Active ingredient

Paricalcitol

Composition

Active ingredient:

paricalcitol 1 mcg;

Excipients:

ethanol;

butylated hydroxytoluene;

medium chain triglycerides;

gelatin;

glycerol;

titanium dioxide;

iron oxide black dye;

purified water;

black ink Opacode® WB (ethanol, propylene glycol, black iron oxide dye, polyvinyl acetate phthalate, water, isopropanol, macrogol 400, ammonium hydroxide)

Contraindications

hypersensitivity to any component of the drug;
hypervitaminosis D;
hypercalcemia;
combined use with phosphates or vitamin D derivatives;
children under 18 years of age (clinical studies have not been conducted);
lactation period.

With caution: combined use with cardiac glycosides.

Side Effects

From the side of the central nervous system: infrequently – dizziness.

From the digestive system: uncommon – taste perversion, constipation, dry mouth, dyspepsia, gastritis, abnormal results of liver tests.

From the skin: often – skin rash; uncommon: skin itching, urticaria.

From the musculoskeletal system: infrequently – muscle cramps of the lower extremities.

Other: infrequently – allergic reactions.

Adverse reactions in patients with stage 5 chronic kidney disease described in a phase III clinical trial

From the digestive system: often – anorexia, diarrhea, gastrointestinal disorders.

From the side of the central nervous system: often – dizziness.

From the skin: often – acne.

Other: often – breast pain, hypercalcemia, hypocalcemia.

Overdose

Symptoms: An overdose of paricalcitol capsules can cause hypercalcemia, hypercalciuria and hyperphosphatemia, as well as a marked decrease in PTH secretion. Consuming large amounts of calcium and phosphorus while taking paricalcitol capsules may lead to similar problems.

Treatment of acute accidental overdose of paricalcitol capsules requires emergency care. If the fact of overdose is detected after a relatively short time, you can induce vomiting or perform gastric lavage, which will help prevent further absorption of paricalcitol. If the drug has already passed through the stomach, taking petroleum jelly can help speed up its removal from the intestines. Serum concentrations of electrolytes (especially calcium), the rate of urinary calcium excretion, and ECG changes that may be associated with hypercalcemia should be determined. Such monitoring is very important for patients receiving digitalis preparations. Discontinuation of calcium supplements and a low-calcium diet are also indicated in case of accidental overdose. Given the relatively short duration of action of paricalcitol, the measures mentioned may be sufficient. To treat severe hypercalcemia, it is possible to use drugs such as phosphoric acid salts and corticosteroids, as well as forced diuresis.

Storage conditions

At 15–25 °C (do not freeze)

Shelf life

2 years

Manufacturer

Catalent Pharma Solutions LLC, USA