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.

Active ingredient

Paricalcitol

Composition

Active ingredient:

paricalcitol 1 mcg;

Associates:

ethanol;

butylhydroxytoluene;

medium-chain triglycerides;

gelatin;

glycerol;

titanium dioxide;

black iron oxide dye;

Purified water;

Opacod® WB black ink (ethanol, propylene glycol, ferric oxide black dye, polyvinyl acetate phthalate, water, isopropanol, macrochloride 400, ammonium hydroxide)

Water

How to take, the dosage

Orally, regardless of meals, once a day, daily or 3 times a week.

Contraindications

• high sensitivity to any component of the drug
• hypervitaminosis D
• hypercalcemia
• coadministration of phosphates or vitamin D derivatives
• children under 18 years of age (no clinical studies have been conducted).co-administration with phosphates or vitamin D derivatives;
• children under 18 years of age (no clinical studies have been conducted);
• lactation period.

With caution: co-administration with cardiac glycosides.

Side effects

CNS disorders: infrequent – dizziness.

Digestive system disorders: infrequent – perversion of taste, constipation, dry mouth, dyspepsia, gastritis, abnormal results of liver tests.

Skin disorders: frequently – skin rash; infrequently – skin itching, urticaria.

Muscular system disorders: infrequent – cramps of the muscles of the lower extremities.

Others: infrequent – allergic reactions.

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

Gastrointestinal system: frequently – anorexia, diarrhea, gastrointestinal disorders.

CNS disorders: often – dizziness.

Skin disorders: often – acne.

Others: often – pain in the mammary gland, hypercalcemia, hypocalcemia.

Overdose

Symptoms: Overdose of paricalcitol in capsules may cause hypercalcemia, hypercalciuria and hyperphosphatemia, as well as a marked decrease in PTH secretion. Consumption of large amounts of calcium and phosphorus at the same time as taking paricalcitol in capsules may lead to similar disorders.

The treatment of an acute accidental overdose of paricalcitol in capsules requires urgent care. If an overdose is detected after a relatively short time, vomiting or gastric lavage can be induced, which will help prevent further absorption of paricalcitol. If the drug has already passed through the stomach, taking Vaseline oil may help to eliminate it from the intestine as quickly as possible. Serum concentrations of electrolytes (especially calcium), urinary calcium excretion rate and ECG changes that may be associated with hypercalcemia should be determined. Such monitoring is very important for patients receiving foxglove medication. Discontinuation of calcium-containing supplements and adherence to a low-calcium diet are also indicated in case of accidental drug overdose. Given the relatively short duration of action of paricalcitol, the measures mentioned may be sufficient. Drugs such as phosphoric acid salts and GCS and – forced diuresis may be used to treat severe hypercalcemia.