Uniplar 1mcg Softgel 1 Strip

✔️ Side Effects

Vomiting, Edema, Palpitation, Chills, Pneumonia, Lightheadedness, GI bleeding, Flu, Sepsis, Hypokalemia, Hypercalcemia, Increase in blood creatinine

✔️ Overdose Effects:

Excessive Uniplar use can cause hypercalcemia, hypercalciuria, and hyperphosphatemia, leading to excessive PTH suppression.

Treatment of Overdose:

• Supportive care, including gastric lavage or inducing vomiting if recently ingested.
• Mineral oil may help promote excretion.
• Frequent serum calcium and ECG monitoring is essential, especially in digitalis users.
• If severe hypercalcemia persists, treatments such as phosphates, corticosteroids, or forced diuresis may be considered.
• Uniplar is not significantly removed by dialysis.

✔️ Dosage & Administration

For CKD Stages 3 and 4 in Adults:

Paricalcitol soft gel capsules can be taken orally once daily or three times a week, ensuring doses are not given more frequently than every other day.

Initial Dosage (Based on Baseline PTH Levels):

• PTH <500 pg/ml:
  • Daily: 1 mcg
  • Three times a week: 2 mcg
• PTH >500 pg/ml:
  • Daily: 2 mcg
  • Three times a week: 4 mcg

Dosage Adjustment Based on PTH Levels:

• If PTH remains the same or changes by less than 30% → Increase the dose by 1 mcg daily or 2 mcg three times a week.
• If PTH decreases by 30%-60% → Maintain the current dose.
• If PTH decreases by more than 60% or falls below 60 pg/ml → Reduce dose by 1 mcg daily or 2 mcg three times a week.

Patients taking the lowest dose (1 mcg daily) requiring a dose reduction should switch to 1 mcg thrice a week. If further reduction is needed, the medication should be paused and restarted at a lower frequency.

For CKD Stage 5 in Adults:

Paricalcitol capsules are administered orally three times per week (not more frequently than every other day). The starting dose is determined using the formula:

Dose (mcg) = Baseline PTH (pg/ml) ÷ 80

Dosage Adjustments:

• Every four weeks, the dose may be increased by 1 mcg while maintaining the three-times-per-week schedule.
• At any time, the dose may be decreased by 1 mcg.
• If dose reduction is required while on the lowest dose (1 mcg three times per week), the medication may be temporarily discontinued and restarted as needed.

For CKD Stage 5 Pediatric Patients:

• The initial dose is calculated as Dose (mcg) = Baseline PTH (pg/ml) ÷ 120 (rounded down to the nearest whole number).
• Dose adjustments follow a similar pattern as in adults, increasing or decreasing by 1 mcg as needed.

Always follow the advice of a registered physician when using this medication.

✔️ Administration:

Uniplar capsules can be taken with or without food.

✔️ Monitoring:

Serum calcium and phosphorus levels should be regularly monitored, especially during dose adjustments and concurrent use with strong CYP3A inhibitors. If hypercalcemia occurs, the dose should be reduced or temporarily stopped until levels normalize.

✔️ Drug Interactions

• Strong CYP3A inhibitors (e.g., ketoconazole) may increase Uniplar’s exposure—use cautiously.
• Cholestyramine and mineral oil may interfere with Uniplar absorption. To prevent this, take Uniplar at least one hour before or 4-6 hours after these substances.

✔️ Contraindications

Uniplar should not be used in patients with hypercalcemia or vitamin D toxicity.

✔️ Pediatric Patients

(10-16 years old): Uniplar is proven safe and effective in managing secondary hyperparathyroidism in CKD Stages 3-5.

✔️ Geriatric Patients:

Clinical studies did not show significant safety or efficacy differences between older and younger adults, but some elderly patients may be more sensitive.

✔️ Pregnancy & Lactation

• Pregnancy: Limited data on Paricalcitol use in pregnancy exist, making it unclear whether it poses risks for birth defects or miscarriage. However, chronic kidney disease itself carries risks during pregnancy. Studies on animals have shown fetal loss at high doses, particularly at levels causing maternal toxicity.
• Lactation: It is unknown if Paricalcitol is excreted in human milk. Animal studies suggest the presence of the drug in milk, but due to species differences, the impact on humans remains uncertain. Because of the risk of hypercalcemia in breastfed infants, breastfeeding is not recommended while using this medication.

✔️ Precautions & Warnings

• Hypercalcemia: Overuse of vitamin D or its metabolites can lead to severe hypercalcemia, which may cause cardiac arrhythmias, seizures, vascular calcification, and soft tissue calcification. Patients should be monitored for symptoms such as fatigue, confusion, appetite loss, nausea, vomiting, constipation, excessive thirst, frequent urination, and weight loss.
• Digitalis Toxicity: Hypercalcemia increases the risk of digitalis toxicity, so caution is required when prescribing Uniplar alongside digitalis.

✔️ Storage:

Store below 30°C in a dry, light-protected place. Keep out of children's reach.