; Uremia 2 (3%) 0 (0%)
Nervous 12 (20%) 2 (7%)
Dizziness 4 (7%) 0 (0%)
Insomnia 3 (5%) 0 (0%)
Anxiety 2 (3%) 0 (0%)
Respiratory 8 (13%) 4 (15%)
Sinusitis 2 (3%) 0 (0%)
Urogenital System 6 (10%) 4 (15%)
Urinary Tract Infection 2 (3%) 0 (0%)
OVERDOSAGE
Excessive administration of Zemplar Capsules can cause hypercalcemia, hypercalciuria, and hyperphosphatemia, and over suppression of PTH (see WARNINGS).
Treatment of Overdosage
The treatment of acute overdosage of Zemplar Capsules should consist of general supportive measures. If drug ingestion is discovered within a relatively short time, induction of emesis or gastric lavage may be of benefit in preventing further absorption. If the drug has passed through the stomach, the administration of mineral oil may promote its fecal elimination. Serial serum electrolyte determinations (especially calcium), rate of urinary calcium excretion, and assessment of electrocardiographic abnormalities due to hypercalcemia should be obtained. Such monitoring is critical in patients receiving digitalis. Discontinuation of supplemental calcium and institution of a low-calcium diet are also indicated in accidental overdosage. Due to the relatively short duration of the pharmacological action of paricalcitol, further measures are probably unnecessary. If persistent and markedly elevated serum calcium levels occur, there are a variety of therapeutic alternatives that may be considered depending on the patient's underlying condition. These include the use of drugs such as phosphates and corticosteroids, as well as measures to induce an appropriate forced diuresis.
DOSAGE AND ADMINISTRATION
CKD Stages 3 and 4
Zemplar Capsules may be administered daily or three times a week. When dosing three times weekly, the dose should be administered no more frequently than every other day. The average weekly doses for both daily and three times a week dosage regimens are similar (see CLINICAL STUDIES).
Zemplar Capsules may be taken without regard to food. No dosing adjustment is required in patients with mild and moderate hepatic impairment.
Initial Dose
The initial dose of Zemplar Capsules for CKD Stage 3 and 4 patients is based on baseline intact parathyroid hormone (iPTH) levels.
Baseline iPTH Level Daily Dose Three Times a Week Dose*
* To be administered not more often than every other day
≤ 500 pg/mL 1 mcg 2 mcg
> 500 pg/mL 2 mcg 4 mcg
Dose Titration
Dosing must be individualized and based on serum or plasma iPTH levels, with monitoring of serum calcium and serum phosphorus. The following is a suggested approach in titration.
Dose Adjustment at 2 to 4 Week Intervals
iPTH Level Relative to Baseline Zemplar Capsule Dose Daily Dosage Three Times a Week Dosage*
* To be administered not more often than every other day
The same or increased
Decreased by < 30% Increase 1 mcg 2 mcg
Decreased by ≥ 30%, ≤ 60% Maintain
Decreased > 60%
iPTH < 60 pg/mL Decrease 1 mcg 2 mcg
If a patient is taking the lowest dose on the daily regimen and a dose reduction is needed, the dose can be decreased to 1 mcg three times a week. If a further dose reduction is required, the drug should be withheld as needed and can be restarted at a lower dose. If a patient is on a calcium-based phosphate binder, the binder dose may be decreased or withheld, or the patient may be s |
