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Banner Pharmacaps Drugs

• Progesterone
  

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  Progesterone

  

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  Prevention of Endometrial Hyperplasia

  Progesterone capsules should be given as a single daily dose at bedtime, 200 mg orally for 12 days sequentially per 28-day cycle, to postmenopausal women with a uterus who are receiving daily conjugated estrogens tablets.

  Treatment of Secondary Amenorrhea

  Progesterone capsules may be given as a single daily dose of 400 mg at bedtime for 10 days.

  Some women may experience difficulty swallowing progesterone capsules. For these women, progesterone capsules should be taken with a glass of water while in the standing position.

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• Paricalcitol
  

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  Paricalcitol

  

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  2.1 Chronic Kidney Disease Stages 3 and 4

  Paricalcitol capsules may be administered daily or three times a week. When dosing three times weekly, the dose should be administered not more frequently than every other day. The total weekly doses for both daily and three times a week dosage regimens are similar [see Clinical Studies (14.1) ].

  Paricalcitol 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 paricalcitol capsules for CKD Stages 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 to dose titration.

  Dose Adjustment at 2 to 4 Week Intervals iPTH Level Relative to Baseline Paricalcitol Capsule Dose Daily Dosage Three Times a Week Dosage*

  *   To be administered not more often than every other day

  The same, increased ordecreased by < 30% Increase dose by 1 mcg 2 mcg Decreased by ≥ 30% and ≤ 60% Maintain dose - - Decreased by > 60% oriPTH < 60 pg/mL Decrease dose by 1 mcg 2 mcg

  If a patient is taking the lowest dose, 1 mcg, 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 restarted at a lower dosing frequency. If a patient is on a calcium-based phosphate binder, the phosphate-binder dose may be decreased or withheld, or the patient may be switched to a non-calcium-based phosphate binder. If hypercalcemia or an elevated Ca x P is observed, the dose of paricalcitol should be reduced or withheld until these parameters are normalized.

  Serum calcium and phosphorus levels should be closely monitored after initiation of paricalcitol capsules, during dose titration periods and during co-administration with strong CYP3A inhibitors [see Warnings and Precautions (5.3), Drug Interactions (7) and Clinical Pharmacology (12.3) ].

  2.2 Chronic Kidney Disease Stage 5

  Paricalcitol capsules are to be administered three times a week, not more frequently than every other day.

  Paricalcitol 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 paricalcitol capsules in micrograms is based on a baseline iPTH level (pg/mL)/80. To minimize the risk of hypercalcemia patients should be treated only after their baseline serum calcium has been adjusted to 9.5 mg/dL or lower [see Clinical Pharmacology (12.2) and Clinical Studies (14.2) ].

  Dose Titration

  Subsequent dosing should be individualized and based on iPTH, serum calcium and phosphorus levels. A suggested dose titration of paricalcitol capsules is based on the following formula:

  Titration dose (micrograms) = most recent iPTH level (pg/ml)/80

  Serum calcium and phosphorus levels should be closely monitored after initiation, during dose titration periods, and with co-administration of strong P450 3A inhibitors. If an elevated serum calcium or elevated Ca x P is observed and the patient is on a calcium-based phosphate binder, the binder dose may be decreased or withheld, or the patient may be switched to a non-calcium-based phosphate binder. If serum calcium or Ca x P are elevated, the dose should be decreased by 2 to 4 micrograms lower than that calculated by the most recent iPTH/80. If further adjustment is required, the dose of paricalcitol capsules should be reduced or withheld until these parameters are normalized.

  As iPTH approaches the target range, small, individualized dose adjustments may be necessary in order to achieve a stable iPTH. In situations where monitoring of iPTH, Ca or P occurs less frequently than once per week, a more modest initial and dose titration ratio (e.g., iPTH/100) may be warranted.

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