Paricalcitol 5 ug/mL
Paricalcitol · INJECTION, SOLUTION · Accord Healthcare, Inc.
Paricalcitol is a injection, solution containing paricalcitol at 5 ug/mL, taken intravenous. Manufactured by Accord Healthcare, Inc..
Key Facts
- Brand Name
- Paricalcitol
- Generic Name
- Paricalcitol
- NDC Code (Product)
16729-311- Manufacturer
- Accord Healthcare, Inc.
- Strength
- 5 ug/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA207174
- Drug Class
- Vitamin D2 Analog [EPC]; Vitamin D Analog [EPC]
- Marketing Start
- 03/24/2016
Recall History
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
AbbVie Inc.
Failed Content Uniformity Specifications
Dr. Reddy's Laboratories, Inc.
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Abbott Laboratories
CGMP Deviations: There is potential that Abbott's third party manufacturer, Hospira, may have applied a foreign (incorrect) stopper to vials in a specific lot of Zemplar Injection.
Aidapak Services, LLC
Labeling: Label Mixup: PARICALCITOL, Capsule, 1 mcg may have potentially been mislabeled as one of the following drugs: ASCORBIC ACID, Tablet, 500 mg, NDC 60258014101, Pedigree: AD23082_19, EXP: 5/6/2014; CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W002666, EXP: 6/5/2014.
Amerisource Health Services
Failed Impurities/Degradation Specifications: This repackaged product was recalled by its manufacturer due to failed results for impurities.
Dr. Reddy's Laboratories, Inc.
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Dr. Reddy's Laboratories, Inc.
Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.
Teva Pharmaceuticals USA
Failed Impurities/Degradation Specifications: out of specification test results for impurities during stability testing.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE 1.1 Chronic Kidney Disease Stages 3 and 4 Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with Chronic Kidney Disease (CKD) Stages 3 and 4. Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (Paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. 1.2 Chronic Kidney Disease Stage 5 Paricalcitol Capsules are indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with CKD Stage 5 in patients on hemodialysis (HD) or peritoneal dialysis (PD). Pediatric use information for patients 10 to 16 years of age is approved for AbbVie Inc.’s Zemplar (Paricalcitol) capsules. However, due to AbbVie Inc.’s marketing exclusivity rights, this drug product is not labeled with that pediatric information. Paricalcitol is a vitamin D analog indicated in adults for the prevention and treatment of secondary hyperparathyroidism associated with: Chronic kidney disease (CKD) Stages 3 and 4 (1.1). CKD Stage 5 in patients on hemodialys…
Dosage & Administration
2 DOSAGE & ADMINISTRATION 2.1 Chronic Kidney Disease Stages 3 and 4 in Adults Administer Paricalcitol Capsules orally once daily or three times a week. [see Clinical Studies (14.1)] . When dosing three times weekly, do not administer more frequently than every other day. Initial Dose Table 1. Recommended Paricalcitol Capsules Starting Dose Based upon Baseline iPTH Level Baseline iPTH Level Daily Dose Three Times a Week Dose* Less than or equal to 500 pg/mL 1 mcg 2 mcg More than 500 pg/mL 2 mcg 4 mcg * To be administered not more often than every other day Dose Titration Table 2. Recommended Paricalcitol Capsules Dose Titration Base upon iPTH Level Dose Adjustment at 2 to 4 Week Intervals iPTH Level Relative to Baseline Paricalcitol Capsule Dose Daily Dosage Three Times a Week Dosage* The same, increased or decreased by less than 30% Increase dose by 1 mcg 2 mcg Decreased by more than or equal to 30% and less than or equal to 60% Maintain dose - - Decreased by more than 60% or iPTH less than 60 pg/mL Decrease dose by 1 mcg 2 mcg * To be administered not more often than every other day If a patient is taking the lowest dose, 1 mcg, on the daily regimen and a dose reduction is needed,…
Contraindications
4 CONTRAINDICATIONS Paricalcitol Capsules should not be given to patients with evidence of hypercalcemia or vitamin D toxicity [see Warnings and Precautions (5.1)]. Evidence of hypercalcemia (4). Evidence of vitamin D toxicity (4).
Drug Interactions
7 DRUG INTERACTIONS Table 5 shows the clinically significant drug interactions with Paricalcitol capsules. Table 5: Clinically Significant Drug Interactions with Paricalcitol CYP3A Inhibitors Clinical Impact Paricalcitol is partially metabolized by CYP3A. Hence, exposure of paricalcitol will increase upon coadministration with strong CYP3A inhibitors such as but not limited to: boceprevir, clarithromycin, conivaptan, grapefruit juice, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, ritonavir, saquinavir, telaprevir, telithromycin, voriconazole. Intervention Dose adjustment of Paricalcitol capsules may be necessary. Monitor closely for iPTH and serum calcium concentrations, if a patient initiates or discontinues therapy with a strong CYP3A4 inhibitor. Cholestyramine Clinical Impact Drugs that impair intestinal absorption of fat-soluble vitamins, such as cholestyramine, may interfere with the absorption of paricalcitol. Intervention Recommend to take Paricalcitol capsules at least 1 hour before or 4 to 6 hours after taking cholestyramine (or at as great an interval as possible) to avoid impeding absorption of paricalcitol.…
Adverse Reactions
6 ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. 6.1 Clinical Trials Experience CKD Stages 3 and 4 Adults The safety of Paricalcitol Capsules has been evaluated in three 24-week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 CKD Stages 3 and 4 patients. Six percent (6%) of Paricalcitol Capsules treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. Adverse events occurring in the Paricalcitol Capsules group at a frequency of 2% or greater and more frequently than in the placebo group are presented in: Table 3. Table 3. Adverse Reactions by Body System Occurring in ≥ 2% of Subjects in the Paricalcitol Capsules-Treated Group of Three, Double-Blind, Placebo-Controlled CKD Stages 3 and 4 Studies Number (%) of Subjects Adverse Events a Paricalcitol Capsules (n = 107) Placebo (n =113) Overall 88 (82%) 86 (76%) Ear and Labyrinth Disorders Vert…
Frequently Asked Questions
What is Paricalcitol used for?
Paricalcitol contains Paricalcitol. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Paricalcitol a controlled substance?
Paricalcitol is not classified as a controlled substance by the DEA.
What is the generic name for Paricalcitol?
The generic name for Paricalcitol is Paricalcitol. There are 4 other brand versions of Paricalcitol.
What is the NDC code for Paricalcitol 5 ug/mL?
The NDC (National Drug Code) for Paricalcitol 5 ug/mL is 16729-311, listed by Accord Healthcare, Inc..