with baseline serum calcium ≤ 9.5 mg/dL [see Clinical Pharmacology (12.2) and Dosage and Administration (2.2)].
Figure 2. Mean Values for Serum iPTH Over Time in a Phase 3, Double-Blind, Placebo-Controlled CKD Stage 5 Study
How Supplied/Storage and Handling
Zemplar Capsules are available as 1 mcg, 2 mcg, and 4 mcg capsules.
The 1 mcg capsule is an oval, gray, soft gelatin capsule imprinted with Abbott “A” logo and ZA, and is available in the following package size:
Bottles of 30 (NDC 0074-4317-30)
The 2 mcg capsule is an oval, orange-brown, soft gelatin capsule imprinted with Abbott “A” logo and ZF, and is available in the following package size:
Bottles of 30 (NDC 0074-4314-30)
The 4 mcg capsule is an oval, gold soft gelatin capsule imprinted with Abbott “A” logo and ZK, and is available in the following package size:
Bottles of 30 (NDC 0074-4315-30)
Storage
Store Zemplar Capsules at 25°C (77°F). Excursions permitted between 15°- 30°C (59°- 86°F). See USP Controlled Room Temperature.
Patient Counseling Information
Patients should be advised:
•of the most common adverse reactions with use of Zemplar Capsules, which include diarrhea, hypertension, dizziness and vomiting.
•to adhere to instructions regarding diet and phosphorus restriction.
•to contact a health care provider if you develop symptoms of elevated calcium, (e.g. feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination and weight loss).
•to return to the physician's office for routine monitoring. More frequent monitoring is necessary during the initiation of therapy, following dose changes or when potentially interacting medications are started or discontinued.
•to inform their physician of all medications, including prescription and nonprescription drugs, supplements, and herbal preparations they are taking and any change to their medical condition. Patients should also be advised to inform their physicians prescribing a new medication that they are taking Zemplar Capsules.
© Abbott
Abbott Laboratories
North Chicago, IL 60064, U.S.A.
NDC 0074–4314–30
Zemplar®(paricalcitol) capsules 2mcg 30 Capsules
Rx only Abbott
NDC 0074–4317–73
Zemplar®(paricalcitol) capsules 1 mcg
For cost savings information on your prescription, call 1•877•Zemplar
Professional Sample – Not for Sale Contains 1 Patient Sample of 7 Capsules THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN
Rx only Abbott
www.Zemplar.com