Medications and Drugs
Pharmacy Author: Omudhome Ogbru, PharmD
Medical and Pharmacy Editor:
Jay W. Marks, MD
GENERIC NAME: zoledronic acid
BRAND NAME: Reclast
DRUG CLASS AND MECHANISM: Zoledronic acid is an injectable drug belonging to a class
of drugs called bisphosphonates that strengthen bone and are used primarily to
treat osteoporosis. Zoledronic
acid also is the active drug in Zometa. Other injectable bisphosphonates
include etidronate (Didronel) and pamidronate (Aredia). Bone is in a
constant state of remodeling in which
old bone is removed by cells called osteoclasts, and new bone is laid down
by cells called osteoblasts. Zoledronic acid inhibits bone removal by osteoclasts. The
FDA approved Reclast in August 2007.
PRESCRIPTION: Yes
GENERIC AVAILABLE: Yes
PREPARATIONS: Solution: 5 mg/100 ml
STORAGE: Unopened bottles should be kept at room temperature 15-30 C
(59-86 F). Opened bottles of solution are stable for 24 hours at 2-8 C
(36-46 F).
PRESCRIBED FOR: Zoledronic
acid is used for treatment of osteoporosis in postmenopausal women and men
as well as Paget's disease of bone
in men and women. It also is used to prevent osteoporosis in postmenopausal
women and treatment of steroid-induced osteoporosis.
DOSING: Zoledronic acid is given intravenously over no less than 15 minutes.
Administration of acetaminophen or
ibuprofen may reduce infusion related
reactions.
- For treatment of postmenopausal osteoporosis, a
single 5 mg infusion once a year is recommended.
- For prevention of postmenopausal osteoporosis the recommended dose is 5 mg
every two years.
- Paget's disease of bone is treated with a single 5 mg infusion. Patients
with Paget's disease should also receive 1500 mg of elemental calcium and 800
IU vitamin D daily, especially during the 2 weeks after the injection of
zoledronic acid.
- For prevention or treatment of steroid-induced osteoporosis, the
recommended dose is 5 mg once yearly.
DRUG INTERACTIONS: Combining zoledronic acid with aminoglycosides or loop
diuretics may lead to reduced calcium in blood. Zoledronic acid should be used
with caution in patients who are taking drugs that affect kidney function.
Since Reclast contains the same active ingredient as Zometa (zoledronic acid),
patients treated with Zometa should not receive Reclast.
PREGNANCY: Zoledronic acid should not be administered to
pregnant women.
Women of childbearing age should be advised to use a reliable method of birth
control.
NURSING MOTHERS: It is not known whether zoledronic acid is excreted in human
milk. Since many drugs are excreted in human milk, and zoledronic acid binds to
bone long-term, zoledronic acid should not be administered to
nursing women.
SIDE EFFECTS: The most common adverse reactions of zoledronic acid are fever,
muscle pain, and headache, arthralgia, and pain in hands and feet. Severe bone,
joint, and muscle pain may occur. Postmenopausal women treated with Reclast have
rarely reported osteonecrosis (bone death) of the jaw.
Reference: FDA Prescribing Information
Last Editorial Review: 1/3/2008
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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