"Sept. 1, 2011 -- The FDA warns that the osteoporosis drug Reclast (zoledronic acid) raises the risk of kidney failure.
The warning is targeted at patients who already suffer from kidney impairment. It's also aimed at those who are tak"...
(zoledronic acid) for Intravenous Infusion
Reclast contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is:
Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2 • H2O and a molar mass of 290.1 g/Mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of the Reclast solution for infusion is approximately 6.0 – 7.0.
Reclast Injection is available as a sterile solution in bottles for intravenous infusion. One bottle with 100 mL solution contains 5.330 mg of zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid on an anhydrous basis.
Inactive Ingredients: 4950 mg of mannitol, USP; and 30 mg of sodium citrate, USP.
What are the possible side effects of zoledronic acid (Reclast, Zometa)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- urinating less than usual or not at all;
- drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;
- swelling, weight gain, feeling short of breath;
- muscle spasms, numb or tingly feeling (especially around your mouth);
- fever, chills, body aches, flu...
What are the precautions when taking zoledronic acid injection (Reclast)?
Before using zoledronic acid, tell your doctor or pharmacist if you are allergic to it; or to other bisphosphonates such as alendronate or risedronate; or if you have trouble breathing (wheezing) after taking aspirin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, low calcium levels in the blood, problem taking calcium/vitamin D supplements, recent or planned dental surgery (e.g., tooth removal), certain gut problems (malabsorption, surgery on the small intestine), treatment with zoledronic acid (e.g., for cancer), parathyroid/thyroid...
Last reviewed on RxList: 4/25/2016
This monograph has been modified to include the generic and brand name in many instances.
Additional Reclast Information
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