Country: United States
Language: English
Source: NLM (National Library of Medicine)
ZOLEDRONIC ACID (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)
Fresenius Kabi USA, LLC
Zoledronic Acid
ZOLEDRONIC ACID ANHYDROUS 5 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Zoledronic acid injection is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, zoledronic acid injection reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of fracture, defined as a recent low-trauma hip fracture, zoledronic acid injection reduces the incidence of new clinical fractures [ see Clinical Studies (14.1) ]. Zoledronic acid injection is indicated for prevention of osteoporosis in postmenopausal women [ see Clinical Studies (14.2) ]. Zoledronic acid injection is indicated for treatment to increase bone mass in men with osteoporosis [ see Clinical Studies (14.3) ]. Zoledronic acid injection is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic glucocorticoids i
Zoledronic acid injection, 5 mg/100 mL is supplied as follows: Handling After opening the solution, it is stable for 24 hours at 2 to 8°C (36 to 46°F). If refrigerated, allow the refrigerated solution to reach room temperature before administration. Storage Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F) [see USP Controlled Room Temperature].
Abbreviated New Drug Application
Fresenius Kabi USA, LLC ---------- MEDICATION GUIDE Zoledronic Acid (ZOE-le-DRON-ik AS-id) Injection Read the Medication Guide that comes with zoledronic acid injection before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking with your doctor about your medical condition or treatment. Talk to your doctor if you have any questions about zoledronic acid injection. What is the most important information I should know about zoledronic acid injection? You should not receive zoledronic acid injection if you are already receiving Zometa. Both zoledronic acid injection and Zometa contain zoledronic acid. Zoledronic acid injection can cause serious side effects including: 1. Low calcium levels in your blood (hypocalcemia) 2. Severe kidney problems 3. Severe jaw bone problems (osteonecrosis) 4. Bone, joint or muscle pain 5. Unusual thigh bone fractures 1. Low calcium levels in your blood (hypocalcemia). Zoledronic acid injection may lower the calcium levels in your blood. If you have low blood calcium before you start taking zoledronic acid injection, it may get worse during treatment. Your low blood calcium must be treated before you take zoledronic acid injection. Most people with low blood calcium levels do not have symptoms, but some people may have symptoms. Call your doctor right away if you have symptoms of low blood calcium such as: • Spasms, twitches, or cramps in your muscles • Numbness or tingling in your fingers, toes, or around your mouth Your doctor may prescribe calcium and vitamin D to help prevent low calcium levels in your blood, while you take zoledronic acid injection. Take calcium and vitamin D as your doctor tells you to. 2. Severe kidney problems. Severe kidney problems may happen when you take zoledronic acid injection. Severe kidney problems may lead to hospitalization or kidney dialysis and can be life-threatening. Your risk of kidney problems is higher if you: • already have kidney problems • take a d Read the complete document
ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ZOLEDRONIC ACID INJECTION SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZOLEDRONIC ACID INJECTION. ZOLEDRONIC ACID INJECTION INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Zoledronic acid injection is a bisphosphonate indicated for: •Treatment and prevention of postmenopausal osteoporosis (1.1, 1.2) •Treatment to increase bone mass in men with osteoporosis (1.3) •Treatment and prevention of glucocorticoid-induced osteoporosis (1.4) •Treatment of Paget’s disease of bone in men and women (1.5) Limitations of Use Optimal duration of use has not been determined. For patients at low-risk for fracture, consider drug discontinuation after 3 to 5 years of use (1.6) (1) DOSAGE AND ADMINISTRATION Infusion given intravenously over no less than 15 minutes: (2) Treatment of postmenopausal osteoporosis (2.2); treatment to increase bone mass in men with osteoporosis (2.4): treatment and prevention of glucocorticoid-induced osteoporosis (2.5): 5 mg once a year Prevention of postmenopausal osteoporosis: 5 mg once every 2 years (2.3) Treatment of Paget’s disease of bone: a single 5 mg infusion. Patients should receive 1500 mg elemental calcium and 800 international units vitamin D daily (2.6) DOSAGE FORMS AND STRENGTHS 5 mg in a 100 mL ready-to-infuse solution (3) (3) CONTRAINDICATIONS Hypocalcemia (4) Patients with creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment (4, 5.3) Hypersensitivity to any component of zoledronic acid injection (4, 6.2) WARNINGS AND PRECAUTIONS _Products Containing Same Active Ingredient:_Patients receiving Zometa should not receive zoledronic acid injection (5.1) _Hypocalcemia _may worsen during treatment _. _Patients must be adequately supplemented with calcium and vitamin D (5.2) _Renal Impairment: _A single dose should not exceed 5 mg and th Read the complete document