Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
ZOLEDRONIC ACID (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)
Mylan Institutional LLC
ZOLEDRONIC ACID
ZOLEDRONIC ACID ANHYDROUS 5 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Zoledronic acid injection is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone with elevations in serum alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for complications from their disease [see Clinical Studies (14.5)] . Zoledronic acid is contraindicated in patients with the following conditions: In female rats given daily subcutaneous doses of 0.01, 0.03, or 0.1 mg/kg, beginning 15 days before mating and continuing through gestation, parturition and lactation, dystocia and periparturient mortality were observed in pregnant rats allowed to deliver starting at 0.01 mg/kg/day (0.1 times the human 5 mg intravenous dose, based on AUC). Also, there was an increase in stillbirths and a decrease in neonate survival starting at 0.03 mg/kg/day (0.3 times the human 5 mg dose), while the number of viable newborns and pup body weig
Zoledronic acid injection is supplied as follow: Each vial contains 5 mg/100 mL. NDC 67457-619-10 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 20° to 25°C (68° to 77°F); excursions permitted between 15º to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]
Abbreviated New Drug Application
ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION Mylan Institutional 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. Unusual thigh bone fractures 5. Bone, joint or muscle pain 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 Прочитайте повний документ
ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION MYLAN INSTITUTIONAL 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, FOR INTRAVENOUS INFUSION INITIAL U.S. APPROVAL: 2001 INDICATIONS AND USAGE Zoledronic acid injection is a bisphosphonate indicated for: • DOSAGE AND ADMINISTRATION Infusion given intravenously over no less than 15 minutes: • DOSAGE FORMS AND STRENGTHS 5 mg in a 100 mL ready-to-infuse solution (3) CONTRAINDICATIONS • • • WARNINGS AND PRECAUTIONS • • • • • • ADVERSE REACTIONS The most common adverse reactions (greater than 10%) were pyrexia, myalgia, headache, arthralgia, pain in extremity (6.1). Other important adverse reactions were flu-like illness, nausea, vomiting, diarrhea (6.2), and eye inflammation (6.1). TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT MYLAN AT 1-877-446-3679 (1-877-4-INFO- RX) OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • • Treatment of Paget’s disease of bone in men and women (1.5) 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) 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) _Products Containing Same Active Ingredient_: Patients receiving Zometa should not receive zoledronic acid (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 the duration of infusion should be no less than 15 minutes. Renal toxicity may be greater in patients with underlying renal impairment or with other risk factors, including adv Прочитайте повний документ