Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
zoledronic acid (UNII: 6XC1PAD3KF) (zoledronic acid anhydrous - UNII:70HZ18PH24)
Meitheal Pharmaceuticals Inc.
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: - Hypocalcemia [see Warnings and Precautions (5.2)] - Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure [see Warnings and Precautions (5.3)] . - Known hypersensitivity to zoledronic acid or any components of zoledronic acid injection. Hypersensitivity reactions including urticaria, angioedema, and anaphylactic reaction/shock have been reported [see Adverse Reactions (6.2)] . Risk Summary Available data on the use of zoledronic acid in pregnant
Zoledronic Acid Injection is supplied in a clear, glass bottle 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 between 15° and 30°C (59° and 86°F). [See USP Controlled Room Temperature.] The container closure is not made with natural rubber latex.
Abbreviated New Drug Application
ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION Meitheal Pharmaceuticals Inc. ---------- 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 Baca dokumen lengkapnya
ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION MEITHEAL PHARMACEUTICALS INC. ---------- 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: Treatment of Paget's disease of bone in men and women (1.5) DOSAGE AND ADMINISTRATION Infusion given intravenously over no less than 15 minutes: 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) 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 (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 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 advanced age or dehydration. Monitor creatinine clearance before each dose (2.7, 5.3) _Osteonecrosis of the Jaw (ONJ)_ has been reported. All patients should have a routine oral exam by the prescriber prior to treatment (5.4) _Atypical Femur Fractures_ have been reported. Patients with thigh or groin pain should be evaluated to rule out a femoral fracture (5.5) _Severe Bone, Joint, and Muscle Pain_ may occur. Withhold future doses of zoledronic acid if severe symptoms occur Baca dokumen lengkapnya