ZOLEDRONIC ACID injection, solution

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

ZOLEDRONIC ACID (UNII: 6XC1PAD3KF) (ZOLEDRONIC ACID ANHYDROUS - UNII:70HZ18PH24)

थमां उपलब्ध:

Mylan Institutional LLC

INN (इंटरनेशनल नाम):

ZOLEDRONIC ACID

रचना:

ZOLEDRONIC ACID ANHYDROUS 5 mg in 100 mL

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

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

उत्पाद समीक्षा:

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.]

प्राधिकरण का दर्जा:

Abbreviated New Drug Application

सूचना पत्रक

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION
Mylan Institutional LLC
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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

उत्पाद विशेषताएं

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
•
•
•
•
•
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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
•
•
•
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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