ZOLEDRONIC ACID injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

zoledronic acid (UNII: 6XC1PAD3KF) (zoledronic acid anhydrous - UNII:70HZ18PH24)

Disponible desde:

Meitheal Pharmaceuticals Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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

Resumen del producto:

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.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

ZOLEDRONIC ACID- ZOLEDRONIC ACID INJECTION, SOLUTION
Meitheal Pharmaceuticals Inc.
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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

Ficha técnica

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