BREVIBLOC- esmolol hydrochloride injection

देश: संयुक्त राज्य

भाषा: अंग्रेज़ी

स्रोत: NLM (National Library of Medicine)

सक्रिय संघटक:

ESMOLOL HYDROCHLORIDE (UNII: V05260LC8D) (ESMOLOL - UNII:MDY902UXSR)

थमां उपलब्ध:

Baxter Healthcare Corporation

INN (इंटरनेशनल नाम):

ESMOLOL HYDROCHLORIDE

रचना:

ESMOLOL HYDROCHLORIDE 10 mg in 1 mL

प्रशासन का मार्ग:

INTRAVENOUS

प्रिस्क्रिप्शन प्रकार:

PRESCRIPTION DRUG

चिकित्सीय संकेत:

BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. BREVIBLOC injection is also indicated in noncompensatory sinus tachycardia where, in the physician’s judgment, the rapid heart rate requires specific intervention. BREVIBLOC injection is intended for short-term use. BREVIBLOC (Esmolol Hydrochloride) injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery, on emergence from anesthesia and in the postoperative period, when in the physician’s judgment such specific intervention is considered indicated. Use of BREVIBLOC injection to prevent such events is not recommended. BREVIBLOC (Esmolol Hydrochloride) injection is contraindicated in patients with: Esmolol hydrochlo

उत्पाद समीक्षा:

BREVIBLOC PREMIXED Injection BREVIBLOC PREMIXED Double Strength Injection BREVIBLOC Injection Store at 25˚C (77˚F). Excursions permitted to 15˚-30˚C (59˚-86˚F) [see USP Controlled Room Temperature]. Protect from freezing. Avoid excessive heat. Each bag contains no preservative. Once drug has been withdrawn from ready-to-use bag, the bag should be used within 24 hours, with any unused portion discarded. Visually inspect the container. If the administration port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Do not use plastic containers in series connections. Such use could result in an embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. Do not remove unit from overwrap until ready to use. Do not use if overwrap has been previously opened or damaged. The overwrap is a moisture barrier. The inner bag maintains sterility of the solution. Tear overwrap at notch and remove premixed bag. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing the inner bag firmly. If leaks are found, discard solution, as sterility may be impaired. Do not use unless the solution is clear (colorless to light yellow) and the seal is intact. Preparation for intravenous administration:

प्राधिकरण का दर्जा:

New Drug Application

उत्पाद विशेषताएं

BREVIBLOC- ESMOLOL HYDROCHLORIDE INJECTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BREVIBLOC INJECTION
SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BREVIBLOC
INJECTION.
BREVIBLOC (ESMOLOL HYDROCHLORIDE) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1986
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
BREVIBLOC injection is a beta adrenergic blocker indicated for the
short-term treatment of:
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DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
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CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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Warnings and Precautions, Hypoglycemia (5.6) 05/2023
Control of ventricular rate in supraventricular tachycardia including
atrial fibrillation and atrial flutter
and control of heart rate in noncompensatory sinus tachycardia (1.1)
Control of perioperative tachycardia and hypertension (1.2)
Administer intravenously (2.1, 2.2)
Titrate using ventricular rate or blood pressure at ≥4-minute
intervals. (2.1, 2.2)
Supraventricular tachycardia (SVT) or noncompensatory sinus
tachycardia (2.1)
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Optional loading dose: 500 mcg per kg infused over one minute
Then 50 mcg per kg per minute for the next 4 minutes
Adjust dose as needed to a maximum of 200 mcg per kg per minute.
Additional loading doses may be administered
Perioperative tachycardia and hypertension (2.2)
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Loading dose: 500 mcg per kg over 1 minute for gradual control (1 mg
per kg over 30 seconds
for immediate control)
Then 50 mcg per kg per min for gradual control (150 mcg per kg per
minute for immediate
control) adjusted to a maximum of 200 (tachycardia) or 300
(hypertension) mcg per kg per min
(2.2)
Injection: 100 mg/10 mL (10 mg/mL) in 10 mL vial (3)
Injection: 2500 mg/250 mL (10 mg/mL) in 250 mL Premixed Injection bag
(3)
Injection: 2000 mg/100 mL (20 mg/mL) in 100 mL Double Strength
Premixed Injection bag (3)
Severe sinus bradycardia (4)
Heart block great