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MARCAINE - SPINAL (bupivacaine hydrochloride injection, USP - SPINAL)

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MARCAINE - SPINAL Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the...
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1 INDICATIONS AND USAGE

MARCAINE SPINAL is indicated for subarachnoid injection in adults for the production of subarachnoid block (spinal anesthesia).

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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Information

  • Visually inspect this product for particulate matter and discoloration prior to...
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3 DOSAGE FORMS AND STRENGTHS

MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is a clear, colorless solution available as:

  • 15 mg/2 mL (7.5 mg/mL) in single-dose glass ampules.
  • ...
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5 WARNINGS AND PRECAUTIONS

5.1 Use of Spinal Anesthetics During Uterine Contractions

Spinal anesthetics including MARCAINE SPINAL should not be injected during...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions have been reported and described in other sections of the labeling:

  • Allergic-Type Reactions [see...
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7 DRUG INTERACTIONS

7.1 Local Anesthetics

The toxic effects of local anesthetics are additive. If coadministration of other local anesthetics with MARCAINE SPINAL...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

The available data on...

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10 OVERDOSAGE

Clinical Presentation

Acute emergencies from MARCAINE SPINAL are generally related to hypoventilation (and perhaps apnea)...

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11 DESCRIPTION

MARCAINE SPINAL (bupivacaine hydrochloride in dextrose injection) is an amide-local anesthetic and sterile hyperbaric aqueous solution. The route of administration for MARCAINE SPINAL is by subarachnoid...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Bupivacaine blocks the generation and the conduction of nerve impulses, presumably by increasing the threshold for...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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16 HOW SUPPLIED/STORAGE AND HANDLING

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.]...

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17 PATIENT COUNSELING INFORMATION

Allergic-Type Reactions

Assess if the patient has had allergic-type reactions to amide-type local...

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Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

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