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ketamine hydrochloride injection, USP

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ketamine hydrochloride injection, USP Quick Finder

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

Ketamine Hydrochloride Injection is indicated:

  • as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
  • for...
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2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Information

Ketamine Hydrochloride Injection should be administered by or under the direction of...

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3 DOSAGE FORMS AND STRENGTHS

Ketamine Hydrochloride Injection, USP is a clear, colorless, sterile solution available in multiple-dose vials containing either 50 mg ketamine base/mL (equivalent to 57.7 mg ketamine...

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4 CONTRAINDICATIONS

  • Ketamine Hydrochloride Injection is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see Warnings...
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5 WARNINGS AND PRECAUTIONS

5.1 Hemodynamic Instability

Transient increases in blood pressure, heart rate, and cardiac index are frequently observed following...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

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7 DRUG INTERACTIONS

7.1 Theophylline or Aminophylline

Concomitant administration of Ketamine Hydrochloride Injection and theophylline or aminophylline may lower the...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are no adequate...

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9 DRUG ABUSE AND DEPENDENCE

9.1 Controlled Substance

Ketamine Hydrochloride Injection contains ketamine, a Schedule III controlled substance under the Controlled...

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10 OVERDOSAGE

Changes in heart rate and blood pressure, respiratory depression, and apnea may occur with overdosage or by a rapid rate of administration of Ketamine Hydrochloride Injection. Monitor patients for clinically...

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11 DESCRIPTION

Ketamine Hydrochloride Injection, USP for intravenous or intramuscular use, contains ketamine, a nonbarbiturate general anesthetic. Ketamine hydrochloride, USP is a white crystalline powder and has a molecular...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Ketamine Hydrochloride Injection, a racemic mixture of ketamine, is a non-selective, non-competitive antagonist of...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

Ketamine Hydrochloride Injection has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients in 105 separate studies. During the course of these studies, Ketamine...

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16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Ketamine Hydrochloride Injection, USP is a clear colorless solution supplied as the...

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17 PATIENT COUNSELING INFORMATION

  • Studies conducted in young animals and children suggest repeated or prolonged use of general anesthetic or sedation drugs in children younger than 3 years may have negative effects on...
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Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

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LAB-1028-6.0

Revised: 12/...

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