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ketamine hydrochloride injection, USP
If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.
Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.
ketamine hydrochloride injection, USP Quick Finder
Highlights
Indications and Usage
1 INDICATIONS AND USAGE
Ketamine Hydrochloride Injection is indicated:
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- as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation.
- • ...
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Dosage and Administration
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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Dosage Forms and Strengths
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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Contraindications
4 CONTRAINDICATIONS
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- 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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Warnings and Precautions
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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Adverse Reactions
6 ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
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- Hemodynamic Instability [see Warnings and...
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Drug Interactions
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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Use in Specific Populations
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
There are no adequate...
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Drug Abuse and Dependence
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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Overdosage
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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Description
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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Clinical Pharmacology
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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Nonclinical Toxicology
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
...
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Clinical Studies
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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How Supplied/Storage and Handling
16 HOW SUPPLIED/STORAGE AND HANDLING
How Supplied
Ketamine Hydrochloride Injection, USP is a clear colorless solution supplied as the...
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Medication Guide
17 PATIENT COUNSELING INFORMATION
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- 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 their...
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Report Adverse Event
To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:
*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.
If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at(800) 438-1985.
You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.
(800)-332-1088.