ketamine hydrochloride injection, USP How Supplied/Storage and Handling | Pfizer Medical Information - US

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16 HOW SUPPLIED/STORAGE AND HANDLING

How Supplied

Ketamine Hydrochloride Injection, USP is a clear colorless solution supplied as the hydrochloride in concentrations equivalent to ketamine base.

Unit of Sale	Concentration
NDC 0409-2051-05 Box of 10 5 mL Multiple-dose Fliptop Vial	500 mg/5 mL (100 mg/mL)
NDC 0409-2053-10 Box of 10 10 mL Multiple-dose Fliptop Vial	500 mg/10 mL (50 mg/mL)

Storage and Handling

Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Protect from light.

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ketamine hydrochloride injection, USP Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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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.
•

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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:

•: Hemodynamic Instability [see Warnings and...

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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 their...

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

LAB-1028-7....

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Pfizer Safety

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:

Pfizer Safety Reporting Site

*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.

FDA Medwatch

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.