Ketalar Side Effects Center

Last updated on RxList: 7/12/2022
Ketalar Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Ketalar?

Ketalar (ketamine hydrochloride) Injection is a non-barbiturate anesthetic indicated for the induction of anesthesia either alone or prior to the administration of other general anesthetic agents. Ketalar is indicated to supplement low-potency agents, such as nitrous oxide. Ketalar is available in generic form.

What Are Side Effects of Ketalar?

Common side effects of Ketalar include:

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Ketalar?

It is formulated as a slightly acid (pH 3.5 – 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 10, 50, or 100 mg ketamine base per milliliter and contains not more than 0.1 mg/mL Phemerol (benzethonium chloride) added as a preservative. The 10 mg/mL solution has been made isotonic with sodium chloride. Patients need to be accompanied until side effects wear off. The drug has the potential to become addictive.

What Drugs, Substances, or Supplements Interact with Ketalar?

Ketalar may interact with barbiturates or narcotics. Tell your doctor all medications and supplements you use.

Ketalar During Pregnancy and Breastfeeding

The use of Ketalar is not recommended for pregnant patients or for the use of obstetrics and has not been studied in pediatric patients below the age of 16.

Additional Information

Our Ketalar Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

About how much does an adult human brain weigh? See Answer
Ketalar Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your caregivers if you have hallucinations or unusual thoughts while waking up from anesthesia.

Call your doctor at once if you have:

  • painful or difficult urination, increased urination, loss of bladder control, blood in your urine;
  • a light-headed feeling, like you might pass out;
  • slow heart rate, weak or shallow breathing; or
  • jerky muscle movements that may look like convulsions.

Common side effects may include:

  • confusion; or
  • dream-like feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Digestive Disorders: Common Misconceptions See Slideshow
Ketalar Professional Information

SIDE EFFECTS

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

  • Hemodynamic Instability [see WARNINGS AND PRECAUTIONS]
  • Emergence Reactions [see WARNINGS AND PRECAUTIONS]
  • Respiratory Depression [see WARNINGS AND PRECAUTIONS]
  • Pediatric Neurotoxicity [see WARNINGS AND PRECAUTIONS]
  • Drug-Induced Liver Injury [see WARNINGS AND PRECAUTIONS]

The following adverse reactions associated with the use of KETALAR were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular disorders: Elevated blood pressure, heart rate, and cardiac index; decreases in blood pressure and heart rate; arrhythmias; cardiac decompensation (in patients with suspected catecholamine depletion).

Eye disorders: Diplopia, nystagmus, elevation in intraocular pressure.

Gastrointestinal disorders: Anorexia, nausea, vomiting, hepatobiliary dysfunction. Biliary duct dilatation with or without evidence of biliary obstruction has been reported with recurrent use (e.g., misuse/abuse or medically supervised unapproved indications).

Administration site disorders: Local pain and exanthema at the site.

Immune system disorders: Anaphylaxis.

Neurologic disorders: Emergence reactions (post-operative delirium), [see WARNINGS AND PRECAUTIONS]. During administration, enhanced muscle tone and spasms (resembling a partial motor or generalized motor seizure).

Psychiatric disorders: Adverse psychiatric events have occurred and/or persisted days to weeks after ketamine exposure.

Renal and urinary disorders: In individuals with history of chronic ketamine use or abuse, lower urinary tract and bladder symptoms including dysuria, increased urinary frequency, urgency, urge incontinence, and hematuria have been reported [see DOSAGE AND ADMINISTRATION]. In addition, diagnostic studies performed to assess the cause of these symptoms have reported cystitis (including cystitis non-infective, cystitis interstitial, cystitis ulcerative, cystitis erosive and cystitis hemorrhagic) as well as hydronephrosis and reduced bladder capacity.

Respiratory disorders: Respiratory depression and apnea following rapid intravenous administration of high doses of KETALAR; laryngospasm, and airway obstruction.

Skin and subcutaneous tissue disorders: Transient erythema and/or morbilliform rash

DRUG INTERACTIONS

Theophylline Or Aminophylline

Concomitant administration of KETALAR and theophylline or aminophylline may lower the seizure threshold. Consider using an alternative to KETALAR in patients receiving theophylline or aminophylline.

Sympathomimetics And Vasopressin

Sympathomimetics and vasopressin may enhance the sympathomimetic effects of ketamine. Closely monitor vital signs when KETALAR and sympathomimetics or vasopressin are co-administered and consider dose adjustment individualized to the patient’s clinical situation.

Benzodiazepines, Opioid Analgesics, Or Other CNS Depressants

Concomitant use of ketamine with opioid analgesics, benzodiazepines, or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS AND PRECAUTIONS].

Opioid analgesics administered concomitantly with KETALAR may prolong time to complete recovery from anesthesia.

Drug Abuse And Dependence

Controlled Substance

KETALAR contains ketamine, a Schedule III controlled substance under the Controlled Substance Act.

Abuse

Individuals with a history of drug abuse or dependence may be at greater risk for abuse and misuse of KETALAR. Abuse is the intentional, non-therapeutic use of a drug, even once, for its psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed.

In a context of drug abuse, KETALAR may produce a variety of symptoms including anxiety, dysphoria, disorientation, insomnia, flashback, hallucinations, and feelings of floating, detachment and being “spaced out”.

Recurrent high-dose ketamine misuse or abuse may be associated with memory and/or attention impairment.

Dependence

Physical dependence has been reported with prolonged use of ketamine. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or significant dosage reduction of a drug. Withdrawal symptoms have been reported after the discontinuation of frequently used (more than weekly), large doses of ketamine for long periods of time. Reported symptoms of withdrawal associated with daily intake of large doses of ketamine include craving, fatigue, poor appetite, and anxiety.

Tolerance has been reported with prolonged use of ketamine. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose).

Read the entire FDA prescribing information for Ketalar (Ketamine Hydrochloride Injection)

© Ketalar Patient Information is supplied by Cerner Multum, Inc. and Ketalar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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