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Ketalar

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Ketalar

Ketalar

Ketalar Side Effects Center

Medical Editor: Charles Patrick Davis, MD, PhD

Ketalar is a non-barbiturate anesthetic used as an injection indicated for the induction of anesthesia either alone or prior to the administration of other general anesthetic agents. Generic names for Ketalar are ketamine and ketamine hydrochloride. Ketalar is indicated to supplement low-potency agents, such as nitrous oxide. Observed side effects of Ketalar can include low blood pressure, nausea, vomiting.

Ketalar is a non-barbiturate anesthetic. 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. Serious side effects have been reported in as many as 12% of patients; they are psychological states that vary from pleasant dream-like states to hallucinations to delirium all of which may last up to about 24 hours. Patients need to be accompanied until side effects wear off. The drug has the potential to become addictive. 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.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Ketalar in Detail - Patient Information: Side Effects

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

Tell your caregivers at once if you have any of these serious side effects within 24 hours after you receive ketamine:

  • severe confusion;
  • hallucinations;
  • unusual thoughts; or
  • extreme fear.

Less serious side effects may include:

  • dream-like feeling;
  • double vision;
  • jerky muscle movements;
  • dizziness, drowsiness;
  • nausea, vomiting, loss of appetite; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Ketalar (Ketamine Hydrochloride Injection) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ketalar FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Cardiovascular

Blood pressure and pulse rate are frequently elevated following administration of Ketalar alone. However, hypotension and bradycardia have been observed. Arrhythmia has also occurred.

Respiration

Although respiration is frequently stimulated, severe depression of respiration or apnea may occur following rapid intravenous administration of high doses of Ketalar. Laryngospasms and other forms of airway obstruction have occurred during Ketalar anesthesia.

Eye

Diplopia and nystagmus have been noted following Ketalar administration. It also may cause a slight elevation in intraocular pressure measurement.

Psychological

(See Special Note.)

Neurological

In some patients, enhanced skeletal muscle tone may be manifested by tonic and clonic movements sometimes resembling seizures (see DOSAGE AND ADMINISTRATION Section).

Gastrointestinal

Anorexia, nausea and vomiting have been observed; however, this is not usually severe and allows the great majority of patients to take liquids by mouth shortly after regaining consciousness (see DOSAGE AND ADMINISTRATION Section).

General

Anaphylaxis. Local pain and exanthema at the injection site have infrequently been reported. Transient erythema and/or morbilliform rash have also been reported.

For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact JHP at 1-866-923-2547 or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.

Drug Abuse And Dependence

Ketamine has been reported being used as a drug of abuse. Reports suggest that ketamine produces a variety of symptoms including, but not limited to anxiety, dysphoria, disorientation, insomnia, flashbacks, hallucinations, and psychotic episodes. Ketamine dependence and tolerance are possible following prolonged administration. A withdrawal syndrome with psychotic features has been described following discontinuation of long-term ketamine use. Therefore, ketamine should be prescribed and administered with caution.

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

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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