Ketalar

Dosage Forms & Strengths

injectable solution: Schedule III

• 10mg/mL
• 50mg/mL
• 100mg/mL

Anesthesia Induction

Load

• IV: 1-4.5 mg/kg slow IV once 
• Alternatively (off-label): 0.5-2 mg/kg slow IV if adjuvant drugs (eg, midazolam) are used, OR
• IM: 6.5-13 mg/kg IM once
• Alternatively (off-label): 4-10 mg/kg IM once if adjuvant drugs (eg, midazolam) are used

Maintenance

• 50% of IV ketamine induction dose administered PRN, OR
• 0.1-0.5 mg/min IV continuous infusion

Dosage Forms & Strengths

injectable solution: Schedule III

• 10mg/mL
• 50mg/mL
• 100mg/mL

Sedation/Analgesia (Off-label)

ACEP recommends as safe in children

3 months or older

IM

• 4-5 mg/kg IM once, ACEP Clinical Guidelines (Green 2004); may give a repeat dose (range 2-5 mg/kg) if sedation inadequate after 5-10 min or if additional doses are required 

IV

• Various recommendations
• 1.5-2 mg/kg over 30-60 sec; may administer incremental doses of 0.5-2 mg/kg IV q5-15min PRN if initial sedation inadequate (Mace et al., Ann Emerg Med, 44: 342-377 [2004]), OR 
• 0.25-0.5 mg/kg (Harriet Lane)

Oral

• 6-10 mg/kg PO once; mix with 0.2-0.3 mL/kg of a beverage; give 30 min before procedure

16 years or older

Load

• IV: 1-4.5 mg/kg slow IV once
• Alternatively (off-label): 0.5-2 mg/kg slow IV if adjuvant drugs (eg, midazolam) are used, OR
• IM: 6.5-13 mg/kg IM once
• Alternatively (off-label): 4-10 mg/kg IM once if adjuvant drugs (eg, midazolam) are used

Maintenance

• 50% of IV ketamine induction dose administered PRN, OR
• 0.1-0.5 mg/min IV continuous infusion

You should not receive ketamine if you are allergic to it, or if you have untreated or uncontrolled hypertension (high blood pressure).

Before you receive ketamine, tell your doctor if you have heart disease, high blood pressure, a history of alcoholism, or if you recently drank large amounts of alcohol.

Ketamine may be harmful to an unborn baby. Tell your doctor if you are pregnant.

You may feel strange or slightly confused when you first come out of anesthesia. Tell your caregivers if these feelings are severe or unpleasant. It may take you longer to recover from anesthesia with ketamine if you have recently used a barbiturate (Butisol, Mebaral, Seconal, Nembutal, Solfoton, and others) or narcotic medication (Vicodin, Dilaudid, OxyContin, Percocet, Actiq, Duragesic, Methadose, Dolophine, Kadian, MS Contin, and others).

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.

This medication may impair your thinking or reactions. You will probably not be allowed to drive yourself home after your surgery or medical procedure. Avoid driving or operating machinery for at least 24 hours after you have received ketamine.

Call your doctor at once if you have a serious side effect such as slow heart rate, weak or shallow breathing, feeling like you might pass out, pain or burning when you urinate, or jerky muscle movements that may look like convulsions.

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

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.

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

(See Special Note.)

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

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).

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)

You should not receive ketamine if you have untreated or uncontrolled hypertension (high blood pressure).

Do not receive this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Tell your caregivers at once if you have serious side effects within 24 hours after you receive ketamine, including severe confusion, hallucinations, unusual thoughts, or extreme fear.

You should not receive ketamine if you are allergic to it, or if you have untreated or uncontrolled hypertension (high blood pressure).

You should not receive ketamine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

To make sure ketamine is safe for you, tell your doctor if you have:

• heart disease;

• high blood pressure;

• a history of alcoholism; or

• if you recently drank large amounts of alcohol.

Ketamine may be harmful to an unborn baby. Before you receive ketamine, tell your doctor if you are pregnant.

Anesthesia medicine may affect brain development in a child under 3, or an unborn baby whose mother receives this medicine during late pregnancy. These effects may be more likely when the anesthesia is used for 3 hours or longer, or used for repeated procedures. Effects on brain development could cause learning or behavior problems later in life.

Negative brain effects from anesthesia have been seen in animal studies. However, studies in human children receiving single short uses of anesthesia have not shown a likely effect on behavior or learning. More research is needed.

In some cases, your doctor may decide to postpone a surgery or procedure based on these risks. Treatment may not be delayed in the case of life-threatening conditions, medical emergencies, or surgery needed to correct certain birth defects.

Ask your doctor for information about all medicines that will be used during your surgery or procedure. Also ask how long the procedure will last.

It is not known whether ketamine passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur. Your vital signs will be closely watched while you are under anesthesia to make sure the medication is not causing any harmful effects.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Not hungry.
• Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.

Published studies in animals demonstrate that the use of anesthetic agents during the period of rapid brain growth or synaptogenesis results in widespread neuronal and oligodendrocyte cell loss in the developing brain and alterations in synaptic morphology and neurogenesis. Based on comparisons across species, the window of vulnerability to these changes is believed to correlate with exposures in the third trimester through the first several months of life, but may extend out to approximately 3 years of age in humans.

In primates, exposure to 3 hours of an anesthetic regimen that produced a light surgical plane of anesthesia did not increase neuronal cell loss, however, treatment regimens of 5 hours or longer increased neuronal cell loss. Data in rodents and in primates suggest that the neuronal and oligodendrocyte cell losses are associated with subtle but prolonged cognitive deficits in learning and memory. The clinical significance of these nonclinical findings is not known, and healthcare providers should balance the benefits of appropriate anesthesia in neonates and young children who require procedures against the potential risks suggested by the nonclinical data. (See WARNINGS/Pediatric Neurotoxicity, Use in Pregnancy, and Pediatric Use).

In published studies, intraperitoneal administration of ketamine at doses greater than 40 mg/kg induced vacuolation in neuronal cells of the posterior cingulate and retrosplenial cortices in adult rats, similar to what has been reported in rodents administered other NMDA receptor antagonists.  These vacuoles were demonstrated to be reversible and did not progress to degeneration or neuronal death up to doses of 80 mg/kg (1.2 times the human dose of 10 mg/kg based on body surface area).  A no-effect level for neuronal vacuolation was 20 mg/kg intraperitoneal (0.3 times a human dose of 10 mg/kg on a body surface area basis).  The window of vulnerability to these changes is believed to correlate with exposures in humans from the onset of puberty through adulthood.  The relevance of this finding to humans is unknown.

Distributed by:
Par Pharmaceutical
Chestnut Ridge, NY 10977

R05/17

OS115J-01-90-03

3000442H

Applies to ketamine: injection solution

Along with its needed effects, ketamine (the active ingredient contained in Ketalar) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking ketamine:

• Bloody or cloudy urine
• bluish lips or skin
• blurred vision
• chest pain or discomfort
• confusion
• confusion as to time, place, or person
• convulsions
• cough
• difficult or troubled breathing
• difficult, burning, or painful urination
• difficulty with swallowing
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fainting
• fast, slow, or irregular heartbeat
• frequent urge to urinate
• hives
• holding false beliefs that cannot be changed by fact
• irregular, fast or slow, or shallow breathing
• itching
• not breathing
• pale or blue lips, fingernails, or skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• seeing, hearing, or feeling things that are not there
• shortness of breath
• skin rash
• sweating
• tightness in the chest
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness

Some side effects of ketamine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Double vision
• dream-like state
• flushing or redness of the skin
• loss of appetite
• nausea
• pain at the injection site
• seeing double
• uncontrolled eye movements
• unusually warm skin
• vomiting
• weight loss