KETAMINE

Ketamine Pregnancy Warnings

Animal studies failed to show adverse effects in the fetus at up to 5 times the average human IV dose for 3 consecutive doses. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

Use is not recommended. AU TGA pregnancy category: B3 US FDA pregnancy category: Not assigned

Ketamine Breastfeeding Warnings

Use is not recommended. Excreted into human milk: Likely Excreted into animal milk: Yes

Breastmilk levels of this drug have not been measured after administration to humans. Minimal data indicate that use in nursing mothers may not affect the breastfed infant or lactation. This drug should only be used with careful monitoring during breastfeeding.

For the Consumer

Applies to ketamine: injection solution

In addition to its needed effects, some unwanted effects may be caused by ketamine. In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking ketamine, check with your doctor or nurse immediately:

Incidence not known

• 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 of the side effects that can occur with ketamine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Incidence not known

• 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

For Healthcare Professionals

Applies to ketamine: compounding powder, injectable solution, intravenous solution

Cardiovascular

Common (1% to 10%): Blood pressure increased, heart rate increased, increased pulse rate

Uncommon (0.1% to 1%): Bradycardia, arrhythmia, hypotension

Frequency not reported: Arrhythmia[Ref]

Respiratory

Common (1% to 10%): Respiratory rate increased

Uncommon (0.1% to 1%): Respiratory depression, laryngospasm

Rare (less than 0.1%): Obstructive airway disorder, apnea[Ref]

Ocular

Common (1% to 10%): Nystagmus, diplopia

Frequency not reported: Intraocular pressure increased[Ref]

Gastrointestinal

Common (1% to 10%): Nausea, vomiting, anorexia

Rare (less than 0.1%): Salivary hypersecretion[Ref]

Musculoskeletal

Common (1% to 10%): Hypertonia, tonic clonic movements[Ref]

Local

Uncommon (0.1% to 1%): Injection site pain, injection site rash[Ref]

Dermatologic

Common (1% to 10%): Erythema, morbilliform rash[Ref]

Psychiatric

Common (1% to 10%): Hallucination, abnormal dreams, nightmare, confusion, agitation, abnormal behavior

Uncommon (0.1% to 1%): Anxiety

Rare (less than 0.1%): Delirium, flashback, dysphoria, insomnia, disorientation

Frequency not reported: Psychotic episodes[Ref]

Genitourinary

Rare (less than 0.1%): Cystitis, hemorrhagic cystitis[Ref]

Hepatic

Frequency not reported: Liver function test abnormal[Ref]

Hypersensitivity

Common (1% to 10%): Anaphylactic reaction

Safety and efficacy have not been established in patients younger than 16 years.

Consult WARNINGS section for additional precautions.

Dosage

Applies to the following strength(s): 100 mg/mL ; 50 mg/mL ; 10 mg/mL ; 10 mg/mL-NaCl 0.9% ; 1 mg/mL-NaCl 0.9% ; 50 mg/5 mL ; 100 mg/10 mL ; 50 mg/5 mL-NaCl 0.9% ; 100 mg/10 mL-NaCl 0.9%

This information is not a substitute for medical advice. ALWAYS consult your doctor or pharmacist.

Usual Adult Dose for Anesthesia

IV:

-Induction: 1 to 4.5 mg/kg IV; alternatively, 1 to 2 mg/kg IV at a rate of 0.5 mg/kg/min; (2 mg/kg dose provides 5 to 10 minutes of surgical anesthesia within 30 seconds)

-Maintenance: The maintenance dose should be adjusted according to the patient’s anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.

IM:

-Induction: 6.5 to 13 mg/kg IV; (9 to 13 mg/kg IV provides 12 to 25 minutes of surgical anesthesia)

-Maintenance: The maintenance dose should be adjusted according to the patient’s anesthetic needs and whether an additional anesthetic is employed. Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia.

Comments:

-This drug should be administered slowly over a period of 60 seconds (more rapid administration may result in respiratory depression and enhanced pressor response).

-The larger the total dose, the longer will be complete recovery.

-Because of rapid induction following the initial IV injection, the patient should be in a supported position during administration.

Usual Pediatric Dose for Anesthesia

16 years and older: See adult dosing

Renal Dose Adjustments

Data not available

Liver Dose Adjustments

Data not available

Dose Adjustments

-The individual response is somewhat varied depending on the dose, route of administration, and age of patient, so that the dosage recommendation cannot be absolutely fixed. The drug should be titrated against the patient’s requirements.

-Diazepam (2 to 5 mg over 60 seconds), administered in a separate syringe, may be used along with ketamine IV infusion for induction or maintenance of anesthesia. In most cases, 15 mg of IV diazepam or less will suffice.

-Adult patients induced with ketamine augmented with IV diazepam may be maintained on ketamine given by slow microdrip infusion technique at a dose of 0.1 to 0.5 mg/min, augmented with diazepam 2 to 5 mg administered IV as needed. In many cases, 20 mg or less of IV diazepam total for combined induction and maintenance will suffice. However, slightly more diazepam may be required depending on the nature and duration of the operation, physical status of the patient, and other factors. The incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by this maintenance dosage program.

Dialysis

Data not available

Other Comments

Administration advice:

-This drug should be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response.

General:

-Because of rapid induction following the initial IV injection, the patient should be in a supported position during administration.

-Since aspiration may occur and since protective reflexes may also be diminished by supplementary anesthetics and muscle relaxants, the possibility of aspiration should be considered.

-This drug is recommended for use in the patient whose stomach is not empty when, in the judgment of the practitioner, the benefits of the drug outweigh the possible risks.

-Atropine, scopolamine, or another drying agent should be given at an appropriate interval prior to induction.

-Purposeless and tonic-clonic movements of extremities may occur during the course of anesthesia. These movements do not imply a light plane and are not indicative of the need for additional doses.

-This drug has a wide margin of safety; several instances of unintentional administration of overdoses of up to 10 times that usually required have been followed by prolonged but complete recovery.

-The larger the total dose administered, the longer will be the time to complete recovery.

-This drug is compatible with commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.

-The regimen of a reduced dose of this drug, supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents such as nitrous oxide and oxygen.

-Elevation of blood pressure begins shortly after injection, reaches a maximum within a few minutes and usually returns to preanesthetic values within 15 minutes after injection. In the majority of cases, the systolic and diastolic blood pressure peaks from 10% to 50 % above preanesthetic levels shortly after induction of anesthesia, but the elevation can be higher or longer in individual cases.

Reconstitution advice:

-The 100 mg/mL concentration should not be injected IV without proper dilution. It is recommended the drug be diluted with an equal volume of either Sterile Water for injection, USP, Normal Saline, or 5% Dextrose in Water.

Brands

Available Brands

• Etamine [ Swiss Parenterals ]
• Ketamax [ Rotexmedica GmbH ]

Also marketed as

• Ketacor [ Duopharma (M) Sdn Bhd ]