Ketamine (injection route)


    Brand Name

    US Brand Name

    Ketalar

    Canadian Brand Name

    Ketamine Hydrochloride

    Ketamine Hydrochloride SDZ

    Ketamine Hydrochloride SDZ - Preservative Free

    Ketamine Hydrochloride SDZ with Preservative


    Description

    Ketamine injection is used alone or together with other medicines to produce loss of consciousness before and during surgery or a medical procedure. It belongs to the group of medicines called general anesthetics.

    This medicine is to be given only by or under the immediate supervision of your doctor.

    This product is available in the following dosage forms:

    • Solution

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of ketamine injection in children younger than 16 years of age. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ketamine injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution and an adjustment in the dose for patients receiving ketamine injection.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Acepromazine
    • Alfentanil
    • Alprazolam
    • Amifampridine
    • Aminophylline
    • Amobarbital
    • Anileridine
    • Aripiprazole
    • Asenapine
    • Baclofen
    • Benperidol
    • Benzhydrocodone
    • Bromazepam
    • Buprenorphine
    • Bupropion
    • Buspirone
    • Butabarbital
    • Butalbital
    • Butorphanol
    • Calcium Oxybate
    • Cannabidiol
    • Cannabis
    • Carbamazepine
    • Carbinoxamine
    • Carisoprodol
    • Carphenazine
    • Cetirizine
    • Chloral Hydrate
    • Chlordiazepoxide
    • Chlorpromazine
    • Chlorzoxazone
    • Clobazam
    • Clonazepam
    • Clorazepate
    • Clozapine
    • Codeine
    • Cyclobenzaprine
    • Daridorexant
    • Dexmedetomidine
    • Diacetylmorphine

    Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Atracurium

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

    • Ethanol

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • Alcohol use disorder or
    • Brain or nerve disease or
    • Drug use disorder, history of or
    • Heart disease or
    • Liver disease or
    • Lung or breathing problems (eg, respiratory depression)—Use with caution. May make these conditions worse.
    • Hypertension (high blood pressure), severe—Should not be used in patients with this condition.

    Proper Use

    A nurse or other trained health professional will give you this medicine in a medical facility. This medicine is given as a shot into a muscle or into a vein.


    Precautions

    It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

    Tell your doctor if you are pregnant or breastfeeding. Ketamine may harm your unborn baby.

    Ketamine may cause serious reactions (eg, brain or nerve problems) to children younger than 3 years of age. Check with your doctor right away if your child has blurred or double vision, difficulty in walking, drooping eyelids, headache, jaw pain, numbness or tingling in the fingers and toes, pain in the testicles, or weakness.

    This medicine may cause serious liver problems. Tell your doctor right away if you have bloating of stomach, dark urine, light-colored stools, nausea and vomiting, stomach pain, yellow eyes or skin.

    This medicine may make you dizzy, drowsy, or confused. Do not drive or do anything else that could be dangerous within 24 hours of receiving this medicine.

    This medicine may make you have unusual thoughts or behaviors after the surgery. You might feel confused or excited, or you might see or hear things that are not really there. You might feel as if you are dreaming while you are awake. Call your doctor if these thoughts or behaviors are severe or last longer than 24 hours.

    This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are barbiturates or medicine for seizures or other anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are receiving this medicine.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    Side Effects

    Along with its needed effects, a medicine 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:

    Incidence not known

    • Bloody or cloudy urine
    • bluish lips or skin
    • blurred or change in vision
    • burning while urinating
    • chest pain, discomfort, or tightness
    • confusion
    • confusion as to time, place, or person
    • cough
    • 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, itching, skin rash
    • holding false beliefs that cannot be changed by fact
    • irregular, fast or slow, or shallow breathing
    • loss of vision
    • 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
    • seizures
    • sweating
    • trouble breathing
    • unusual excitement, nervousness, or restlessness
    • unusual tiredness or weakness

    Some side effects 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:

    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

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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