Imalgene 100mg/ml 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.
Imalgene 100mg/ml is given only by or under the immediate supervision of a medical doctor trained to use it. If you will be receiving Imalgene 100mg/ml during surgery, your doctor or anesthesiologist will give you the medicine and closely follow your progress.
Imalgene 100mg/ml indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
Imalgene 100mg/ml hydrochloride injection is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Imalgene 100mg/ml hydrochloride is best suited for short procedures but it can be used, with additional doses, for longer procedures.
Imalgene 100mg/ml hydrochloride injection is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents.
Imalgene 100mg/ml hydrochloride injection is indicated to supplement low-potency agents, such as nitrous oxide.
Specific areas of application are described in the CLINICAL PHARMACOLOGY Section.
How should I use Imalgene 100mg/ml?
Use Imalgene 100mg/ml as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Imalgene 100mg/ml is usually administered as an injection at your doctor's office, hospital, or clinic by those experienced in administering general anesthetics, in maintaining an airway, and in controlling respiration.
Do not use Imalgene 100mg/ml if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.
Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.
If you miss a dose of Imalgene 100mg/ml, contact your doctor right away.
Ask your health care provider any questions you may have about how to use Imalgene 100mg/ml.
Uses of Imalgene 100mg/ml in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Use: Labeled Indications
Anesthesia: Induction and maintenance of general anesthesia
Off Label Uses
Data from a limited number of patients in open-label, prospective clinical trials suggest that Imalgene 100mg/ml may be beneficial for the treatment of severe agitation and violent behavior. However, the dosage range varies considerably and an optimal dosage has not been established. Additional data is necessary to further define the role of Imalgene 100mg/ml in this condition. Since there is limited data on the safety and efficacy of Imalgene 100mg/ml in this setting, the Neurocritical Care Society recommends reservation of Imalgene 100mg/ml for patients who do not respond to more frequently recommended antiepileptic drug treatment.
Imalgene 100mg/ml description
Imalgene 100mg/ml contains Ketamine HCl equivalent to Imalgene 100mg/ml base per mL. It also contains benzethonium chloride and water for injection. Additionally, the 10-mg/mL vial also contains sodium chloride.
Imalgene 100mg/ml dosage
Note: Barbiturates and Imalgene 100mg/ml hydrochloride, being chemically incompatible because of precipitate formation, should not be injected from the same syringe.
If the Imalgene 100mg/ml hydrochloride dose is augmented with diazepam, the two drugs must be given separately. Do not mix Imalgene 100mg/ml hydrochloride and diazepam in syringe or infusion flask. For additional information on the use of diazepam, refer to the WARNINGS and DOSAGE AND ADMINISTRATION Sections of the diazepam insert.
While vomiting has been reported following Imalgene 100mg/ml hydrochloride administration, some airway protection may be afforded because of active laryngeal-pharyngeal reflexes. However, since aspiration may occur with Imalgene 100mg/ml hydrochloride and since protective reflexes may also be diminished by supplementary anesthetics and muscle relaxants, the possibility of aspiration must be considered. Imalgene 100mg/ml hydrochloride 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.
Onset And Duration
Because of rapid induction following the initial intravenous injection, the patient should be in a supported position during administration.
The onset of action of Imalgene 100mg/ml hydrochloride is rapid; an intravenous dose of 2 mg/kg (1 mg/lb) of body weight usually produces surgical anesthesia within 30 seconds after injection, with the anesthetic effect usually lasting five to ten minutes. If a longer effect is desired, additional increments can be administered intravenously or intramuscularly to maintain anesthesia without producing significant cumulative effects.
Intramuscular doses, in a range of 9 to 13 mg/kg (4 to 6 mg/lb) usually produce surgical anesthesia within 3 to 4 minutes following injection, with the anesthetic effect usually lasting 12 to 25 minutes.
As with other general anesthetic agents, the individual response to Imalgene 100mg/ml hydrochloride is somewhat varied depending on the dose, route of administration, and age of patient, so that dosage recommendation cannot be absolutely fixed. The drug should be titrated against the patient's requirements.
The initial dose of Imalgene 100mg/ml hydrochloride administered intravenously may range from 1 mg/kg to 4.5 mg/kg (0.5 to 2 mg/lb). The average amount required to produce five to ten minutes of surgical anesthesia has been 2 mg/kg (1 mg/lb).
Alternatively, in adult patients an induction dose of 1 mg to 2 mg/kg intravenous Imalgene 100mg/ml at a rate of 0.5 mg/kg/min may be used for induction of anesthesia. In addition, diazepam in 2 mg to 5 mg doses, administered in a separate syringe over 60 seconds, may be used. In most cases, 15 mg of intravenous diazepam or less will suffice. The incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by this induction dosage program.
Note: The 100 mg/mL concentration of Imalgene 100mg/ml hydrochloride should not be injected intravenously 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.
Rate of Administration
It is recommended that Imalgene 100mg/ml hydrochloride be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response.
The initial dose of Imalgene 100mg/ml hydrochloride administered intramuscularly may range from 6.5 to 13 mg/kg (3 to 6 mg/lb). A dose of 10 mg/kg (5 mg/lb) will usually produce 12 to 25 minutes of surgical anesthesia.
Maintenance Of Anesthesia
The maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic agent is employed.
Increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia. However, it should be noted that 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 of the anesthetic.
It should be recognized that the larger the total dose of Imalgene 100mg/ml hydrochloride administered, the longer will be the time to complete recovery.
Adult patients induced with Imalgene 100mg/ml hydrochloride augmented with intravenous diazepam may be maintained on Imalgene 100mg/ml hydrochloride given by slow microdrip infusion technique at a dose of 0.1 to 0.5 mg/minute, augmented with diazepam 2 to 5 mg administered intravenously as needed. In many cases 20 mg or less of intravenous 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.
To prepare a dilute solution containing 1 mg of Imalgene 100mg/ml per mL, aseptically transfer 10 mL from a 50 mg per mL vial or 5 mL from a 100 mg per mL vial to 500 mL of 5% Dextrose Injection, USP or Sodium Chloride (0.9%) Injection, USP (Normal Saline) and mix well. The resultant solution will contain 1 mg of Imalgene 100mg/ml per mL.
The fluid requirements of the patient and duration of anesthesia must be considered when selecting the appropriate dilution of Imalgene 100mg/ml hydrochloride injection. If fluid restriction is required, Imalgene 100mg/ml hydrochloride injection can be added to a 250 mL infusion as described above to provide a Imalgene 100mg/ml hydrochloride concentration of 2 mg/mL. Imalgene 100mg/ml hydrochloride injection 10 mg/mL vials are not recommended for dilution.
Imalgene 100mg/ml hydrochloride is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.
The regimen of a reduced dose of Imalgene 100mg/ml hydrochloride supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents such as nitrous oxide and oxygen.
Imalgene 100mg/ml hydrochloride injection is supplied as the hydrochloride in concentrations equivalent to Imalgene 100mg/ml base.
NDC 42023-137-10 - Each 20-mL multi-dose vial contains 10 mg/mL. Supplied in cartons of 10.
NDC 42023-138-10 - Each 10-mL multi-dose vial contains 50 mg/mL. Supplied in cartons of 10.
NDC 42023-139-10 - Each 5-mL multi-dose vial contains 100 mg/mL. Supplied in cartons of 10.
Store between 20° to 25°C (68° to 77°F).
Protect from light.
Manufactured and Distributed by: JHP Pharmaceuticals, LLC, Rochester, MI 48307. Revised: Feb 2013
Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with Imalgene 100mg/ml.
Imalgene 100mg/ml is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.
Imalgene 100mg/ml may potentiate the neuromuscular-blocking effects of atracurium and tubocurarine including respiratory depression with apnoea.
The use of halogenated anaesthetics concomitantly with Imalgene 100mg/ml can lengthen the elimination half-life of Imalgene 100mg/ml and delay recovery from anaesthesia. Concurrent use of Imalgene 100mg/ml (especially in high doses or when rapidly administered) with halogenated anaesthetics can increase the risk of developing bradycardia, hypotension or decreased cardiac output.
The use of Imalgene 100mg/ml with other CNS depressants (eg, ethanol, phenothiazines, sedating H1-blockers or skeletal muscle relaxants) can potentiate CNS depression and/or increase risk of developing respiratory depression. Reduced doses of Imalgene 100mg/ml may be required with concurrent administration of other anxiolytics, sedatives and hypnotics.
Imalgene 100mg/ml has been reported to antagonise the hypnotic effect of thiopental.
Patients taking thyroid hormones have an increased risk of developing hypertension and tachycardia when given Imalgene 100mg/ml.
Concomitant use of antihypertensive agents and Imalgene 100mg/ml increases the risk of developing hypotension.
When Imalgene 100mg/ml and theophylline are given concurrently, a clinically significant reduction in the seizure threshold is observed. Unpredictable extensor-type seizures have been reported with concurrent administration of these agents.
Incompatibilities: Imalgene 100mg/ml is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.
Cardiovascular: Blood pressure and pulse rate are frequently elevated following administration of Imalgene 100mg/ml hydrochloride 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 Imalgene 100mg/ml hydrochloride. Laryngospasms and other forms of airway obstruction have occurred during Imalgene 100mg/ml hydrochloride anesthesia.
Eye: Diplopia and nystagmus have been noted following Imalgene 100mg/ml hydrochloride administration. It also may cause a slight elevation in intraocular pressure measurement.
Genitourinary: Severe irritative and inflammatory urinary tract and bladder symptoms including cystitis have been reported in individuals with history of chronic Imalgene 100mg/ml use or abuse.
Neurological: In some patients, enhanced skeletal muscle tone may be manifested by tonic and clonic movements sometimes resembling seizures.
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.
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
Imalgene 100mg/ml has been reported being used as a drug of abuse.
Reports suggest that Imalgene 100mg/ml produces a variety of symptoms including, but not limited to anxiety, dysphoria, disorientation, insomnia, flashbacks, hallucinations, and psychotic episodes.
Imalgene 100mg/ml dependence and tolerance are possible following prolonged administration. A withdrawal syndrome with psychotic features has been described following discontinuation of long-term Imalgene 100mg/ml use. Therefore, Imalgene 100mg/ml should be prescribed and administered with caution.
You should not receive Imalgene 100mg/ml if you are allergic to it, or if you have untreated or uncontrolled hypertension (high blood pressure).
Before you receive Imalgene 100mg/ml, tell your doctor if you have heart disease, high blood pressure, a history of alcoholism, or if you recently drank large amounts of alcohol.
Imalgene 100mg/ml 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 Imalgene 100mg/ml 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 Imalgene 100mg/ml: 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 Imalgene 100mg/ml.
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.
DTP/NCI. "ketamine: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
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