Aneket

Aneket contains Ketamine HCl equivalent to Aneket base per mL. It also contains benzethonium chloride and water for injection. Additionally, the 10-mg/mL vial also contains sodium chloride.

As an anaesthetic agent for diagnostic and surgical procedures. When used by IV or IM injection, Aneket is best suited for short procedures. With additional doses or by IV infusion, Aneket can be used for longer procedures. If skeletal muscle relaxation is desired, a muscle relaxant should be used and respiration should be supported.

For the induction of anaesthesia prior to the administration of other general anaesthetic agents.

To supplement other anaesthetic agents.

Specific areas of application or types of procedures: When the IM route of administration is preferred.

Debridement, painful dressings and skin grafting in burned patients, as well as other superficial surgical procedures.

Neurodiagnostic procedures eg, pneumoencephalograms, ventriculograms, myelograms and lumbar punctures.

Diagnostic and operative procedures of the eye, ear, nose and mouth, including dental extractions.

Note: Eye movements may persist during ophthalmological procedures.

Anaesthesia in poor-risk patients with depression of vital functions or where depression of vital functions must be avoided, if at all possible.

Orthopaedic procedures eg, closed reductions, manipulations, femoral pinning, amputations and biopsies.

Sigmoidoscopy and minor surgery of the anus and rectum, circumcision and pilonidal sinus.

Cardiac catheterization procedures.

Caesarian section; as an induction agent in the absence of elevated blood pressure.

Anaesthesia in the asthmatic patient, either to minimise the risks of an attack of bronchospasm developing, or in the presence of bronchospasm where anaesthesia cannot be delayed.

Aneket 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.

Aneket is given only by or under the immediate supervision of a medical doctor trained to use it. If you will be receiving Aneket during surgery, your doctor or anesthesiologist will give you the medicine and closely follow your progress.

Note: All doses are given in terms of Aneket base.

Adults, Elderly (>65 years) and Children: For surgery in elderly patients, Aneket has been shown to be suitable either alone or supplemented with other anaesthetic agents.

Preoperative Preparations: Aneket has been safely used alone when the stomach was not empty. However, since the need for supplemental agents and muscle relaxants cannot be predicted, when preparing for elective surgery, it is advisable that nothing be given by mouth for at least 6 hrs prior to anaesthesia.

Premedication with an anticholinergic agent (eg, atropine, hyoscine or glycopyrolate) or another drying agent should be given at an appropriate interval prior to induction to reduce Aneket-induced hypersalivation.

Midazolam, diazepam, lorazepam or flunitrazepam used as a premedicant or as an adjunct to Aneket, have been effective in reducing the incidence of emergence reactions.

Onset and Duration: As with other general anaesthetic agents, the individual response to Aneket is somewhat varied depending on the dose, route of administration, age of patient and concomitant use of other agents, so that dosage recommendation cannot be absolutely fixed. The dose should be titrated against the patient's requirements.

Because of rapid induction following IV injection, the patient should be in a supported position during administration. An IV dose of 2 mg/kg of body weight usually produces surgical anaesthesia within 30 sec after injection and the anaesthetic effect usually lasts 5-10 min. An IM dose of 10 mg/kg of body weight usually produces surgical anaesthesia within 3-4 min following injection and the anaesthetic effect usually lasts 12-25 min. Return to consciousness is gradual.

Aneket as the Sole Anaesthetic Agent: IV Infusion: The use of Aneket by continuous infusion enables the dose to be titrated more closely, thereby reducing the amount of Aneket administered compared with intermittent administration. This results in a shorter recovery time and better stability of vital signs.

A solution containing Aneket 1 mg/mL in 5% dextrose or 0.9% sodium chloride is suitable for administration by infusion.

General Anaesthesia Induction: An infusion corresponding to 0.5-2 mg/kg as total induction dose.

Maintenance of Anaesthesia: Anaesthesia may be maintained using a microdrip infusion of 10-45 mcg/kg/min (approximately 1-3 mg/min).

The rate of infusion will depend on the patient's reaction and response to anaesthesia. The dosage required may be reduced when a long-acting neuromuscular-blocking agent is used.

Intermittent Injection: Induction: IV Route: The initial dose of Aneket administered IV may range from 1-4.5 mg/kg (in terms of Aneket base). The average amount required to produce 5-10 min of surgical anaesthesia has been 2 mg/kg. It is recommended that IV administration be accomplished slowly (over a period of 60 sec). More rapid administration may result in respiratory depression and enhanced pressor response.

Note: The Aneket 100 mg/mL concentration should not be injected IV without proper dilution. It is recommended that the drug be diluted with an equal volume of either sterile water for injection, normal saline or 5% dextrose in water.

IM Route: The initial dose of Aneket administered IM may range from 6.5-13 mg/kg (in terms of Aneket base). A low initial IM dose of 4 mg/kg has been used in diagnostic manoeuvers and procedures not involving intensely painful stimuli. A dose of 10 mg/kg will usually produce 12-25 min of surgical anaesthesia.

Maintenance of General Anaesthesia: Lightening of anaesthesia may be indicated by nystagmus, movements in response to stimulation and vocalization. Anaesthesia is maintained by the administration of additional doses of Aneket by either the IV or IM route.

Each additional dose is from ½ to the full induction dose recommended previously for the route selected for maintenance, regardless of the route used for induction.

The larger the total amount of Aneket administered, the longer will be the time to complete recovery.

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

Aneket as Induction Agent Prior to the Use of Other General Anaesthetics: Induction is accomplished by a full IV or IM dose of Aneket as defined previously. If Aneket has been administered IV and the principal anaesthetic is slow-acting, a 2nd dose of Aneket may be required 5-8 min following the initial dose. If Aneket has been administered IM and the principal anaesthetic is rapid-acting, administration of the principal anaesthetic may be delayed up to 15 min following the injection of Aneket.

Aneket as Supplement to Anaesthetic Agents: Aneket is clinically compatible with the commonly used general and local anaesthetic agents when an adequate respiratory exchange is maintained. The dose of Aneket for use in conjunction with other anaesthetic agents is usually in the same range as the dosage stated previously; however, the use of another anaesthetic agent may allow a reduction in the dose of Aneket.

Management of Patients in Recovery: Following the procedure, the patient should be observed but left undisturbed. This does not preclude the monitoring of vital signs. If during the recovery, the patient shows any indication of emergence delirium, consideration may be given to the use of diazepam (5-10 mg IV in an adult). A hypnotic dose of a thiobarbiturate (50-100 mg IV) may be used to terminate severe emergence reactions. If any 1 of these agents is employed, the patient may experience a longer recovery period.

Hepatic Insufficiency: Dose reductions should be considered in patients with cirrhosis or other types of liver impairment.

Administration: For IV infusion, IV or IM injection.

See also:
What is the most important information I should know about Aneket?

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

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

Aneket 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 Aneket 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 Aneket: 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 Aneket.

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.

Use Aneket as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Aneket 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 Aneket 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 Aneket, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Aneket.

Use: Labeled Indications

Anesthesia: Induction and maintenance of general anesthesia

Off Label Uses

Agitation, severe

Data from a limited number of patients in open-label, prospective clinical trials suggest that Aneket 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 Aneket in this condition. Since there is limited data on the safety and efficacy of Aneket in this setting, the Neurocritical Care Society recommends reservation of Aneket for patients who do not respond to more frequently recommended antiepileptic drug treatment.

See also:
What other drugs will affect Aneket?

Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with Aneket.

Aneket is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.

Aneket may potentiate the neuromuscular-blocking effects of atracurium and tubocurarine including respiratory depression with apnoea.

The use of halogenated anaesthetics concomitantly with Aneket can lengthen the elimination half-life of Aneket and delay recovery from anaesthesia. Concurrent use of Aneket (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 Aneket 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 Aneket may be required with concurrent administration of other anxiolytics, sedatives and hypnotics.

Aneket 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 Aneket.

Concomitant use of antihypertensive agents and Aneket increases the risk of developing hypotension.

When Aneket 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: Aneket is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.

See also:
What are the possible side effects of Aneket?

Cardiovascular

Blood pressure and pulse rate are frequently elevated following administration of Aneket 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 Aneket. Laryngospasms and other forms of airway obstruction have occurred during Aneket anesthesia.

Eye

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

Psychological

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

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