New England Ketamine

 

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Rapid Depression and Chronic Pain Relief

We Provide The Most Affordable

Ketamine

Treatments in New England

Proudly Serving Our Veteran Community

 

Ketamine Benefits

Rapid depression relief without the side effects associated with anti-depressants

Rapid depression relief without the side effects associated with anti-depressants

Pronounced anxiety reduction, especially when paired with supplementary therapy

Pronounced anxiety reduction, especially when paired with supplementary therapy

Helps alleviate chronic pain and decreases requirements for pain medications, which are often times mood altering and addictive

Helps alleviate chronic pain and decreases requirements for pain medications, which are often times mood altering and addictive

Decreases alcohol consumption associated with major depressive disorders

Decreases alcohol consumption associated with major depressive disorders

Conditions We Treat

Conventional treatments for depression are often times inadequate. One third of patients are medication resistant, and almost half report having a hard time tolerating the side effect profile of these anti-depressant medications. Now, Depression is the leading cause of disability in the world, emphasizing our need for treatment options with greater efficacy. 

Major Depression

Conventional treatments for depression are often times inadequate. One third of patients are medication resistant, and almost half report having a hard time tolerating the side effect profile of these anti-depressant medications. Now, Depression is the leading cause of disability in the world, emphasizing our need for treatment options with greater efficacy.  The prevalence of Post traumatic stress disorder (PTSD) in the general population is roughly 5%. The incidence jumps to 20% in individuals exposed to military combat, neglect, violence, abuse, and rape. 

Post Traumatic Stress Disorder

The prevalence of Post traumatic stress disorder (PTSD) in the general population is roughly 5%. The incidence jumps to 20% in individuals exposed to military combat, neglect, violence, abuse, and rape.  Migraines are a chronic type of headache that causes moderate to severe pain that is throbbing or pulsing in nature. 

Migraines

Migraines are a chronic type of headache that causes moderate to severe pain that is throbbing or pulsing in nature.  Chronic pain changes your whole life: alters your personality, limits your ability to work, and often times is associated with dependency on addictive substances for relief. Most individuals with chronic pain have co-existing co- morbid depression, making it challenging to treat. Ketamine infusions have shown to reverse some of the negative effects of chronic opioid use, and doesn't have the negative side effects of chronic anti-inflammatory drugs. It is used in the majority of hospitals as THE pain reliever for patients in severe pain on opioid blocking medications. 

Chronic Pain

Chronic pain changes your whole life: alters your personality, limits your ability to work, and often times is associated with dependency on addictive substances for relief. Most individuals with chronic pain have co-existing co- morbid depression, making it challenging to treat. Ketamine infusions have shown to reverse some of the negative effects of chronic opioid use, and doesn’t have the negative side effects of chronic anti-inflammatory drugs. It is used in the majority of hospitals as THE pain reliever for patients in severe pain on opioid blocking medications.  Anxiety is one of the most common mental illnesses in the United States, afflicting 40 million adults. See if ketamine infusion therapy is right for you.

Major Anxiety Disorder

Anxiety is one of the most common mental illnesses in the United States, afflicting 40 million adults. See if ketamine infusion therapy is right for you. Do you have a central pain syndrome that is not responding to oral medications, nerve blocks or a spinal cord stimulator? Ketamine therapy, and lidocaine infusions should be able to help.

NeuroPathic Pain

Do you have a central pain syndrome that is not responding to oral medications, nerve blocks or a spinal cord stimulator? Ketamine therapy, and lidocaine infusions should be able to help.

“The two most important days in your life are the day you are born and the day you find out why.”

We found our “WHY.” We are here to help you get back on track to find yours. Pain, trauma, and depression, derail us from our mission in life. The dark times leave us isolated, confused, and lost. Feeling alone, and disconnected, life seems pretty meaningless. It’s Not. And your existence is proof. Our mission is to get you back to purposeful living. To make your mental health or chronic pain condition manageable enough that you are able to reconnect. To Reconnect with your friends, loved ones, hobbies, and career. To plug you back in to your passion, purpose, and mission.

Healing

Starts Now

New England Ketamine:  depression treatment|pain relief

Our Mission

To provide the residents of New England with affordable, safe, and individualized care, focusing on community members suffering from mental health disorders and chronic pain. 

Get Back to Happy

Ketamine infusion therapy, at low doses, repairs damaged neural pathways in your brain caused by chronic pain and incapacitating mental health conditions.

Our Vision

 New England Ketamine is
an essential community contributor 
setting the standard of care
for healing, health, and wellness.

Our Focus 

Our focus is on helping you heal. We seek to accomplish this through transformational experience, integrative therapeutic techniques, collaborative practice, and our inclusive community. But we need your help. The power to heal is coming from you, we are just helping you harness it. That means we require your active participation. We will work together on your treatment plan, Pre and post infusion huddles, daily mood checks, and infusion scheduling. We will also collaborate on designing your healing space. We want you feeling safe, loved, and at ease during your treatments. If all that sounds overwhelming, no worries, we are happy to take the lead. Working together, we can get you back to where you want to be.

Our Commitment 

We promise to be there for you from day 1, until you no longer need us. We are committed to seeing you through the healing process, and will be there to help you get through the painful struggles. 

We Can Help

If you or a loved one are suffering from severe depression, PTSD, anxiety, or need chronic pain relief, ketamine therapy may succeed where other treatments have failed. 

Ketamine Videos

  • The Experimental Ketamine Cure for Depression| Click for video

  • Ketamine for Treatment-Resistant Depression: Top 10 Medical Innovations 2017| click for Video

  • How A Drug Helps Me Cope With My Kids’ Suicides| click for video

  • Ketamine Booster Infusions for Severe Depression & PTSD| click for video

Dramatic Changes In Mood
Within Hours

Get Back to Feeling Good
We Can Kick Start Your Recovery

Proven Treatment
For Chronic Pain

Ketamine Facts

Ketamine is a synthetic medicine that has primarily been used as an anesthetic agent in humans and animals for over 50 years.

What is Ketamine?

Ketamine is a synthetic medicine that has primarily been used as an anesthetic agent in humans and animals for over 50 years. In low to moderate income countries, surgery can be performed without oxygen, electricity, or experienced anesthesia professionals, using ketamine as the sole anesthetic agent. In the United States, under the care of an experienced Nurse Anesthesiologist, intravenous Ketamine is extremely safe, even in large doses

Is Ketamine safe?

In low to moderate income countries, surgery can be performed without oxygen, electricity, or experienced anesthesia professionals, using ketamine as the sole anesthetic agent. In the United States, under the care of an experienced Nurse Anesthesiologist, intravenous Ketamine is extremely safe, even in large doses 1962 First synthesized 1963 Patented as a human anaesthetic in Belgium 1966 Patented as a human anaesthetic in the United States 1970 Approved for use in anaesthesia by the US Food and Drug Administration 1960s-70s The most widely-used battlefield anaesthetic in the Vietnam War 1970s Use of ketamine in veterinary medicine began 1985 Added to the WHO Essential Medicines List as an intravenous anaesthetic 2000 Research started on the use of ketamine to treat depression-WHO ketamine facts

50 years of ketamine in medicine

1962 First synthesized 1963 Patented as a human anaesthetic in Belgium 1966 Patented as a human anaesthetic in the United States 1970 Approved for use in anaesthesia by the US Food and Drug Administration 1960s-70s The most widely-used battlefield anaesthetic in the Vietnam War 1970s Use of ketamine in veterinary medicine began 1985 Added to the WHO Essential Medicines List as an intravenous anaesthetic 2000 Research started on the use of ketamine to treat depression-WHO ketamine facts "Ketamine is a versatile medicine and possibly the most widely used anaesthetic in the world. It is listed as an essential medicine, meaning that it should be available at all times in adequate amounts for health care needs. It was added to the WHO Model List of Essential Medicines in 1985 and is also on the Model List of Essential Medicines for Children. Ketamine is also effective for relieving pain. In addition, it is the most widely used anaesthetic in veterinary surgery. In recent years, there has been extensive research into the potential use of ketamine as a treatment for depressive disorders and in epilepsy."-World Health Organization

Ketamine and Global Health

“Ketamine is a versatile medicine and possibly the most widely used anaesthetic in the world. It is listed as an essential medicine, meaning that it should be available at all times in adequate amounts for health care needs. It was added to the WHO Model List of Essential Medicines in 1985 and is also on the Model List of Essential Medicines for Children. Ketamine is also effective for relieving pain. In addition, it is the most widely used anaesthetic in veterinary surgery. In recent years, there has been extensive research into the potential use of ketamine as a treatment for depressive disorders and in epilepsy.”-World Health Organization The WHO Expert Committee on Drug Dependence has recommended that ketamine should not be controlled under the international drug control conventions due to its essential role in surgery in low-resource countries and in emergencies

The Importance of Ketamine

The WHO Expert Committee on Drug Dependence has recommended that ketamine should not be controlled under the international drug control conventions due to its essential role in surgery in low-resource countries and in emergencies

Ketamine FAQ

THE

STATS

Suicide

2nd Leading Cause of Death

For Ages 10-34

4th Leading Cause of Death

For Ages 35-54

10th Leading Cause of Death| Overall

47K+ US Suicide Deaths Annually

-10 Leading Causes of Death by Age Group, CDC, United States-2017

Chronic Pain

 20%| U.S. adults who suffer from Chronic Pain

8%| US adults who suffer from high-impact chronic pain—meaning pain that limited at least one major life activity

25 Million| # of Americans suffering daily from chronic pain

National Suicide Prevention Lifeline

If you need immediate help

1-800-273-8255

PTSD

10%

Lifetime PTSD Prevalence in women

3%

Lifetime PTSD Prevalence in men

14%

Iraq  and Afghanistan Veteran PTSD prevalence 

Veteran Suicide Statistics

6000K+

Veteran Suicides Annually

1.5 X

 greater suicide rate for Veterans than for non-Veteran adults

1.8 X

 greater suicide rate for women Veterans than for non-Veteran women

22 Warriors Veteran Suicide Foundation

Immediate Help

1-800-273-8255

  • FDA Clinical Prescribing Information| Ketamine| accessdata.fda.gov

    CIII KETALAR – ketamine hydrochloride injection JHP Pharmaceuticals LLC

    SPECIAL NOTE EMERGENCE REACTIONS HAVE OCCURRED IN APPROXIMATELY 12 PERCENT OF PATIENTS. THE PSYCHOLOGICAL MANIFESTATIONS VARY IN SEVERITY BETWEEN PLEASANT DREAM-LIKE STATES, VIVID IMAGERY, HALLUCINATIONS, AND EMERGENCE DELIRIUM. IN SOME CASES THESE STATES HAVE BEEN ACCOMPANIED BY CONFUSION, EXCITEMENT, AND IRRATIONAL BEHAVIOR WHICH A FEW PATIENTS RECALL AS AN UNPLEASANT EXPERIENCE. THE DURATION ORDINARILY IS NO MORE THAN A FEW HOURS; IN A FEW CASES, HOWEVER, RECURRENCES HAVE TAKEN PLACE UP TO 24 HOURS POSTOPERATIVELY. NO RESIDUAL PSYCHOLOGICAL EFFECTS ARE KNOWN TO HAVE RESULTED FROM USE OF KETALAR. THE INCIDENCE OF THESE EMERGENCE PHENOMENA IS LEAST IN THE ELDERLY (OVER 65 YEARS OF AGE) PATIENT. ALSO, THEY ARE LESS FREQUENT WHEN THE DRUG IS GIVEN INTRAMUSCULARLY AND THE INCIDENCE IS REDUCED AS EXPERIENCE WITH THE DRUG IS GAINED. THE INCIDENCE OF PSYCHOLOGICAL MANIFESTATIONS DURING EMERGENCE, PARTICULARLY DREAM-LIKE OBSERVATIONS AND EMERGENCE DELIRIUM, MAY BE REDUCED BY USING LOWER RECOMMENDED DOSAGES OF KETALAR IN CONJUNCTION WITH INTRAVENOUS DIAZEPAM DURING INDUCTION AND MAINTENANCE OF ANESTHESIA. (See DOSAGE AND ADMINISTRATION Section.) ALSO, THESE REACTIONS MAY BE REDUCED IF VERBAL, TACTILE, AND VISUAL STIMULATION OF THE PATIENT IS MINIMIZED DURING THE RECOVERY PERIOD. THIS DOES NOT PRECLUDE THE MONITORING OF VITAL SIGNS. IN ORDER TO TERMINATE A SEVERE EMERGENCE REACTION, THE USE OF A SMALL HYPNOTIC DOSE OF A SHORT-ACTING OR ULTRA SHORT-ACTING BARBITURATE MAY BE REQUIRED. WHEN KETALAR IS USED ON AN OUTPATIENT BASIS, THE PATIENT SHOULD NOT BE RELEASED UNTIL RECOVERY FROM ANESTHESIA IS COMPLETE AND THEN SHOULD BE ACCOMPANIED BY A RESPONSIBLE ADULT.

    DESCRIPTION Ketalar is a nonbarbiturate anesthetic chemically designated dl 2-(0-chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride. It is formulated as a slightly acid (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 10, 50 or 100 mg ketamine base per milliliter and contains not more than 0.1 mg/mL Phemerol® (benzethonium chloride) added as a preservative. The 10 mg/mL solution has been made isotonic with sodium chloride.

    CLINICAL PHARMACOLOGY Ketalar is a rapid-acting general anesthetic producing an anesthetic state characterized by profound analgesia, normal pharyngeallaryngeal reflexes, normal or slightly enhanced skeletal muscle tone, cardiovascular and respiratory stimulation, and occasionally a transient and minimal respiratory depression. A patent airway is maintained partly by virtue of unimpaired pharyngeal and laryngeal reflexes. (See WARNINGS and PRECAUTIONS Sections.) The biotransformation of Ketalar includes N-dealkylation (metabolite I), hydroxylation of the cyclohexone ring (metabolites III and IV), conjugation with glucuronic acid and dehydration of the hydroxylated metabolites to form the cyclohexene derivative (metabolite II). Following intravenous administration, the ketamine concentration has an initial slope (alpha phase) lasting about 45 minutes with a half-life of 10 to 15 minutes. This first phase corresponds clinically to the anesthetic effect of the drug. The anesthetic action is terminated by a combination of redistribution from the CNS to slower equilibrating peripheral tissues and by hepatic biotransformation to metabolite I. This metabolite is about 1/3 as active as ketamine in reducing halothane requirements (MAC) of the rat. The later half-life of ketamine (beta phase) is 2.5 hours. The anesthetic state produced by Ketalar has been termed “dissociative anesthesia” in that it appears to selectively interrupt association pathways of the brain before producing somatesthetic sensory blockade. It may selectively depress the thalamoneocortical system before significantly obtunding the more ancient cerebral centers and pathways (reticular-activating and limbic systems). 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 (see CONTRAINDICATIONS Section). Ketamine has a wide margin of safety; several instances of unintentional administration of overdoses of Ketalar (up to ten times that usually required) have been followed by prolonged but complete recovery. Ketalar has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients from 105 separate studies. During the course of these studies Ketalar was administered as the sole agent, as induction for other general agents, or to supplement low-potency agents. Reference ID: 3096050 Specific areas of application have included the following: 1. debridement, painful dressings, and skin grafting in burn patients, as well as other superficial surgical procedures. 2. neurodiagnostic procedures such as pneumonencephalograms, ventriculograms, myelograms, and lumbar punctures. See also Precaution concerning increased intracranial pressure. 3. diagnostic and operative procedures of the eye, ear, nose, and mouth, including dental extractions. 4. diagnostic and operative procedures of the pharynx, larynx, or bronchial tree. NOTE: Muscle relaxants, with proper attention to respiration, may be required (see PRECAUTIONS Section). 5. sigmoidoscopy and minor surgery of the anus and rectum, and circumcision. 6. extraperitoneal procedures used in gynecology such as dilatation and curettage. 7. orthopedic procedures such as closed reductions, manipulations, femoral pinning, amputations, and biopsies. 8. as an anesthetic in poor-risk patients with depression of vital functions. 9. in procedures where the intramuscular route of administration is preferred. 10. in cardiac catheterization procedures. In these studies, the anesthesia was rated either “excellent” or “good” by the anesthesiologist and the surgeon at 90% and 93%, respectively; rated “fair” at 6% and 4%, respectively; and rated “poor” at 4% and 3%, respectively. In a second method of evaluation, the anesthesia was rated “adequate” in at least 90%, and “inadequate” in 10% or less of the procedures.

    INDICATIONS AND USAGE Ketalar is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketalar is best suited for short procedures but it can be used, with additional doses, for longer procedures. Ketalar is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents. Ketalar is indicated to supplement low-potency agents, such as nitrous oxide. Specific areas of application are described in the

    CLINICAL PHARMACOLOGY Section.

    CONTRAINDICATIONS Ketamine hydrochloride is contraindicated in those in whom a significant elevation of blood pressure would constitute a serious hazard and in those who have shown hypersensitivity to the drug.

    WARNINGS Cardiac function should be continually monitored during the procedure in patients found to have hypertension or cardiac decompensation. Postoperative confusional states may occur during the recovery period. (See Special Note.) Respiratory depression may occur with overdosage or too rapid a rate of administration of Ketalar, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.

    PRECAUTIONS General Ketalar should be used by or under the direction of physicians experienced in administering general anesthetics and in maintenance of an airway and in the control of respiration. Because pharyngeal and laryngeal reflexes are usually active, Ketalar should not be used alone in surgery or diagnostic procedures of the pharynx, larynx, or bronchial tree. Mechanical stimulation of the pharynx should be avoided, whenever possible, if Ketalar is used alone. Muscle relaxants, with proper attention to respiration, may be required in both of these instances. Resuscitative equipment should be ready for use. The incidence of emergence reactions may be reduced if verbal and tactile stimulation of the patient is minimized during the recovery period. This does not preclude the monitoring of vital signs (see Special Note). The intravenous dose should be administered over a period of 60 seconds. More rapid administration may result in respiratory depression or apnea and enhanced pressor response. In surgical procedures involving visceral pain pathways, Ketalar should be supplemented with an agent which obtunds visceral pain. Use with caution in the chronic alcoholic and the acutely alcohol-intoxicated patient. An increase in cerebrospinal fluid pressure has been reported following administration of ketamine hydrochloride. Use with extreme caution in patients with preanesthetic elevated cerebrospinal fluid pressure. Information for Patients As appropriate, especially in cases where early discharge is possible, the duration of Ketalar and other drugs employed during the conduct of anesthesia should be considered. The patients should be cautioned that driving an automobile, operating hazardous machinery or engaging in hazardous activities should not be undertaken for 24 hours or more (depending upon the dosage of Ketalar and consideration of other drugs employed) after anesthesia. Drug Interactions Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with Ketalar. Ketalar is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is Reference ID: 3096050 maintained. Usage in Pregnancy Since the safe use in pregnancy, including obstetrics (either vaginal or abdominal delivery), has not been established, such use is not recommended (see ANIMAL PHARMACOLOGY AND TOXICOLOGY, Reproduction). Geriatric Use Clinical studies of ketamine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. Pediatric Use Safety and effectiveness in pediatric patients below the age of 16 have not been established.

    ADVERSE REACTIONS Cardiovascular: Blood pressure and pulse rate are frequently elevated following administration of Ketalar 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 Ketalar. Laryngospasms and other forms of airway obstruction have occurred during Ketalar anesthesia. Eye: Diplopia and nystagmus have been noted following Ketalar 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 ketamine use or abuse. Psychological: (See Special Note.) Neurological: In some patients, enhanced skeletal muscle tone may be manifested by tonic and clonic movements sometimes resembling seizures (see DOSAGE AND ADMINISTRATION Section). 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 (see DOSAGE AND ADMINISTRATION Section). 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 your 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.

    OVERDOSAGE Respiratory depression may occur with overdosage or too rapid a rate of administration of Ketalar, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.

    DOSAGE AND ADMINISTRATION Note: Barbiturates and Ketalar, being chemically incompatible because of precipitate formation, should not be injected from the same syringe. If the Ketalar dose is augmented with diazepam, the two drugs must be given separately. Do not mix Ketalar 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. Preoperative Preparations: 1. While vomiting has been reported following Ketalar administration, some airway protection may be afforded because of active laryngeal-pharyngeal reflexes. However, since aspiration may occur with Ketalar and since protective reflexes may also be diminished by supplementary anesthetics and muscle relaxants, the possibility of aspiration must be considered. Ketalar is recommended for use in the patient whose stomach is not empty when, in the judgment of the practitioner, the Reference ID: 3096050 benefits of the drug outweigh the possible risks. 2. 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 Ketalar 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. Dosage: As with other general anesthetic agents, the individual response to Ketalar 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. Induction: Intravenous Route: The initial dose of Ketalar 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 ketamine 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 Ketalar 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 Ketalar be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response. Intramuscular Route: The initial dose of Ketalar 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 Ketalar administered, the longer will be the time to complete recovery. Adult patients induced with Ketalar augmented with intravenous diazepam may be maintained on Ketalar 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. Dilution: To prepare a dilute solution containing 1 mg of ketamine 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 ketamine per mL. The fluid requirements of the patient and duration of anesthesia must be considered when selecting the appropriate dilution of Ketalar. Reference ID: 3096050 If fluid restriction is required, Ketalar can be added to a 250 mL infusion as described above to provide a Ketalar concentration of 2 mg/mL. Ketalar 10 mg/mL vials are not recommended for dilution. Supplementary Agents: Ketalar 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 Ketalar supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents such as nitrous oxide and oxygen. HOW SUPPLIED Ketalar is supplied as the hydrochloride in concentrations equivalent to ketamine base. NDC 42023-113-10 — Each 20-mL multi-dose vial contains 10 mg/mL. Supplied in cartons of 10. NDC 42023-114-10 — Each 10-mL multi-dose vial contains 50 mg/mL. Supplied in cartons of 10. NDC 42023-115-10 — Each 5-mL multi-dose vial contains 100 mg/mL. Supplied in cartons of 10. Store at 20° to 25°C (68° to 77°F). (See USP controlled room temperature.) Protect from light. Rx only.

    ANIMAL PHARMACOLOGY AND TOXICOLOGY

    Toxicity: The acute toxicity of Ketalar has been studied in several species. In mature mice and rats, the intraperitoneal LD50 values are approximately 100 times the average human intravenous dose and approximately 20 times the average human intramuscular dose. A slightly higher acute toxicity observed in neonatal rats was not sufficiently elevated to suggest an increased hazard when used in pediatric patients. Daily intravenous injections in rats of five times the average human intravenous dose and intramuscular injections in dogs at four times the average human intramuscular dose demonstrated excellent tolerance for as long as 6 weeks. Similarly, twice weekly anesthetic sessions of one, three, or six hours’ duration in monkeys over a four- to six-week period were well tolerated.

    Interaction with Other Drugs Commonly Used for Preanesthetic Medication: Large doses (three or more times the equivalent effective human dose) of morphine, meperidine, and atropine increased the depth and prolonged the duration of anesthesia produced by a standard anesthetizing dose of Ketalar in Rhesus monkeys. The prolonged duration was not of sufficient magnitude to contraindicate the use of these drugs for preanesthetic medication in human clinical trials.

    Blood Pressure: Blood pressure responses to Ketalar vary with the laboratory species and experimental conditions. Blood pressure is increased in normotensive and renal hypertensive rats with and without adrenalectomy and under pentobarbital anesthesia. Intravenous Ketalar produces a fall in arterial blood pressure in the Rhesus monkey and a rise in arterial blood pressure in the dog. In this respect the dog mimics the cardiovascular effect observed in man. The pressor response to Ketalar injected into intact, unanesthetized dogs is accompanied by a tachycardia, rise in cardiac output and a fall in total peripheral resistance. It causes a fall in perfusion pressure following a large dose injected into an artificially perfused vascular bed (dog hindquarters), and it has little or no potentiating effect upon vasoconstriction responses of epinephrine or norepinephrine. The pressor response to Ketalar is reduced or blocked by chlorpromazine (central depressant and peripheral α-adrenergic blockade), by β-adrenergic blockade, and by ganglionic blockade. The tachycardia and increase in myocardial contractile force seen in intact animals does not appear in isolated hearts (Langendorff) at a concentration of 0.1 mg of Ketalar or in Starling dog heart-lung preparations at a Ketalar concentration of 50 mg/kg of HLP. These observations support the hypothesis that the hypertension produced by Ketalar is due to selective activation of central cardiac stimulating mechanisms leading to an increase in cardiac output. The dog myocardium is not sensitized to epinephrine and Ketalar appears to have a weak antiarrhythmic activity. Metabolic Disposition: Ketalar is rapidly absorbed following parenteral administration. Animal experiments indicated that Ketalar was rapidly distributed into body tissues, with relatively high concentrations appearing in body fat, liver, lung, and brain; lower concentrations were found in the heart, skeletal muscle, and blood plasma. Placental transfer of the drug was found to occur in pregnant dogs and monkeys. No significant degree of binding to serum albumin was found with Ketalar. Balance studies in rats, dogs, and monkeys resulted in the recovery of 85% to 95% of the dose in the urine, mainly in the form of degradation products. Small amounts of drug were also excreted in the bile and feces. Balance studies with tritium-labeled Ketalar in human subjects (1 mg/lb given intravenously) resulted in the mean recovery of 91% of the dose in the urine and 3% in the feces. Peak plasma levels averaged about 0.75 µg/mL, and CSF levels were about 0.2 µg/mL, 1 hour after dosing. Ketalar undergoes N-demethylation and hydroxylation of the cyclohexanone ring, with the formation of water-soluble conjugates which are excreted in the urine. Further oxidation also occurs with the formation of a cyclohexanone derivative. The unconjugated Ndemethylated metabolite was found to be less than one-sixth as potent as Ketalar. The unconjugated demethyl cyclohexanone derivative was found to be less than one-tenth as potent as Ketalar. Repeated doses of Ketalar administered to animals did not produce any detectable increase in microsomal enzyme activity. Reference ID: 3096050 Reproduction: Male and female rats, when given five times the average human intravenous dose of Ketalar for three consecutive days about one week before mating, had a reproductive performance equivalent to that of saline-injected controls. When given to pregnant rats and rabbits intramuscularly at twice the average human intramuscular dose during the respective periods of organogenesis, the litter characteristics were equivalent to those of saline-injected controls. A small group of rabbits was given a single large dose (six times the average human dose) of Ketalar on Day 6 of pregnancy to simulate the effect of an excessive clinical dose around the period of nidation. The outcome of pregnancy was equivalent in control and treated groups. To determine the effect of Ketalar on the perinatal and postnatal period, pregnant rats were given twice the average human intramuscular dose during Days 18 to 21 of pregnancy. Litter characteristics at birth and through the weaning period were equivalent to those of the control animals. There was a slight increase in incidence of delayed parturition by one day in treated dams of this group. Three groups each of mated beagle bitches were given 2.5 times the average human intramuscular dose twice weekly for the three weeks of the first, second, and third trimesters of pregnancy, respectively, without the development of adverse effects in the pups.

    Prescribing Information as of March 2012. Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 3000442C Reference ID: 3096050

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