Important Safety Information

Important safety information about Ketamine Treatment

Elevate Ketamine connects individuals with licensed clinicians who are skilled in diagnosing and treating anxiety, depression, and other mental health conditions. If a licensed clinician determines that ketamine is a suitable treatment after a clinical evaluation, they may prescribe ketamine tablets, compounded by pharmacies according to Section 503A of the federal Food, Drug, and Cosmetic Act (FDCA). Medications compounded under Section 503A do not require FDA approval, meaning the FDA has not confirmed the safety and effectiveness of the compounded ketamine for treating anxiety, depression, or other mental health conditions. Nonetheless, scientific literature supports the use of ketamine for these purposes as noted below.

• Depression
  • Harvard Gazette
  • Springer Link
• PTSD
  • Psychology Today
• Anxiety
  • ADAA

Ketamine is classified as a Schedule III controlled substance. Other ketamine-containing drugs, which must meet FDA approval requirements, have been approved by the FDA as intravenous or intramuscular injection solutions for the induction and maintenance of general anesthesia. However, these drugs have not been FDA-approved for anxiety, depression, or other mental health conditions, nor have they been approved in tablet form. The approved label is available here.

Ketamine can cause serious side effects, including but not limited to: sedation; dissociation; psychiatric events or worsening of psychiatric disorders, particularly in individuals with schizophrenia, severe personality disorders, or other serious mental conditions; dependence, abuse, and misuse; anxiety; increased blood pressure or heart rate; respiratory depression; lower urinary tract and bladder symptoms, such as frequent urination, urinary incontinence, painful urination, blood in the urine, or reduced bladder size; altered sense of time; dry mouth; elevated intraocular or intracranial pressure; loss of appetite; confusion; nausea/vomiting; blurred vision; and slurred speech.

The FDA has warned that administering compounded ketamine at home may carry additional risks due to the absence of an onsite healthcare provider to monitor for adverse reactions, such as sedation and dissociation.

Elevate Ketamine’s protocols and guidelines are designed to reduce the likelihood of experiencing these side effects or other adverse reactions, and should be followed meticulously. Ketamine should only be used as prescribed by the treating clinician.

Do not begin ketamine treatment if any of the following conditions apply to you:

• Allergy to ketamine
• Symptoms of psychosis or mania
• Uncontrolled high blood pressure
• Congestive heart failure (CHF) or other serious heart conditions
• Severe respiratory problems
• History of elevated intraocular or intracranial pressure
• History of hyperthyroidism
• Other serious medical illnesses
• Currently pregnant, nursing, or attempting to conceive

Ketamine can cause moderate psychological dependency in some individuals.

In rare instances, frequent and heavy use of ketamine has been linked to increased urination frequency, urinary incontinence, painful urination, blood in the urine, and reduced bladder size.

Ketamine may exacerbate issues in individuals with schizophrenia, severe personality disorders, or other serious mental health conditions. Those with a personal or family history of psychosis should exercise caution when using any psychoactive substance, including ketamine, and should discuss potential risks with their clinician before starting treatment.

The dissociative effects of ketamine may increase patient vulnerability and the risk of accidents.

To ensure safety and promote positive outcomes, adhere to these ketamine treatment guidelines:

• Avoid operating any vehicles (e.g., car, motorcycle, bicycle) or heavy machinery after treatment until you’ve had a full night’s sleep.
• Do not take benzodiazepines or stimulants for 24 hours before your treatment.
• Continue taking your antihypertensive medication as prescribed.
• Do not take ketamine while hungover or with alcoholic beverages.
• Avoid consuming solid foods within 3 hours before treatment and liquids within 1 hour before treatment.
• Always have a peer treatment monitor physically present during ketamine treatment.