What is the most important information I should know about Ketamine and Esketamine (Spravato)?

Ketamine and Esketamine can cause serious side effects, including:
Sedation and dissociation. They may cause sleepiness (sedation), fainting, dizziness, spinning sensation, anxiety, or feeling disconnected from yourself, your thoughts, feelings, space and time (dissociation). These side effects almost invariably resolve within two hours after the treatment. To address these possible side effects patients at Manlove Brain + Body Health are monitored for serious side effects for at least 2 hours after taking Ketamine or Esketamine. For your safety, we will decide when you are ready to leave the healthcare setting.

Abuse and misuse. There is a risk for abuse and physical and psychological dependence with Ketamine and Esketamine treatment. During your treatment, the Manlove Brain + Body Health staff will watch for signs of abuse and dependence. It is important that you tell us if you have ever abused or been dependent on alcohol, prescription medicines, or street drugs.

Risk Evaluation and Mitigation Strategy. Because of the risks for sedation, dissociation, and abuse and misuse, Esketamine (Spravato) is only available through a restricted program called the SPRAVATO™ Risk Evaluation and Mitigation Strategy (REMS) Program. SPRAVATO™ can only be administered at healthcare settings such as Manlove Brain + Body Health which are certified in the SPRAVATO™ REMS Program.

Increased risk of suicidal thoughts or actions. Ketamine and Esketamine may cause worsening of depression and suicidal thoughts and behaviors, especially during the first few months of treatment and when the dose is changed. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a higher risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression or a history of suicidal thoughts or actions.

How can I watch for and try to prevent suicidal thoughts and actions?
Pay close attention to any changes, especially sudden changes, in mood, behavior, thoughts, or feelings, or if you develop suicidal thoughts or actions. Call Manlove Brain + Body Health right away if you have any new or sudden changes in mood, behavior, thoughts, or feelings. Keep all follow-up visits with your healthcare provider as scheduled. Feel free to call Manlove Brain + Body Health between visits if needed . . . Call your healthcare provider between visits as needed, especially if you have concerns about symptoms.

Please call Manlove Brain + Body Health right away if you have any of the following symptoms, especially if they are new,
worse, or worry you:
• attempts to commit suicide
• thoughts about suicide or dying
• worsening depression
• other unusual changes in behavior or mood

Do not take Ketamine and Esketamine if you:
• have blood vessel (aneurysmal vascular) disease (including in the brain, chest, abdominal aorta, arms and legs)
• have an abnormal connection between your veins and arteries (arteriovenous malformation)
• have a history of bleeding in the brain
• are allergic to Esketamine or Ketamine

Before you take Ketamine and Esketamine tell your Manlove Brain + Body Health clinician about all of your medical conditions, including
• if you have heart or brain problems, including:
• high blood pressure (hypertension)
•  slow or fast heartbeats that cause shortness of breath, chest pain, lightheadedness, or fainting
• history of heart attack
• history of stroke
• heart valve disease or heart failure
• history of brain injury or any condition where there is increased pressure in the brain
• have liver problems
• have ever had a condition called “psychosis” (see, feel, or hear things that are not there, or believe in things that are not true)
• are pregnant or plan to become pregnant. Ketamine and Esketamine may harm your  baby. You should not take Ketamine and Esketamine
if you are pregnant. Tell your Manlove Brain + Body Health clinician right away if you become pregnant during treatment with Ketamine and
Esketamine If you are able to become pregnant, talk to your healthcare provider about methods to prevent pregnancy during treatment with
Ketamine and Esketamine.
• are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with Ketamine and Esketamine

Tell your healthcare provider about all the medicines that you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Ketamine or Eskatamine with certain medicines may cause side effects. Especially tell your healthcare provider if you take Central Nervous System (CNS) depressants, psychostimulants, or Monoamine oxidase inhibitors (MAOIs) medicines.

How will I take Ketamine and Esketamine?
Ketamine is given intravenously under the supervision of a Certified Nurse Practitioner in the Manlove Brain + Body Health office. You will be monitored closely by the Certified Nurse Practitioner who will decide when you are ready to leave our office. You will need to plan for a caregiver or family member to drive you home after taking Ketamine. If you miss a Ketamine treatment, your healthcare provider may change your dose and treatment schedule. Some people taking Ketamine get nausea and vomiting. You should not eat for at least 2 hours before taking Ketamine and not drink liquids at least 30 minutes before taking Ketamine. Intravenous Ketamine is usually given 3 times per week for 2 weeks followed by a maintenance program.

Esketamine (Spravato) is a nasal spray administrated by yourself, under the supervision of a healthcare provider in the Manlove Brain + Body Health office. Your Clinical Nurse Practitioner will show you how to use the Esketamine (Spravato) nasal spray device. We will tell you how  much Esketamine (Spravato) you will take and when you will take it.During and after each use of the Esketamine (Spravato) nasal spray device, you will be checked by a healthcare provider in our office who will decide when you are ready to leave our office. You will need to plan for a caregiver or family member to drive you home after taking Esketamine (Spravato). If you miss an Esketamine (Spravato) treatment, your healthcare provider may change your dose and treatment schedule. Some people taking Esketamine (Spravato) get nausea and vomiting. You should not eat for at least 2 hours before taking Esketamine (Spravato) and not drink liquids at least 30 minutes before taking Esketamine (Spravato). If you take a nasal corticosteroid or nasal decongestant medicine take these  medicines at least 1 hour before taking Esketamine (Spravato).

What should I avoid while taking Ketamine and Esketamine?
Do not drive, operate machinery, or do anything where you need to be completely alert after taking Ketamine or Esketamine. Do not take part in these activities until the next day following a restful sleep.

What are the possible side effects of Ketamine and Esketamine?
Ketamine or Esketamine may cause serious side effects including:
• Increased blood pressure. Ketamine or Esketamine can cause a temporary increase in your blood pressure that may last for about 4 hours
after taking a dose. Your healthcare provider will check your blood pressure before taking Ketamine or Esketamine and for at least 2 hours
after you take Ketamine or Esketamine. Tell your healthcare provider right away if you get chest pain, shortness of breath, sudden severe
headache, change in vision, or seizures after taking Ketamine or Esketamine.
• Problems with thinking clearly. Tell your healthcare provider if you have problems thinking or remembering.
• Bladder problems. Tell your healthcare provider if you develop trouble urinating, such as a frequent or urgent need to urinate, pain when
urinating, or urinating frequently at night.
• The most common side effects of Ketamine or Esketamine when used along with an antidepressant taken by mouth include: dissociation,
dizziness, nausea, sedation, spinning sensation, reduced sense of touch and sensation, anxiety, lack of energy, increased blood pressure,
vomiting, and feeling drunk