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When considering the use of Spravato at a 56 mg dose, it's important to be aware of several safety concerns:

Blood Pressure Increases: Spravato can cause a temporary rise in blood pressure, typically peaking around 40 minutes after administration and lasting up to four hours. Patients with conditions like aneurysmal vascular disease, arteriovenous malformation, or a history of intracerebral hemorrhage should not use Spravato due to the risk posed by increased blood pressure. Before starting treatment, healthcare providers should assess blood pressure and monitor it closely during and after administration.

Sedation and Dissociation: The medication may lead to sedation (feeling sleepy) and dissociation (feeling disconnected from reality). Patients are required to be monitored by a healthcare professional for at least two hours after each dose to ensure safety. It's advised not to drive or operate machinery until the day after receiving Spravato.

Potential for Abuse and Misuse: Spravato contains esketamine, which has the potential for abuse and dependence. Patients with a history of substance abuse should be carefully evaluated before starting treatment, and all patients should be monitored for signs of misuse.

Suicidal Thoughts and Behaviors: Antidepressants, including Spravato, may increase the risk of suicidal thoughts and behaviors, especially in individuals under 25 years old. Patients should be closely monitored for any worsening of depression or emergence of suicidal thoughts, particularly during the initial treatment period and when doses are adjusted.

Respiratory Depression: There have been reports of respiratory depression (slowed breathing) associated with Spravato use. Patients should be observed for any signs of breathing difficulties during and after administration.

Use in Specific Populations: Spravato is not recommended for use in pregnant or breastfeeding women due to potential risks to the fetus or infant. Its safety and effectiveness have not been established in pediatric patients. Elderly patients may have an increased risk of falls and should be monitored accordingly.

Given these risks, Spravato is only available through a restricted program called the SPRAVATO Risk Evaluation and Mitigation Strategy (REMS). This ensures that the medication is administered in certified healthcare settings where patients can be appropriately monitored.

When using Spravato (esketamine) at a 56 mg dose, it's important to be aware of potential interactions with other substances:

• Central Nervous System (CNS) Depressants: Combining Spravato with medications that depress the CNS, such as benzodiazepines, opioids, or alcohol, can enhance sedation. This may lead to increased drowsiness and impaired motor function. Therefore, it's crucial to monitor for excessive sedation when these substances are used together.

• Psychostimulants: Concurrent use of Spravato with stimulants like amphetamines, Methylphenidate, Modafinil, or Armodafinil can result in elevated blood pressure. Regular monitoring of blood pressure is recommended during such combined use.

• Monoamine Oxidase Inhibitors (MAOIs): Using Spravato alongside MAOIs may also lead to increased blood pressure. Close monitoring of blood pressure is advised when these medications are taken together.

• Nasal Medications: Studies have shown that using nasal decongestants (like Oxymetazoline) or nasal corticosteroids (such as Mometasone) one hour before administering Spravato does not significantly affect its absorption or effectiveness. However, it's advisable to use these nasal medications at least one hour prior to Spravato to ensure optimal efficacy.

• Caffeine: Both Spravato and caffeine can raise blood pressure. If you regularly consume caffeine-containing foods or beverages, it's important to monitor your blood pressure and discuss your caffeine intake with your healthcare provider.

Always inform your healthcare provider about all medications, supplements, and substances you are using to ensure safe and effective treatment with Spravato.