Ketamine Nasal Spray Compounded

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Why is Ketamine Nasal Spray Prescribed?

Esketamine nasal spray is utilized alongside oral antidepressants to manage treatment-resistant depression (TRD), a type of depression that does not improve with standard treatments. It is also prescribed for adults with major depressive disorder (MDD) who experience severe depressive symptoms and suicidal thoughts or actions. Esketamine, a member of the NMDA receptor antagonist class, modifies the activity of certain neurotransmitters in the brain to alleviate depressive symptoms.

Usage Instructions for Esketamine Nasal Spray

Esketamine nasal spray is administered as a liquid directly into the nostrils. For managing treatment-resistant depression, the typical regimen includes spraying twice a week for the first four weeks, followed by once a week during weeks five through eight. For ongoing treatment, it may be used weekly or biweekly as directed by a healthcare provider. It is recommended to avoid eating for at least two hours and drinking liquids for at least 30 minutes before using the nasal spray to ensure optimal absorption.

Special Precautions and Considerations

Before starting the esketamine nasal spray, inform your doctor and pharmacist if you have any allergies to esketamine, ketamine, or other medications, as well as any components of the nasal spray. Provide a comprehensive list of all prescription and over-the-counter medications, vitamins, nutritional supplements, and herbal products you are currently taking or planning to take. Specifically, mention any use of amphetamines, anti-anxiety medications, MAO inhibitors (e.g., phenelzine, procarbazine), other mental illness medications, and substances like modafinil or opioid pain relievers.

If you are using nasal corticosteroids (e.g., ciclesonide, mometasone) or nasal decongestants (e.g., oxymetazoline, phenylephrine), apply them at least one hour before using esketamine nasal spray. Notify your healthcare provider if you have any conditions affecting blood vessels in the brain, chest, stomach, or limbs; arteriovenous malformation; or a history of brain bleeding. Additional information should be disclosed if you have experienced a stroke, heart attack, brain injury, or conditions leading to increased brain pressure.

Esketamine nasal spray may affect fetal development, so inform your doctor if you are pregnant or breastfeeding. If undergoing surgery, including dental procedures, inform your healthcare provider or dentist about your use of esketamine nasal spray.

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Ketamine is not FDA-approved for the treatment of any psychiatric disorder. However, the “S” form of ketamine, which is derived from ketamine and known as Spravato (esketamine), is a Schedule III controlled substance that was approved by FDA in 2019 as a nasal spray for treatment-resistant depression in adults and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior, in conjunction with an oral antidepressant. Because of the potential risks associated with Spravato (esketamine), including sedation, dissociation, and abuse or misuse, its label contains Boxed Warnings, and Spravato is subject to strict safety controls on dispensing and administration under a safety program called a Risk Evaluation and Mitigation Strategy (REMS). The Spravato REMS [1] program requires Spravato (esketamine) to be dispensed and administered in healthcare settings that are certified in the REMS. Spravato (esketamine) cannot be dispensed for use outside the certified healthcare setting. Patients must be monitored inside the healthcare setting after administration for a minimum of two hours until patients are safe to leave.Tags:BUY KETAMIN IN EUROPE, BUY KETAMIN ONLINE, buy ketamine, Buy Ketamine Crystals, Buy ketamine crystals Online, Buy ketamine Nasal spray, buy ketamine online, BUY KETAMINE ONLINE IN EUROPE, buy ketamine powder, buy ketamine powder online, how long does ketamine last, how long does ketamine stay in your system, is ketamine a psychedelic, is ketamine addictive, is ketamine legal, ke, KETAMIN AUSTRALIA FOR SALE, KETAMIN FOR SALE IN EUROPE KETAMINE FOR SALE, KETAMIN FOR SALE USA, KETAMIN NASAL SPRAY FOR SALE, ketamine, ketamine assisted psychotherapy, ketamine buy, ketamine clinic, Ketamine Crystals for Sale, ketamine dosage, ketamine for anxiety, Ketamine for Depression, ketamine for pain, ketamine for sale, ketamine for sale online, KETAMINE FOR SALE ONLINE USA, KETAMINE FOR SALE UK, KETAMINE FOR SALE US, ketamine half life, ketamine horse tranquilizer, ketamine infusion, ketamine infusion for pain, ketamine infusion therapy, ketamine infusions, KETAMINE LIQUID FOR SALE, ketamine nasal spray, ketamine overdose, KETAMINE PILLS, KETAMINE POWDER FOR SALE, ketamine reddit, KETAMINE SPRAVATO, ketamine therapy, ketamine therapy near me, ketamine treatment near me ketamine ptsd, LIQUID KETAMIN FOR SALE, Order ketamine Online, tamine addiction, what is ketamine

Though esketamine is derived from racemic ketamine, they are not the same drug. Animal studies have shown that racemic ketamine can cause lesions in the brains of rodents;[2] the relevance of this finding to humans is unknown. Animal studies with esketamine do not show these brain lesions.[3]

FDA is aware that some pharmacies compound nasal spray formulations of ketamine either alone or in combination with other ingredients, and there have been a concerning number of case reports of adverse events in recent years. Given these reports and the lack of standardized safety measures associated with the use of compounded ketamine nasal sprays, patients may be at risk of serious adverse events and potential misuse and abuse. FDA is issuing this alert due to the increased awareness of adverse events reported, the seriousness of these adverse events, and the likelihood that adverse events related to compounded drug products are under-reported, given that pharmacies that compound drugs under section 503A generally do not report them.

Case Findings and Discussion

FDA searched the FDA Adverse Event Reporting System (FAERS) database and the medical literature from April 2011 through January 2022 and identified five cases, reported between 2016-2021, associated with psychiatric events such as delusion, dissociation, visual hallucination, and panic attack as well as abuse and misuse[b] following the use of compounded ketamine nasal spray. The reported concentrations of compounded ketamine nasal spray ranged from 125 – 200 mg/mL. Frequency of use varied from three sprays three times a day to six sprays eight times a day. The amount of medication administered to the patients with each spray is unknown. In most case reports, the patients self-administered the product at home, and it is unknown whether they were observed or monitored by a healthcare professional.

Because compounded ketamine nasal spray products are not FDA-approved, there is no FDA-approved dosing regimen for these products. There are also no data to support dosing conversion between Spravato (esketamine) nasal spray and compounded ketamine nasal spray. However, although ketamine is not identical to Spravato, ketamine includes both enantiomers of the molecule, including Spravato’s active ingredient, esketamine. Ketamine and Spravato (esketamine) also share a mechanism of action in that both are N-methyl D-aspartate receptor antagonists. Given these similarities, it is plausible that, in addition to the warnings and precautions associated with FDA-approved ketamine, psychiatric events could be induced or worsened with the use of compounded ketamine nasal spray, especially given the fact that FDA is aware that it is being used at different doses and a higher frequency than are currently approved for Spravato (esketamine). The benefit and risk profile for Spravato (esketamine) has been established, as described in the FDA-approved labeling and the approved Spravato REMS program, with elements to assure safe use. However, the benefit and risk profile for compounded ketamine nasal spray has not been evaluated. As such, FDA has concerns about increased potential risk of adverse events, misuse, and abuse associated with compounded ketamine nasal spray given the apparent different doses, higher frequency of use compared to Spravato (esketamine), and at home administration reported to the FAERS database.

Conclusion

There is no FDA-approved ketamine nasal spray product. Compounded drugs are not FDA-approved, which means FDA has not evaluated their safety, effectiveness, or quality before marketing. Therefore, compounded drugs should only be used in patients whose medical needs cannot be met by an FDA-approved drug. The dispensing of compounded ketamine nasal spray for home use when safe and effective dosing for psychiatric indications has not been established may place the patient at risk for serious psychiatric adverse events, misuse, and abuse. Healthcare professionals should be advised that animal studies have shown an association between racemic ketamine and brain lesions, and that the implications of the animal findings to humans are unknown. FDA recommends that healthcare professionals be aware of the potential risks associated with compounded ketamine nasal spray.

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