NURS 6630 Week 7 Therapy for Patients With Schizophrenia

NURS 6630 Week 7 Therapy for Patients With Schizophrenia

A Sample Answer For the Assignment: NURS 6630 Week 7 Therapy for Patients With Schizophrenia

Description Of the Psychopharmacological Medication Agent

Cariprazine is a psychopharmacological drug sold under the brand name Vraylar. It is an adult atypical antipsychotic drug of the second generation prescribed to treat schizophrenia and bipolar disorder. Cariprazine acts by altering dopamine and serotonin quantities in the brain, which alleviates symptoms including mania, hallucinations, and disordered thinking. The drug is offered as tablets and is typically ingested once daily.

Cariprazine has been given FDA approval for the management of schizophrenia and adult-onset bipolar disorder. Cariprazine is recommended for schizophrenia as a monotherapy or as an additional medication to lessen relapse frequency (Pinto et al., 2019). In individuals with bipolar I disorder who have responded to initial therapy, cariprazine is recommended for the acute management of manic or mixed episodes and for the maintenance of a calm mood.

Research for Non-FDA Uses

One area of research interest has been the use of cariprazine for the treatment of major depressive disorder (MDD). Several clinical trials have been conducted to evaluate the efficacy and safety of cariprazine as an adjunctive treatment for MDD, with some studies showing promising results. A study found that cariprazine as an adjunctive treatment to an antidepressant was effective in reducing depressive symptoms in patients with MDD who had not responded to prior antidepressant treatment (Pinto et al., 2019).

Another potential non-FDA use of cariprazine is for the treatment of substance use disorders. Preclinical studies have suggested that cariprazine may be effective in reducing drug-seeking behavior and reinstatement of drug use in animal models of addiction. Additionally, a pilot study published in the Journal of Dual Diagnosis in 2018 found that cariprazine may be useful for the treatment of cocaine use disorder in humans.

Drug Classification

Cariprazine is classified as a second-generation atypical antipsychotic medication. This class of drugs is used to treat various psychiatric disorders, including schizophrenia and bipolar disorder, by modulating the levels of dopamine and other neurotransmitters in the brain (Pinto et al., 2019). Second-generation atypical antipsychotics are considered to be a newer class of antipsychotic drugs compared to first-generation antipsychotics, and they have been developed to offer better efficacy and fewer side effects.

Cariprazine is structurally similar to aripiprazole, another atypical antipsychotic medication. Both medications are partial agonists at the dopamine D2 receptor and the serotonin 5-HT1A receptor, which means that they can stimulate or inhibit these receptors depending on the level of activity of the neurotransmitter. This unique pharmacological profile is thought to contribute to the efficacy and tolerability of cariprazine in the treatment of psychiatric disorders.

 Mechanism of Action

Cariprazine’s mechanism of action is complex and involves modulation of multiple neurotransmitter systems in the brain, including dopamine and serotonin. Specifically, cariprazine acts as a partial agonist at dopamine D2 and D3 receptors and a partial agonist at serotonin 5-HT1A receptors, while also acting as an antagonist at serotonin 5-HT2A receptors (Laszlovszky et al., 2021).

The partial agonist activity at dopamine D2 and D3 receptors allows cariprazine to modulate the dopaminergic pathways in the brain, which are known to be involved in the pathophysiology of schizophrenia and bipolar disorder. By acting as a partial agonist, cariprazine can both stimulate and inhibit these receptors, depending on the level of dopamine activity in the brain.

This unique pharmacological profile is thought to contribute to the medication’s ability to improve symptoms such as delusions, hallucinations, and disorganized thinking. In addition to its effects on dopamine, cariprazine also has partial agonist activity at serotonin 5-HT1A receptors, which are involved in the regulation of mood, anxiety, and cognition. By modulating the activity of these receptors, cariprazine may help to improve symptoms of depression and anxiety that are commonly associated with schizophrenia and bipolar disorder.

Pharmacokinetics and Pharmacodynamics

Cariprazine is an orally administered medication that is rapidly absorbed by the body, with peak plasma concentrations occurring within 3-4 hours of ingestion. The bioavailability of cariprazine is estimated to be approximately 52%, which means that about half of the medication reaches systemic circulation following oral administration (Laszlovszky et al., 2021).

Once absorbed, cariprazine is extensively metabolized in the liver by enzymes such as cytochrome P450 3A4 (CYP3A4) and cytochrome P450 2D6 (CYP2D6). The metabolites of cariprazine are primarily eliminated through urine and feces, with approximately 26% of the dose being eliminated in urine and 51% in feces.

Cariprazine acts as an antagonist at serotonin 5-HT2A receptors, which are involved in the regulation of sensory perception, cognition, and mood. By blocking the activity of these receptors, cariprazine may help to reduce the risk of side effects such as hallucinations and agitation that are associated with other antipsychotic medications.

Appropriate Dosing, Administration Route, and any Considerations for Dosing Alterations

The recommended starting dose for cariprazine in the treatment of schizophrenia is 1.5 mg/day, taken orally with or without food. The dose may be increased gradually over several days to a target dose of 4.5 mg/day, based on the patient’s response and tolerability. The maximum recommended dose is 6 mg/day.

For the treatment of bipolar disorder, the recommended starting dose is 1.5 mg/day, taken orally with or without food (Fagiolini et al., 2020). The dose may be increased gradually over several days to a target dose of 3 mg/day, based on the patient’s response and tolerability. The maximum recommended dose is 6 mg/day.

Cariprazine is available in tablet form and should be taken orally once daily, before or after meals. The tablets should be swallowed whole and should not be crushed or chewed (Fagiolini et al., 2020). Cariprazine may interact with other medications that affect the metabolism of the medication, such as CYP3A4 and CYP2D6 inhibitors or inducers. Patients taking these medications may require a dose adjustment of cariprazine to ensure optimal efficacy and tolerability.

Considerations Of Use and Dosing in Specific Specialty Populations

Children and adolescents

Not approved for use in children and adolescents under the age of 18 years old.

Elderly

Elderly patients may be more sensitive to the effects of cariprazine due to changes in metabolism and clearance of the medication (Fagiolini et al., 2020). Therefore, the dose may need to be adjusted in elderly patients to avoid adverse effects such as sedation, orthostatic hypotension, or extrapyramidal symptoms.

Pregnancy and breastfeeding

Cariprazine should only be used during pregnancy or breastfeeding if the potential benefits to the mother outweigh the potential risks to the fetus or infant.

Suicidal behaviors

May increase the risk of suicidal thoughts or behaviors, especially in children and young adults. Patients should be closely monitored for signs of suicidal ideation, especially during the first few months of treatment or after a change in dose.

Half-life

Half-life is the amount of time it takes for half of the initial dose of a drug to be eliminated from the body.  The half-life of a medication is important because it determines the frequency and timing of dosing and can affect the drug’s efficacy and potential for adverse effects (Fagiolini et al., 2020).  The half-life of cariprazine is approximately 2-4 days, meaning it takes 2-4 days for half of the initial dose of cariprazine to be eliminated from the body.

This relatively long half-life suggests that cariprazine may be suitable for once-daily dosing, but it may take longer to reach a steady state and may require a longer time to clear from the body if dosing is discontinued. The half-life of cariprazine should be taken into account when determining appropriate dosing regimens and monitoring for potential adverse effects.

Side effects

Common side effects of cariprazine include:

• Restlessness
• Extrapyramidal symptoms (such as tremors or muscle stiffness)
• Sedation
• Nausea
• Vomiting
• Constipation
• Headache
• Weight gain

Contraindications for use including significant drug to drug interactions

Contraindications for the use of cariprazine include:

• Hypersensitivity to cariprazine or any component of the formulation
• Unstable heart disease
• QTc prolongation
• Severe hepatic impairment
• Severe renal impairment
• Known history of prolonged QT syndrome

Significant drug-to-drug interactions include:

• Strong CYP3A4 inhibitors can increase the concentration of cariprazine in the body, potentially leading to increased side effects (Edinoff et al., 2020).
• Strong CYP3A4 inducers (such as rifampin and phenytoin) can decrease the concentration of cariprazine in the body, potentially reducing its efficacy.

Overdose Considerations

An overdose of cariprazine can be dangerous and potentially life-threatening. Symptoms of an overdose may include severe sedation, seizures, confusion, cardiac arrhythmias, and respiratory depression (Edinoff et al., 2020). In the event of an overdose, immediate medical attention should be sought.

Diagnostics and labs monitoring

• Complete blood count
• Liver function tests
• Electrolyte levels

Comorbidities Considerations

Cardiovascular disease: Cariprazine can cause changes in blood pressure and heart rate, so caution is advised in patients with cardiovascular disease. Blood pressure and heart rate should be monitored regularly during treatment.

Diabetes: Cariprazine can cause changes in blood glucose levels, so caution is advised in patients with diabetes. Blood glucose levels should be monitored regularly during treatment.

Seizure disorder: Cariprazine can lower the seizure threshold, so caution is advised in patients with a history of seizures or epilepsy (Edinoff et al., 2020).

Renal or hepatic impairment: Cariprazine is metabolized in the liver and excreted in the kidneys, so caution is advised in patients with renal or hepatic impairment. Dose adjustments may be necessary.

Substance use disorder: Cariprazine may have potential for abuse or dependence, so caution is advised in patients with a history of substance use disorder.

Pregnancy or breastfeeding: The safety of cariprazine during pregnancy and breastfeeding is not well-established, and the potential risks and benefits should be carefully considered before prescribing to women who are pregnant or breastfeeding.

Legal and Ethical Considerations

One of the most critical legal considerations is obtaining informed consent from patients. Healthcare providers must explain the potential benefits and risks of cariprazine, as well as any alternative treatments that may be available. Informed consent is critical to ensuring that patients understand the implications of taking medication, and that they are fully informed about their treatment options.

Another legal consideration is the off-label use of cariprazine. While cariprazine is approved by the

FDA for the treatment of schizophrenia and bipolar disorder, healthcare providers may also prescribe it for off-label uses (Rancans et al., 2021). Off-label use is legal, but it must be based on clinical judgment and the best available evidence. Providers should also be aware of any potential legal risks associated with off-label use.

Prescribing practices are also essential legal and ethical considerations. Healthcare providers must prescribe cariprazine at the appropriate dosage and monitor patients for side effects or adverse reactions. Providers should also follow established medical guidelines and best practices when prescribing cariprazine or any other medication.

Healthcare providers must protect patient privacy by following all relevant privacy laws and regulations, such as HIPAA. This includes keeping patient medical records confidential and only sharing information with other healthcare providers on a need-to-know basis. Finally, healthcare providers may be held liable for any harm that their patients experience as a result of medication errors or other negligent actions.

Pertinent Patient Education Considerations

Dosing and administration

Patients should be educated on how to take cariprazine, including the appropriate dosage and administration route. Patients should also be advised to take the medication as directed by their healthcare provider and not to adjust their dose or stop taking the medication without consulting their provider.

Side effects and adverse reactions

Patients should be informed about the potential side effects and adverse reactions of cariprazine. They should be advised to contact their healthcare provider immediately if they experience any side effects, such as dizziness, nausea, or constipation.

Drug interactions

Patients should be informed of potential drug interactions with cariprazine, including over-the-counter medications, herbal supplements, and other prescription drugs. Patients should be advised to consult their healthcare provider before taking any new medications (Rancans et al., 2021).

Importance of compliance

Patients should be educated on the importance of compliance with their cariprazine treatment regimen. Skipping doses or discontinuing treatment without consulting their healthcare provider can lead to a worsening of their condition.

Pregnancy and breastfeeding

Patients should be informed about the potential risks of taking cariprazine during pregnancy or while breastfeeding. Patients who are pregnant or breastfeeding should consult their healthcare provider before taking cariprazine.

Suicide risk

Patients should be advised of the potential risk of suicide associated with cariprazine and other medications used to treat mental illness. Patients should be advised to contact their healthcare provider immediately if they experience any suicidal thoughts or behaviors.

References

Correll, C. U., & Schooler, N. R. (2020). Negative symptoms in schizophrenia: a review and clinical guide for recognition, assessment, and treatment. Neuropsychiatric Disease and Treatment, 519-534. Doi: 10.2147/NDT.S225643

Edinoff, A., Ruoff, M. T., Ghaffar, Y. T., Rezayev, A., Jani, D., Kaye, A. M., … & Urits, I. (2020). Cariprazine to treat schizophrenia and bipolar disorder in adults. Psychopharmacology Bulletin, 50(4), 83. https://doi.org/10.1211/pj.2015.20069435

Fagiolini, A., Alcalá, J. Á., Aubel, T., Bienkiewicz, W., Bogren, M. M., Gago, J., Cerveri, G., Colla, M., Sanchez, F. C., Cuomo, A., Helge, F., Iacoponi, E., Karlsson, P., Peddu, P., Pettorruso, M., Pereira, H. J., Schölin, J. S., & Vernaleken, I. B. (2020). Treating schizophrenia with cariprazine: From clinical research to clinical practice. Real world experiences and recommendations from an international panel. Annals of General Psychiatry, 19(1). https://doi.org/10.1186/s12991-020-00305-3

Laszlovszky, I., Barabássy, Á., & Németh, G. (2021). Cariprazine, a broad-spectrum antipsychotic for the treatment of schizophrenia: Pharmacology, efficacy, and safety. Advances in Therapy, 38(7), 3652-3673. https://doi.org/10.1007/s12325-021-01797-5

Pinto, J. V., Saraf, G., Vigo, D., Keramatian, K., Chakrabarty, T., & Yatham, L. N. (2019). Cariprazine in the treatment of bipolar disorder: A systematic review and meta‐analysis. Bipolar Disorders, 22(4), 360-371. https://doi.org/10.1111/bdi.12850

Rancans, E., Dombi, Z. B., Mátrai, P., Barabássy, Á., Sebe, B., Skrivele, I., & Németh, G. (2021). The effectiveness and safety of cariprazine in schizophrenia patients with negative symptoms and insufficient effectiveness of previous antipsychotic therapy: An observational study. International Clinical Psychopharmacology, 36(3), 154-161. https://doi.org/10.1097/yic.0000000000000351

Study Guide for Medication Treatment Schizophrenia Spectrum and Other Psychosis Disorders

Antipsychotic medication has been the common and standard method of treatment patients with Schizophrenia. These medications provide the patients with a therapeutic and safe environment effective in controlling symptoms (Chang et al., 2021). Schizophrenia is a disorder affecting the sensory nerves and also creating a great disturbance in the thinking process.

Both generic and non-generic drugs have been important in the treatment of Schizophrenia and other disorders. These antipsychotic drugs are commonly used because of the wide spectrum of receptor activity, especially in stabilizing dopamine and serotine levels in the brain. Again, they are effective in controlling symptoms. Therefore, the purpose of this write-up is to develop a study guide for an antipsychotic drug.

Drug Description

Paliperidone Palmitate is a drug used in treating Schizophrenia. Its brand name is Invega Sustenna. This drug is approved by the FDA to treat Schizophrenia and other psychosis disorders. The drug is approved to treat the schizoaffective disorder as either adjunctive therapy or monotherapy.

Non-FDA uses

Invega Sustenna belongs to the general class of antipsychotics, and its non-FDA uses include the treatment of depression and treating hallucinations.

• According to Kverno & Rozenberg (2021), Invega Sustenna is used in treating depression despite the reviews showing that it has been given a rating of 3.9 out of 10 in treating depression. Lower doses of Invega Sustenna are advised when a patient is suffering from mild depression.
• Invega Sustenna has been found to reduce hallucinations and help patients better think of themselves (Kverno & Rozenberg, 2021).

According to the Schizophrenia and Related Disorders Alliance of America, approximately 3.5 million people in the United States are diagnosed with schizophrenia (n.d.), and it is one of the leading causes of disability. In practice, patients may present with delusions, hallucinations, disorganized thinking, disorganized or abnormal motor behavior, as well as other negative symptoms that can be disabling for these individuals.

Not only are these symptoms one of the most challenging symptom clusters you will encounter, many are associated with other disorders, such as depression, bipolar disorder, and disorders on the schizophrenia spectrum. As a psychiatric nurse practitioner, you must understand the underlying neurobiology of these symptoms to select appropriate therapies and improve outcomes for patients.
This week, as you examine antipsychotic therapies, you explore the assessment and treatment of patients with psychosis and schizophrenia. You also consider ethical and legal implications of these therapies.

Reference:

Schizophrenia and Related Disorders Alliance of America. (n.d.). About schizophrenia.https://sardaa.org/resources/about-schizophrenia/#:~:text=Quick%20Facts%20About%20Schizophrenia.%20Schizophrenia%20can%20be%20found,is%20one%20of%20the%20leading%20causes%20of%20disability
Learning Objectives
Students will:
• Assess client factors and history to develop personalized therapy plans for patients with insomnia
• Analyze factors that influence pharmacokinetic and pharmacodynamic processes in patients requiring therapy for insomnia
• Assess patient factors and history to develop personalized plans of antipsychotic therapy for patients
• Analyze factors that influence pharmacokinetic and pharmacodynamic processes in patients requiring antipsychotic therapy
• Synthesize knowledge of providing care to patients presenting for antipsychotic therapy
• Analyze ethical and legal implications related to prescribing antipsychotic therapy to patients across the lifespan

Learning Resources

Required Readings (click to expand/reduce)

Freudenreich, O., Goff, D. C., & Henderson, D. C. (2016). Antipsychotic drugs. In T. A. Stern, M. Favo, T. E. Wilens, & J. F. Rosenbaum. (Eds.), Massachusetts General Hospital psychopharmacology and neurotherapeutics (pp. 72–85). Elsevier.

American Psychiatric Association. (2019). Practice guideline for the treatment of patients with schizophrenia. https://www.psychiatry.org/File%20Library/Psychiatrists/Practice/Clinical%20Practice%20Guidelines/APA-Draft-Schizophrenia-Treatment-Guideline.pdf

Clozapine REMS. (2015). Clozapine REMS: The single shared system for clozapine. https://www.clozapinerems.com/CpmgClozapineUI/rems/pdf/resources/Clozapine_REMS_A_Guide_for_Healthcare_Providers.pdf

Funk, M. C., Beach, S. R., Bostwick, J. R., Celano, C. M., Hasnain, M., Pandurangi, A., Khandai, A., Taylor, A., Levenson, J. L., Riba, M., & Kovacs, R. J. (2018). Resource document on QTc prolongation and psychotropic medications. American Psychiatric Association. https://www.psychiatry.org/File%20Library/Psychiatrists/Directories/Library-and-Archive/resource_documents/Resource-Document-2018-QTc-Prolongation-and-Psychotropic-Med.pdf

Kay, S. R., Fiszbein, A., & Opler, L. A. (1987). The Positive and Negative Syndrome Scale (PANSS) for schizophrenia. Schizophrenia Bulletin, 13(2), 261–276. https://doi.org/10.1093/schbul/13.2.261

Levenson, J. C., Kay, D. B., & Buysse, D. J. (2015). The pathophysiology of insomnia. Chest, 147(4), 1179–1192. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4388122/

McClellan, J. & Stock. S. (2013). Practice parameter for the assessment and treatment of children and adolescents with schizophrenia. Journal of the American Academy of Child and Adolescent Psychiatry, 52(9), 976–990. https://www.jaacap.org/article/S0890-8567(09)62600-9/pdf

Naber, D., & Lambert, M. (2009). The CATIE and CUtLASS studies in schizophrenia: Results and implications for clinicians. CNS Drugs, 23(8), 649–659. https://doi.org/10.2165/00023210-200923080-00002

Medication Resources (click to expand/reduce)

U.S. Food & Drug Administration. (n.d.). Drugs@FDA: FDA-approved drugs. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm

Note: To access the following medications, use the Drugs@FDA resource. Type the name of each medication in the keyword search bar. Select the hyperlink related to the medication name you searched. Review the supplements provided and select the package label resource file associated with the medication you searched. If a label is not available, you may need to conduct a general search outside of this resource provided. Be sure to review the label information for each medication as this information will be helpful for your review in preparation for your Assignments.
• amisulpride
• aripiprazole
• asenapine
• brexpiprazole
• cariprazine
• chlorpromazine
• clozapine
• flupenthixol
• fluphenazine
• haloperidol
• iloperidone
• loxapine
• lumateperone • lurasidone
• olanzapine
• paliperidone
• perphenazine
• pimavanserin
• quetiapine
• risperidone
• sulpiride
• thioridazine
• thiothixene
• trifluoperazine
• ziprasidone

Required Media (click to expand/reduce)

Case study: Pakistani woman with delusional thought processes
Note: This case study will serve as the foundation for this week’s Assignment.

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Optional Resources (click to expand/reduce)

Chakos, M., Patel, J. K., Rosenheck, R., Glick, I. D., Hammer, M. B., Tapp, A., Miller, A. L., & Miller, D. D. (2011). Concomitant psychotropic medication use during treatment of schizophrenia patients: Longitudinal results from the CATIE study. Clinical Schizophrenia & Related Psychoses, 5(3), 124–134. https://doi.org/10.3371/CSRP.5.3.2

Fangfang, S., Stock, E. M., Copeland, L. A., Zeber, J. E., Ahmedani, B. K., & Morissette, S. B. (2014). Polypharmacy with antipsychotic drugs in patients with schizophrenia: Trends in multiple health care systems. American Journal of Health-System Pharmacy, 71(9), 728–738. https://doi.org/10.2146/ajhp130471

Lin, L.