Psychotropic Medications and Clinical Practice Adults Training for Clinicians Daniel Castellanos, MD...

Psychotropic Medications and Clinical Practice

AdultsTraining for Clinicians

Daniel Castellanos, MDMedical Director, South Florida Behavioral Health Network

Psychotropic Medications

Training

Castellanos Psychotropic Meds Training 2015

Disclosures

Assistant Dean for Graduate Medical EducationFounding Chair, Department of Psychiatry & Behavioral Health,

Professor, Psychiatry & Behavioral Health and PediatricsHerbert Wertheim College of Medicine, Florida International University

&Consultant, Florida Medicaid Drug Therapy

Management Program for Behavioral HealthUniversity of South Florida/

State of Florida Agency for Healthcare Administration

No relevant financial disclosures

This training about psychotropic medications was developed for consumers to help them make informed decisions and assist other consumers who are prescribed these medications.

This training reviews expectations for the safe and effective use of psychotropic medications in the State of Florida.

Disclaimer The author has used reasonable care and skill in compiling the content of this training. However, he accepts no responsibility or liability for any inaccuracy or errors and omissions, or for any damage or injury to persons or property arising out of the accessing or use of any of the materials contained in this presentation and material accessed from it. Individual prescribers are responsible for their prescribing practices. Specific questions about medications should be consulted with the prescriber.

Introduction


Recognize common mental health disorders in adults

Identify the names and indications for use of commonly prescribed psychotropic medications

Recognize how psychotropic medications are used

Recognize common psychotropic medication side effects

Identify your responsibilities in the treatment process

Identify what to do if you have concerns about the psychotropic medications prescribed to consumers whose care you are involved with

Goals & Objectives


Is Off Label prescribing of psychotropic medications inappropriate?

What is “Off Label” prescribing?:Use of a medication for a condition not approved in the product labeling by the FDA


Off Label

Prescribing

The FDA observes that accepted medical practice includes medication use that is not reflected in approved medication labeling

Many psychotropic medications that are not FDA approved for a specific use can be precribed “off label” to appropriately manage different and difficult problems


Off Label

Prescribing

When the benefits of treatment outweigh the risks, psychotropic medications may be prescribed. Without treatment, these individuals could suffer serious or dangerous consequences

Achieving the appropriate balance between clinical effective use and the known risks and side effects associated with these treatments requires individualized medical decision making


Mental Health Disorders


What makes a mental health problem

clinical (need for treatment)?

ImpairmentSeverity


Psychotropic Medications Training 2015

Serious Mental Illness - Adults


In 2011, an estimated 45.6 million adults aged 18 or older in the United States had a mental illness in the past year

This represents 19.6 percent of all adults in this country

These estimates were stable between 2008 (44.0 million, 19.6 percent) and 2011

Overall, only about half of those affected receive treatment

Miami-Dade: 9.1% of the population SMI/SPMI

Mental Health Disorders - Adults


ANY Mental Illness - Adults


Serious Mental Illness - Adults


Substance Use Disorders in past year 2013


Co-Occurring Substance Use Disorder & Mental Issues 2013


Adults lifetime

prevalence

Source: Kessler, et al, National Comorbidity Survey, 2005

Any substance

use disorder14.6%

Any anxiety disorder

28.8%Major

depression 16.6%

ADHD8.1%

PTSD6.8%

Bipolar Disord

er3.9%OCD

1.6%


Mental health matters at every stage of life and requires an integrated continuum of services ranging from prevention to recovery.

Mental health can be improved: With earlier identification and intervention With improved access to services at the

right time By establishing best practices and

improving standards of care By coordinating mental health care across

school, medical and community environments

Treatment


The Treatment Plan is a tool that helps coordinate, monitor and guide treatment interventions.

The Treatment Plan: Should be developed based on the best

available evidence Involves a continuous process that is

updated on a regular basis and as needed Defines target problems that will be the

focus of treatment Defines the plan to monitor the child,

short and long term

Treatment Plan




Psychotropic medications (sometimes called psychotherapeutic medications) are used to treat emotional and behavioral health symptoms and psychiatric disorders

They affect mood, thoughts, behaviors, and how a person processes information and perceives his or

her surroundings

What are Psychotropic Medications?


The classes of psychotropic medications to be reviewed are:

Stimulants and Other Medications Used to Treat ADHD

AntidepressantsAntipsychoticsMood stabilizersAnxiolyticsSedative/Hypnotics/Sleep MedicationsMiscellaneous:

√Antihistamine Medications√Medications used to Treat Side Effects of Antipsychotics

Remember: Not all medications your consumer is taking may be covered here.

Names & Uses of Commonly Prescribed Psychotropic Medications


Medication Metabolism

Factors that affect the metabolism of medications may include the sex and age of an individual.

Drug metabolism is the body's processing and excreting of medications.


Medication Metabolism

Many people who take prescription drugs should avoid eating certain foods. For ex, grapefruit, which can inhibit metabolism of certain medicines.

Doctors should carefully look at a patient's other medications before prescribing drugs that commonly interact.




The classes of psychotropic medications to be reviewed are:

Stimulants and Other Medications Used to Treat ADHD

AntidepressantsAntipsychoticsMood stabilizersAnxiolyticsMiscellaneous - Antihistamine Medications

Remember: Not all medications your child is taking may be covered here. It is important to talk with the doctor to learn about each medication.



Stimulants & Other Medications

Used to Treat ADHD

Stimulants & Other Medications Used to

Treat ADHD

Psychotropic Medications Training


Stimulants and other medications are commonly used to treat Attention-Deficit/Hyperactivity Disorder (ADHD)

Symptoms of ADHD interfere with functioning at school, work and in daily living and may include:

Short attention span Inability to stay still Being impulsive

Medications Used to Treat ADHD


Groups: Stimulants:

Usually first line/choice meds Controlled substances Amphetamine basedMethylphenidate

Non-stimulant medications:NOT controlled substancesAtomoxetine Clonidine, clonidine ER & guanfacine, guanfacine ER

Others (typically off label)



What does it mean that stimulants are controlled substances by DEA (Schedule II)?: One prescription supply only (usually one month)

No refills Cannot be called in or faxed to the pharmacy

(Paper prescription is needed) Potential for abuse



Examples of stimulants (DEA Schedule II controlled substances):

Mixed Amphetamine salts: Adderall®, Adderall XR®

Methylphenidate: Ritalin®, Daytrana® Patch

Methylphenidate ER: Concerta®, Metadate CD®, Ritalin LA®

Quillivant XR®

Dextroamphetamine: Dexedrine

Dexmethylphenidate: Focalin®, Focalin XR®

Lisdexamphetamine: Vyvanse®



FDA Max FDA Approved for ADHD

Generic Name Brand Name® per day Children & Adol Adults

Mixed Amphetamine salts Adderall 40 mg Yes No

Mixed Amphetamine salts XR Adderall XR 30 mg Yes Yes

Clonidine Catapres * 0.4 mg No No

Methylphenidate Daytrana Patch 30 mg Yes No

Methylphenidate ER

ConcertaMetadate CD

Ritalin LAQuillivant XR

72 mg60 mg60 mg60 mg

Yes Yes

Dextroamphetamine Dexedrine 40 mg Yes No

Dexmethylphenidate Focalin 20 mg Yes No

Dexmethylphenidate XR Focalin XR 30 mg Yes Yes

Guanfacine ER Intuniv * 4 mg Yes No

Clonidine ER Kapvay * 0.4 mg Yes No

Methylphenidate Ritalin 60 mg Yes No

Atomoxetine Strattera * 100 mg Yes Yes

Guanfacine Tenex * 4 mg No No

Lisdexamphetamine Vyvanse 70 mg Yes Yes

Bupropion Wellbutrin SR/XL* 300 mg No No

Stimulants & Other Medications Used to Treat ADHD


Stimulants








Methylphenidate ER

ConcertaMetadate CD



Yes Yes









Lisdexamphetamine Vyvanse 70 mg Yes YesBupropion Wellbutrin SR/XL* 300 mg No No









Methylphenidate ER

ConcertaMetadate CD



Yes Yes









Lisdexamphetamine Vyvanse 70 mg Yes Yes

Bupropion Wellbutrin SR/XL* 300 mg No No









Methylphenidate ER

ConcertaMetadate CD



Yes Yes






Methylphenidate Ritalin, Methylin 60 mg Yes No



Lisdexamphetamine Vyvanse 70 mg Yes YesBupropion Wellbutrin SR/XL* 300 mg No No



Decreased appetite Stomachaches Headaches Trouble falling asleep Irritability Higher blood pressure and heart rate Jitteriness Being “too” quiet Tics Problems with growing

Stimulants Side Effects


Rare, Unexpected, Serious

Psychosis/Mania Cardiovascular Risks (May include sudden cardiac

death, dizziness, chest pain, stroke and arrhythmias in persons with serious pre-existing heart problems)

Skin rashes Dependence

Stimulants Side Effects II


Nonstimulants:Atomoxetine (Strattera®) - Side Effects:

Stomach aches Increased liver enzymes Suicidal behaviors

Clonidine, clonidine ER/Kapvay® & guanfacine, guanfacine ER/Intuniv® - Side Effects: Tiredness Sedation Headaches Stomach aches Lowering of blood pressure

Medications Used to Treat ADHD Side Effects


Medications Used to Treat ADHD Duration of Effect


Time (hours) 0 5 10

0

15

20

Mean

pla

sma l

eve

ls (

ng

/mL

)Absorption & Duration

5

10

MethylphenidateConcerta®Adderall XR®Vyvanse®

Effective concentration


Concerta


Antidepressants

Antidepressants



About one in 10 Americans take antidepressants

Roughly the third most common prescription medication in US

Antidepressants are used in consumers to treat:Depressive disordersAnxiety disordersObsessive-Compulsive Disorder (OCD)other conditions.

Antidepressants


Antidepressant Medications

In 2013 two new antidepressants approved by the FDA for the treatment of major depressive disorder:

Vortioxetine (Brintellix®)

Levomilnacipran CR (Fetzima®)


Generic Name Brand Name®FDA Max

per dayFDA Approved for Major Depression

Vortioxetine Brintellix 20 mg Adults

Citalopram Celexa 60 mg Adults

Duloxetine Cymbalta 60 mg Adults

Velanfaxine Effexor 225 mg Adults

Venlafaxine XR Effexor XR 225 mg Adults

Selegine Emsam patch 12 mg Adults

Levomilnacipran CR Fetzima 120 mg Adults

Escitalopram Lexapro 30 mgChildren & Adol (12-17);

Adults

Fluvoxamine Luvox 300 mg No

Fluvoxamine CR Luvox CR 300 mg No

Paroxetine Paxil, Pexeva 50 mg Adults

Paroxetine CR Paxil CR 62.5 mg Adults

Desvenlafaxine Pristiq 400 mg Adults

Fluoxetine Prozac 60 mgChildren & Adol (8-17);

Adults

Mirtazapine Remeron 45 mg Adults

Fluoxetine Serafem 80 mg No

Doxepin Silenor 6 mg No

Vilazodone Viibryd 40 mg Adults

Bupropion Wellbutrin 450 mg Adults

Bupropion SR/XL Wellbutrin SR/XL; Aplenzin 400 mg(SR) /

450(XL)Adults

Sertraline Zoloft 200 mgs Adults

Antidepressants - Newer


Generic Name Brand Name®FDA Max

per dayFDA Approved for Major Depression

Clomipramine Anafranil200 mg (children/adol)

250 mg (adults)No

Doxepin Sinequan 300 mg Adults

Trazodone Desyrel; Oleptro* 300 mg Adults

Amitryptiline Elavil 300 mg Adults

Nortryptiline Pamelor 200 mg Adults

Imipramine Tofranil 300 mg Adults

Antidepressants - Older

*Extended release version Castellanos Psychotropic Meds Training 2015

Antidepressant medications can be effective in the treatment of other disorders.

In adults certain antidepressants are FDA approved for the treatment of:Bulimia NervosaGeneralized Anxiety DisorderObsessive Compulsive Disorder (OCD)Panic DisorderPremenstrual Dysphoric Disorder (PMDD)Posttraumatic Stress Disorder (PTSD)Social Anxiety Disorder (FKA Social Phobia)

Antidepressants & Other Disorders


Generic Name Brand Name®Bulimia Nervosa

Generalized Anxiety Disorder

Obsessive Compulsiv

eDisorder

Panic Disorder

Premenstrual Dysphoric

DisorderPTSD

Social Anxiety Disorder

Vortioxetine Brintellix

Citalopram Celexa

Duloxetine Cymbalta

Velanfaxine Effexor

Venlafaxine XR Effexor XR

Selegine Emsam patch

Fetzima Levomilnacipran CR

Escitalopram Lexapro

Fluvoxamine Luvox

Fluvoxamine CR Luvox CR

Paroxetine Paxil, Pexeva

Paroxetine CR Paxil CR

Desvenlafaxine Pristiq

Fluoxetine Prozac

Mirtazapine Remeron

Fluoxetine Serafem

Doxepin Silenor

Vilazodone Viibryd

Bupropion Wellbutrin

Bupropion SR/XL Wellbutrin SR/XL

Sertraline Zoloft Psychotropic Medications Training 2015

Antidepressants – Newer- FDA Indications Adults

Headache Nausea Upset stomach Trouble sleeping Jitteriness Dry mouth Easily bruising

Antidepressants Side Effects


Rare, Unexpected, Serious

Low blood sodium Allergic reactions Seizures (bupropion/Wellbutrin) Mania

Antidepressants Side Effects


Antidepressants


SSRIs – FDA Category C pregnancy precaution: no adequate and well-controlled studies in humans to determine the effect of the SSRI on the fetus

Research findings on the effects of antidepressants on the growing baby are mixed and inconclusive

Even though most risks found by researchers have been low, the potential risk of a rare heart and lung condition known as persistent pulmonary hypertension of the newborn (PPHN) has been identified

Antidepressants should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus

Antidepressants & Pregnancy


How Long Should Antidepressants be Taken?


Antipsychotics

Antipsychotics



These medications may improve:Psychotic symptoms (eg, hallucinations, delusions, impaired

reality, disorganized thinking, etc) Bipolar mood changes, such as manic episodes; bipolar

depression less soDepression, as an adjunct to antidepressantsIrritability, associated with autism spectrum disorderAgitation or aggression

Antipsychotics


Antipsychotic medications are used to treat schizophrenia and other psychotic disorders and certain mood disorders

These medications may improve psychotic symptoms including hallucinations, delusions, impaired reality and disorganized thinking

Antipsychotics also help stabilize mood, such as manic episodes

Antipsychotic medications are sometimes referred to as neuroleptics or neuroleptic medications

Antipsychotics


These medications may improve:Psychotic symptoms (eg, hallucinations, delusions, impaired

reality, disorganized thinking, etc) Bipolar mood changes, such as manic episodes; bipolar

depression less soDepression, as an adjunct to antidepressantsIrritability, associated with autism spectrum disorderAgitation or aggression

Antipsychotics


Antipsychotic medications are FDA approved to treat:

Schizophrenia spectrum & other psychotic disorders Bipolar and related disorders Major Depressive Disorder (augmentation)

Antipsychotics

Addition of antipsychotic meds to antidepressants is called augmentation.Augmentation of antidepressants with atypical antipsychotics is effective in some cases of depression (nonpsychotic).



Schizophrenia spectrum & other psychotic disorders Bipolar and related disorders Major Depressive Disorder (augmentation)Autism Spectrum Disorder (irritability):

Aripiprazole (Abilify)Risperidone (Risperdal)

Acute treatment of agitation:Aripiprazole (Abilify)Loxitane (Adasuve#) - InhalerOlanzapine (Zyprexa)Ziprasidone (Geodon)

Antipsychotics


Antipsychotic Medications

In 2015 new antipsychotics approved by the FDA:

Aripiprazole lauroxil (Aristada®) – use up to 6 wks

Brexpiprazole (Rexulti®)

Cariprazine (Vraylar®)

Paliperidone (Invega Trinza®) – use every 12 wks


Digital medicine

09.08.15 - FDA Accepts First Digital Medicine New Drug Application….Otsuka and Proteus Digital Health

Castellanos Psychotropic Medications Training 2015

Collects physiological & behavioral metrics: Heart rate Blood pressure Activity Body angle Sleep

Generic Name Brand FDA Rec Max FDA Approved in

Name® per day Schizophrenia Mania/Bipolar

Aripiprazole Abilify 30 mg Adols (13-17); AdultsChild & Adols (10-17);

Adults

Aripiprazole Abilify Maintena* 400 mg/month Adults No

Asenapine Saphris 20 mg AdultsChild & Adols (10-17);

AdultsBrexpiprazole Rexulti 4mg Adults NoCariprazine Vraylar 6mg Adults Adults

Clozapine Clozaril 900 mg Adults NoIloperidone Fanapt 24 mg Adults Adults

Lurasidone Latuda160 mg-Schizophrenia

120 mg-BPD DepressionAdults

Adults (Bipolar Depression only)

Loxapine Adasuve 10 mg (Inhaled) Adults- Agitation only Adults- Agitation onlyOlanzapine Olanzapine Relprevv* 405 mg/4wks Adults AdultsOlanzapine Zyprexa 20 mg Adols (13-17); Adults Adols (13-17); Adults

Paliperidone Invega 12 mg Adults AdultsPaliperidone Invega Sustanna* 234 mg/4 wks Adults NoPaliperidone Invega Trinza* 819 mg/ 12 wks Adults No

Quetiapine Seroquel 800 mg Adols (13-17); AdultsChild & Adols (10-17);

Adults

Risperidone Risperdal 8 mg Adols (13-17); AdultsChild & Adols (10-17);

Adults

Risperidone Risperdal Consta* 50 mg/2 wks Adults Adults

Ziprasidone Geodon 80 mg Adults Adults

Antipsychotics - Newer

Generic Name Brand Name® FDA Max per day FDA Approved for

Schizophrenia Mania/Bipolar

Haloperidal Haldol◄ 60 mgChild & Adol (3-17)

AdultsNo

Haloperidal Haldol Decanoate* 300 mg/mo Adults No

Loxapine Loxitane 250 mgChild & Adol (12-

17)Adults

No

Thioridazine Mellaril 800 mg Adults No

Thiothixene Navane 60 mgChild & Adol (12-

17)Adults

No

Pimozide Orap ◄ 10 mg No No

FluphenazineNo current brand

name exists40 mg Adults No

Fluphenazine Prolixin Decanoate* 75 mg/2 wks Adults No

Trifluoperazine Stelazine 80 mgChild & Adol (6-17)

AdultsNo

Chlorprmazine Thorazine 2,000 mgChild & Adol (1-17)

AdultsNo

Perphenazine Trilafon 64 mg Adults No

Antipsychotics - Older


Natural History of Schizophrenia


Bipolar Disorder

Bipolar Depression

Mania

Maintenance

Euthymia/Baseline

Hypomania



Schizophrenia spectrum & other psychotic disorders Bipolar and related disorders Major Depressive Disorder (augmentation)


Antipsychotics

Addition of antipsychotic meds to antidepressants is called augmentation.Augmentation of antidepressants with atypical antipsychotics is effective in some cases of depression (nonpsychotic).

Generic Name

Brand Name®

Major Depressive Disorder

(Augmentation)

Bipolar Depressio

n

Agitation- Acute

Treatment

Aripiprazole Abilify

Loxapine Adasuve

Ziprasidone Geodon

Lurasidone Latuda

Brexiprazole Rexulti

Quetiapine Seroquel

Quetiapine + Fluoxetine

Symbyax

Olanzapine Zyprexa

AntipsychoticsOther FDA Indications in ADULTS


Drowsiness Dizziness Dry mouth Blurred vision Constipation Stiffness Restlessness Drooling Rapid heartbeat Sensitivity to the sun Skin rashes Increased appetite and weight gain Menstrual problems

Antipsychotics Side Effects


Rare, unexpected, serious

Enlargement of breasts in males Galactorrhea (flow of milk from the breast when not pregnant) Dangerous drop in white blood cells (clozapine) Seizures (clozapine) Tardive dyskinesia (TD; potentially irreversible involuntary

movements) Neuroleptic malignant syndrome (NMS; increased temperature,

muscular rigidity, altered mental state, changes in kidney functioning)

Antipsychotics Side Effects II


QT prolongation (changes in heart’s electrical activity): May prolong QT interval and may be associated with arrhythmia and sudden death

Use with caution in children and adolescents with cardiovascular problems

Antipsychotics Warnings & Precautions


Metabolic Changes:Atypical antipsychotic drugs have been associated with

metabolic changes that may increase cardiovascular/ cerebrovascular risk, such as:heart diseasestrokediabetes

These metabolic changes include: Increased blood sugar (hyperglycemia) Increased lipids (dyslipidemia)Weight gain

Antipsychotics Warnings & Precautions II


Side Effects of Atypical Antipsychotics: Changes in Risk Perception


Side Effects of Atypical Antipsychotics


FDA Category C pregnancy precaution Antipsychotics are associated with increased

gestational weight & diabetes and with increased risk of preterm birth

Findings in relation to malformations are inconclusive

Potential risk for abnormal muscle movements (extrapyramidal signs or EPS) and withdrawal symptoms in newborns whose mothers were treated with these drugs during the third trimester of pregnancy

Clozapine is considered a Category B medication

Antipsychotics & Pregnancy


Mood Stabilizers

Mood Stabilizers

Psychotropic Medication Training


Mood stabilizers are medications used to treat bipolar disorder with or without an antipsychotic

Many antiepileptic medications (medicines for seizures) can work as mood stabilizers

Interventions for bipolar disorder are not necessarily directed at “curing” the disorder but at optimally managing it over time. The outcome is better when treatment is continuous rather than “on and off” over time

Mood Stabilizers


Generic Name Brand Name® FDA Max per dayFDA Approved for Bipolar Disorder

Divalproex/Valproic AcidDepakote/Depakene*;

Stavzor60 mg / kg Adults

Lithium Eskalith / Lithobid* 1,800 mg Adults

Lamotrigine Lamictal 0.15-3.0 mg / kg Adults

Gabapentin Neurontin 1,800 mg No

Carbamazapine Tegretol / Equetro*1,000 mg children;

1,200 mg adultsAdults

Topiramate Topamax 5-9 mg / kg No

Oxcarbazapine Trileptal 1,800 mg No

Mood Stabilizers


Excessive thirst Frequent urination Nausea Fine hand tremor Muscles twitches Acne Itching, rash EKG changes Weight gain

Lithium (Eskalith, Lithobid) Side Effects

O



Blackouts Loss of coordination Seizures Slurred speech Fast, slow, irregular, or pounding heartbeat. Hallucinations Changes in vision Swelling of the eyes, face, lips, tongue, throat, hands, feet,

ankles, or lower legs Hypothyroidism

Lithium (Eskalith, Lithobid) Side Effects II


Changes in weight Nausea Stomach pain Vomiting Anorexia Changes in appetite. Vomiting Diarrhea Constipation Skin rash Increased suicidal thoughts and behaviors

Rare, unexpected, serious Liver or pancreatic damage Polycystic ovarian syndrome (PCOS)

Valproic acid / divalproex sodium (Depakote) Side Effects


Headaches Dizziness Diarrhea Rash Pruritus (itchiness) Negative mood adverse reactions Sleep changes Increased suicidal thoughts and behaviors

Rare, unexpected, serious Liver or pancreatic damage Steven Johnson Syndrome: A serious, potentially fatal allergic

reaction that leads to a skin rash and sores in the mouth

REMEMBER: If a consumer develops a rash while taking Lamotrigine (Lamictal) immediately contact the doctor

Lamotrigine (Lamictal) Side Effects


Mood stabilizers may effect the metabolism, liver, kidneys, and thyroid

Consumers taking Valproic acid / divalproex sodium (Depakote), Lithium or Carbamazepine (Tegretol/Equetro) should have routine blood work to make sure the dose is safe and effective. Levels are usually checked in the morning before the medication is given to the consumer

Mood Stabilizers


The FDA has issued a warning for all of the mood stabilizers listed previously EXCEPT lithium.

This warning alerts people to the “increased risk of suicidal thinking and behavior…”

REMEMBER: Consumers taking any mood stabilizer (except lithium) should be monitored for new or worsened suicidal thoughts and behaviors. Talk to the doctor or prescriber if this happens.

Mood Stabilizers & Suicidality


Caution should be exercised when…Consumers with pre-existing medical problems

are prescribed a mood stabilizer in which there may be an interaction

Examples:lithium in persons with renal, cardiovascular or thyroid problems

divalproex (Depakote) in persons with liver problems

topiramate (Topamax) in consumers with glaucoma

Mood Stabilizers Warnings & Precautions


Category C: No adequate and well-controlled studies in humans to determine the effect of the SSRI on the fetus

Lamotrigine (Lamictal)Gabapentin (Neurontin)Oxcarbazepine (Trileptal)

Category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Lithium (Eskalith, Lithobid)Valproate/divalproex (Depakote)Topiramate (Topamax) Carbamazepine (Tegretol)

Mood Stabilizers & Pregnancy


Generic Name Brand Name® FDA Max per dayFDA Approved for Bipolar Disorder

Divalproex/Valproic Acid Depakote/Depakene* 60 mg / kg Adults

Lithium Eskalith / Lithobid* 1,800 mg Adults

Lamotrigine Lamictal 0.15-3.0 mg / kg Adults

Gabapentin Neurontin 1,800 mg No

Carbamazapine Tegretol / Equetro*1,000 mg children;

1,200 mg adultsAdults

Topiramate Topamax 5-9 mg / kg No

Oxcarbazapine Trileptal 1,800 mg No

Mood Stabilizers


Anxiolytics &

Other Anti-Anxiety Medications

Anxiolytics & Other Anti-Anxiety Medications



Generic Name Brand Name® FDA Max per dayFDA Approved

for Anxiety

Lorazepam Ativan 10 mg Adults

Buspirone Buspar * 60 mg Adults

Clonazepam Klonopin 4 mg Adults

Chlordiazepoxide Librium 300 mg (IV/IM) ◄ Adults

Diazepam Valium 40 mg Adults

Alprazolam Xanax 6 mg Adults

Anxiolytics and Other Anti-Anxiety Medications


Anxiolytics or anti-anxiety medications and antidepressants are the most commonly used medications for anxiety disorders

Benzodiazepines (BZs) are a group of anxiolytic medications that work differently than antidepressant medications:BZs generally start working more quickly

BZs help improve situational anxiety but are less effective in preventing or maintaining anxiety under control

The effects of BZs usually do not last for a full day

BZs are classified as controlled substances (Schedule IV)

BZs can result in dependence



Examples of Benzodiazepines (DEA controlled substances):Lorazepam: Ativan®Clonazepam: Klonopin®Chlordiazepoxide: Librium®Diazepam: Valium®Alprazolam: Xanax®

Anxiolytics - Benzodiazepines


Buspirone (Buspar) is an anti-anxiety medication that is not a benzodiazepine and:

Unlike benzodiazepines typically takes at least two weeks to begin working

Usually should be taken 2 – 3 times per day Is not classified as a controlled substance Has little scientific support for its use in children and

adolescents



Tiredness Drowsiness Dizziness Unsteadiness when walking Upset stomach Blurred vision Headache Confusion Memory problems Nightmares Depression Increased suicidal thoughts and behaviors

(clonazepam/Klonopin, clorazepate/Tranxene)

Anxiolytics and Other Anti-Anxiety Medications Side Effects


What does it mean that benzodiazepines are controlled substances by DEA (Schedule IV)?:

Can be written with refills if appropriate Can be called in or faxed to the pharmacy Potential for abuse



What does it mean that benzodiazepines are controlled substances by DEA (Schedule IV)?:

Can be written with refills if appropriate Can be called in or faxed to the pharmacy Potential for abuse




Respiratory depression (Dose dependent, with more severe effects occurring with high doses)

Disinhibition Hypomania in persons with depression Blood dyscracias (abnormality of blood cells) Liver problems Seizures (withdrawal)

Anxiolytics and Other Anti-Anxiety Medications Side Effects II


Generic Name Brand Name® FDA Max per dayFDA Approved

for Anxiety

Lorazepam Ativan 10 mg Adults

Buspirone Buspar * 60 mg Adults

Clonazepam Klonopin 4 mg Adults

Chlordiazepoxide Librium 300 mg (IV/IM) ◄ Adults

Diazepam Valium 40 mg Adults

Alprazolam Xanax 6 mg Adults




Complex sleep-related behavior: Egs, getting up during the night and "sleep eating," making phone calls, having sex, and getting into the car and driving while not fully awake

Sedative/Hypnotics/Sleep MedicationsSide Effects III



Sedative/Hypnotics/Sleep Medications

Sedative/Hypnotics/Sleep Meds

SFBHN Psychotropic Medications

Training

Insomnia is defined as repeated difficulty with sleep initiation, maintenance, consolidation, or quality that occurs despite adequate time and opportunity for sleep and that results in some form of daytime impairment.

As many as 95% of Americans have reported an episode of insomnia at some point during their lives.


Sedative/Hypnotics/Sleep medications

Medications for insomnia are sometimes called sedatives or hypnotics

Most are controlled substance s & may be habit forming

Certain populations may require lower doses (eg, women; elderly)

Certain preparations are longer acting; some are taken sublingual (below the tongue)


Sedative/Hypnotics/Sleep medications

Generic Name Brand Name® FDA MaxFDA Approved for Insomnia

per day Adults

ZolpidemAmbien; Edluar

Ambien CR Intermezzo*

10 mg12.5 mg3.5 mg

Yes

Suvorexant Belsomra 30 mg Yes

Diphenhydramine Benadryl, others 300 mg OTC

Flurazepam Dalmane 30 mg Yes

Trazodone Desyrel 375 mg No

Quazepam Doral 15 mg Yes

Triazolam Halcion 0.5 mg Yes

Eszopiclone Lunesta 3 mg Yes

Estazolam Prosom 2 mg Yes

Mirtazapine Remeron 45 mg No

Temazepam Restoril 30 mg Yes

Ramelteon Rozerem 8 mg Yes

Doxepin Silenor 6 mg Yes

Doxepin Sinequan 300 mg No

Zaleplon Sonata 20 mg Yes

Doxylamine Unisom 25 mg OTC

Melatonin Multiple products 10 mg OTCValerian root Multiple products 1000 mg OTC


Remember…Certain Sedative/Hypnotics/Sleep Medications are controlled substances by DEA (Schedule IV):

Can be written with refills if appropriate Can be called in or faxed to the pharmacy Potential for abuse.



Generic Name Brand Name® FDA MaxFDA Approved for

Insomnia

per day Adults

ZolpidemAmbien; Edluar

Ambien CR Intermezzo*

10 mg12.5 mg3.5 mg

Yes

Suvorexant Belsomra 30 mg Yes

Diphenhydramine Benadryl, others 300 mg OTC

Flurazepam Dalmane 30 mg Yes

Trazodone Desyrel 375 mg No

Quazepam Doral 15 mg Yes

Triazolam Halcion 0.5 mg Yes

Eszopiclone Lunesta 3 mg Yes

Estazolam Prosom 2 mg Yes

Mirtazapine Remeron 45 mg No

Temazepam Restoril 30 mg Yes

Ramelteon Rozerem 8 mg Yes

Doxepin Silenor 6 mg Yes

Doxepin Sinequan 300 mg No

Zaleplon Sonata 20 mg Yes

Doxylamine Unisom 25 mg OTC

Melatonin Multiple products 10 mg OTC

Valerian root Multiple products 1000 mg OTC

DEA controlled substances (Schedule IV)Sedative/Hypnotics/Sleep Medications

Tiredness Drowsiness Dizziness Dryness of mouth Unsteadiness when walking Next morning impairment for activities that

require alertness Headache Nausea


Sedative/Hypnotics/Sleep MedicationsSide Effects


Respiratory depression (Dose dependent, with more severe effects occurring with high doses)

Mood Changes Memory problems


Sedative/Hypnotics/Sleep MedicationsSide Effects II


Complex sleep-related behavior: Egs, getting up during the night and "sleep eating," making phone calls, having sex, and getting into the car and driving while not fully awake.


Sedative/Hypnotics/Sleep MedicationsSide Effects III

Miscellaneous Medications

Misc Meds


Training

Antihistamine Medications Medications used to Treat Side Effects of

Antipsychotics


Antihistamine medications, or antihistaminics, primary indication is to treat allergies

These medicines are also contained in certain cold remedies

Partly because of their relatively safe side effect profile, sometimes these medications are used off-label for the management of insomnia, agitation and aggression

Miscellaneous - Antihistamine Medications


Drowsiness Excitability (Especially in young children) Dry mouth Increased appetite Itchiness Headaches Diarrhea Constipation Weight gain

Rare, unexpected, serious Shakiness (Usually with higher doses) Seizures (Usually with higher doses) Dangerous drop in white blood cells.

Miscellaneous - Antihistamine MedicationsSide Effects


Generic Name Brand Name® FDA Max per dayFDA Approved for

Agitation & Insomnia

Diphenhydramine Benadryl 100 mg No

Hydroxyzine Vistaril 400 mg No

Miscellaneous - Antihistamine Medications


These medicines can be useful to treat certain side effects secondary to antipsychotic use

Side effects that could be helped with these meds:Muscle stiffness/rigidityMuscle spasms of the back, neck and eyesDrooling

Misc - Medications used to Treat Side Effects of Antipsychotics


Drowsiness Excitability Dry mouth Blurry vision Nausea/ upset stomach Constipation Weight gain

Rare, unexpected, serious Confusion Inability to urinate

Misc-Medications used to Treat the Side Effects of Antipsychotics Side Effects


GenericName

BrandName®

FDA Max per day

FDA Approved

to help side effects of Antipsychotics

Trihexyphenidyl Artane 15 mg Adults

Benztropine Cogentin 6 mg Adults

Misc–Medications used to Treat Side Effects of Antipsychotics


Responsibilities During Treatment


What is true informed consent: A joint decision-making process in which the individual, to the extent of his/her capacity, is involved in discussions about his/her health care to improve long-term outcomes and to foster trust and a better clincian-consumer relationship.Engaging individuals helps:

Empower them Encourages their active involvement in the decisions

that affect their lives Improves adherence Is more likely to have improved health outcomes

Engaging Individuals to Participate in the Decision Process


Continuous process: With the individual Family, caretakers or other important people

if appropriateInformation must be presented at age,

intellectually and developmentally appropriate level and language

There is no substitute for informed individuals

Engaging Individuals to Participate in the Decision process II


What to do if You Have Concerns


Use common sense!

Report concerns or questions of possible side effects to the physician This may require some persistence Insist on a call back Make yourself available for a call back Schedule a new appointment if needed



As with all medical issues, if an emergency is suspected call 911 or arrange for the child to go to the nearest emergency department

If you are not sure what to do = ACT! Discuss with a supervisor Call the doctor

What to do if You Have Concerns II


Use common sense!

Can it wait???

Encourage the consumer to contact the prescriber with concerns or questions:

This may require some persistence

Insist on a call back

Make themselves available for a call back

Schedule a new appointment if needed

Consider reporting directly to the prescriber concerns or questions of possible side effects



As with all medical issues, if an emergency is suspected call 911 or arrange for the consumer to go to the nearest emergency department

If you are not sure what to do = ACT! Discuss with a supervisor Call the doctor

What to do if You Have Concerns II


1. Is the individual’s condition or presentation life threatening?

2. Could the person’s condition worsen on the way to the hospital?

3. Could transporting the individual result in injury?

4. Would distance or traffic conditions cause a delay in getting a person to the hospital?

When should you call 911?


Medications can be an important part of treatment for some emotional and behavioral disorders.

Psychotropic medications should only be used as one part of a comprehensive treatment plan.

Ongoing evaluation and monitoring by a physician is essential.

Each clinician is also an important part of the monitoring process.

Informed decision making is important.


Psychotropic Medications Summary

APPROPRIATE use of medications is the key.

Taking too much or too little of a medication can have undesired consequences!

It is very important to take medications as prescribed.

Consumers should never add or stop a medication without consulting the prescribing doctor.


Psychotropic Medications Summary II

Parting Thoughts

Our community is our future.

We all share a responsibility for our community’s welfare.

Daniel Castellanos, MD


Date post:	29-Jan-2016
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Psychotropic Medications and Clinical Practice Adults Training for Clinicians Daniel Castellanos, MD...

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