Does latuda cause drowsiness

Contents

Latuda Side Effects

Generic Name: lurasidone

Medically reviewed by Drugs.com. Last updated on Nov 11, 2018.

  • Overview
  • Side Effects
  • Dosage
  • Professional
  • Interactions
  • More

Note: This document contains side effect information about lurasidone. Some of the dosage forms listed on this page may not apply to the brand name Latuda.

In Summary

Common side effects of Latuda include: psychomotor impairment, akathisia, basal ganglia disease, bradykinesia, cogwheel rigidity, drowsiness, hypokinesia, muscle rigidity, nausea, parkinson’s disease, sedated state, tremor, altered serum glucose, and drooling. Other side effects include: oculogyric crisis, trismus, agitation, anxiety, dystonia, torticollis, increased serum prolactin, and weight gain. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to lurasidone: oral tablet

Warning

Oral route (Tablet)

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Lurasidone is not approved for the treatment of patients with dementia-related psychosis. An increased risk of suicidal thoughts and behavior was found in pediatric and young adult patients taking antidepressants. Monitor for clinical worsening and emergence of suicidal thoughts and behaviors.

Along with its needed effects, lurasidone (the active ingredient contained in Latuda) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking lurasidone:

More common

  • Absence of or decrease in body movement
  • difficulty with swallowing
  • drooling
  • inability to sit still
  • incremental or ratchet-like movement of the muscle
  • loss of balance control
  • mask-like face
  • muscle discomfort
  • muscle trembling, jerking, or stiffness
  • need to keep moving
  • restlessness
  • rigid or stiff muscles
  • shakiness in the legs, arms, hands, or feet
  • shuffling walk
  • slow movements
  • slow reflexes
  • slurred speech
  • stiffness of the arms and legs
  • tic-like (jerky) movements of the head, face, mouth, and neck
  • trembling or shaking of the hands or feet
  • twisting movements of the body
  • uncontrolled movements, especially of the face, neck, and back

Less common

  • Arm, back, or jaw pain
  • blurred vision
  • burning while urinating
  • changes in patterns and rhythms of speech
  • chest pain or discomfort
  • chills
  • cold sweats
  • confusion
  • difficult or painful urination
  • difficulty opening the mouth
  • difficulty with breathing
  • dizziness
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • fixed position of the eye
  • headache
  • high fever
  • inability to move the eyes
  • inability to speak
  • increased blinking or spasms of the eyelid
  • increased sweating
  • lockjaw
  • loss of bladder control
  • muscle spasm, especially of the neck and back
  • nervousness
  • pale skin
  • pounding in the ears
  • seizures
  • severe muscle stiffness
  • severe or sudden headache
  • slow or fast heartbeat
  • slurred speech
  • sticking out of the tongue
  • sweating
  • temporary blindness
  • tiredness
  • trouble with breathing, speaking, or swallowing
  • troubled breathing with exertion
  • uncontrolled twisting movements of the neck, trunk, arms, or legs
  • unusual bleeding or bruising
  • unusual facial expressions
  • unusual tiredness or weakness
  • unusually pale skin
  • weakness in the arm or leg on one side of the body, sudden and severe

Rare

  • Black, tarry stools
  • bloody urine
  • breast pain or swelling
  • cough
  • dark-colored urine
  • decreased frequency or amount of urine
  • fever
  • increased thirst
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • lower back or side pain
  • muscle cramp, pain, or stiffness
  • nausea
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the face, fingers, or lower legs
  • swollen glands
  • vomiting
  • weight gain

Incidence not known

  • Decreased urine output
  • hives or welts, itching, skin rash
  • loss of consciousness
  • redness of the skin
  • swelling of the throat or tongue
  • tightness in the chest

Some side effects of lurasidone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Anxiety
  • belching
  • drowsiness
  • dry mouth
  • heartburn
  • hyperventilation
  • indigestion
  • irritability
  • relaxed and calm feeling
  • sleepiness or unusual drowsiness
  • stomach discomfort, upset, or pain
  • trouble sleeping
  • unusually deep sleep
  • unusually long duration of sleep

Less common

  • Abnormal dreams
  • back pain
  • blurred vision
  • burning feeling in the chest or stomach
  • decreased appetite
  • diarrhea
  • feeling of constant movement of self or surroundings
  • indigestion
  • sensation of spinning
  • sweating
  • tenderness in the stomach area
  • watering of mouth and drooling

Rare

  • Decreased interest in sexual intercourse
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • unexpected or excess milk flow from the breasts

For Healthcare Professionals

Applies to lurasidone: oral tablet

General

The most commonly reported adverse events included somnolence, akathisia, extrapyramidal symptoms, and nausea.

Metabolic

Common (1% to 10%): Decreased appetite, increased appetite, increased weight

Uncommon (0.1% to 1%): Hyponatremia, increase in blood sugar levels/blood glucose increased

In uncontrolled, long-term schizophrenia trials, this drug was associated with a mean increase in glucose from baseline of 1.8 mg/dL at 24 weeks, 0.8 mg/dL at 36 weeks, and 2.3 mg/dL at 52 weeks. Similar results were observed in bipolar depression studies. The proportion of patients with a 7% or greater increase in body weight was 4.8% (compared with 3.3% for placebo). Pooled data from short-term trials showed a mean weight gain of 0.43 kg in treated patients (compared with -0.2 kg in placebo).

Gastrointestinal

Very common (10% or more): Nausea (up to 17.4%), dyspepsia (up to 11%)

Uncommon (0.1% to 1%): Dysphagia, flatulence, gastritis

Frequency not reported: Difficulty swallowing, tongue protrusion, tongue spasm, tongue swelling

Nervous system

Akathisia and extrapyramidal symptoms were dose-related.

Common (1% to 10%): Dizziness, dyskinesia, dystonia/acute dystonia, tardive dyskinesia

Uncommon (0.1% to 1%): Cerebrovascular accident/adverse reactions, dysarthria, gait disturbance, lethargy, syncope, vertigo

Rare (less than 0.1%): Neuroleptic malignant syndrome, seizure

Frequency not reported: Abnormal glabellar reflex, bradykinesia, cogwheel rigidity, convulsion, drooling, hyperkinesia, hypersomnia, hypersomnolence, hypokinesia, motor impairment, oromandibular dystonia, sedation, stroke, tremor

Psychiatric

Very common (10% or more): Insomnia (up to 11%)

Common (1% to 10%): Abnormal dreams, agitation, anxiety, psychomotor hyperactivity, restlessness

Uncommon (0.1% to 1%): Activation of mania/hypomania, catatonia, nightmare, panic attack, sleep disorder

Rare (less than 0.1%): Suicidal behavior/ideation

Frequency not reported: Cognitive impairment, psychomotor retardation

Hematologic

Uncommon (0.1% to 1%): Anemia

Rare (less than 0.1%): Eosinophilia

Frequency not reported: Agranulocytosis, leukopenia, neutropenia

Cardiovascular

Common (1% to 10%): Hypertension, tachycardia

Frequency not reported: Deep vein thrombosis, venous thromboembolism

Musculoskeletal

Common (1% to 10%): Back pain, increased blood creatinine phosphokinase, musculoskeletal stiffness

Uncommon (0.1% to 1%): Joint stiffness, myalgia, neck pain

Rare (less than 0.1%): Rhabdomyolysis

Frequency not reported: Muscle rigidity, muscle spasms, neck muscle spasm, torticollis, trismus

Dermatologic

Common (1% to 10%): Rash, pruritus

Uncommon (0.1% to 1%): Hyperhidrosis

Frequency not reported: , Stevens-Johnson syndrome, urticaria

Postmarketing reports: Bullous dermatitis, maculopapular rash, pustular rash, severe cutaneous reactions, skin eruption, skin exfoliation

Genitourinary

Common (1% to 10%): Urinary tract infection

Uncommon (0.1% to 1%): Amenorrhea, dysmenorrhea, dysuria, erectile dysfunction

Rare (less than 0.1%): Breast enlargement, breast pain, galactorrhea

Renal

Common (1% to 10%): Elevated serum creatinine/increased creatinine phosphokinase

Rare (less than 0.1%): Renal failure

Endocrine

Uncommon (0.1% to 1%): Elevated prolactin levels/blood prolactin increased

Frequency not reported: Hyperprolactinemia

Hepatic

Uncommon (0.1% to 1%): Alanine aminotransferase increased

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Rare (less than 0.1%): Angioedema

Frequency not reported: Allergic rhinitis

Immunologic

Very common (10% or more): Viral infection (up to 11%)

Common (1% to 10%): Influenza

Ocular

Common (1% to 10%): Blurred vision

Frequency not reported: Oculogyric crisis

Other

Common (1% to 10%): Fatigue

Rare (less than 0.1%): Sudden death

Frequency not reported: Body temperature dysregulation, falls, neonatal drug withdrawal syndrome

Respiratory

Common (1% to 10%): Nasopharyngitis, oropharyngeal pain, rhinitis

Frequency not reported: Difficulty breathing, nasal congestion, rhinorrhea, pulmonary embolism, throat tightness, upper respiratory tract infection

Postmarketing reports: Dyspnea, throat swelling

1. Cerner Multum, Inc. “UK Summary of Product Characteristics.” O 0

2. Cerner Multum, Inc. “Australian Product Information.” O 0

3. “Product Information. Latuda (lurasidone).” Sunovion Pharmaceuticals Inc, Marlborough, MA.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer

More about Latuda (lurasidone)

  • During Pregnancy or Breastfeeding
  • Dosage Information
  • Drug Images
  • Drug Interactions
  • Compare Alternatives
  • Support Group
  • Pricing & Coupons
  • En Español
  • 620 Reviews
  • Generic Availability
  • Drug class: atypical antipsychotics
  • FDA Approval History

Consumer resources

  • Latuda
  • Latuda (Advanced Reading)

Professional resources

  • Latuda (AHFS Monograph)
  • … +1 more

Related treatment guides

  • Bipolar Disorder
  • Schizophrenia

lurasidone (Latuda)

Brand Names: Latuda

Generic Name: lurasidone

  • What is lurasidone (Latuda)?
  • What are the possible side effects of lurasidone (Latuda)?
  • What is the most important information I should know about lurasidone (Latuda)?
  • What should I discuss with my healthcare provider before taking lurasidone (Latuda)?
  • How should I take lurasidone (Latuda)?
  • What happens if I miss a dose (Latuda)?
  • What happens if I overdose (Latuda)?
  • What should I avoid while taking lurasidone (Latuda)?
  • What other drugs will affect lurasidone (Latuda)?
  • Where can I get more information (Latuda)?

What is lurasidone (Latuda)?

Lurasidone is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.

Lurasidone is used to treat schizophrenia in adults and teenagers who are at least 13 years old.

Lurasidone is also used to treat episodes of depression related to bipolar disorder (manic depression) in adults and children who are at least 10 years old.

Lurasidone may also be used for purposes not listed in this medication guide.

634020302_PB

round, white, imprinted with L20

634020304_PB

round, white, imprinted with L40

634020306_PB

oblong, white, imprinted with L60

634020308_PB

oval, green, imprinted with L80

What are the possible side effects of lurasidone (Latuda)?

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

High doses or long-term use of lurasidone can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take lurasidone, the more likely you are to develop a serious movement disorder. The risk of this side effect is higher in diabetics and older adults (especially women).

Call your doctor at once if you have:

  • any new or unusual muscle movements you cannot control;
  • a light-headed feeling, like you might pass out;
  • a seizure (convulsions);
  • (in women) irregular menstrual periods, breast or vaginal changes, nipple discharge;
  • (in men) breast swelling, impotence;
  • trouble swallowing;
  • low blood cell counts–sudden weakness or ill feeling, fever, chills, sore throat, mouth sores, swollen gums, pain when swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;
  • high blood sugar–increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or
  • severe nervous system reaction–very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

  • drowsiness;
  • weight gain;
  • tremors, muscle stiffness, problems with muscle movement;
  • feeling restless or being unable to sit still;
  • nausea, vomiting;
  • runny nose; or
  • sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about lurasidone (Latuda)?

Lurasidone is not approved for use in psychotic conditions related to dementia. Lurasidone may increase the risk of death in older adults with dementia-related conditions.

Some young people have thoughts about suicide when first taking medicine to treat depression. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact with lurasidone, and some drugs should not be used together.

Latuda

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling:

  • Increased Mortality in Elderly Patients with Dementia-Related Psychosis
  • Suicidal Thoughts and Behaviors
  • Cerebrovascular Adverse Reactions, Including Stroke, in Elderly Patients with Dementia-related Psychosis
  • Neuroleptic Malignant Syndrome
  • Tardive Dyskinesia
  • Metabolic Changes
  • Hyperprolactinemia
  • Leukopenia, Neutropenia, and Agranulocytosis
  • Orthostatic Hypotension and Syncope
  • Falls
  • Seizures
  • Potential for Cognitive and Motor Impairment
  • Body Temperature Dysregulation
  • Activation of Mania/Hypomania
  • Dysphagia
  • Neurological Adverse Reactions in Patients with Parkinson’s Disease or Dementia with Lewy Bodies
  • .

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Adults

The information below is derived from an integrated clinical study database for LATUDA consisting of 3799 adult patients exposed to one or more doses of LATUDA for the treatment of schizophrenia, and bipolar depression in placebo-controlled studies. This experience corresponds with a total experience of 1250.9 patient-years. A total of 1106 LATUDA-treated patients had at least 24 weeks and 371 LATUDA-treated patients had at least 52 weeks of exposure.

Adverse events during exposure to study treatment were obtained by general inquiry and voluntarily reported adverse experiences, as well as results from physical examinations, vital signs, ECGs, weights and laboratory investigations. Adverse experiences were recorded by clinical investigators using their own terminology. In order to provide a meaningful estimate of the proportion of individuals experiencing adverse events, events were grouped in standardized categories using MedDRA terminology.

Schizophrenia

The following findings are based on the short-term, placebo-controlled premarketing adult studies for schizophrenia in which LATUDA was administered at daily doses ranging from 20 to 160 mg (n=1508).

Commonly Observed Adverse Reactions:

The most common adverse reactions (incidence ≥ 5% and at least twice the rate of placebo) in patients treated with LATUDA were somnolence, akathisia, extrapyramidal symptoms, and nausea.

Adverse Reactions Associated with Discontinuation of Treatment:

A total of 9.5% (143/1508) LATUDA-treated patients and 9.3% (66/708) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with LATUDA that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in LATUDA-Treated Patients:

Adverse reactions associated with the use of LATUDA (incidence of 2% or greater, rounded to the nearest percent and LATUDA incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with schizophrenia) are shown in Table 17.

Table 17: Adverse Reactions in 2% or More of LATUDA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in Adult Short-term Schizophrenia Studies

Percentage of Patients Reporting Reaction
LATUDA
Body System or Organ Class Placebo
(N=708)
(%)
20mg/day
(N=71)
(%)
40mg/day
(N=487)
(%)
80 mg/day
(N=538)
(%)
120 mg/day
(N=291)
(%)
160 mg/day
(N=121)
(%)
AllLATUDA
(N=1508)
(%)
Gastrointestinal Disorders
Nausea 5 11 10 9 13 7 10
Vomiting 6 7 6 9 9 7 8
Dyspepsia 5 11 6 5 8 6 6
Salivary Hypersecretion <1 1 1 2 4 2 2
Musculoskeletal and Connective Tissue Disorders
Back Pain 2 0 4 3 4 0 3
Nervous System Disorders
Somnolence* 7 15 16 15 26 8 17
Akathisia 3 6 11 12 22 7 13
Extrapyramidal Disorder** 6 6 11 12 22 13 14
Dizziness 2 6 4 4 5 6 4
Psychiatric Disorders
Insomnia 8 8 10 11 9 7 10
Agitation 4 10 7 3 6 5 5
Anxiety 4 3 6 4 7 3 5
Restlessness 1 1 3 1 3 2 2
Note: Figures rounded to the nearest integer
* Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence
** Extrapyramidal symptoms include adverse event terms: bradykinesia, cogwheel rigidity, drooling, dystonia, extrapyramidal disorder, hypokinesia, muscle rigidity, oculogyric crisis, oromandibular dystonia, parkinsonism, psychomotor retardation, tongue spasm, torticollis, tremor, and trismus

Dose-Related Adverse Reactions in the Schizophrenia Studies

Bipolar Depression (Monotherapy)

The following findings are based on the adult short-term, placebo-controlled premarketing study for bipolar depression in which LATUDA was administered at daily doses ranging from 20 to 120 mg (n=331).

Commonly Observed Adverse Reactions:

The most common adverse reactions (incidence ≥5%, in either dose group, and at least twice the rate of placebo) in patients treated with LATUDA were akathisia, extrapyramidal symptoms, somnolence, nausea, vomiting, diarrhea, and anxiety.

Adverse Reactions Associated with Discontinuation of Treatment:

A total of 6.0% (20/331) LATUDA-treated patients and 5.4% (9/168) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with LATUDA that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in LATUDA-Treated Patients:

Adverse reactions associated with the use of LATUDA (incidence of 2% or greater, rounded to the nearest percent and LATUDA incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with bipolar depression) are shown in Table 18.

Table 18: Adverse Reactions in 2% or More of LATUDA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the Adult Short-term Monotherapy Bipolar Depression Study

Body System or Organ Class
Dictionary-derived Term
Percentage of Patients Reporting Reaction
Placebo
(N=168)
(%)
LATUDA
20-60 mg/day
(N=164)
(%)
LATUDA
80-120 mg/day
(N=167)
(%)
All LATUDA
(N=331)
(%)
Gastrointestinal Disorders
Nausea 8 10 17 14
Vomiting 2 2 6 4
Diarrhea 2 5 3 4
Dry Mouth 4 6 4 5
Infections and Infestations
Nasopharyngitis 1 4 4 4
Influenza 1 <1 2 2
Urinary Tract Infection <1 2 1 2
Musculoskeletal and Connective Tissue Disorders
Back Pain <1 3 <1 2
Nervous System Disorders
Extrapyramidal Symptoms* 2 5 9 7
Akathisia 2 8 11 9
Somnolence** 7 7 14 11
Psychiatric Disorders
Anxiety 1 4 5 4
Note: Figures rounded to the nearest integer
*Extrapyramidal symptoms include adverse event terms: bradykinesia, cogwheel rigidity, drooling, dystonia, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, oculogyric crisis, oromandibular dystonia, parkinsonism, psychomotor retardation, tongue spasm, torticollis, tremor, and trismus
** Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence

Dose-Related Adverse Reactions in the Monotherapy Study:

Bipolar Depression

Adjunctive Therapy With Lithium Or Valproate

The following findings are based on two adult short-term, placebo-controlled premarketing studies for bipolar depression in which LATUDA was administered at daily doses ranging from 20 to 120 mg as adjunctive therapy with lithium or valproate (n=360).

Commonly Observed Adverse Reactions:

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) in subjects treated with LATUDA were akathisia and somnolence.

Adverse Reactions Associated with Discontinuation of Treatment:

A total of 5.8% (21/360) LATUDA-treated patients and 4.8% (16/334) of placebo-treated patients discontinued due to adverse reactions. There were no adverse reactions associated with discontinuation in subjects treated with LATUDA that were at least 2% and at least twice the placebo rate.

Adverse Reactions Occurring at an Incidence of 2% or More in LATUDA-Treated Patients:

Adverse reactions associated with the use of LATUDA (incidence of 2% or greater, rounded to the nearest percent and LATUDA incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with bipolar depression) are shown in Table 19.

Table 19: Adverse Reactions in 2% or More of LATUDA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the Adult Short-term Adjunctive Therapy Bipolar Depression Studies

Body System or Organ Class
Dictionary-derived Term
Percentage of Patients Reporting Reaction
Placebo
(N=334)
(%)
LATUDA
20 to 120 mg/day
(N=360)
(%)
Gastrointestinal Disorders
Nausea 10 14
Vomiting 1 4
General Disorders
Fatigue 1 3
Infections and Infestations
Nasopharyngitis 2 4
Investigations
Weight Increased <1 3
Metabolism and Nutrition Disorders
Increased Appetite 1 3
Nervous System Disorders
Extrapyramidal Symptoms* 9 14
Somnolence** 5 11
Akathisia 5 11
Psychiatric Disorders
Restlessness <1 4
Note: Figures rounded to the nearest integer
*Extrapyramidal symptoms include adverse event terms: bradykinesia, cogwheel rigidity, drooling, dystonia, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, oculogyric crisis, oromandibular dystonia, parkinsonism, psychomotor retardation, tongue spasm, torticollis, tremor, and trismus
** Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence

Adolescents

The following findings are based on the short-term, placebo-controlled adolescent study for schizophrenia in which LATUDA was administered at daily doses ranging from 40 (N=110) to 80 mg (N=104).

Commonly Observed Adverse Reactions:

The most common adverse reactions (incidence ≥5% and at least twice the rate of placebo) in adolescent patients (13 to 17 years) treated with LATUDA were somnolence, nausea, akathisia, extrapyramidal symptoms (non-akathisia, 40mg only), vomiting, and rhinorrhea/rhinitis (80mg only).

Adverse Reactions Associated with Discontinuation of Treatment:

The incidence of discontinuation due to adverse reactions between LATUDA-and placebo-treated adolescent patients (13 to 17 years) was 4% and 8%, respectively.

Adverse Reactions Occurring at an Incidence of 2% or More in LATUDA-Treated Patients:

Adverse reactions associated with the use of LATUDA (incidence of 2% or greater, rounded to the nearest percent and LATUDA incidence greater than placebo) that occurred during acute therapy (up to 6-weeks in adolescent patients with schizophrenia) are shown in Table 20.

Table 20: Adverse Reactions in 2% or More of LATUDA-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the Adolescent Short-term Schizophrenia Study

Body System or Organ Class
Dictionary-derived Term
Percentage of Patients Reporting Reaction
Placebo
(N=112)
LATUDA
40 mg/day
(N=110)
LATUDA
80 mg/day
(N=104)
All LATUDA
(N=214)
Gastrointestinal Disorders
Nausea 3 13 14 14
Vomiting 2 8 6 8
Diarrhea 1 3 5 4
Dry Mouth 0 2 3 2
Infections and Infestations
Viral Infection** 6 11 10 10
Rhinitis*** 2 <1 8 4
Oropharyngeal pain 0 <1 3 2
Tachycardia 0 0 3 1
Nervous System Disorders
Somnolence* 7 15 13 15
Akathisia 2 9 9 9
Dizziness 1 5 5 5
Note: Figures rounded to the nearest integer
* Somnolence includes adverse event terms: hypersomnia, sedation, and somnolence
** Viral Infection includes adverse event terms: nasopharyngitis, influenza, viral infection, upper respiratory tract infection *** Rhinitis incudes adverse event terms: rhinitis, allergic rhinitis, rhinorrhea, and nasal congestion

Extrapyramidal Symptoms

Adults

In the short-term, placebo-controlled schizophrenia studies, for LATUDA-treated patients, the incidence of reported events related to extrapyramidal symptoms (EPS), excluding akathisia and restlessness, was 13.5% versus 5.8% for placebo-treated patients. The incidence of akathisia for LATUDA-treated patients was 12.9% versus 3.0% for placebo-treated patients. Incidence of EPS by dose is provided in Table 21.

Table 21: Incidence of EPS Compared to Placebo in Adult Schizophrenia Studies

In the short-term, placebo-controlled, study of schizophrenia in adolescents, the incidence of EPS, excluding events related to akathisia, for LATUDA-treated patients was higher in the 40 mg (10%) and the 80 mg (7.7%) treatment groups vs. placebo (3.6%); and the incidence of akathisia-related events for LATUDA-treated patients was 8.9% vs. 1.8% for placebo-treated patients. Incidence of EPS by dose is provided in Table 22.

Table 22: Incidence of EPS Compared to Placebo in the Adolescent Schizophrenia Study

Adverse Event Term LATUDA
Placebo
(N=112)
(%)
40 mg/day
(N=110)
(%)
80 mg/day
(N=104)
(%)
All EPS events 5 14 14
All EPS events, excluding Akathisia/Restlessness 4 7 7
Akathisia 2 9 9
Parkinsonism** <1 4 0
Dyskinesia <1 <1 1
Dystonia* 0 <1 1
Note: Figures rounded to the nearest integer
* Dystonia includes adverse event terms: dystonia, trismus, oculogyric crisis, oromandibular dystonia, tongue spasm, and torticollis
** Parkinsonism includes adverse event terms: bradykinesia, drooling, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, parkinsonism, and psychomotor retardation

Monotherapy

In the adult short-term, placebo-controlled monotherapy bipolar depression study, for LATUDA-treated patients, the incidence of reported events related to EPS, excluding akathisia and restlessness was 6.9% versus 2.4% for placebo-treated patients. The incidence of akathisia for LATUDA-treated patients was 9.4% versus 2.4% for placebo-treated patients. Incidence of EPS by dose groups is provided in Table 23.

Table 23: Incidence of EPS Compared to Placebo in the Adult Monotherapy Bipolar Depression Study

Adverse Event Term Placebo
(N=168)
(%)
LATUDA
20 to 60 mg/day
(N=164)
(%)
80 to 120 mg/day
(N=167)
(%)
All EPS events 5 12 20
All EPS events, excluding Akathisia/Restlessness 2 5 9
Akathisia 2 8 11
Dystonia* 0 0 2
Parkinsonism** 2 5 8
Restlessness <1 0 3
Note: Figures rounded to the nearest integer
* Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus
** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor

Adjunctive Therapy with Lithium or Valproate

In the adult short-term, placebo-controlled adjunctive therapy bipolar depression studies, for LATUDA-treated patients, the incidence of EPS, excluding akathisia and restlessness, was 13.9% versus 8.7% for placebo. The incidence of akathisia for LATUDA-treated patients was 10.8% versus 4.8% for placebo-treated patients. Incidence of EPS is provided in Table 24.

Table 24: Incidence of EPS Compared to Placebo in the Adult Adjunctive Therapy Bipolar Depression Studies

Adverse Event Term Placebo
(N=334)
(%)
LATUDA
20 to 120 mg/day
(N=360)
(%)
All EPS events 13 24
All EPS events, excluding Akathisia/Restlessness 9 14
Akathisia 5 11
Dystonia* <1 1
Parkinsonism** 8 13
Restlessness <1 4
Note: Figures rounded to the nearest integer
* Dystonia includes adverse event terms: dystonia, oculogyric crisis, oromandibular dystonia, tongue spasm, torticollis, and trismus
‘ ** Parkinsonism includes adverse event terms: bradykinesia, cogwheel rigidity, drooling, extrapyramidal disorder, glabellar reflex abnormal, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor

In the short-term, placebo-controlled schizophrenia and bipolar depression studies, data was objectively collected on the Simpson Angus Rating Scale (SAS) for extrapyramidal symptoms (EPS), the Barnes Akathisia Scale (BAS) for akathisia and the Abnormal Involuntary Movement Scale (AIMS) for dyskinesias.

Adults

Adolescents

onotherapy

Adjunctive Therapy with Lithium or Valproate

Dystonia

Class Effect

Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with high potency and at higher doses of first-generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

Adults

Adolescents

In the short-term, placebo-controlled, adolescent schizophrenia study, dystonia occurred in 1% of LATUDA-treated patients (1% LATUDA 40 mg and 1% LATUDA 80 mg) compared to 0% of patients receiving placebo. No patients discontinued the clinical study due to dystonic events.

Monotherapy

In the adult short-term, flexible-dose, placebo-controlled monotherapy bipolar depression study, dystonia occurred in 0.9% of LATUDA-treated subjects (0.0% and 1.8% for LATUDA 20 to 60 mg/day and LATUDA 80 to 120 mg/day, respectively) compared to 0.0% of subjects receiving placebo. No subject discontinued the clinical study due to dystonic events.

Adjunctive Therapy with Lithium or Valproate

In the adult short-term, flexible-dose, placebo-controlled adjunctive therapy bipolar depression studies, dystonia occurred in 1.1% of LATUDA-treated subjects (20 to 120 mg) compared to 0.6% of subjects receiving placebo. No subject discontinued the clinical study due to dystonic events.

Other Adverse Reactions Observed During The Premarketing Evaluation Of LATUDA

Following is a list of adverse reactions reported by adult patients treated with LATUDA at multiple doses of ≥ 20 mg once daily within the premarketing database of 2905 patients with schizophrenia. The reactions listed are those that could be of clinical importance, as well as reactions that are plausibly drug-related on pharmacologic or other grounds. Reactions listed in Table 16 or those that appear elsewhere in the LATUDA label are not included. Although the reactions reported occurred during treatment with LATUDA, they were not necessarily caused by it.

Reactions are further categorized by organ class and listed in order of decreasing frequency according to the following definitions: those occurring in at least 1/100 patients (frequent) (only those not already listed in the tabulated results from placebo-controlled studies appear in this listing); those occurring in 1/100 to 1/1000 patients (infrequent); and those occurring in fewer than 1/1000 patients (rare).

Blood and Lymphatic System Disorders: Infrequent: anemia

Cardiac Disorders: Frequent: tachycardia; Infrequent: AV block 1st degree, angina pectoris, bradycardia

Ear and Labyrinth Disorders: Infrequent: vertigo

Eye Disorders: Frequent: blurred vision

Gastrointestinal Disorders: Frequent: abdominal pain, diarrhea; Infrequent: gastritis

General Disorders and Administrative Site Conditions: Rare: sudden death

Investigations: Frequent: CPK increased

Metabolism and Nutritional System Disorders: Frequent: decreased appetite

Musculoskeletal and Connective Tissue Disorders: Rare: rhabdomyolysis

Nervous System Disorders: Infrequent: cerebrovascular accident, dysarthria

Psychiatric Disorders: Infrequent: abnormal dreams, panic attack, sleep disorder

Renal and Urinary Disorders: Infrequent: dysuria; Rare: renal failure

Reproductive System and Breast Disorders: Infrequent: amenorrhea, dysmenorrhea; Rare: breast enlargement, breast pain, galactorrhea, erectile dysfunction

Skin and Subcutaneous Tissue Disorders: Frequent: rash, pruritus; Rare: angioedema

Vascular Disorders: Frequent: hypertension

Clinical Laboratory Changes

Adults

Serum Creatinine: In short-term, placebo-controlled trials, the mean change from Baseline in serum creatinine was +0.05 mg/dL for LATUDA-treated patients compared to +0.02 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 3.0% (43/1453) of LATUDA-treated patients and 1.6% (11/681) on placebo. The threshold for high creatinine value varied from > 0.79 to > 1.3 mg/dL based on the centralized laboratory definition for each study (Table 25).

Table 25: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in Adult Schizophrenia Studies

Adolescents

Serum Creatinine: In the short-term, placebo-controlled, adolescent schizophrenia study, the mean change from Baseline in serum creatinine was −0.009 mg/dL for LATUDA-treated patients compared to +0.017 mg/dL for placebo-treated patients. A creatinine shift from normal to high (based on the centralized laboratory definition) occurred in 7.2% (14/194) of LATUDA-treated patients and 2.9% (3/103) on placebo (Table 26).

Table 26: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in the Adolescent Schizophrenia Study

Laboratory Parameter Placebo
(N=103)
LATUDA
40 mg/day
(N=97)
LATUDA
80 mg/day
(N=97)
Serum Creatinine Elevated 2.9% 7.2% 7.2%

Monotherapy

Serum Creatinine: In the adult short-term, flexible-dose, placebo-controlled monotherapy bipolar depression study, the mean change from Baseline in serum creatinine was +0.01 mg/dL for LATUDA-treated patients compared to -0.02 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 2.8% (9/322) of LATUDA-treated patients and 0.6% (1/162) on placebo (Table 27).

Table 27: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in the Adult Monotherapy Bipolar Depression Study

Laboratory Parameter Placebo
(N=168)
LATUDA
20 to 60 mg/day
(N=164)
LATUDA
80 to 120 mg/day
(N=167)
Serum Creatinine Elevated <1% 2% 4%

Adjunctive Therapy with Lithium or Valproate

Serum Creatinine: In adult short-term, placebo-controlled premarketing adjunctive studies for bipolar depression, the mean change from Baseline in serum creatinine was +0.04 mg/dL for LATUDA-treated patients compared to -0.01 mg/dL for placebo-treated patients. A creatinine shift from normal to high occurred in 4.3% (15/360) of LATUDA-treated patients and 1.6% (5/334) on placebo (Table 28).

Table 28: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in the Adult Adjunctive Therapy Bipolar Depression Studies

Laboratory Parameter Placebo
(N=334)
LATUDA
20 to 120 mg/day
(N=360)
Serum Creatinine Elevated 2% 4%

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of Latuda. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hypersensitivity Reactions: Urticaria, throat swelling, tongue swelling, and dyspnea.

Hyponatremia

Read the entire FDA prescribing information for Latuda (Lurasidone HCL Tablets for Oral Administration)

lurasidone (Rx)

Black Box Warnings

Increased mortality in elderly patients with dementia-related psychosis

  • Not indicated for dementia-related psychosis
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death; lurasidone is not approved for the treatment of patients with dementia-related psychosis; placebo-controlled trials with other atypical antipsychotics showed higher incidence of cerebrovascular adverse reactions (eg, CVA, TIA), including fatalities, compared with placebo

Suicidal thoughts and behaviors

  • Antidepressants increased the risk of suicidal thoughts and behavior in children and young adults in short-term studies; closely monitor all antidepressant-treated patients for clinical worsening, and for emergence of suicidal thoughts and behaviors

Contraindications

Hypersensitivity

Coadministration with strong CYP3A4 inhibitors (eg, ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil)

Coadministration with strong CYP3A4 inducers (eg, rifampin, St. John’s wort, phenytoin, carbamazepine)

Cautions

Possibility of suicide attempt inherent to psychotic illness; close supervision required when therapy is initiated, dosage is changed, or drug is discontinued; the risk of suicidal thoughts and behaviors in pediatric and young adult patients extends to longer-term use (eg, >4 months) is unknown; there is substantial evidence from placebo-controlled maintenance studies in adults with MDD that antidepressants delay the recurrence of depression

Antidepressant treatment can increase the risk of developing a manic or hypomanic episode, particularly in patients with bipolar disorder

Patients with Parkinson’s disease or dementia with Lewy bodies are reported to have an increased sensitivity to antipsychotic medication

Orthostatic hypotension and syncope reported, possibly due to its alpha-1receptor antagonism

Risk of neuroleptic malignant syndrome (NMS) reported in association with administration of antipsychotic drugs, including lurasidone; clinical manifestations of NMS (eg, hyperpyrexia, muscle rigidity, altered mental status, evidence of autonomic instability); additional symptoms (eg, elevated creatine phosphokinase, myoglobinuria , acute renal failure); the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses or may even arise after discontinuation of treatment; if NMS is suspected, immediately discontinue therapy and provide intensive symptomatic treatment and monitoring

Hyperprolactinemia reported; galactorrhea, amenorrhea, gynecomastia, and impotence reported with prolactin-elevating compounds; long-standing hyperprolactinemia, when associated with hypogonadism, may lead to decreased bone density in both female and male patients

Exercise caution in patients with a history of seizures or with conditions that lower the seizure threshold (eg, Alzheimer’s dementia); conditions that lower the seizure threshold may be more prevalent in patients ≥65 years

May cause leukopenia, neutropenia, and agranulocytosis; monitor patients with neutropenia should for fever or other signs of infection and treat promptly if symptoms occur; discontinue treatment in patients with severe neutropenia (ANC

May disrupt body temperature regulation

May lead to cognitive and motor impairment; caution patients about operating hazardous machinery

Incidence of cerebrovascular effects (eg, transient ischemic attacks, stroke) may increase

Esophageal dysmotility or aspiration may occur

May increase QT interval: In trials, increase in baseline adjusted QTc intervals did not exceed mean based on individual correction method (QTcI) was 7.5 ms (120-mg dose) and 4.6 ms (600-mg dose) observed at 2-4 hours after dosing; additionally, in separate trial, QTc did not increase by >60 msec from baseline or exceed 500 msec with supratherapeutic doses (ie, 120 mg/day, 600 mg/day)

Acute overdose: If antiarrhythmic therapy is administered, disopyramide, procainamide, and quinidine carry theoretical hazard of additive QT-prolonging effects when given to patient with acute lurasidone overdose

Motor instability, somnolence, and orthostatic hypotension reported, which may lead to falls and, consequently, fractures or other fall-related injuries; assess risk of falls when initiating treatment and recurrently for patients receiving repeated doses, particularly the elderly, with diseases, conditions, or medications that could exacerbate these effects

Metabolic changes with atypical antipsychotic use

  • Hyperglycemia, some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, reported; monitor glucose control in patients with an established diagnosis of diabetes mellitus who are started on atypical antipsychotics
  • Monitor symptoms of hyperglycemia (eg, polydipsia, polyuria, polyphagia, weakness)
  • In the 6-week, placebo-controlled study of pediatric patients with bipolar depression, mean change in fasting glucose was +1.6 mg/dL for lurasidone 20-80 mg/day
  • Undesirable alterations in lipids observed
  • Weight gain observed; clinically monitor weight

Tardive dyskinesia

  • Extrapyramidal symptoms, including pseudoparkinsonism, acute dystonic reactions, akathisia, and tardive dyskinesia may occur; risk of tardive dyskinesia may increase in the elderly; risk of dystonia may increase with high doses
  • Risk of developing tardive dyskinesia and likelihood of it becoming irreversible may increase as the duration of treatment and total cumulative dose of antipsychotic drugs administered to the patient increase

Drug interactions overview

  • Coadministration with strong (eg, ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil) and moderate CYP3A4 inhibitors increased exposure of lurasidone (see Dosage Modifications, Contraindications)
  • Coadministration with strong (eg, rifampin, avasimibe, St. John’s wort, phenytoin, carbamazepine) and moderate CYP3A4 inducers decreased exposure of lurasidone (see Dosage Modifications, Contraindications)

How does this medication work? What will it do for me?

Lurasidone belongs to the group of medications called atypical antipsychotics. It is used to treat symptoms of schizophrenia in adults and adolescents (aged 15 to 17 years). Symptoms of schizophrenia are believed to be caused by an imbalance of certain chemicals in the brain known as neurotransmitters. This medication works by affecting the actions of these neurotransmitters. Lurasidone is also used to treat the symptoms of depression associated with bipolar disorder in adults.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

20 mg
Each white-to-off-white, round tablet, debossed with “L20” on one side, contains 20 mg of lurasidone hydrochloride. Nonmedicinal ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, pregelatinized starch, and Opadry (hypromellose, titanium dioxide, and polyethylene glycol).

40 mg
Each white-to-off-white, round tablet, debossed with “L40” on one side, contains 40 mg of lurasidone hydrochloride. Nonmedicinal ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, pregelatinized starch, and Opadry (hypromellose, titanium dioxide, and polyethylene glycol).

60 mg
Each white-to-off-white, capsule-shaped tablet, debossed with “L60” on one side, contains 60 mg of lurasidone hydrochloride. Nonmedicinal ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, pregelatinized starch, and Opadry (hypromellose, titanium dioxide, and polyethylene glycol).

80 mg
Each pale green, oval tablet, debossed with “L80” on one side, contains 80 mg of lurasidone hydrochloride. Nonmedicinal ingredients: carnauba wax, croscarmellose sodium, FD&C Blue No. 2 Aluminum Lake, hypromellose, magnesium stearate, mannitol, pregelatinized starch, Opadry (hypromellose, titanium dioxide, and polyethylene glycol), and yellow ferric oxide.

120 mg
Each white-to-off-white, oval tablet, debossed with “L120” on one side, contains 120 mg of lurasidone hydrochloride. Nonmedicinal ingredients: carnauba wax, croscarmellose sodium, hypromellose, magnesium stearate, mannitol, pregelatinized starch, and Opadry (hypromellose, titanium dioxide, and polyethylene glycol).

How should I use this medication?

For the treatment of schizophrenia, the usual recommended starting dose is 40 mg once a day. Your dose may be increased depending on how you respond to the medication. Many people experience benefit from this medication at 40 mg or 80 mg daily. The maximum recommended dose for adolescents is 80 mg daily.

For the treatment of depression associated with bipolar disorder, the usual recommended starting dose is 20 mg once daily. Your doctor may increase your dose depending on how well you respond to treatment. Many people experience benefit from this medication at doses of 20 mg to 60 mg daily.

Lurasidone should be taken with food (at least 350 calories) and swallowed whole with water at approximately the same time each day. Do not stop taking this medication or change the time of the day you take it without consulting your doctor.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important that this medication be taken exactly as prescribed by your doctor to ensure that you are getting the maximum benefit from the medication. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take lurasidone if you:

  • are allergic to lurasidone or any ingredients of the medication
  • are taking certain medications that interact with lurasidone (e.g., ketoconazole or rifampin).

For a complete list of interactions, see the “What other drugs could interact with this medication?” section.

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • drowsiness or sleepiness
  • nausea
  • restlessness
  • tremor, muscle stiffness, slowing of movement
  • vomiting
  • weight gain

Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • constipation (new or worsening)
  • decreased sexual function (men)
  • difficulty swallowing
  • feeling faint or dizzy, losing consciousness, or feeling a change in the way your heart beats (palpitations)
  • involuntary movements mainly of your face or tongue
  • menstrual changes
  • signs of a blood clot in blood vessels, such as sudden vision change or dizziness, chest pain, or pain and swelling in one leg muscle
  • swelling of the breasts
  • symptoms of an infection (e.g., fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
  • symptoms of blood clots (e.g., swelling, pain, and redness in an arm or leg that can be warm to touch, or sudden chest pain and difficulty breathing)
  • symptoms of decreased blood pressure (e.g., lightheadedness or fainting when rising too quickly from a sitting or lying position)
  • symptoms of increased blood sugar (e.g., feeling very thirsty, feeling very hungry, needing to urinate more than usual, weakness or tiredness, feeling sick to your stomach, confusion, fruity-smelling breath)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • long-lasting (greater than 4 hours in duration) and painful erection of the penis
  • seizure
  • signs of neuroleptic malignant syndrome (e.g., pronounced muscle stiffness or inflexibility with high fever, rapid or irregular heartbeat, sweating, confusion, or reduced consciousness)
  • symptoms of a severe allergic reaction such as swelling of the mouth, face, lips, or tongue, possibly with difficulty breathing
  • symptoms of a stroke (e.g., sudden weakness or numbness of the face, arms, or legs; dizziness; headache; difficulty speaking; vision problems), even if they occur for a short period of time
  • very dark (“tea-coloured”) urine, muscle tenderness, aching

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Blood clots: Lurasidone may increase the risk of blood clots, especially in the lower leg. Talk to your doctor or pharmacist if you have risk factors for developing blood clots (e.g., a family history of blood clots, recent major surgery, immobility due to air travel or other reason). Contact your doctor immediately if you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision, or difficulty speaking.

Body temperature: This medication, like other antipsychotic medications, can disrupt the body’s ability to control body temperature. People who exercise vigorously, who are exposed to extreme heat, are dehydrated, or are taking anticholinergic medications (e.g., benztropine, oxybutynin) are more at risk. Contact your doctor as soon as possible if you feel very hot and are unable to cool.

Diabetes: Lurasidone, like other similar medications, can increase blood sugar levels. If you have diabetes or are at risk for diabetes (e.g., family history of diabetes, obesity), discuss with your doctor how this medication may affect your medical condition and whether any special monitoring is needed. If you develop symptoms of high blood sugar (e.g., excessive thirst or hunger, weakness, confusion, weight loss), contact your doctor.

Drowsiness/reduced alertness: Lurasidone may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how this medication affects you.

Heart conditions: Do not take lurasidone if you have a history of abnormal heart rhythms (including QT prolongation), slow heartbeat, or low potassium or magnesium levels, or if you are taking a medication that can cause QT prolongation (e.g., quinidine, procainamide, amiodarone, moxifloxacin). If you are at risk for heart rhythm problems (e.g., people with heart failure, angina, low potassium or magnesium levels), discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney function: If you have kidney problems or reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Low blood pressure: Lurasidone may cause a lowering of blood pressure when rising from a sitting or lying position, or a racing heart rate, especially during the few weeks of treatment. If you feel dizzy or lightheaded or feel your pulse is racing, and this feeling does not go away after a few minutes, call your doctor. Because this medication can cause dizziness or lightheadedness, do not get up too quickly after you have been sitting or lying for prolonged periods. If you have heart disease (e.g., heart failure, heart attack) or are taking medications that lower blood pressure, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Movement disorders: There is a risk of developing tardive dyskinesia (TD), a condition involving repetitive, uncontrollable, and purposeless movements (such as grimacing; tongue protrusion; lip smacking; puckering; rapid eye blinking; rapid movements of the arms, legs, and body trunk). If you experience any of these symptoms, contact your doctor immediately.

Neuroleptic malignant syndrome (NMS): A risk of developing this condition has been associated with antipsychotic medications, including lurasidone. If you experience increased sweating and sensations of warmth, muscle stiffness, emotional and behavioural changes, or irregular heartbeat, contact your doctor immediately. People taking this medication should take care to avoid becoming overheated or dehydrated.

Prolactin levels: As with other antipsychotics, lurasidone can elevate levels of the hormone prolactin. This may lead to symptoms such as spontaneous flow of milk from the breast, irregular menstruation, breast enlargement in males, diminished sexual function in males, and decreased bone strength. If you experience any of these symptoms, contact your doctor.

Seizures: Lurasidone may reduce seizure control for people with a history of seizures or those who are at risk of developing seizures. If you have a history of seizures, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Suicidal behaviour: People taking this medication may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. These symptoms may occur within several weeks after starting this medication. If you experience these side effects or notice them in a family member who is taking this medication, contact your doctor immediately. You should be closely monitored by your doctor for emotional and behaviour changes while taking this medication.

Tardive dyskinesia: Lurasidone, like some other antipsychotic medications, may cause tardive dyskinesia (TD) to develop. TD is a potentially irreversible syndrome of involuntary, repetitive movements of the face and tongue muscles. Although TD appears most commonly in seniors, especially women, it is impossible to predict who will develop it. The risk of developing TD increases with higher doses and long-term treatment. If you experience muscle twitching or abnormal movements of the face or tongue, contact your doctor as soon as possible.

Weight gain: Lurasidone may cause weight gain. Consult your doctor or pharmacist if you find the change to be of concern.

White blood cells: As with other antipsychotics, lurasidone can lower the number of infection-fighting white blood cells in your blood. This can increase your risk of infections. If you experience frequent colds or other infections, contact your doctor. Your doctor will monitor your white blood cell levels with blood tests during treatment with lurasidone.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Babies born to mothers that take this medication in the last 3 months of pregnancy may experience withdrawal symptoms after they are born, including breathing problems, difficulty feeding or irritability. If you have been taking this medication during pregnancy, make sure that everyone involved in caring for you and your baby are aware.

Breast-feeding: It is not known if lurasidone passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using lurasidone for the treatment of schizophrenia has not been established for children less than 15 years of age. The safety and effectiveness of using lurasidone for the treatment of depression associated with bipolar disorder has not been established for children less than 18 years of age.

Seniors: Seniors with dementia who take lurasidone or other similar medications are at an increased risk of dying. There may be a higher risk of liver, kidney, and heart problems, and a higher risk of drug interactions for seniors. Talk to your doctor about the risks and benefits of using this medication.

What other drugs could interact with this medication?

There may be an interaction between lurasidone and any of the following:

  • abiraterone acetate
  • alcohol
  • alpha agonists (e.g., clonidine, methyldopa)
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamfetamine, methamphetamine)
  • angiotensin-converting enzyme inhibitors (ACEIs; captopril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candesartan, irbesartan, losartan)
  • antihistamines (e.g., cetirizine, doxylamine, diphenhydramine, hydroxyzine, loratadine)
  • anti-Parkinson medications (e.g., amantadine, apomorphine, bromocriptine, levodopa, pramipexole, ropinirole)
  • antipsychotics (e.g., chlorpromazine, clozapine, haloperidol, olanzapine, quetiapine, risperidone)
  • aprepitant
  • azelastine
  • “azole” antifungals (e.g., ketoconazole, fluconazole, itraconazole)
  • barbiturates (e.g., pentobarbital, phenobarbital)
  • benzodiazepines (e.g., alprazolam, diazepam, lorazepam, midazolam)
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • bicalutamide
  • boceprevir
  • bosentan
  • brimonidine
  • bromocriptine
  • buprenorphine
  • buspirone
  • cabergoline
  • calcium channel blockers (e.g., amlodipine, diltiazem, nifedipine, verapamil)
  • cannabis
  • chloral hydrate
  • cimetidine
  • cobicistat
  • conivaptan
  • crizotinib
  • cyclobenzaprine
  • cyclosporine
  • dabrafenib
  • dasatinib
  • deferasirox
  • dextromethorphan
  • diabetes medications (e.g., chlorpropamide, glipizide, glyburide, insulin, metformin, nateglinide, rosiglitazone)
  • disopyramide
  • diuretics (e.g., furosemide, hydrochlorothiazide)
  • dofetilide
  • donepezil
  • dopamine
  • dronabinol
  • dronedarone
  • droperidol
  • enzalutamide
  • epinephrine
  • ergot alkaloids (e.g., ergotamine, dihydroergotamine)
  • galantamine
  • general anesthetics (medications used to put people to sleep before surgery)
  • gabapentin
  • grapefruit juice
  • HIV non-nucleoside reverse transcriptase inhibitors (e.g., delavirdine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, lopinavir, nelfinavir, ritonavir)
  • imatinib
  • lithium
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • methylphenidate
  • metoclopramide
  • metronidazole
  • mifepristone
  • mirtazapine
  • mitotane
  • modafinil
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • muscle relaxants (e.g., baclofen, cyclobenzaprine, methocarbamol, orphenadrine)
  • nabilone
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • nefazodone
  • norepinephrine
  • norfloxacin
  • olopatadine
  • pimozide
  • procainamide
  • quinidine
  • rifabutin
  • rifampin
  • rivastigmine
  • St. John’s wort
  • scopolamine
  • seizure medications (e.g., carbamazepine, gabapentin, levetiracetam, phenytoin, topiramate)
  • selective serotonin reuptake inhibitors (SSRIs; e.g., citalopram, fluoxetine, paroxetine, sertraline)
  • serotonin-norepinephrine reuptake inhibitors (SNRIs; e.g., desvenlafaxine, duloxetine, venlafaxine)
  • siltuximab
  • stiripentol
  • tapentadol
  • tetrabenazine
  • tetracyclines (e.g., doxycycline, minocycline, tetracycline)
  • tetrahydrocannabinol
  • thalidomide
  • tocilizumab
  • tramadol
  • trazodone
  • tricyclic antidepressants (e.g., amitriptyline, clomipramine, desipramine, trimipramine)
  • “triptan” migraine medications (e.g., eletriptan, sumatriptan)
  • tryptophan
  • zolpidem
  • zopiclone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2020. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Latuda

The Overdose is Gross: What Happens to your Body when you O.D.

A drug overdose may seem like something that won’t happen to you or someone that you love.

You know that there is an overdose danger associated with using drugs but you may think that you never intend to overdose and therefore it won’t happen to you, or that only some teens get addicted but you won’t.

Drug overdose is becoming increasingly common, and the consequences aren’t pretty. Overdose can happen when you consume too much of one particular drug, or when you mix one or more drugs together. It also happens quite easily when using street drugs, because you can’t be sure of the exact dosage.

What Happens to Your Body When You Overdose?

There are many symptoms of overdose that you should be aware of, and you should know that most of them are not attractive. If you overdose, your friends and others around you might see you experience the following:

  • Your heart will start to race, and you might begin sweating. You can easily become confused or disoriented, and you may even lose consciousness.
  • Vomiting and diarrhea are common during a drug overdose, and you won’t be able to control it. Blood in your vomit or in your stool are signs of life-threatening complications.
  • You might begin hallucinating. You will be seeing things that don’t really exist, and you will be talking about things that do not make sense to those around you.
  • You may become agitated and paranoid. This could make others around you feel very concerned and confused, and you may say things that you do not really mean.
  • You could have seizures, which can result in physical injury — both external and internal.

What are the Consequences of Overdose?

The consequences of overdose are severe. In many cases, overdose leads to death.

Overdose kills more people each year than car accidents, falling and guns.

According to the Center for Disease Control, 105 people die every day from drug overdose in the United States. In total, 38,329 deaths as a result of drug overdose in 2010, and more than 30,000 of those deaths were unintentional.

If a drug overdose does not lead to death, it can lead to serious, long-term consequences. Some people who overdose on drugs and survive have to live with permanent brain damage. Hypoxic brain injury results when there is not enough oxygen flowing to the brain, and it is a consequence of drug overdose, specifically heroin overdose.

This type of brain damage can impact your ability to see or hear properly. It can leave you uncoordinated and unable to move easily. It can make it more difficult for you to think clearly and it can damage your memory. It can make it challenging for you to read and write.

Any type of drug use puts you at risk for overdose. In most cases, the overdose is not intentional. You may not think that your recreational drug use will lead to overdose, but it can happen quickly and easily. If you or someone you love is using and abusing drugs and alcohol, the best thing you can do is get help from professionals who can give you the treatment and guidance you need to get on the path toward a better life.

To learn more about overdose and to get help, give us a call at 877-466-0620.

This Is Exactly What Happens When You Overdose

Despite the alarming increase in US opioid overdoses, most of us would be hard pressed to describe exactly what happens in the body during one. Here’s a step-by-step explainer.

While there’s no one circumstance that will push a body over the edge from a high to an overdose, there are certain things that appear to put a person at greater risk: Having been in detox and then returning to the drugs, mixing opioids with other sedatives (like alcohol or benzos), and in some cases, using them in high doses (thanks to the existence of super-powerful opioids like fentanyl and carfentanil, this can happen unbeknownst to the user).

A person on the verge of an overdose rarely realizes what is happening to them, but there are easily recognizable signs that other people might spot, including extreme drowsiness, cold hands, cloudy thinking, nausea and/or vomiting, and especially slowed breathing (fewer than ten breaths per minute).

First, the drug spreads throughout your body. When you take an opioid, whether a pill or an injectable, the drug enters the body and travels through your synapses, through the heart and into your lungs, where the blood gets flushed with oxygen before getting drawn back into the heart once again.

With the next pump of your heart, your now opioid-rich blood is pushed out to the rest of the body, where it plugs into the system of opioid receptors all over your body.

Images: Rena Medow

When it hits the brain, you get happy. Once the opioid molecules are ferried across the blood-brain barrier, they enter a section of the brain at the center of your reward circuitry called the nucleus accumbens, where the happiness hormone dopamine is produced. There, the drug latches onto GABAergic neurons.

Imagine GABA as a dam: They make sure our dopamine doesn’t overflow, which can cause agitation and paranoia. Opioid molecules blow that dam open, and let dopamine spill over into the bloodstream, creating a feeling of bliss, way beyond what our GABA cells would normally allow us to experience.

Soon the high evens out, and even before the rush is over, you might start to nod off, head dipping and jerking as you drift between waking and sleeping.

Your breath starts to slow. The opioid works on the systems that control both sleep and breathing: At the base of your brain lies a respiratory control center that drives your breathing, reacting to the level of carbon dioxide and oxygen in your blood to spur you to breathe. During an overdose, the slowed breathing that occurs with opioid ingestion of any kind becomes dangerously slow, leading to a complete stop.

Then your heart. Your heart rate slows as the opioid suppresses neurological signals. The oxygen level falls low enough that the heart starts having abnormal rhythms; the heart is not beating properly. At this point some overdose patients have sudden cardiac arrest.

Things begin to shut down. Because there is an overwhelming amount of opioid in your brain, your body stops receiving the correct signals at all to breathe. Your lungs and heart are barely working.

With lungs and heart barely working, your brain begins to be damaged by lack of oxygen. The brain is highly sensitive to lack of oxygen; permanent brain damage sets in after four minutes of oxygen deprivation in most situations. Variables such as the temperature of the body can affect the damage to the brain—the colder the body, the more reduced the brain damage. If you’re receiving CPR during this period, brain damage can be prevented or reduced.

You foam at the mouth, or choke. Sometimes opioid overdose can include pulmonary edema (fluid leak into the airspaces of the lung). This is a noncardiogenic pulmonary edema, meaning it is not caused by fluid backup from a failing heart; doctors are still unsure of the exact mechanism behind this event. This manifests as foam coming out of your mouth.

It is not uncommon for opioid overdose patients to experience aspiration. This is when your body’s natural gag response is suppressed or eliminated by the opioid’s effects on the respiratory control center of the brain. As you become increasingly less conscious, the natural secretions in the back of the throat are not ejected or swallowed. Opioid patients who vomit can also aspirate their vomit and die.

Your brain gets permanently damaged. Opioid overdose can cause seizures from lack of oxygen to the brain. These seizures can further damage the brain. Brain damage–from mild to severe–is not often discussed with opioid overdose but is a real possibility. Overdose patients can end up paralyzed and unable to speak.

Narcan can reverse the effects. Narcan, an anti-overdoes medication that is widely available, can usually reverse these effects. Sometimes overdose patients have to be given multiple treatments of Narcan, depending on the amount of opioids in their system. Narcan can always be attempted for revival if the patient is still alive. Given through an IV, Narcan works in seconds, given through a shot or with nasal spray, within minutes. Narcan moves into the receptors of the brain where the opioid is stuck, knocks the opioid molecules off the receptor, and replaces them. The opioid is then metabolized in the body. Narcan generally has no side effects.

If a patient overdosed on Oxycontin, which has a slow release in the gut, they can be revived from overdose only to overdose again. They may need an IV infusion of Narcan in slow-release, until the opioids are cleared from the body.

People who have overdosed on heroin can go into full, immediate withdrawal after a Narcan dosing, so doctors will typically attempt to give small, repeated doses of Narcan to avoid a patient waking and immediately leaving the hospital in search of more opioids.

Information provided by Anthony Morocco, ER doctor at Sharp Memorial Hospital in San Diego, CA.

Read This Next: The Men Who Catch Your Lobsters Are Self-Medicating With Heroin

What is an overdose?

Overdose (OD) happens when a toxic amount of a drug, or combination of drugs overwhelms the body.

People can overdose on lots of things, including alcohol, Tylenol, opioids or a mixture of drugs. Opioid overdoses happen when there are so many opioids or a combination of opioids and other drugs in the body that the victim is not responsive to stimulation and/or breathing is inadequate. This happens because opioids fit into specific receptors that also affect the drive to breathe. If someone can not breathe or is not breathing enough, the oxygen levels in the blood decrease and the lips and fingers turn blue- this is called cyanosis. This oxygen starvation eventually stops other vital organs like the heart, then the brain. This leads to unconsciousness, coma, and then death. Within 3-5 minutes without oxygen, brain damage starts to occur, soon followed by death. With opioid overdoses, surviving or dying wholly depends on breathing and oxygen. Fortunately, this process is rarely instantaneous; people slowly stop breathing which usually happens minutes to hours after the drug was used. While people have been “found dead with a needle in their arm,” more often there is time to intervene between when an overdose starts and before a victim dies.

Graphics: Maya Doe-Simkins

Heroin, prescription opioids (like Oxycontin, Fentanyl, Morphine, Vicodin, Percocet, etc.) and other downers such as alcohol and benzodiazepines (like Xanax, Klonopin, Valium, Ativan, etc.) are a particularly dangerous combo, since they all affect the body’s central nervous system, which slows breathing, blood pressure, and heart rate, and in turn reduces body temperature.

In a stimulant overdose drugs like speed, cocaine, and ecstasy raise the heart rate, blood pressure, and body temperature, and speed up breathing. This can lead to a seizure, stroke, heart attack or death.

Next Page: Understanding Naloxone

About the author

Leave a Reply

Your email address will not be published. Required fields are marked *