Latuda 80mg (Latuda 80mg) is an antipsychotic medicine. It works by changing the effects of chemicals in the brain.
Latuda 80mg is used to treat schizophrenia in adults.
Latuda 80mg is also used to treat episodes of depression in people with bipolar disorder (manic depression).
Latuda 80mg indications
An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Schizophrenia
Latuda 80mg is indicated for the treatment of patients with schizophrenia.
The efficacy of Latuda 80mg in schizophrenia was established in five 6-week controlled studies of adult patients with schizophrenia.
The effectiveness of Latuda 80mg for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use Latuda 80mg for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
Depressive Episodes Associated with Bipolar I Disorder
Monotherapy: Latuda 80mg is indicated as monotherapy for the treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression). The efficacy of Latuda 80mg was established in a 6-week monotherapy study in adult patients with bipolar depression.
Adjunctive Therapy with Lithium or Valproate: Latuda 80mg is indicated as adjunctive therapy with either lithium or valproate for the treatment of patients with major depressive episodes associated with bipolar I disorder (bipolar depression). The efficacy of Latuda 80mg as adjunctive therapy was established in a 6-week study in adult patients with bipolar depression who were treated with lithium or valproate.
The effectiveness of Latuda 80mg for longer-term use, that is, for more than 6 weeks, has not been established in controlled studies. Therefore, the physician who elects to use Latuda 80mg for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient.
The efficacy of Latuda 80mg in the treatment of mania associated with bipolar disorder has not been established.
How should I use Latuda 80mg?
Use Latuda 80mg as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Latuda 80mg comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Latuda 80mg refilled.
Take Latuda 80mg by mouth with food (at least 350 calories).
Swallow Latuda 80mg whole. Do not split, crush, or chew before swallowing.
Do not eat grapefruit or drink grapefruit juice while you use Latuda 80mg.
Do not suddenly stop taking Latuda 80mg without checking with your doctor. You may have an increased risk of side effects. If you need to stop Latuda 80mg, your doctor may need to gradually lower your dose.
Take Latuda 80mg on a regular schedule to get the most benefit from it. Taking Latuda 80mg at the same time each day will help you remember to take it.
Continue to take Latuda 80mg even if you feel well. Do not miss any doses.
If you miss a dose of Latuda 80mg, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once unless your doctor tells you to. If you are not sure what to do, call your doctor.
Ask your health care provider any questions you may have about how to use Latuda 80mg.
Uses of Latuda 80mg in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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This medication is used to treat certain mental/mood disorders (such as schizophrenia, depression associated with bipolar disorder). Latuda 80mg helps you to think more clearly, feel less nervous, and take part in everyday life. It may also help to decrease hallucinations (hearing/seeing things that are not there). In addition, this medication may improve your mood, sleep, appetite, and energy level. Latuda 80mg is a psychiatric medication that belongs to the class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.
How to use Latuda 80mg
Read the Medication Guide provided by your pharmacist before you start taking Latuda 80mg and each time you get a refill. If you have any questions, ask your doctor or pharmacist.
Take this medication by mouth with food as directed by your doctor, usually once daily. Dosage is based on your medical condition, kidney/liver function, other drugs you are taking, and your response to treatment.
Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day.
Continue taking this medication exactly as prescribed, even if you are feeling better and thinking more clearly. Do not increase your dose or take this drug more often than prescribed. Your symptoms will not improve any faster, and your risk of side effects will increase. Do not stop taking this medication without consulting your doctor.
Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.
Tell your doctor if your condition does not improve or if it worsens. It may take several weeks before you feel the full benefit of this medication.
Latuda 80mg description
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Latuda 80mg is an atypical antipsychotic developed by Dainippon Sumitomo Pharma. It was approved by the U.S. Food and Drug Administration (FDA) for treatment of schizophrenia on October 29, 2010 and is currently pending approval for the treatment of bipolar disorder in the United States. (Wikipedia)
Latuda 80mg dosage
Latuda 80mg Dosage
Generic name: Latuda 80mg hydrochloride 20mg
Dosage form: tablet, film coated
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Schizophrenia
The recommended starting dose of Latuda 80mg is 40 mg once daily. Initial dose titration is not required. Latuda 80mg has been shown to be effective in a dose range of 40 mg per day to 160 mg per day. The maximum recommended dose is 160 mg per day.
Depressive Episodes Associated with Bipolar I Disorder
The recommended starting dose of Latuda 80mg is 20 mg given once daily as monotherapy or as adjunctive therapy with lithium or valproate. Initial dose titration is not required. Latuda 80mg has been shown to be effective in a dose range of 20 mg per day to 120 mg per day as monotherapy or as adjunctive therapy with lithium or valproate. The maximum recommended dose, as monotherapy or as adjunctive therapy with lithium or valproate, is 120 mg per day. In the monotherapy study, the higher dose range (80 mg to 120 mg per day) did not provide additional efficacy, on average, compared to the lower dose range (20 to 60 mg per day) [see Clinical Studies (14.2).
Administration Instructions
Latuda 80mg should be taken with food (at least 350 calories). Administration with food substantially increases the absorption of Latuda 80mg. Administration with food increases the AUC approximately 2-fold and increases the Cmax approximately 3-fold. In the clinical studies, Latuda 80mg was administered with food.
Dose Modifications in Special Populations
Renal Impairment
Dose adjustment is recommended in moderate (creatinine clearance: 30 to <50 mL/min) and severe renal impairment (creatinine clearance <30 mL/min) patients. The recommended starting dose is 20 mg per day. The dose in these patients should not exceed 80 mg per day.
Hepatic Impairment
Dose adjustment is recommended in moderate (Child-Pugh Score = 7 to 9) and severe hepatic impairment (Child-Pugh Score = 10 to 15) patients. The recommended starting dose is 20 mg per day. The dose in moderate hepatic impairment patients should not exceed 80 mg per day and the dose in severe hepatic impairment patients should not exceed 40 mg/day.
Dose Modifications Due to Drug Interactions
Concomitant Use with CYP3A4 Inhibitors
Latuda 80mg should not be used concomitantly with a strong CYP3A4 inhibitor (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.).
If Latuda 80mg is being prescribed and a moderate CYP3A4 inhibitor (e.g. diltiazem, atazanavir, erythromycin, fluconazole, verapamil etc.) is added to the therapy, the Latuda 80mg dose should be reduced to half of the original dose level. Similarly, if a moderate CYP3A4 inhibitor is being prescribed and Latuda 80mg is added to the therapy, the recommended starting dose of Latuda 80mg is 20 mg per day, and the maximum recommended dose of Latuda 80mg is 80 mg per day.
Grapefruit and grapefruit juice should be avoided in patients taking Latuda 80mg, since these may inhibit CYP3A4 and alter Latuda 80mg concentrations.
Concomitant Use with CYP3A4 Inducers
Latuda 80mg should not be used concomitantly with a strong CYP3A4 inducer (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). If Latuda 80mg is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Latuda 80mg dose after chronic treatment (7 days or more) with the CYP3A4 inducer.
Latuda 80mg is predominantly metabolized by CYP3A4. Latuda 80mg should not be used concomitantly with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin, ritonavir, voriconazole, mibefradil, etc.) or strong CYP3A4 inducers (e.g., rifampin, avasimibe, St. John's wort, phenytoin, carbamazepine, etc.). The Latuda 80mg dose should be reduced to half of the original level when used concomitantly with moderate inhibitors of CYP3A4 (e.g., diltiazem, atazanavir, erythromycin, fluconazole, verapamil, etc.). If Latuda 80mg is used concomitantly with a moderate CYP3A4 inducer, it may be necessary to increase the Latuda 80mg dose.
Lithium: It is not necessary to adjust the Latuda 80mg dose when used concomitantly with lithium (Figure 1).
Valproate: It is not necessary to adjust the Latuda 80mg dose when used concomitantly with valproate. A dedicated drug-drug interaction study has not been conducted with valproate and Latuda 80mg. Based on pharmacokinetic data from the bipolar depression studies valproate levels were not affected by Latuda 80mg, and Latuda 80mg concentrations were not affected by valproate.
Grapefruit: Grapefruit and grapefruit juice should be avoided in patients taking Latuda 80mg, since these may inhibit CYP3A4 and alter Latuda 80mg concentrations.
Figure 1: Impact of Other Drugs on Latuda 80mg Pharmacokinetics
Potential for Latuda 80mg to Affect Other Drugs
No dose adjustment is needed for lithium, substrates of P-gp, CYP3A4 (Figure 2) or valproate when coadministered with Latuda 80mg. ).
Figure 2: Impact of Latuda 80mg on Other Drugs
Drug Abuse And Dependence
Controlled Substance
Latuda 80mg is not a controlled substance.
Abuse
Latuda 80mg has not been systematically studied in humans for its potential for abuse or physical dependence or its ability to induce tolerance. While clinical studies with Latuda 80mg did not reveal any tendency for drug-seeking behavior, these observations were not systematic and it is not possible to predict the extent to which a CNS-active drug will be misused, diverted and/or abused once it is marketed. Patients should be evaluated carefully for a history of drug abuse, and such patients should be observed carefully for signs of Latuda 80mg misuse or abuse (e.g., development of tolerance, drug-seeking behavior, increases in dose).
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 (Hyperglycemia and Diabetes Mellitus, Dyslipidemia, and Weight Gain)
Hyperprolactinemia
Leukopenia, Neutropenia, and Agranulocytosis
Orthostatic Hypotension and Syncope
Seizures
Potential for Cognitive and Motor Impairment
Body Temperature Dysregulation
Suicide
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.
The information below is derived from an integrated clinical study database for Latuda 80mg consisting of 3799 patients exposed to one or more doses of Latuda 80mg 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 80mg-treated patients had at least 24 weeks and 371 Latuda 80mg-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 studies for schizophrenia in which Latuda 80mg 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 80mg were somnolence, akathisia, extrapyramidal symptoms, and nausea.
Adverse Reactions Associated with Discontinuation of Treatment
A total of 9.5% (143/1508) Latuda 80mg-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 80mg that were at least 2% and at least twice the placebo rate.
Adverse Reactions Occurring at an Incidence of 2% or More in Latuda 80mg-Treated Patients
Adverse reactions associated with the use of Latuda 80mg (incidence of 2% or greater, rounded to the nearest percent and Latuda 80mg incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with schizophrenia) are shown in Table 15.
Table 15: Adverse Reactions in 2% or More of Latuda 80mg-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in Short-term Schizophrenia Studies
Body System or Organ Class
Percentage of Patients Reporting Reaction
Placebo
(N=708)
(%)
Latuda 80mg
20 mg/day
(N=71)
(%)
40 mg/day
(N=487)
(%)
80 mg/day
(N=538)
(%)
120 mg/day
(N=291)
(%)
160 mg/day
(N=121)
(%)
All Latuda 80mg
(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
Dose-Related Adverse Reactions in the Schizophrenia Studies
Akathisia and extrapyramidal symptoms were dose-related. The frequency of akathisia increased with dose up to 120 mg/day (5.6% for Latuda 80mg 20 mg, 10.7% for Latuda 80mg 40 mg, 12.3% for Latuda 80mg 80 mg, and 22.0% for Latuda 80mg 120 mg). Akathisia was reported by 7.4% (9/121) of patients receiving 160 mg/day. Akathisia occurred in 3.0% of subjects receiving placebo. The frequency of extrapyramidal symptoms increased with dose up to 120 mg/day (5.6% for Latuda 80mg 20 mg, 11.5% for Latuda 80mg 40 mg, 11.9% for Latuda 80mg 80 mg, and 22.0% for Latuda 80mg 120 mg).
Bipolar Depression (Monotherapy)
The following findings are based on the short-term, placebo-controlled premarketing study for bipolar depression in which Latuda 80mg 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 80mg 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 80mg-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 80mg that were at least 2% and at least twice the placebo rate.
Adverse Reactions Occurring at an Incidence of 2% or More in Latuda 80mg-Treated Patients
Adverse reactions associated with the use of Latuda 80mg (incidence of 2% or greater, rounded to the nearest percent and Latuda 80mg incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with bipolar depression) are shown in Table 16.
Table 16: Adverse Reactions in 2% or More of Latuda 80mg-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in a Short-term Monotherapy Bipolar Depression Study
Body System or Organ Class Dictionary-derived Term
** Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence
Dose-Related Adverse Reactions in the Monotherapy Study
In the short-term, placebo-controlled study (involving lower and higher Latuda 80mg dose ranges) the adverse reactions that occurred with a greater than 5% incidence in the patients treated with Latuda 80mg in any dose group and greater than placebo in both groups were nausea (10.4%, 17.4%), somnolence (7.3%, 13.8%), akathisia (7.9%, 10.8%), and extrapyramidal symptoms (4.9%, 9.0%) for Latuda 80mg 20 to 60 mg/day and Latuda 80mg 80 to 120 mg/day, respectively.
Bipolar Depression
Adjunctive Therapy with Lithium or Valproate
The following findings are based on two short-term, placebo-controlled premarketing studies for bipolar depression in which Latuda 80mg 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 80mg were akathisia and somnolence.
Adverse Reactions Associated with Discontinuation of Treatment
A total of 5.8% (21/360) Latuda 80mg-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 80mg that were at least 2% and at least twice the placebo rate.
Adverse Reactions Occurring at an Incidence of 2% or More in Latuda 80mg-Treated Patients
Adverse reactions associated with the use of Latuda 80mg (incidence of 2% or greater, rounded to the nearest percent and Latuda 80mg incidence greater than placebo) that occurred during acute therapy (up to 6 weeks in patients with bipolar depression) are shown in Table 17.
Table 17: Adverse Reactions in 2% or More of Latuda 80mg-Treated Patients and That Occurred at Greater Incidence than in the Placebo-Treated Patients in the Short-term Adjunctive Therapy Bipolar Depression Studies
Body System or Organ Class Dictionary-derived Term
** Somnolence includes adverse event terms: hypersomnia, hypersomnolence, sedation, and somnolence
Extrapyramidal Symptoms
Schizophrenia
In the short-term, placebo-controlled schizophrenia studies, for Latuda 80mg-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 80mg-treated patients was 12.9% versus 3.0% for placebo-treated patients. Incidence of EPS by dose is provided in Table 18.
Table 18: Incidence of EPS Compared to Placebo in Schizophrenia Studies
Adverse Event Term
Placebo
(N=708)
(%)
Latuda 80mg
20 mg/day
(N=71)
(%)
40 mg/day
(N=487)
(%)
80 mg/day
(N=538)
(%)
120 mg/day
(N=291)
(%)
160 mg/day
(N=121)
(%)
All EPS events
9
10
21
23
39
20
All EPS events, excluding Akathisia/ Restlessness
6
6
11
12
22
13
Akathisia
3
6
11
12
22
7
Dystonia*
< 1
0
4
5
7
2
Parkinsonism**
5
6
9
8
17
11
Restlessness
1
1
3
1
3
2
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, hypokinesia, muscle rigidity, parkinsonism, psychomotor retardation, and tremor
Bipolar Depression
Monotherapy
In the short-term, placebo-controlled monotherapy bipolar depression study, for Latuda 80mg-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 80mg-treated patients was 9.4% versus 2.4% for placebo-treated patients. Incidence of EPS by dose groups is provided in Table 19.
Table 19: Incidence of EPS Compared to Placebo in the Monotherapy Bipolar Depression Study
Adverse Event Term
Placebo
(N=168)
(%)
Latuda 80mg
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
In the short-term, placebo-controlled adjunctive therapy bipolar depression studies, for Latuda 80mg-treated patients, the incidence of EPS, excluding akathisia and restlessness, was 13.9% versus 8.7% for placebo. The incidence of akathisia for Latuda 80mg-treated patients was 10.8% versus 4.8% for placebo-treated patients. Incidence of EPS is provided in Table 20.
Table 20: Incidence of EPS Compared to Placebo in the Adjunctive Therapy Bipolar Depression Studies
Adverse Event Term
Placebo
(N=334)
(%)
Latuda 80mg 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
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.
Schizophrenia
The mean change from baseline for Latuda 80mg-treated patients for the SAS, BAS and AIMS was comparable to placebo-treated patients, with the exception of the Barnes Akathisia Scale global score (Latuda 80mg, 0.1; placebo, 0.0). The percentage of patients who shifted from normal to abnormal was greater in Latuda 80mg-treated patients versus placebo for the BAS (Latuda 80mg, 14.4%; placebo, 7.1%), the SAS (Latuda 80mg, 5.0%; placebo, 2.3%) and the AIMS (Latuda 80mg, 7.4%; placebo, 5.8%).
Bipolar Depression
Monotherapy
The mean change from baseline for Latuda 80mg-treated patients for the SAS, BAS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in Latuda 80mg-treated patients versus placebo for the BAS (Latuda 80mg, 8.4%; placebo, 5.6%), the SAS (Latuda 80mg, 3.7%; placebo, 1.9%) and the AIMS (Latuda 80mg, 3.4%; placebo, 1.2%).
Adjunctive Therapy with Lithium or Valproate
The mean change from baseline for Latuda 80mg-treated patients for the SAS, BAS and AIMS was comparable to placebo-treated patients. The percentage of patients who shifted from normal to abnormal was greater in Latuda 80mg-treated patients versus placebo for the BAS (Latuda 80mg, 8.7%; placebo, 2.1%), the SAS (Latuda 80mg, 2.8%; placebo, 2.1%) and the AIMS (Latuda 80mg, 2.8%; placebo, 0.6%).
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.
Schizophrenia
In the short-term, placebo-controlled schizophrenia clinical studies, dystonia occurred in 4.2% of Latuda 80mg-treated subjects (0.0% Latuda 80mg 20 mg, 3.5% Latuda 80mg 40 mg, 4.5% Latuda 80mg 80 mg, 6.5% Latuda 80mg 120 mg and 2.5% Latuda 80mg 160 mg) compared to 0.8% of subjects receiving placebo. Seven subjects (0.5%, 7/1508) discontinued clinical trials due to dystonic events – four were receiving Latuda 80mg 80 mg/day and three were receiving Latuda 80mg 120 mg/day.
Bipolar Depression
Monotherapy
In the short-term, flexible-dose, placebo-controlled monotherapy bipolar depression study, dystonia occurred in 0.9% of Latuda 80mg-treated subjects (0.0% and 1.8% for Latuda 80mg 20 to 60 mg/day and Latuda 80mg 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 short-term, flexible-dose, placebo-controlled adjunctive therapy bipolar depression studies, dystonia occurred in 1.1% of Latuda 80mg-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 80mg
Following is a list of adverse reactions reported by patients treated with Latuda 80mg 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 15 or those that appear elsewhere in the Latuda 80mg label are not included. Although the reactions reported occurred during treatment with Latuda 80mg, 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
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
Schizophrenia
Serum Creatinine: In short-term, placebo-controlled trials, the mean change from Baseline in serum creatinine was +0.05 mg/dL for Latuda 80mg-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 80mg-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 21).
Table 21: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in Schizophrenia Studies
Laboratory Parameter
Placebo
(N=708)
Latuda 80mg 20 mg/day
(N=71)
Latuda 80mg 40 mg/day
(N=487)
Latuda 80mg 80 mg/day
(N=538)
Latuda 80mg 120 mg/day
(N=291)
Latuda 80mg 160 mg/day
(N=121)
Serum Creatinine Elevated
2%
1%
2%
2%
5%
7%
Bipolar Depression
Monotherapy
Serum Creatinine: In the 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 80mg-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 80mg-treated patients and 0.6% (1/162) on placebo (Table 22).
Table 22: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in a Monotherapy Bipolar Depression Study
Laboratory Parameter
Placebo
(N=168)
Latuda 80mg 20 to 60 mg/day
(N=164)
Latuda 80mg 80 to 120 mg/day
(N=167)
Serum Creatinine Elevated
< 1%
2%
4%
Adjunctive Therapy with Lithium or Valproate
Serum Creatinine: In 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 80mg-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 80mg-treated patients and 1.6% (5/334) on placebo (Table 23).
Table 23: Serum Creatinine Shifts from Normal at Baseline to High at Study End-Point in the Adjunctive Therapy Bipolar Depression Studies
Latuda 80mg is not for use in psychotic conditions related to dementia. Latuda 80mg may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.
You should not use this medication if you are allergic to Latuda 80mg, or if you are also using ketoconazole (Extina, Ketozole, Nizoral, Xolegal) or rifampin (Rifater, Rifadin, Rifamate).
Before you take Latuda 80mg, tell your doctor if you have liver disease, kidney disease, heart disease, high blood pressure, heart rhythm problems, a history of heart attack or stroke, high cholesterol or triglycerides, low white blood cell (WBC) counts, seizures, diabetes, Parkinson's disease, trouble swallowing, or a history of breast cancer or suicidal thoughts.
While you are taking Latuda 80mg, you may be more sensitive to temperature extremes such as very hot or cold conditions. Avoid getting too cold, or becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Latuda 80mg.
Latuda 80mg may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Drinking alcohol can increase certain side effects of Latuda 80mg.
Stop using Latuda 80mg and call your doctor at once if you have very stiff (rigid) muscles, high fever, sweating, confusion, fast or pounding heartbeats, feeling like you might pass out, tremors, or twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.
There are many other drugs that can interact with Latuda 80mg. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.
DailyMed. "LURASIDONE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
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