Lucipral tablets

Lucipral

  • Active Ingredient: Risperidone
  • 4 mg, 2 mg, 1 mg
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What is Lucipral?

The active ingredient of Lucipral brand is risperidone. Risperidone is a antipsychotic medicine. It works by changing the effects of chemicals in the brain. Risperidone USP is a white to slightly beige powder. It is practically insoluble in water, freely soluble in methylene chloride, and soluble in methanol and 0.1 N HCl . Risperidone tablets, USP are for oral administration and available in 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg strengths. Inactive ingredients are lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, magnesium stearate, hypromellose, titanium dioxide and polyethylene glycol 400. The 0.25 mg, 0.5 mg, 3 mg and 4 mg tablets contain D&C Yellow # 10 aluminum lake. The 0.5 mg and 4 mg tablets also contain FD&C Blue # 2 aluminum lake. The 2 mg tablets contain iron oxide yellow, iron oxide red, and iron oxide black.

Used for

Lucipral is used to treat diseases such as: Agitation, Anxiety, Asperger Syndrome, Autism, Bipolar Disorder, Body Dysmorphic Disorder, Borderline Personality Disorder, Depression, Head Injury, Mania, Nightmares, Paranoid Disorder, Post Traumatic Stress Disorder, Schizoaffective Disorder, Schizophrenia, Severe Mood Dysregulation, Social Anxiety Disorder, Tic Disorder.

Side Effect

Possible side effects of Lucipral include: dandruff; pain or tenderness around the eyes and cheekbones; twisting body movements; intramuscular powder for suspension extended release; agitation.

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How it works

Lucipral belongs to a class of drugs called atypical antipsychotics. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.

Lucipral works by affecting the amount of certain chemicals called neurotransmitters that occur naturally in your brain. It’s thought that people with schizophrenia, bipolar disorder, and autism have an imbalance of certain neurotransmitters. This drug may improve this imbalance.

Lucipral oral tablet may cause drowsiness. It may also cause other side effects.

Mechanism Of Action

The mechanism of action of RISPERDAL®, in schizophrenia, is unknown. However, it has been proposed that the drug's therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism. The clinical effect from RISPERDAL® results from the combined concentrations of Lucipral and its major metabolite, 9-hydroxyLucipral . Antagonism at receptors other than D2 and 5HT2 may explain some of the other effects of RISPERDAL®.

SGAs Included in RCTs

Lucipral is the most studied SGA in children for treatment of ASDs and DBDs, with 12 of 17 RCTs identified during this review pertaining to Lucipral. In other therapeutic domains such as schizophrenia and bipolar disorder, Lucipral is also commonly used. A large part of the reason for the disproportional number of studies involving Lucipral is that it was the first SGA to market, other than clozapine. Due to the risk for agranulocytosis (a severe deficiency of infection-fighting granulocytes, or neutrophils, in the blood) clozapine use has been restricted and extra monitoring is required. In North America, this rare but potentially fatal adverse effect sharply limits clozapine prescribing to only approved indications of schizophrenia and schizoaffective disorder, and only after two other antipsychotic trials are undertaken. These risks and precautions along with its high adverse effect burden make clozapine an unsuitable candidate for treatment of ASDs and DBDs. Lucipral was still under U.S. patent protection when the BPCA, with its incentivization of pediatric medication trials, was signed into law in 2002. Lucipral was the first SGA to obtain FDA approval for treatment of irritability of autism in 2006, followed by aripiprazole in 2009.

No RCTs for ASDs or DBDs were identified involving asenapine, clozapine, lurasidone, paliperidone, or ziprasidone. Other than clozapine (see reasons limiting its use detailed above), the other four drugs are relative newcomers to the SGA market, with market release dates subsequent to publication of the bulk of the RCT data detailed in this chapter. Despite the lack of regulatory approval in Canada, Lucipral and aripiprazole are in some ways now considered established treatments for ASDs and DBDs, and there may be less clinical interest in studying the newer SGAs for these indications. Lucipral is now available in generic formulations in both Canada and the United States, and the drug cost is a fraction of that of branded treatments still under patent protection such as aripiprazole and other newer SGAs.

Michael Stewart, Reviewed by Sid Dajani | Last edited 22 Jun 2017 | Certified by The Information Standard

Lucipral is prescribed for a variety of problems affecting thoughts, feelings or behaviours. Ask your doctor if you are unsure why it has been prescribed for you.

The most common side-effects are feeling drowsy or dizzy, headache and sleeping problems.

ANNOTATED BIBLIOGRAPHY

References updated: 04 June 2018

15 months; only 1 had ALT elevation , degree of surveillance unclear; abstract only).

1 month after discontinuation).

4 years; ultrasound suggested fatty liver).

3300 patients]; average monthly weight gain in pounds was +0.1 with placebo, +0.8 olanzapine, 0.6 Lucipral, -0.3 ziprasidone; a 5% increase in weight occurred after one year in 13% of placebo, 39% haloperidol, 20% ziprasidone, 45% Lucipral and 60% olanzapine treated subjects).

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RISPERDAL® (Lucipral) Tablets

INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. RISPERDAL® (Lucipral) is not approved for the treatment of patients with dementia-related psychosis.

Before taking Lucipral

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking Lucipral it is important that your doctor knows:

  • If you are pregnant or breast-feeding.
  • If you have a heart condition or blood vessel disease.
  • If you have liver, k >

Serious side effects

Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Death from infection and stroke in seniors with dementia
  • high fever (above 100.4°F, or 38°C)
  • heavy sweating
  • stiff muscles
  • confusion
  • changes in your breathing, heart rhythm, and blood pressure
  • kidney failure, with symptoms such as weight gain, lethargy, or urinating less than normal or not at all
  • movements in your face, tongue, or other body parts that you can’t control
  • feeling very thirsty
  • needing to urinate more often than normal
  • feeling very hungry
  • weakness or tiredness
  • nausea
  • confusion
  • fruity-smelling breath
  • High cholesterol and triglyceride levels
  • breast enlargement
  • milky discharge from your nipple
  • erectile dysfunction (trouble getting or keeping an erection)
  • loss of your menstrual period
  • lightheadedness
  • fainting
  • dizziness
  • fever
  • infection
  • Trouble thinking, and impaired judgment and motor skills
  • Seizures
  • Trouble swallowing
  • Priapism (painful erection lasting more than four hours)
  • Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.

    Lucipral oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.

    To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

    Examples of drugs that can cause interactions with Lucipral are listed below.

    Why it’s used

    Lucipral is used to treat the symptoms of several psychiatric conditions. These include:

    • Schizophrenia. This is a mental illness that causes changes in thinking or perception. People with this condition may hallucinate (see or hear things that aren’t there) or have delusions (false beliefs about reality).
    • Acute manic or mixed episodes caused bybipolar I disorder. This drug may be given alone or with the drugs lithium or divalproex. People with bipolar disorder have intense mood episodes. These may include mania (an overly joyful or excited state), depression, or a mixture of both.
    • Irritability associated with autism.Autism affects how a person acts, interacts with others, learns, and communicates. Symptoms of irritability may include aggression towards others, harming yourself, temper tantrums, and mood swings.

    Lucipral may be used as part of a combination therapy. This means you may need to take it with other medications.

    What Is Lucipral and How Does It Work?

    Lucipral is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, irritability associated with autistic disorder). This medication can help you to think clearly and take part in everyday life.

    Lucipral belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

    Lucipral may also be used in combination with other medication to treat depression.

    Lucipral is available under the following different brand names: Risperdal, Risperdal Consta, and Risperdal M-Tab.

    Children

    Lucipral has been assessed in children with autistic disorder and disruptive behavior in a multicenter, two-part, open study (103 c ) . Part one consisted of a 4-month open phase in 63 children (aged 5–17 years; 49 boys) taking risper > n = 16 ) or continued ( n = 16 ); there were more relapses in those who took placebo ( n = 10 ) than in those who continued to take risper > n = 2 ). One of six dropouts in the first part of the study was due to an adverse event (constipation); over the 6 months of the study there was a mean weight gain of 5.1 kg.

    Bipolar Mania – Adjunctive Therapy With Lithium Or Valproate

    The efficacy of RISPERDAL® with concomitant lithium or valproate in the treatment of acute manic or mixed episodes was established in one controlled trial in adult patients who met the DSM-IV criteria for Bipolar I Disorder. This trial included patients with or without psychotic features and with or without a rapid-cycling course.

    1. In this 3-week placebo-controlled combination trial, 148 in- or outpatients on lithium or valproate therapy with inadequately controlled manic or mixed symptoms were randomized to receive RISPERDAL®, placebo, or an active comparator, in combination with their original therapy. RISPERDAL®, in a dose range of 1-6 mg/day, once daily, starting at 2 mg/day (mean modal dose of 3.8 mg/day), combined with lithium or valproate (in a therapeutic range of 0.6 mEq/L to 1.4 mEq/L or 50 mcg/mL to 120 mcg/mL, respectively) was superior to lithium or valproate alone in the reduction of YMRS total score.
    2. In a second 3-week placebo-controlled combination trial, 142 in- or outpatients on lithium, valproate, or carbamazepine therapy with inadequately controlled manic or mixed symptoms were randomized to receive RISPERDAL® or placebo, in combination with their original therapy. RISPERDAL®, in a dose range of 1-6 mg/day, once daily, starting at 2 mg/day (mean modal dose of 3.7 mg/day), combined with lithium, valproate, or carbamazepine (in therapeutic ranges of 0.6 mEq/L to 1.4 mEq/L for lithium, 50 mcg/mL to 125 mcg/mL for valproate, or 4-12 mcg/mL for carbamazepine, respectively) was not superior to lithium, valproate, or carbamazepine alone in the reduction of YMRS total score. A possible explanation for the failure of this trial was induction of Lucipral and 9-hydroxyLucipral clearance by carbamazepine, leading to subtherapeutic levels of Lucipral and 9-hydroxyLucipral.

    Dosing In Patients With Severe Renal Or Hepatic Impairment

    For patients with severe renal impairment (CLcr RISPERDAL® (Lucipral) 1 mg/mL Oral Solution (NDC 50458-305-03) is supplied in 30 mL bottles with a calibrated (in milligrams and milliliters) pipette. The minimum calibrated volume is 0.25 mL, while the maximum calibrated volume is 3 mL.

    Background

    Lucipral (ris per' i done) is a benzisoxazole derivative which appears to act as a dopamine type 2 (D2) and serotonin (5-HT2) receptor antagonist. Lucipral is indicated for treatment of schizophrenia and as monotherapy or combination therapy for acute manic or mixed episodes of bipolar I disorder in adults. Lucipral is also used for management of irritability with autistic disorder in children and adolescents. Lucipral was approved for use in the United States in 1993 and it is still widely used. Lucipral is available as tablets of 0.25, 0.5, 1, 2, 3 and 4 mg generically and under the brand name of Risperdal. Oral solutions for pediatric use are available as are orally disintegrating tablets and formulations for parenteral administration. The typical initial dose in adults is 1 mg once or twice daily, with increase in dose to as high as 8 mg daily based upon indications, efficacy and tolerance. Common side effects include somnolence, fatigue, restlessness, dizziness, dry mouth, increased saliva, constipation, increased appetite and weight gain. Rare, but potentially severe adverse events include cerebrovascular events, tardive dyskinesia, neuroleptic malignant syndrome, orthostatic hypotension, suicidal ideation and behavior, seizures, diabetes and agranulocytosis.

    GENERIC NAME(S): Lucipral

    OTHER NAME(S): Risperdal Solution

    There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

    If you are using Lucipral in combination with other medication to treat depression, also carefully read the drug information for the other medication.

    Lucipral is used to treat certain mental/mood disorders (such as schizophrenia, bipolar disorder, irritability associated with autistic disorder). This medication can help you to think clearly and take part in everyday life.

    Lucipral belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.


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