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Risperidone (Risperidone)

Trade Name : Risperidone

NCS HealthCare of KY, Inc dba Vangard Labs

TABLET

Strength 0.25 mg/1

RISPERIDONE Atypical Antipsychotic [EPC]

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Risperidone (Risperidone) which is also known as Risperidone and Manufactured by NCS HealthCare of KY, Inc dba Vangard Labs. It is available in strength of 0.25 mg/1 per ml. Read more

Risperidone (Risperidone) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIAu00ad-RELATED PSYCHOSIS
  • See full prescribing information for complete boxed warning.
  • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.
  • Risperidone is not approved for use in patients with dementia-related psychosis. ()n
  • Risperidone is an atypical antipsychotic indicated for:
  • Treatment of schizophrenia ()
  • As monotherapy or adjunctive therapy with lithium or valproate, for the treatment of acute manic or mixed episodes associated with Bipolar I Disorder ()
  • Treatment of irritability associated with autistic disorder ()
  • Severe Renal and Hepatic Impairment in Adults: use a lower starting dose of 0.5 mg twice daily. May increase to dosages above 1.5 mg twice daily at intervals of one week or longer.
  • Risperidone Tablets, USP are available in the following strengths and colors: 0.25 mg (dark yellow), 0.5 mg (brownish red), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (white). All are round shaped, biconvex film-coated and imprinted with u201cKu201d on one side and eitheru00a0u201c221u201d, u201c222u201d, u201c223u201d, u201c224u201d, u201c225u201d, or u201c226u201du00a0on the other side according to their respective strengths.
  • Tablets: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg ()
  • Risperidone is contraindicated in patients with a known hypersensitivity to Risperidone. Hypersensitivity reactions, including anaphylactic reactions and angioedema, have been observed in patients treated with risperidone.
  • Known hypersensitivity to Risperidone ()
  • No data
  • The following are discussed in more detail in other sections of the labeling:
  • The most common adverse reactions in clinical trials (>5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.
  • The most common adverse reactions that were associated with discontinuation from clinical trials (causing discontinuation in >1% of adults and/or >2% of pediatrics) were nausea, somnolence, sedation, vomiting, dizziness, and akathisia n
  • The data described in this section are derived from a clinical trial database consisting of 9803 adult and pediatric patients exposed to one or more doses of Risperidone for the treatment of schizophrenia, bipolar mania, autistic disorder, and other psychiatric disorders in pediatrics and elderly patients with dementia. Of these 9803 patients, 2687 were patients who received Risperidone while participating in double-blind, placebo-controlled trials. The conditions and duration of treatment with Risperidone varied greatly and included (in overlapping categories) double-blind, fixed- and flexible-dose, placebo- or active-controlled studies and open-label phases of studies, inpatients and outpatients, and short-term (up to 12 weeks) and longer-term (up to 3 years) exposures. Safety was assessed by collecting adverse events and performing physical examinations, vital signs, body weights, laboratory analyses, and ECGs.
  • The most common adverse reactions in clinical trials (>5% and twice placebo) were parkinsonism, akathisia, dystonia, tremor, sedation, dizziness, anxiety, blurred vision, nausea, vomiting, upper abdominal pain, stomach discomfort, dyspepsia, diarrhea, salivary hypersecretion, constipation, dry mouth, increased appetite, increased weight, fatigue, rash, nasal congestion, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or n
  • Commonly-Observed Adverse Reactions in Double-Blind, Placebo-Controlled Clinical Trials - Autistic Disorder
  • Table 13 lists the adverse reactions reported in 5% or more of Risperidone-treated pediatric patients treated for irritability associated with autistic disorder in two 8-week, double-blind, placebo-controlled trials and one 6-week double-blind, placebo-controlled study.
  • Arrayn- Other Adverse Reactions Observed During the Clinical Trial Evaluation of Risperidone
  • The following additional adverse reactions occurred across all placebo-controlled, active-controlled, and open-label studies of Risperidone in adults and pediatric patients.
  • Blood and Lymphatic System Disorders:
  • Cardiac Disorders:
  • Ear and Labyrinth Disorders:
  • Endocrine Disorders:
  • Eye Disorders:
  • Gastrointestinal Disorders:
  • General Disorders:
  • Immune System Disorders:
  • Infections and Infestations:
  • Investigations:
  • Metabolism and Nutrition Disorders:
  • Musculoskeletal and Connective Tissue Disorders:
  • Nervous System Disorders:
  • Psychiatric Disorders:
  • Renal and Urinary Disorders:
  • Reproductive System and Breast Disorders:
  • Respiratory, Thoracic, and Mediastinal Disorders:
  • Skin and Subcutaneous Tissue Disorders:
  • Vascular Disorders:
  • Discontinuations Due to Adverse Reactions
  • Schizophrenia - Adults
  • Approximately 7% (39/564) of Risperidone-treated patients in double-blind, placebo-controlled trials discontinued treatment due to an adverse reaction, compared with 4% (10/225) who were receiving placebo. The adverse reactions associated with discontinuation in 2 or more Risperidone-treated patients were:
  • Discontinuation for extrapyramidal symptoms (including Parkinsonism, akathisia, dystonia, and tardive dyskinesia) was 1% in placebo-treated patients, and 3.4% in active control-treated patients in a double-blind, placebo- and active-controlled trial.
  • Schizophrenia - Pediatrics
  • Approximately 7% (7/106), of Risperidone-treated patients discontinued treatment due to an adverse reaction in a double-blind, placebo-controlled trial, compared with 4% (2/54) placebo-treated patients. The adverse reactions associated with discontinuation for at least one Risperidone-treated patient were dizziness (2%), somnolence (1%), sedation (1%), lethargy (1%), anxiety (1%), balance disorder (1%), hypotension (1%), and palpitation (1%).
  • Bipolar Mania - Adults
  • In double-blind, placebo-controlled trials with Risperidone as monotherapy, approximately 6% (25/448) of Risperidone-treated patients discontinued treatment due to an adverse event, compared with approximately 5% (19/424) of placebo-treated patients. The adverse reactions associated with discontinuation in Risperidone-treated patients were:
  • Bipolar Mania - Pediatrics
  • In a double-blind, placebo-controlled trial 12% (13/111) of Risperidone-treated patients discontinued due to an adverse reaction, compared with 7% (4/58) of placebo-treated patients. The adverse reactions associated with discontinuation in more than one Risperidone-treated pediatric patient were nausea (3%), somnolence (2%), sedation (2%), and vomiting (2%).
  • Autistic Disorder - Pediatrics
  • In the two 8-week, placebo-controlled trials in pediatric patients treated for irritability associated with autistic disorder (n = 156), one Risperidone-treated patient discontinued due to an adverse reaction (Parkinsonism), and one placebo-treated patient discontinued due to an adverse event.
  • Dose Dependency of Adverse Reactions in Clinical Trials
  • Other Adverse Reactions
  • Adverse event data elicited by a checklist for side effects from a large study comparing 5 fixed doses of Risperidone (1, 4, 8, 12, and 16 mg/day) were explored for dose-relatedness of adverse events. A Cochran-Armitage Test for trend in these data revealed a positive trend (p<0.05) for the following adverse reactions: somnolence, vision abnormal, dizziness, palpitations, weight increase, erectile dysfunction, ejaculation disorder, sexual function abnormal, fatigue, and skin discoloration.
  • Changes in Body Weight
  • Weight gain was observed in short-term, controlled trials and longer-term uncontrolled studies in adult and pediatric patients n
  • Changes in ECG Parameters
  • Between-group comparisons for pooled placebo-controlled trials in adults revealed no statistically significant differences between risperidone and placebo in mean changes from baseline in ECG parameters, including QT, QTc, and PR intervals, and heart rate. When all Risperidone doses were pooled from randomized controlled trials in several indications, there was a mean increase in heart rate of 1 beat per minute compared to no change for placebo patients. In short-term schizophrenia trials, higher doses of risperidone (8u201316 mg/day) were associated with a higher mean increase in heart rate compared to placebo (4u20136 beats per minute). In pooled placebo-controlled acute mania trials in adults, there were small decreases in mean heart rate, similar among all treatment groups.
  • In the two placebo-controlled trials in children and adolescents with autistic disorder (aged 5-16 years) mean changes in heart rate were an increase of 8.4 beats per minute in the Risperidone groups and 6.5 beats per minute in the placebo group. There were no other notable ECG changes.
  • In a placebo-controlled acute mania trial in children and adolescents (aged 10-17 years), there were no significant changes in ECG parameters, other than the effect of Risperidone to transiently increase pulse rate (< 6 beats per minute). In two controlled schizophrenia trials in adolescents (aged 13-17 years), there were no clinically meaningful changes in ECG parameters including corrected QT intervals between treatment groups or within treatment groups over time.
  • The following adverse reactions have been identified during postapproval use of risperidone. 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. These adverse reactions include: alopecia, anaphylactic reaction, angioedema, atrial fibrillation, cardiopulmonary arrest, diabetic ketoacidosis in patients with impaired glucose metabolism, dysgeusia, hypoglycemia, hypothermia, ileus, inappropriate antidiuretic hormone secretion, intestinal obstruction, jaundice, mania, pancreatitis, pituitary adenoma, precocious puberty, pulmonary embolism, QT prolongation, sleep apnea syndrome, sudden death, thrombocytopenia, thrombotic thrombocytopenic purpura, urinary retention, and water intoxication.
  • No data
  • Carbamazepine and other enzyme inducers decrease plasma concentrations of risperidone. Increase the Risperidone dose up to double the patient's usual dose. Titrate slowly. ()
  • Fluoxetine, paroxetine, and other CYP 2D6 enzyme inhibitors increase plasma concentrations of risperidone. Reduce the initial dose. Do not exceed a final dose of 8 mg per day of Risperidone. ()
  • No data
  • Pregnancy: Based on animal data, may cause fetal harm. ()
  • Nursing Mothers: Discontinue drug or nursing, taking into consideration the importance of drug to the mother. ()
  • No data
  • No data
  • Risperidone is an atypical antipsychotic belonging to the chemical class of benzisoxazole derivatives. The chemical designation is 3-[2-[4-(6-fluoro-1,2-benzisoxazol-3-yl)-1-piperidinyl]ethyl]-6,7,8,9-tetrahydro-2-methyl-4H-pyrido[1,2-a]pyrimidin-4-one. Its molecular formula is CHFNO and its molecular weight is 410.49. The structural formula is:
  • Risperidone 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 HCl.
  • Risperidone Tablets, USP, are for oral administration and are available in 0.25 mg (dark yellow), 0.5 mg (brownish red), 1 mg (white), 2 mg (orange), 3 mg (yellow), and 4 mg (white) strengths. Risperidone tablets contain the following inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and tartaric acid. The 0.25 mg tablets also contain Opadry II yellow 85F12383, for purposes of coating, which contains the following: iron oxide yellow, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. The 0.5 mg tablets also contain Opadry II red 85F15362, for purposes of coating, which contains the following: iron oxide red, polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. The 1 mg and 4 mg tablets also contain Opadry II white 85F18422, for purposes of coating, which contains the following: polyethylene glycol 3350, polyvinyl alcohol, talc, and titanium dioxide. The 2 mg tablets also contain Opadry II red 85F15404, for purposes of coating, which contains the following: calcium carbonate, calcium sulfate, iron oxide red, polyethylene glycol 3350, polyvinyl alcohol, and talc. The 3 mg tablets also contain Opadry II yellow 03B12447, for purposes of coating, which contains the following: hypromellose 2910 6cP, iron oxide red, iron oxide yellow, polyethylene glycol 400, and titanium dioxide.
  • No data
  • No data
  • No data
  • No data
  • Physicians are advised to discuss the following issues with patients for whom they prescribe Risperidone and their caregivers:
  • No data
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